September 2013
Introducing Misoprostol for the Management of Postpartum Hemorrhage in Zimbabwe
FINAL REPORT
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Zimbabwe Ministry of Health and Child Care Through the combined efforts of the government, organizations, communities and individuals, the Government of Zimbabwe aims to provide the highest possible level of health and quality of life for all its citizens, and to support their full participation in the socio-‐economic development of the country. This vision requires that every Zimbabwean have access to comprehensive and effective health services. The mission of the Zimbabwe Ministry of Health and Child Care (ZMoHCC) is to provide, administer, coordinate, promote and advocate for the provision of quality health services and care to Zimbabweans while maximizing the use of available resources.
Venture Strategies Innovations (VSI) VSI is a California-‐based nonprofit organization committed to improving women and girl's health in developing countries by creating access to effective and affordable technologies on a large scale. VSI connects women with life-‐saving medicines and services by engaging governments and partners to achieve regulatory approval of quality products and integrating them into national policies and practices.
Zimbabwe Ministry of Health and Child Care The Permanent Secretary Kaguvi Building, 4th Floor Central Avenue (Between 4th and 5th Street) Harare, Zimbabwe Telephone: +263-‐4-‐798537-‐60 Website: http://www.mohcw.gov.zw Venture Strategies Innovations 19200 Von Karman Avenue, Suite 400 Irvine, California 92612 USA Telephone: +1 949 622 5515 Website: www.vsinnovations.org
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Acknowledgements
Zimbabwe Ministry of Health and Child Care: Dr. Bernard Madzima, Director, Maternal and Child Health Ms. Margaret Nyandoro, Deputy Director, Director of Reproductive Health Principal Investigators: Dr. Tsungai Chipato, University of Zimbabwe Dr. Partson Zvandasara, University of Zimbabwe Dr. Velda Mushangwe, University of Zimbabwe VSI program team: Ndola Prata, Medical Director Nuriye Nalan Sahin Hodoglugil, Associate Medical Director Katharine Rivett, Program Manager Engeline Mawere, Regional Program Officer Molly Moran, Monitoring and Evaluation Specialist Alice Mpete, Nurse Administrator Allison Boiles, Communications Specialist This project could not have been completed without the contributions of the expert staff and colleagues at the Zimbabwe Ministry of Health and Child Care (ZMoHCC) and Venture Strategies Innovations (VSI), whose dedication to this operations research and invaluable contributions to its development led to its successful implementation. The operations research benefitted from the participation of the district officials, who contributed to supportive supervision and monitoring of operations research activities. The operations research also benefitted from the participation of community leaders and other community members who led and participated in community awareness activities. Tarra McNally, former VSI Country Representative, initiated the preliminary work on this operations research, and oversaw the activities until July 2013 and Melody Liu provided data management support until August 2013. Debbie Koh provided programmatic support until January 2013. Most importantly, VSI would like to thank all of the women who participated in this operations research.
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Executive Summary
The Zimbabwe Ministry of Health and Child Care (ZMoHCC) is committed to preventing maternal mortality and morbidity due to postpartum hemorrhage by ensuring that women have access to essential medicines at the time of delivery. Postpartum hemorrhage (PPH) is the most common cause of maternal mortality globally, leading to a woman’s death every seven minutes. In Zimbabwe, 14% of all maternal deaths are due to PPH. Ensuring prompt access to high-‐quality prevention and treatment of PPH for all women who deliver is an essential strategy to combat PPH-‐related morbidity and mortality and to make progress toward reaching Millennium Development Goal 5, the reduction of maternal mortality by three-‐quarters by 2015. Misoprostol, an effective, safe, low-‐cost and heat stable uterotonic in tablet form, is recommended by the World Health Organization (WHO) for both PPH prevention and treatment. The ZMoHCC aims to increase the availability of misoprostol throughout the country, with the ultimate goal of ensuring that every Zimbabwean woman has access to a uterotonic drug at the time of delivery. Based on recent evidence, the WHO identified the use of uterotonics as the key intervention in the active management of third stage of labor (AMTSL) package, and recommends that all women giving birth should be offered uterotonics for the prevention of PPH. Oxytocin is recommended as the uterotonic drug of choice, for the prevention and treatment of PPH, and misoprostol is recommended in settings where oxytocin is unavailable or cannot be safely used. Misoprostol is included in the WHO Model List of Essential Medicines for PPH prevention; as well as in the Priority Life-‐saving Medicines for Women and Children. Furthermore, it is included in the life-‐saving commodities list for PPH prevention by the United Nations’ Commission on Life-‐saving Commodities for Women and Children, whose goal is to increase the supply and use of essential commodities. The ZMoHCC and Venture Strategies Innovations (VSI), a U.S. based non-‐profit organization with operations in Harare, collaborated to conduct operations research (OR) to provide evidence on the feasibility and effectiveness of integrating misoprostol for PPH prevention and treatment for use at all levels of health facilities, when oxytocin is not available or cannot be safely used. The ZMoHCC’s and VSI’s joint OR was conducted in 68 health facilities in four districts of Zimbabwe. The OR sites included a) provincial hospitals, b) district hospitals, c) mission hospitals, d) rural hospitals and e) rural health centers (RHCs). A training of trainers was conducted for 40 senior doctors and nurses, followed by cascade trainings for 135 providers (primary care nurses, nurses and midwives) from all sites. Facility services from September 2011 to February 2012 were reviewed to provide a baseline facility assessment. Operations research was conducted from January 2013 to June 2013, during which misoprostol was available for women at these facilities. A baseline facility assessment was conducted at the 68 facilities prior to the introduction of misoprostol. Staff were interviewed and records for services provided from September 2011 to February 2012 were reviewed to collect information on the number of deliveries, PPH management practices, drug supplies, staffing, and facility infrastructure. During the OR, which refers to the period from January to June 2013 where misoprostol was made available at all facilities, PPH management practices were monitored for six months. Focus group discussions were held with Village Health Workers to identify a tool for measuring blood loss during home deliveries, and a community education campaign was conducted with their help on topics that included birth
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preparedness, the importance of a facility delivery, how to recognize signs of excessive bleeding, and the availability of drugs to prevent bleeding at facilities. These messages were incorporated into routine antenatal care (ANC) education sessions and community meetings, and presented on a poster that was displayed in key community sites. While oxytocin was available at over 90% of the facilities at the time of the baseline assessment, over half of the facilities (61%) reported having had a stock-‐out in the past six months. The mean duration of stock-‐outs was highest at RHCs (52 days) and mission hospitals (14 days). Only the provincial hospital did not report a stock-‐out in that period. A total of 8,258 deliveries were recorded at the OR facilities from January to June 2013. Of those, 259 were caesarean sections, and 528 women delivered at home or on the way to the hospital, which left a total of 7,400 vaginal deliveries at the facilities in the OR districts. Place of delivery was not recorded for 71 women. Over one-‐fourth (n=2,147) of vaginal facility deliveries for which facility level data was available took place at the RHCs, with another ten percent (n=730) at the rural hospitals. Almost one-‐third took place at a district hospital (n=2,308), while approximately 15% each took place at the mission hospitals (n=1,064) and the provincial hospital (n=1,134). Near universal uterotonic coverage for PPH prevention at facility deliveries (99%) was achieved during the OR. Misoprostol contributed to this high coverage. Of the women who delivered at a facility for whom district and uterotonic for PPH prevention were recorded, 88% received oxytocin, 9% received misoprostol, 3% received ergometrine and 1% received no uterotonic. In terms of uterotonic coverage for all births, the impact was greatest at the RHCs and rural hospitals where baseline coverage rates were lowest. At RHCs, coverage increased from 81% to 97%, while at rural hospitals, it rose from 78% to 99%. Where uterotonic coverage was high at baseline (for mission, district and provincial hospitals at 99% to 100%), the coverage was unchanged. The use of misoprostol for PPH prevention during the OR was higher at the RHCs and rural hospitals than at the other types of facilities. Over the six months, at RHCs, 21% of maternity cases that were vaginal deliveries and for whom uterotonic data was available were given misoprostol for PPH prevention. At rural hospitals, the corresponding figure was 16%. Training and instruction on dose and route of administration were given to health providers during the OR training sessions, at supervisory visits, and via misoprostol regimen cards. Provider adherence to instructions was high. A correct regimen of 600mcg orally was administered to all women with a vaginal delivery for whom data was recorded. A total of 259 PPH cases among women with vaginal deliveries, for whom data was available on treatment and facility level, were recorded at the OR sites from January to June 2013. Overall, 10% were treated with misoprostol. Misoprostol played the greatest role in PPH treatment at the RHCs and rural hospitals. Over 40% of the total number of PPH cases were treated at these two levels of facilities. At RHCs, 19% (n=15) of the PPH cases were treated with misoprostol; over one-‐fourth (27%; n=6) of the PPH cases at the rural hospitals were treated with misoprostol. The availability of misoprostol played a significant role in the treatment of women suffering from PPH, particularly women living in rural areas who would have had more difficulty reaching a referral hospital in an urban area in a timely fashion.
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The OR provides strong evidence of the role that misoprostol can play in the management of PPH, particularly at RHCs and at rural hospitals, where maintaining a regular supply of oxytocin under optimal conditions can present greater challenges. Providers at these lower-‐level facilities were able to correctly administer misoprostol for PPH prevention and treatment. The addition of misoprostol expands uterotonic coverage, especially to more rural women, reducing the risk of PPH. Ultimately, the burden on referral hospitals of providing PPH treatment to large numbers of women will be reduced. Most importantly, misoprostol can contribute to preventing the unnecessary loss of women’s lives from postpartum hemorrhage. The following recommendations on opportunities to strengthen PPH management services in Zimbabwe are based on the results of the OR and lessons learned by the ZMoHCC and providers during project implementation. Consequently, a number of the recommendations encompass issues related to scaling up PPH management services in Zimbabwe that are not specifically tied to data from the OR.
1. Integrate misoprostol as an additional uterotonic for PPH management at all health facilities that conduct deliveries in Zimbabwe.
2. Ensure that RHCs and rural hospitals can manage PPH in order to decrease costs, both to women and to the health system, of managing complicated PPH cases at higher level facilities.
3. Disseminate and implement the BEmOC guidelines, to ensure that providers can correctly implement PPH management and referrals according to protocols.
4. Provide training and job aids on the use of misoprostol for PPH management, following the service delivery protocols, to all maternity service providers, including physicians, midwives, nurses, primary care nurses, and nurse aides.
5. Incorporate training on misoprostol in PPH management into the pre-‐service curricula of the medical, nursing, and midwifery schools.
6. Increase community awareness through appropriate interventions to ensure uterotonic coverage for all women giving birth.
7. Register misoprostol for obstetric uses in Zimbabwe, as an important first step to ensure the ongoing supply of a high quality product.
8. Adopt and implement procedures for the ordering and distribution of misoprostol to ensure its availability for PPH management in all levels of health facilities, with special attention to ensuring stocks in rural facilities where the need is most often unmet
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Acronyms and Local Terms
AMTSL Active Management of the Third Stage of Labor
ANC Antenatal Care
IEC Information, education and communication
M&E Monitoring and Evaluation
MOH Ministry of Health
MTWG Misoprostol Technical Working Group
PCN Primary Care Nurse
PPH Postpartum hemorrhage
RHC Rural Health Center
TOT Training of trainers
VHW Village Health Workers
VSI Venture Strategies Innovations
WHO World Health Organization
ZMoHCC Zimbabwe Ministry of Health and Child Care
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Table of Contents
Acknowledgements ................................................................................................................................ ii
Executive Summary ............................................................................................................................... iii
Acronyms and Local Terms .................................................................................................................... vi
Table of Contents ................................................................................................................................. vii
List of Boxes, Tables and Figures ......................................................................................................... viii
1. Introduction ....................................................................................................................................... 1
2. Goal and Objectives ........................................................................................................................... 2
3. Background ........................................................................................................................................ 3 3.1 Maternal health services in Zimbabwe ....................................................................................... 3 3.2 Maternal health and postpartum hemorrhage in Zimbabwe ..................................................... 4 3.3 Misoprostol for the management of postpartum hemorrhage .................................................. 5 3.4 Policies and regulations enabling the use of misoprostol in Zimbabwe ..................................... 6 3.5 Rationale for introducing misoprostol for PPH prevention and treatment at all levels of health facilities ............................................................................................................................................. 6
4. Operations Research Components .................................................................................................... 6
5. Methods ............................................................................................................................................ 7 5.1 Participating districts ................................................................................................................... 7 5.2 Participating facilities .................................................................................................................. 8 5.3 Service delivery and referral protocols for PPH prevention and treatment ................................ 9 5.4 Health provider training ............................................................................................................ 11 5.5 Generating community awareness ........................................................................................... 12 5.6 Monitoring and evaluation of the operations research ............................................................ 13 5.7 Data collection tools, data management and data analysis ...................................................... 14
6. Operations Research Implementation Timeline .............................................................................. 16
7. Results ............................................................................................................................................. 16 7.1 Findings from baseline facility assessment ............................................................................... 17 7.2 Operations research findings: PPH prevention ......................................................................... 19 7.3 Operations research findings: PPH cases .................................................................................. 24 7.4 Maternal deaths ........................................................................................................................ 26 7.5 Community awareness .............................................................................................................. 26 7.6 Provider perspectives on introduction of misoprostol for PPH prevention and treatment ...... 29
8. Discussion and Conclusions ............................................................................................................. 31
9. Programmatic Recommendations ................................................................................................... 34
10. References ..................................................................................................................................... 37 Appendix A: MIsoprostol Regimens, Pocket Reference for Clinicians ................................................. 39 Appendix B: Contraceptive Guide, Pocket Reference for Clinicians .................................................... 40 Appendix C: Uterotonics for PPH Prevention, Pocket Reference for Clinicians ................................... 41 Appendix D: Poster for PPH Prevention .............................................................................................. 42
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List of Boxes, Tables and Figures
Box 1: WHO 2012 recommendations for PPH prevention and treatment ............................................ 2 Box 2: Perspectives from providers ..................................................................................................... 31 Table 1: Provider cadres involved in delivering maternal health services ............................................. 4 Table 2: Socio-‐demographic characteristics of participating districts ................................................... 7 Table 3: Description of levels of health facilities, services provided and staffing ................................. 9 Table 4: Distribution of health facilities which participated in operations research by district ............ 9 Table 5: Providers trained for the operations research, by cadre and district .................................... 12 Table 6: Distribution of deliveries according to type and place of delivery by district ........................ 17 Table 7: Some characteristics of the OR facilities according to facility level at baseline ..................... 18 Table 8: Average number of staff according to cadre and facility level at baseline ............................ 18 Table 9: Oxytocin availability and stock outs according to facility level at baseline ........................... 19 Table 10: Uterotonic used for PPH prevention among women who had a vaginal delivery at a facility
according to district .................................................................................................................... 20 Table 11: Uterotonic used for PPH prevention among women who had a vaginal delivery at a facility
according to facility level ............................................................................................................ 21 Table 12: Reported PPH cases among women with facility or home vaginal deliveries according to
facility level and type of uterotonic used for treatment of PPH ................................................. 25 Table 13: Comparison of PPH cases recorded for all facility deliveries, over 6 months, at baseline and
during the OR, by the level of facility .......................................................................................... 26 Table 14: Socio-‐demographic characteristics of village health workers who participated in FGDs .... 27 Table 15: Selected characteristics of providers who responded to the survey ................................... 30
Figure 1: Estimates of the maternal mortality ratio in Zimbabwe between 1994 and 2011 ................. 4 Figure 2: Health facilities that participated in the operations research in the four districts in
Zimbabwe ..................................................................................................................................... 8 Figure 3: Service delivery and referral protocols for PPH prevention and treatment, based on the
level of facility and availability of uterotonics ............................................................................ 11 Figure 4: Data flow and management ................................................................................................. 14 Figure 5: Flow chart illustrating women delivering in the four operations research districts, their
place of delivery and type of delivery ......................................................................................... 17 Figure 6: Flow chart illustrating women delivering at a facility during the operations research and the
uterotonic they received for PPH prevention ............................................................................. 19 Figure 7: Proportion of facility deliveries receiving a uterotonic for PPH prevention, at baseline and
during the operations research ................................................................................................... 21 Figure 8: Total uterotonic coverage at facility deliveries during the operations research .................. 22 Figure 9: Trends in cumulative number of women receiving misoprostol for PPH prevention
according to facility level ............................................................................................................ 22 Figure 10: Trends in the uterotonic used for PPH prevention for vaginal deliveries at rural health
centers ........................................................................................................................................ 23 Figure 11: Trends in the uterotonic used for PPH prevention for vaginal deliveries at rural hospitals 23 Figure 12: Flow chart illustrating location of delivery, type of delivery and the number of women
who were reported to develop PPH ........................................................................................... 24 Figure 13: Cumulative number of people reached with community awareness messages, by
facilitator and month .................................................................................................................. 29 Figure 14: Provider views on misoprostol training, use and access ................................................... 30
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1. Introduction
The Zimbabwe Ministry of Health and Child Care (ZMoHCC) is deeply committed to improving maternal health in Zimbabwe and to increasing access to essential drugs and services. With a population of 12.4 million, Zimbabwe has been facing severe economic challenges, which have adversely affected maternal health outcomes (United Nations Development Program and the Government of Zimbabwe, 2010). From 2000 to 20008, Zimbabwe’s GDP shrunk by an estimated 40% (United Nations Development Program and Government of Zimbabwe, 2010). The proportion of the population living below the Total Consumption Poverty Line (TCPL), which is the minimum expenditure needed to buy a basic basket of items for subsistence, was 72% in 2003 and this percentage is estimated to have increased as a result of the economic crisis of 2008 (United Nations Development Program and the Government of Zimbabwe, 2010). As the economy has worsened, so has access to and delivery of maternal health services, resulting in a high maternal mortality ratio (MMR). Most recent estimates report the MMR at 960 maternal deaths per 100,000 live births (Zimbabwe National Statistics Agency (ZIMSTAT) and ICF International, 2012). Based on the 1994 MMR estimate of 283 per 100,000 live births, there was a 300% increase over fifteen years (Central Statistical Office [Zimbabwe] and Macro International Inc., 1995). The Zimbabwe Ministry of Health and Child Care’s commitment to improving maternal health in Zimbabwe is outlined clearly in their National Maternal and Neonatal Health Roadmap 2007-‐2015, where they lay out evidence-‐based strategies for reversing the decline in maternal health, a key pillar of which is the procurement and distribution of essential maternal health commodities (ZMoHCW, 2007a). Globally, postpartum hemorrhage (PPH) is the most common cause of maternal deaths; one woman dies from PPH every seven minutes (Potts et al., 2010). PPH can also cause long-‐term severe morbidities, including severe anemia (Abou-‐Zahr, 2003). In Zimbabwe, PPH is the primary obstetric cause of maternal death. According to the 2007 Maternal and Perinatal Mortality Study, PPH accounted for 14% of maternal deaths (ZMoHCW, 2007b). The use of uterotonic drugs in the active management of the third stage of labor (AMTSL) is the recommended strategy to reduce blood loss along with additional treatments or interventions. AMTSL has traditionally included: administration of a uterotonic drug, controlled cord traction, and uterine massage. The World Health Organization (WHO) estimates that the correct use of ATMTSL would prevent 60% of PPH cases (WHO, 2006). Recent evidence suggests that within the AMSTL package, it is the administration of a uterotonic drug that has the greatest effect on preventing PPH (Aflaifel and Weeks, 2012). Oxytocin is recommended by the WHO as the first-‐line uterotonic drug for PPH prevention and treatment (WHO, 2012). This recommendation has been included in the recently revised Basic Emergency Obstetric and Newborn Care Training Manuals (Zimbabwe Ministry of Health and Child Welfare, 2012). However, ensuring that all women delivering in a health facility have access to oxytocin has been a challenge, both globally and in Zimbabwe, because of frequent stock-‐outs and quality issues related in part to the cold chain requirements (UN Commission Implementation Planning Meeting, 2012). To ensure the availability of a recommended uterotonic for all women seeking maternity care at government health facilities, the ZMoHCC aimed to make misoprostol available for PPH prevention and treatment, to be used when oxytocin cannot be administered. Registering the drug for PPH prevention and treatment in Zimbabwe will allow for misoprostol to be marketed for these indications and will ensure that an insert with proper dosages and instructions
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for providers and pharmacists is included with the drug, as well as ensure that product quality is monitored by a drug regulatory board. The Medical Research Council of Zimbabwe (MRCZ) requested that operations research (OR) be conducted prior to drug registration, to demonstrate the feasibility and effectiveness of introducing misoprostol for PPH prevention and treatment. In response to this request, the Zimbabwe Ministry of Health and Child Care (ZMoHCC) collaborated with Venture Strategies Innovations (VSI), a US-‐based nonprofit organization, to conduct OR to support the introduction of misoprostol as an additional uterotonic for the management of postpartum hemorrhage at all health facility levels. Box 1: WHO 2012 recommendations for PPH prevention and treatment
This report describes the OR on the introduction of misoprostol by the ZMoHCC conducted with the support of VSI in four districts of Zimbabwe.
2. Goal and Objectives
The main goal of this OR was to assess the feasibility and effectiveness of introducing misoprostol for the prevention and treatment of PPH at all levels of the health care system. The specific objectives were:
• Determine whether introducing misoprostol as an additional uterotonic available at all health facility levels increases the proportion of women with facility-‐based vaginal births who receive a uterotonic from skilled providers immediately after delivery;
• Assess the acceptability of the introduction of misoprostol for the management of PPH among health providers at all levels of health facilities;
• Identify a culturally-‐appropriate method for measuring postpartum blood loss, in order for communities to assess when a woman has lost too much blood after delivery, is facing a life-‐threatening emergency, and requires immediate referral to a health facility;
• Generate evidence to inform future policy on the use of misoprostol for PPH management and provide guidance on scaling up misoprostol use for PPH management at the national level.
PPH Prevention:
1. The use of uterotonics for the prevention of PPH during the third stage of labor is recommended for all births.
2. Oxytocin (10 IU, IV/IM) is the recommended uterotonic drug for the prevention of PPH. 3. In settings where oxytocin is unavailable, the use of other injectable uterotonics (e.g.
ergometrine/methylergometrine or the fixed drug combination of oxytocin and ergometrine) or oral misoprostol (600 mcg) is recommended.
4. In settings where skilled birth attendants are not present and oxytocin is unavailable, the administration of misoprostol (600 mcg PO) by community health care workers and lay health workers is recommended for the prevention of PPH.
PPH Treatment: 1. Intravenous oxytocin is the recommended uterotonic drug for the treatment of PPH. 2. If intravenous oxytocin is unavailable, or if the bleeding does not respond to oxytocin,
the use of intravenous ergometrine, oxytocin-‐ergometrine fixed dose, or a prostaglandin drug (including sublingual misoprostol, 800 mcg) is recommended.
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3. Background
3.1 MATERNAL HEALTH SERVICES IN ZIMBABWE Ensuring that high quality maternal health services are available at all levels of the health care system is a key goal of the ZMoHCC. About two thirds (65%) of Zimbabwean births occur in health facilities, primarily in public sector facilities. Home births are three times more common in rural areas (42%) than in urban areas (14%) (Zimbabwe National Statistics Agency (ZIMSTAT) and ICF International, 2012). To encourage facility deliveries and ensure that women living in rural areas have a safe place to stay in the weeks before giving birth, UNFPA has been working with the ZMoHCC to refurbish 105 maternity waiting homes (UNFPA, 2013). However, even when women reach a health facility for delivery, supply-‐side barriers affect timely provision of quality emergency obstetric care resulting in key constraints to reducing maternal mortality (Knight, 2013). As of 2010 80% of public sector midwifery posts were vacant in Zimbabwe (United Nations Development Program and Government of Zimbabwe, 2010). Additionally, the National Pharmaceutical Company (NatPharm) of Zimbabwe, which is the national drug procurement and distribution body for all government hospitals and clinics, has experienced a sharp decrease in funding over the past two decades, leading to a lack of procurement of essential pharmaceuticals (United Nations Industrial Development Organization, 2011). The key cadres of health providers who are responsible for delivering maternal health services are summarized in Table 1 below. It is noteworthy that the ZMoHCC and Zimbabwe Nursing Council have trained over 4,000 Primary Care Nurses (PCNs) since 2004, in large part, to ensure that basic emergency obstetric and neonatal care (BEmONC) is available at rural health centers (RHCs). Over 95% of PCN posts are currently filled (Taylor, Gomez et al., 2010). Pre-‐service training for PCNs includes a six-‐week rotation in obstetrics; however, the lack of supervision and poor working conditions mean PCNs graduate and function with limited experience and confidence (Taylor et al., 2010). Human resources for health remain a challenge in Zimbabwe, and according to the National Health Strategy: 2009 to 2013, in public sector facilities doctor vacancy is 69%, midwife vacancy is over 78% and nursing tutor vacancy is 62% (ZMoHCW, 2009). Given this shortage of doctors and midwives, ensuring that PCNs are able to effectively deliver basic emergency obstetric and neonatal care (BEmONC) is a strategic goal of the ZMoHCC.
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Table 1: Provider cadres involved in delivering maternal health services*
Title Training and current practice
Medical Doctors General practitioners provide maternal health services at the district level. General Registered Nurses (GRNs) GRNs have three years of training prior to service.
Midwives Midwives have one additional year training post nursing diploma. Midwives formerly staffed rural health centers and district hospitals, but most midwife positions are now vacant.
Clinical Officers GRN /midwives who receive 18 months additional training including surgery such as cesarean sections. Ideally posted at district hospitals, but there are very few occupied posts at this time.
Primary Care Nurses (PCNs)
This second-‐level nursing cadre was revived and renamed in 2003 to fill the staffing gap at the primary health care level. PCNs are professional nurses who are trained for 18 months to provide ANC, normal delivery care, identification and referral of obstetric complications, postnatal care, family planning and integrated management of childhood illness. Each RHC is staffed by 1-‐2 PCNs.
Nurse Aides Nurse aides were general hands who were promoted to the position of nurse aide. They received training from a GRN or PCN on the job. Nurse aides are not allowed to administer injections.
*Adapted from Taylor et al. (2010). Maternal and Child Health Integrated Program: Zimbabwe Situation.
3.2 MATERNAL HEALTH AND POSTPARTUM HEMORRHAGE IN ZIMBABWE The impact of political, economic, and environmental factors on maternal health in Zimbabwe has been particularly notable, and Zimbabwe’s MMR has increased significantly since 1994 (Figure 1). According to Millennium Development Goal (MDG) 5, which aims to reduce the maternal mortality ratio by 75% by 2015, Zimbabwe’s target is to reach an MMR of 174 (United Nations Development Program and Government of Zimbabwe, 2010). This is considered to be unattainable based on recent trends and the current MMR of 960.
Figure 1: Estimates of the maternal mortality ratio in Zimbabwe between 1994 and 2011
¹Central Statistical Office [Zimbabwe] and Macro International Inc. 1995. Zimbabwe Demographic and Health Survey, 1994. Calverton, Maryland: Central Statistical Office and Macro International Inc. ²Central Statistical Office [Zimbabwe] and Macro International Inc. 2000. Zimbabwe Demographic and Health Survey 1999. Calverton, Maryland: Central Statistical Office and Macro International Inc. ³WHO/UNICEF/UNFPA and The World Bank. Maternal mortality in 2005. Estimates developed by WHO, UNICEF, UNFPA and the World Bank. Geneva: World Health Organisation; 2007. ⁴Central Statistical Office (CSO) [Zimbabwe] and Macro International Inc. 2007. Zimbabwe Demographic and Health Survey 2005-‐06. Calverton, Maryland: CSO and Macro International Inc. ⁵Zimbabwe Ministry of Health and Child Welfare. Maternal and Perinatal Mortality Study. Ministry of Health and Child Welfare [Zimbabwe], 2007. ⁶Zimbabwe National Statistics Agency (ZIMSTAT) and ICF International. 2012. Zimbabwe Demographic and Health Survey 2010-‐11. Calverton, Maryland: ZIMSTAT and ICF International Inc.
283
695
880
555
725
960
0
200
400
600
800
1000
1200
1994¹ 1999² 2005³ �2005-‐06⁴ 2007⁵ �2010-‐11⁶
1994¹ 1999² 2005³ �2005-‐06⁴
2007⁵ �2010-‐11⁶
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The primary obstetric causes of maternal death in Zimbabwe, as reported in the 2007 Maternal and Perinatal Mortality Study, were PPH (18.6%), pregnancy induced hypertension/eclampsia (15.7%), sepsis (12.3%), and abortion-‐related causes (2.6%) (ZMoHCW, 2007b). Active Management of the Third Staqe of Labor (AMTSL) shortens the third stage of labor, and is an important preventive measure for PPH (Gulmezoglu et al., 2012). According to the most recent evidence on the AMTSL, WHO recommends the use of uterotonics as the main intervention within the active management of third stage of labor package (WHO, 2012). As most deaths from PPH occur in the first 24 hours after birth (WHO, 2012), it is very important that both preventative and therapeutic measures are available during labor and delivery to prevent mortality due to PPH. Oxytocin, the recommended uterotonic drug to prevent and treat PPH, is an injectable uterotonic and requires a reliable cold chain. It is reported that oxytocin loses effectiveness after three months of being stored at temperatures higher than 30 degrees Celcius (Wilson et al., 2012). In the case of Zimbabwe, the stock outs in facilities, as well as lack of a continuous and reliable cold chain system specifically for oxytocin, could possibly be interfering with both the availability and efficacy of oxytocin. It is reported that providers at lower-‐level facilities often use their vaccine refrigerators to store their oxytocin. In addition, even when oxytocin is refrigerated, the unreliable power supply, and frequent power shortages experienced in health facilities (World Bank, 2012) threaten its stability, thus affecting its efficacy. Providers will not know if their oxytocin is still potent without the time-‐temperature indicator (TTI) on the product package or if the storage temperature has not been carefully tracked (PATH, 2010). Further, oxytocin is administered using a disposable syringe and needle, which necessitates that the provider attending the delivery be trained and authorized to administer injections. However, the reality is that when PCNs are not present at the facility, nurse aids -‐ who are not authorized to provide injections – may be the only trained providers available to attend deliveries. The introduction of misoprostol can help to mitigate these challenges.
3.3 MISOPROSTOL FOR THE MANAGEMENT OF POSTPARTUM HEMORRHAGE Where oxytocin is unavailable or cannot be safely used because of lack of refrigeration, as there is a lack of essential supplies such as syringes, or trained personnel to administer injections, misoprostol can be used effectively for the management of PPH (Geller et al., 2006). Misoprostol is a prostaglandin analogue in tablet form that has been recognized by the international community for its potential to reduce PPH in resource-‐poor settings due to its relative efficacy, ease of administration, and stability in field conditions (Derman et al., 2006; Alfirevic et al., 2007). It has been shown to be effective in reducing the risk of PPH by between 24% (Mobeen et al., 2011) and 47% (Derman et al., 2006). Based on recent evidence, the WHO identified the use of uterotonics as the key intervention within the AMTSL package, and recommends that all women giving birth should be offered uterotonics for the prevention of PPH (WHO, 2012). Oxytocin is recommended as the uterotonic drug of choice for the prevention and treatment of PPH, and misoprostol is recommended in settings where oxytocin is unavailable or cannot be safely used (WHO, 2012). Misoprostol is included in the WHO Model List of Essential Medicines (WHO, 2011b) for PPH prevention; as well as in the Priority Life-‐saving Medicines for Women and Children (WHO, 2011a). Furthermore, it is included in the life-‐saving commodities list for PPH prevention by the United Nations’ Commission on Life-‐saving Commodities for Women and Children (UN Commissioner’s Report, 2012), whose goal is to increase the supply and use of essential commodities. In addition, the World Health Organization recommends that if oxytocin is
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unavailable, or if the bleeding does not respond to oxytocin, 800 mcg sublingual misoprostol is a recommended treatment regimen (WHO, 2012).
3.4 POLICIES AND REGULATIONS ENABLING THE USE OF MISOPROSTOL IN ZIMBABWE As a result of the strong evidence on the safety and efficacy of misoprostol for PPH management in numerous countries and the effectiveness of misoprostol in resource-‐constrained settings, the ZMoHCC supports expanding access to misoprostol in Zimbabwe. Led by the ZMoHCC, a Misoprostol Technical Working Group (MTWG) was formed in January 2011 to include the Zimbabwe Confederation of Midwives (ZICOM) and the Zimbabwe Society of Obstetricians and Gynaecologists (ZSOG). The primary purpose of the MTWG was to provide input on the OR protocols. Through the work of the MTWG hosted within the ZMoHCC, misoprostol is included in the 2011 Essential Drugs List of Zimbabwe (EDLIZ) for obstetric indications. The maternal health indications for which misoprostol is included in the EDLIZ are: prevention and treatment of PPH, induction of labor, pregnancy termination, intrauterine fetal death, missed abortion, and treatment of incomplete abortion and miscarriage (The National Medicine and Therapeutics Policy Advisory Committee [NMTPAC], ZMoHCW, et al., 2011). The most up-‐to-‐date information on the use of misoprostol for PPH prevention and treatment is included in the most recently revised Basic Emergency Obstetric and Newborn Care Training Manuals (ZMoHCW, 2012). With support from the ZMoHCC, Pharmaceutical and Chemical Distributors, a Harare-‐based distributor, submitted an amendment to the Medicines Control Authority of Zimbabwe (MCAZ) to include all obstetric indications in the current registered product, Cipla’s Misoprost 200®.
3.5 RATIONALE FOR INTRODUCING MISOPROSTOL FOR PPH PREVENTION AND TREATMENT AT ALL LEVELS OF HEALTH FACILITIES Given the benefits and additional uterotonic coverage misoprostol can bring through addressing some of the shortcomings discussed above, the OR integrated misoprostol at all levels of health facilities for the management of PPH. Making misoprostol available at all facilities to be used by providers trained in its use was hypothesized to increase overall uterotonic coverage for PPH prevention, as well as to provide an additional option for treatment of PPH where oxytocin is not available.
4. Operations Research Components
In January 2013, the ZMoHCC, with the support of VSI, launched the OR to introduce misoprostol for the management of PPH at all levels of the healthcare system. The OR included four main components:
1) Development of protocols for PPH management service delivery: Service delivery and referral protocols were developed by the MTWG that outlined the uterotonics to be used -‐ including misoprostol-‐ along with the steps and referral chains for PPH prevention and treatment.
2) Training of service providers: Two providers from each of the OR facilities that attend deliveries were trained on the use of misoprostol for PPH prevention and treatment and the new service delivery protocols. The two providers were tasked with sharing the knowledge and information they received with all other providers attending deliveries at their facilities, referred to as “feedback” training. This type of training is commonly used in Zimbabwe.
7
3) Community awareness: A community awareness campaign was conducted by health providers at the facilities, village health workers (VHWs), and OR staff to provide information on the importance of birth preparedness and delivering in a facility, the availability of drugs that can prevent bleeding at facilities, safe delivery practices and how to recognize excessive bleeding at delivery.
4) Monitoring and evaluation: Data were collected on facility deliveries for uterotonic use and coverage, PPH treatment, referrals, as well as community awareness activities, and provider perspectives on the introduction of misoprostol. Supportive supervision was conducted throughout the OR to identify and resolve challenges with program implementation and data collection.
5. Methods
5.1 PARTICIPATING DISTRICTS The Misoprostol Technical Working Group (MTWG) identified four of Zimbabwe’s 59 districts, located in three of the country’s eight provinces, for participation in the OR. These districts were: Mutare, Chimanimani, Matobo and Umguza. Mutare and Chimanimani are located in Manicaland Province in eastern Zimbabwe. Umguza and Matobo districts, both of which are in southern Zimbabwe, are located in Matebeleland North and Matebeleland South Provinces, respectively (Figure 2). The districts were purposively selected by the MTWG with the aim of reflecting the country’s diversity in terms of geographical location, resources, and political affiliation. All of the four districts had high MMRs and relatively poor obstetric services, thus making the OR relevant. Capturing this diversity was intended to help identify the different challenges of introducing misoprostol across a variety of settings and provide more comprehensive insight into how the ZMoHCC could scale up the introduction of misoprostol for PPH management nationally. Socio-‐demographic characteristics of participating districts are presented in Table 2.
Table 2: Socio-‐demographic characteristics of participating districts
Mutare Chimanimani Umguza Matobo Population 434,379 136,055 81,781 110,266 Total fertility rate(a) 4.8 4.8 4.1 4.2 Percentage Delivered in Health Facility (a) 60.9% 60.9% 63.5% 69.3% Median Years of Education Completed (Women) (a) 8.7 8.7 7.2 8.3 Median Years of Education Completed (Men) (a) 9.8 9.8 7.1 7.9 Literacy (Women) (a) 94.4% 94.4% 87.9% 92.9% Literacy (Men) (a) 96.0% 96.0% 83.5% 91.5% Health Insurance Coverage (Women) (a) 4.7% 4.7% 3.0% 4.7% Health Insurance Coverage (Men) (a) 9.6% 9.6% 4.2% 7.4% Wealth quintile(a)
Lowest 17.5% 17.5% 61.0% 26.8% Second 21.5% 21.5% 13.5% 23.2% Middle 29.2% 29.2% 8.6% 26.7% Fourth 20.4% 20.4% 8.5% 17.3% Highest 11.3% 11.3% 8.3% 6.1%
(a) Zimbabwe National Statistics Agency (ZIMSTAT) and ICF International, 2012
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Figure 2: Health facilities that participated in the operations research in the four districts in Zimbabwe
5.2 PARTICIPATING FACILITIES The health care system in Zimbabwe operates on four levels, from the primary to the specialist/referral level: rural health center (RHC), district-‐level hospital, provincial hospital, and central hospital with some variations (clinics, maternity hospitals, mission hospitals, and rural hospitals) depending on the district (Table 3). The referral system is hierarchical with increasingly complex cases referred to higher-‐level facilities. In urban catchment areas (e.g., Harare, Bulawayo), RHCs can refer patients directly to the central hospitals.
MUTARE DISTRICT!Pop. = 434,379!
Rural Health Center = 20!Rural/Mission Hospital = 3!
District Hospital = 1!Provincial Hospital = 1!
CHIMANIMANI DISTRICT!Pop. = 136,055!
Rural Health Center = 15!Rural/Mission Hospital = 5!
District Hospital = 0!Provincial Hospital = 0!
MATOBO DISTRICT!Pop. = 110,266!
Rural Health Center = 8!Rural/Mission Hospital = 4!
District Hospital = 1!Provincial Hospital = 0!
UMGUZA DISTRICT !Pop. = 81,781!
Rural Health Center = 8!Rural/Mission Hospital = 1!
District Hospital = 1 Provincial Hospital = 0!
HARARE!
9
Table 3: Description of levels of health facilities, services provided and staffing*
Level of facility Services Provided Staffing
Central Hospital Specialty services and management of complicated cases
• Obstetricians, gynecologists, neonatologists, pediatricians, pediatric surgeons
• Midwives, General Registered Nurses (GRNs) and State Certified Maternity Nurses (SCMNs)
Provincial hospitals Management of complicated cases
• Obstetricians, gynecologists, neonatologists, pediatricians, anesthetists
• Midwives, GRNs and SCMNs
District /mission hospitals
• Basic Emergency Obstetric and Neonatal Care (BEmONC) and Comprehensive Emergency Obstetric and Neonatal Care (CEmONC)
• Long-‐acting and permanent contraceptive methods
• Supervision of lower levels: rural health centers and Village Health Workers
• District medical officer, MDs • Clinical officers • Midwives, GRNs, nurse anesthetists • Pharmacists
Clinics/Rural Health Centers
• Antenatal care (ANC) • Basic delivery care including ENC; Basic
Emergency Obstetric and Neonatal Care (BEmONC)
• Family planning
• Sometimes a midwife or GRN • SCMN/SCN • Primary Care Nurses • Nurse aides
Village Health Workers
• Immunization; health promotion • Family planning: counseling, resupplies
and referrals
1 VHW per 100 families
*Adapted from: Taylor, P., P. Gomez, et al. (2010). Maternal and Child Health Integrated Program: Zimbabwe Situation. With the exception of Mutare district, all health facilities in the four districts that conducted deliveries participated in the OR, which added up to a total of 68 facilities (Table 4). In Mutare District, only 25 of the 50 eligible facilities could participate due to budgetary constraints, which limited monitoring and supportive supervision activities to 25 facilities per district. The 25 facilities that participated from Mutare district were selected by district officials to include a mixture of facility levels and rural and urban facilities. The three urban health centers from Mutare that participated in the OR are grouped with the RHCs for the purposes of analysis in this report.
Table 4: Distribution of health facilities which participated in operations research by district
Facility Level Participating District
Mutare Chimanimani Umguza Matobo Total Rural Health Center* 20 15 8 8 51 Rural/Mission Hospital 3 5 1 4 13 District Hospital 1 0 1 1 3 Provincial Hospital 1 0 0 0 1 TOTAL 25 20 10 13 68 *Three urban health centers in Mutare District are included in the “Rural Health Center” category
5.3 SERVICE DELIVERY AND REFERRAL PROTOCOLS FOR PPH PREVENTION AND TREATMENT 5.3.1 PPH Prevention Service Delivery and Referral Protocol Women who delivered at a health facility were given oxytocin (10 IU, IM) as the first-‐line uterotonic for PPH prevention; misoprostol (600 mcg, oral) was given if oxytocin was not available (Figure 3).
10
Women were instructed during ANC, in both individual and group sessions, to go to the nearest health facility in the case that they delivered at home and experienced excessive bleeding. 5.3.2 PPH Treatment Service Delivery and Referral Protocol The PPH treatment protocols by facility level developed for the OR were as follows; they were applied the same, regardless of PPH prevention status, or the drugs used for prophylaxis :
• Rural Health Centers: Routine treatment of PPH prior to the OR included the use of only injectable uterotonics, with oxytocin and/or ergometrine. During the OR, misoprostol (800 mcg sublingual) was integrated as an additional treatment option for PPH, in cases where oxytocin was not available or failed as a prevention method or the provider assisting the delivery was not authorized to administer an injection, such as in the absence of a PCN at the time of delivery. If a woman continued to bleed after being treated with any uterotonic, or experienced deterioration in vital signs (blood pressure or pulse), she was referred to a district hospital.
• District Hospitals: Misoprostol (800 mcg sublingual) was integrated as an additional treatment option for PPH at the level of district hospitals, of which some had the capacity for further surgical interventions for PPH treatment depending on the skill sets of the attending doctors. If a woman’s condition deteriorated or if she required a surgical intervention that was not available at the district hospital, she was referred to a provincial or central hospital.
• Provincial/Central Hospitals: All methods of PPH treatment, including injectable uterotonics and surgical care as needed, were available at this level. Misoprostol was integrated as an additional treatment option in cases of oxytocin stock-‐outs, or in addition to oxytocin as needed.
11
Figure 3: Service delivery and referral protocols for PPH prevention and treatment, based on the level of facility and availability of uterotonics*
5.4 HEALTH PROVIDER TRAINING Trainings on misoprostol for PPH management covered the following topics: maternal mortality and the role of PPH; misoprostol use for PPH management; evidence and policies in support of using misoprostol; components of AMTSL; and postpartum contraceptive counseling. Additionally, providers were trained in how to complete the OR data collection tools. Three pocket guides were developed for the OR: one for misoprostol regimens, one for postpartum contraception, and one for all uterotonic regimens. One copy of each guide was distributed to each participating facility (Appendix A-‐C). A four-‐day workshop to train the trainers was conducted in Harare in February 2012 for 40 senior-‐level service providers (doctors, nurses and midwives), district pharmacists and reproductive health officers (RHOs)1 from the four OR districts. As the data collection did not start until January 2013, additional refresher trainings were held in December 2012 for the 40 providers who had attended the initial training of trainers (TOT). The senior refresher trainings were held to review the materials that had initially been presented in February, as well as the final OR protocols and data collection tools. The district nursing officers and community sisters (senior district nurses who supervise the RHCs) from each OR district selected the providers who would participate in the cascade trainings. In most cases, RHCs were staffed by two nurses (typically PCNs), both of whom participated in the OR training. At district and provincial hospitals, nurses who worked in the labor ward participated in the
1 A reproductive health officer is the midwife or doctor at the provincial level who is responsible for managing reproductive health services.
!Oxytocin infusion, 40 units at
30-40 drops/minute!!
OR, IF OXYTOCIN NOT AVAILABLE!
!Ergometrine 0.5 mgs, IM or IV*!
!
OR, IF ERGOMETRINE NOT AVAILABLE!
!Misoprostol 800 mcg sublingual!!SURGICAL INTERVENTION, IF NECESSARY AND AVAILABLE!!
!!!
!!!!
Oxytocin, 10 units IM!!
OR, IF OXYTOCIN NOT AVAILABLE!
!Ergometrine 0.5 mgs, IM or IV*!
!
OR, IF ERGOMETRINE NOT AVAILABLE!
!Misoprostol 800 mcg sublingual!
!!!!
!!!!
!!!
Oxytocin infusion, 40 units at 30-40 drops/minute!
!
OR, IF OXYTOCIN NOT AVAILABLE!
!Ergometrine 0.5 mgs, IM or IV!!
OR, IF ERGOMETRINE NOT AVAILABLE!
!Misoprostol 800 mcg sublingual!
!SURGICAL INTERVENTION IF
NECESSARY!!!!
!!
Bleeds > 500 ml (PPH)!
!Perceived PPH!
!!
Bleeds > 500 ml (PPH)!
!!
Bleeds > 500 ml (PPH)!
Provincial/Central Hospitals!District Hospital!Home! Rural Health Center!
!!!!!!!!!!!!!!!!!!!!!
!!!!!!!!!!!!!!!!!!!!
!!!!!!!!!!!!!!!!!!!!
10 IU oxytocin, IM !If oxytocin NOT available!600 mcg misoprostol oral!
10 IU oxytocin, IM !If oxytocin NOT available!600 mcg misoprostol oral!
Self refer to health facility, treatment according to
facility guidelines!
No uterotonic!
!!!!!!!!!!!!!!!!!!!!
10 IU oxytocin, IM!If oxytocin NOT available, !600 mcg misoprostol oral!
Refer if woman continues to bleed or has a
deterioration in vital signs ! *Facility treatment regimens are the same for all women with PPH, regardless of what, if any, uterotonic was used for PPH prevention!
PREVENTION !!!!TREATMENT!
Refer if woman requires a surgical intervention not available at the district
hospital!
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training. Trainers conducted cascade trainings in December 2012 in Bulawayo and Mutare, where two providers from each of the OR facilities participated. In total, 135 providers were trained, 50 from Mutare District, 40 from Chimanimani District, 25 from Matobo District, and 20 from Umguza District (Table 5). These 135 providers were evaluated at the end of the training with standardized knowledge and skills assessment tools. Providers who attended the cascade trainings were tasked with sharing “feedback” to other providers who were not at the training, but who assist in deliveries at their respective facilities. Providers who received this “feedback” were not assessed using the standardized knowledge and skills assessment tools. Table 5: Providers trained for the operations research, by cadre and district
Mutare Chimanimani Matobo Umguza Provincial and
central hospital health officers
Total
Training of trainers (TOT) 5 5 5 5 20 40
Cascade trainings 50 40 25 20 -‐-‐-‐ 135
Primary Care Nurse 20 22 12 12 -‐-‐ 66
Nurse 25 12 3 4 -‐-‐ 44 Midwife 4 6 8 4 -‐-‐ 22 Sister in Charge 1 2 -‐-‐ 3
TOTAL 55 45 30 25 20 175 During the supportive supervision, data collection tools were reviewed and OR protocols were reviewed and reinforced with providers, to ensure that all providers who were attending deliveries were informed about the OR and the use of misoprostol according to protocols.
5.5 GENERATING COMMUNITY AWARENESS A community education campaign was conducted to educate women and the community about birth preparedness, the importance of delivering in a facility, the availability of drugs to prevent bleeding at health facilities, safe delivery practices, and how to recognize excessive bleeding. Awareness-‐raising activities included the following:
a. Education Sessions during antenatal care (ANC): Women were given information during routine ANC visits about the importance of birth preparedness, delivering in a health facility and attending ANC throughout pregnancy. Women were informed that effective drugs to help prevent and stop bleeding after childbirth were available at the health facility. Women were also educated about how to recognize the need for referral if they had excessive bleeding after a home delivery.
b. Community meetings: Operations research staff and VHWs held general sensitization meetings at the village level to educate communities about the above messages.
c. Print: A general information poster about the importance of delivering in a health facility and how to prevent excessive bleeding after childbirth was developed and displayed in key places in the community and at health facilities (e.g. waiting areas) (Appendix D).
5.5.1 Focus Group Discussions with Vil lage Health Workers If a woman has the possibility to deliver at home, it is critical that she and her family understand when she has bled too much and must be immediately taken to a health facility to stop her bleeding. Focus group discussions (FGDs) were held with VHWs in two districts to identify appropriate local
13
methods for measuring blood loss at delivery. The discussions were held to provide information on local practices at home births, including what (if anything) VHWs were currently using to collect and measure blood loss after delivery. The objective was to identify an easily accessible method for measuring postpartum blood loss, and to establish a threshold for excessive bleeding (defined as bleeding in excess of 500 ml) using that method. The focus groups identified using a zambia (a local cloth that all women own) as the best method to measure blood loss after home deliveries, with two soaked zambias signifying that a woman had bled excessively. This method was then shared as a key message of the community education campaign so that women and communities could better understand when a woman had bled too much after delivery and should be immediately referred to a health facility. Operations research staff members conducted two focus group discussions with VHWs in November and December 2012. The district nursing officers (DNOs) from each district were asked to select VHWs for participation to ensure that some who participated had experience with home deliveries. The DNOs contacted each selected VHW and invited them to participate, explaining that their responses would be confidential. Participating VHWs were reimbursed for their transportation costs and were also given a $10 allowance for the day (the amount paid by other international NGOs for VHW participation), as well as $10 for meals. The focus group discussions were held in two locations. The first was in the city of Mutare in Mutare District, in the conference room of a district hospital. The other was in Umguza District in a central town hall near Nyamandlovu. Both locations were easily accessible by bus for the FGD participants. Each group was led by a facilitator who spoke the group’s primary language (Shona in Mutare District and Ndebele in Umguza District). Each facilitator was a Community Health Nurse with experience conducting FGDs and working with VHWs to ensure that she was viewed by VHWs as a trusted person. District nursing officers selected the facilitators. They were trained by VSI staff to use a discussion guide that was prepared by VSI’s Monitoring and Evaluation team. The guide was composed of ten open-‐ended questions, each of which had between four to five sub-‐questions. A VSI staff member recorded the focus group discussions using a digital voice recorder (DVR).
5.6 MONITORING AND EVALUATION OF THE OPERATIONS RESEARCH VSI, in collaboration with the ZMoHCC, developed data collection tools for the OR (see Section 5.7 Data Collection Tools, Data Management and Data Analysis). Baseline data was collected for the time period September 2011 to February 2012 in order to assess current PPH management practices. The OR was implemented from January 2013 to June 2013. During the period of the OR, service delivery data on PPH management practices were collected on a monthly basis by OR staff. Data on community education sessions and provider perspectives on misoprostol were also collected. Monitoring and evaluation (M&E) activities were undertaken by OR staff hired expressly for the OR. Additionally, VSI’s Zimbabwe Program Officer provided oversight to all M&E activities and, in coordination with high-‐level officials from the ZMoHCC, conducted targeted supportive supervision to facilities that were encountering challenges during the OR. Supportive Supervision Regular monthly visits by OR monitoring staff took place in order to assess the status of the OR and to provide supportive supervision to health providers and other facility staff. OR monitoring staff
14
ensured that providers were following the correct clinical protocols that had been laid out for the OR. If there were protocol violations, they worked with providers to ensure that they understood how to correct them. They also reviewed all data collection tools, confirming that forms were being filled out correctly and that there were no additional issues to be addressed or need to retrain providers. In addition to quantitative data collected with the monitoring and evaluation tools, OR staff also collected qualitative information from providers and district supervisors about the OR to monitor the fidelity of implementation and to ensure timely identification of challenges.
5.7 DATA COLLECTION TOOLS, DATA MANAGEMENT AND DATA ANALYSIS The ZMoHCC and VSI collaboratively developed data collection tools for the OR. The tools included the Facility Assessment Tool; Monthly Facility Form; Community Education Logbook; updated Delivery Registry; Maternity Record Form; and Provider Survey. The data flow for each tool is represented in Figure 4. Figure 4: Data flow and management
Facility Assessment Tool Baseline data from the 68 facilities participating in the OR was collected by OR monitoring staff in August 2012 prior to the initiation of any OR program components. The baseline gathered information on current PPH management practices, delivery costs and available equipment. The data was gathered using the Facility Assessment Tool developed for the OR. OR staff completed a Facility Assessment Tool at each of the 68 OR facilities. These tools were then mailed to VSI’s M&E team in Irvine, CA, where they were entered into Microsoft Excel and then exported into Stata/SE 12 (StataCorp 2011) for analysis.
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15
Monthly Facil ity Form OR staff used a Monthly Facility Form to record key service delivery indicators, misoprostol stock, and challenges or questions that providers brought up during monitoring visits. Monthly Facility Forms were completed during the OR by OR monitoring staff during their monthly supervisory visits. The OR monitoring staff then entered the forms into an Excel spreadsheet and emailed them to the VSI Zimbabwe Program Officer in Harare, as well as to VSI’s M&E team in Irvine, CA. Revised Delivery Registry and Maternity Record Form All health facilities in Zimbabwe conducting deliveries currently keep a Delivery Registry to record information about each woman admitted for delivery, as well as women who delivered at home and came to the facility for emergency or postnatal care. This registry was slightly revised for the OR to capture information on the uterotonic used for PPH treatment as well as whether a woman measured blood loss at a home delivery before coming to the facility. Health providers at the OR facilities completed the Delivery Registry for every woman who delivered at the health facility and for women who delivered at home and came to the facility for a postnatal visit. OR monitoring staff copied data from the Delivery Registries to the Maternity Record Form during monthly site visits. The VSI Data Manager in Harare entered these data into a central database using Epi Info 3.5.4. The database was analyzed by VSI staff in Irvine, Ca. using Stata/SE 12 (StataCorp 2011). Community Education Logbook A Community Education Logbook was completed by providers, VHWs, and OR monitoring staff to capture the number of community educations sessions they led, the date of the education sessions, and how many community members were involved. Health providers at OR sites and VHWs completed the Community Education Logbook when they held education sessions about misoprostol. VHW logbooks were deposited at the OR sites. OR monitoring staff collected the logbooks and mailed them to the VSI Zimbabwe Program Officer in Harare, who mailed them to VSI’s M&E team in Irvine, CA. Data from the Community Education Logbooks were entered into Microsoft Excel and analyzed by VSI’s M&E team using Stata/SE 12 (StataCorp 2011). Provider Survey All providers who participated in the OR and were trained on the appropriate use of misoprostol for PPH were asked to complete a short self-‐administered survey to share their perspectives on the program, their level of acceptability with misoprostol for PPH management, their level of satisfaction using misoprostol, challenges they experienced, and any other relevant experiences with using misoprostol for PPH management. In May and June, 2013, OR monitoring staff distributed and collected the surveys as part of their routine supervisory visits. Providers completed the surveys in private and returned them to the monitor in a sealed envelope; they took an average of less than 15 minutes to complete. The OR monitoring staff left a copy of the survey and an envelope if one of the providers was not present during the visit; the provider then completed the survey and returned it to the OR monitoring staff member at the next visit. The completed Provider Surveys were collected by OR monitoring staff and mailed to the VSI Data Manager in Harare. The VSI Data Manager in Harare then entered the data using Epi Info 3.5.4. This database was analyzed by the VSI M&E team in Irvine, CA using Stata/SE 12 (StataCorp 2011). Final data analysis for this report was conducted by VSI’s M&E team in August 2013. The final technical report was written by VSI’s M&E team in September 2013 in Irvine, CA.
16
6. Operations Research Implementation Timeline
All of the OR activities, including the preparatory phase, implementation, data collection and analysis, took place between 2010 and 2013. The ZMoHCC and VSI were responsible for the ongoing management and oversight of the OR activities. A formal, full assessment of the capacity of stakeholders to register and introduce misoprostol into the health system was conducted in November 2010. During this assessment, VSI staff met with representatives from the ZMoHCC and the National Pharmaceutical Company of Zimbabwe (Natpharm), and various maternal health stakeholders. In February 2012, VSI conducted a training of trainers (TOT), which was followed by the cascade training and a senior refresher training of providers in December 2012. In July and August 2012, the ZMoHCC and VSI staff conducted facility assessments at all facilities in the four OR districts to gather baseline information about resources, staffing and current PPH management practices. The protocol for the operations research was approved by the Medical Research Council of Zimbabwe (MRCZ), the Medicines Control Authority of Zimbabwe (MCAZ) and the Joint Research Ethics Committee (JRECH) in November 2012. Provision of services with misoprostol was initiated only after ensuring that facilities had the required supplies. For this reason, implementation started at different times in the different districts. Implementation began between January and February 2013. At the end of March 2013, MCAZ and MRCZ conducted facility site visits to check for protocol compliance and regulation of misoprostol by pharmacists and providers. US-‐based VSI staff conducted a monitoring and evaluation visit in April 2013, during which time they visited 33 facilities across all four districts (eight in Mutare, eight in Chimanimani, eight in Matobo and nine in Umguza). At the beginning of June 2013 VSI replaced all current misoprostol stock in the OR facilities with new stock to enable the facilities to continue to offer misoprostol for PPH management throughout the OR, until the ZMoHCC restocks them through Natpharm. Operations research implementation ended at the end of June 2013. During the two months that followed, VSI staff cleaned and analyzed OR data and wrote the final report.
7. Results
The final sample used for data analysis captured information on a total of 8,258 women who either delivered or received postnatal service immediately after delivery in an OR facility between January and June 2013 (Figure 5). Of the 8,258 women in the Delivery Registries, data was missing on the location of delivery for 71 women. Of the remaining 8,187 women for whom place of delivery was recorded, 94% (n=7,659) delivered at a facility, while 6% (n=510) delivered at home and 0.2% (n=18) delivered on the way to a facility. Of the women who delivered at a facility, 97% (n=7,400) had vaginal deliveries, while 3% (n=259) had cesarean sections.
17
Figure 5: Flow chart illustrating women delivering in the four operations research districts, their place of delivery and type of delivery (January – June 2013)
District level differences were observed for the location and type of delivery (Table 6). While Mutare district had the highest proportion of facility deliveries (95%) and cesarean sections (5%), Umguza district had the highest proportion of home deliveries (17%), followed by Chimanimani district (9%). Table 6: Distribution of deliveries according to type and place of delivery by district (January – June 2013)
Chimanimani (n=1,676)
Matobo (n=734)
Mutare (n=5,327)
Umguza (n=447)
Total* (n=8,184)
Facility 1,523 (90.9%)
681 (92.8%)
5,081 (95.4%)
372 (83.2%)
7,657 (93.6%)
Vaginal deliveries 1,513 (99.3%)
678 (99.6%)
4,835 (95.2%)
372 (100%)
7,398 (96.6%)
Caesarean section 10 (0.7%)
3 (0.4%)
246 (4.8%) 0 259
(3.4%)
Home 149 (8.9%)
53 (7.2%)
232 (4.4%)
75 (16.8%)
509 (6.2%)
On the way to the facility
4 (0.2%)
0 (0%)
14 (0.3%)
0 (0%)
18 (0.2%)
*Of the 8,258 women whose deliveries were recorded during the OR, 54 women had missing information on place of delivery, three women had missing district information and 17 women were missing both characteristics.
7.1 FINDINGS FROM BASELINE FACILITY ASSESSMENT Table 7 summarizes some of the basic findings from the baseline assessment, in relation to infrastructure characteristics of the facilities, as well as their staffing and supplies. During the assessment, nearly 40% of the RHCs reported not having electricity or a power source, which is essential to refrigerate oxytocin as described in the earlier sections (Table 7). In addition, with the exception of the provincial hospital in Mutare, monthly power outages were reported at all facility levels. Around two-‐thirds of rural, mission and district hospitals had a maternity waiting home, as opposed to only 37% of RHCs. Provincial and mission hospitals had the highest mean number of beds in their maternity wards (n=30 and n=18, respectively), while RHCs had the lowest (n=4). When the data for the 51 health centers was further disaggregated into 48 rural and 3 urban health centers, the mean number of beds in maternity wards for RHCs was three, while the mean number of beds for urban health centers was twelve (data not shown).
All Women n = 8,258
Women who delivered at a facility n = 7,659
Vaginal Delivery n = 7,400
Cesarean seccon n = 259
Women who delivered at home n = 510
Vaginal Delivery n= 510
Women who delivered on the way to a facility
n = 18
Vaginal Delivery n = 18
Place of delivery not recorded n = 71
18
Table 7: Some characteristics of the OR facilities according to facility level at baseline (September 2011 – February 2012)
Rural Health Center (n=51)
Rural Hospital
(n=8)
Mission Hospital
(n=5)
District Hospital
(n=3)
Provincial Hospital
(n=1)
Total (n=68)
Facility has electricity/power 31 (60.8%)
8 (100.0%)
4 (80.0%)
3 (100.0%)
1 (100.0%)
47 (69.1%)
Mean number of days per month facilities reported experiencing power outages
8.7 6.1 3.7 4.8 0 7.7
Facility has a maternity waiting home
19 (37.3%)
5 (62.5%)
3 (60.0%)
2 (66.7%) 0 29
(42.7%) Mean number of beds in maternity ward (min; max)
3.5 (0; 23)
9.4 (5; 14)
17.6 (2; 27)
9.3 (1; 21) 30 5.9
(0; 30) The cadre and number of staff varied by facility level. There were an average of two PCNs at each RHC, five at rural hospitals and seven at mission hospitals (Table 8). Very few doctors were reported at any facility level other than the provincial hospital, which reported 15 doctors on staff. When the data on health centers was further disaggregated into rural and urban health centers, the most notable change was in the number of midwives recorded as working at the facilities. Rural health centers reported an average of 0.4 midwives (ranging from 0 to 4), while the three urban health centers that participated in the OR reported an average of 11 midwives (ranging from one to 18) (data not shown). Table 8: Average number of staff according to cadre and facility level at baseline (September 2011 – February 2012)
Rural Health
Center (n=51)
Rural Hospital (n=8)
Mission Hospital
(n=5)
District Hospital
(n=3)
Provincial Hospital
(n=1) Primary care nurses (min; max)
1.8 (0; 5)
5.3 (1; 13)
7.2 (0; 24) 0 0
Nurses (min; max)
1.1 (0; 15)
6.8 (2; 16)
5.0 (1; 17)
6.7 (3; 11) 235
Midwives (min; max)
1.0 (0; 18)
1.5 (0; 4)
3.6 (0; 9)
5 (4; 6) 24
Clinical Officers (min; max)
0.1 (0; 1) 0 0.2
(0; 1) 0 0
Doctors (min; max)
0.1 (0; 2)
0.3 (0; 2)
1 (0; 3)
1.3 (1; 2) 15
While oxytocin was available at over 90% of the facilities at the time of the baseline assessment, over half of the facilities (61%) reported having had a stock-‐out in the past six months (Table 9). The mean duration of stock-‐outs was highest at RHCs (52 days) and mission hospitals (14 days). Only the provincial hospital did not report a stock-‐out of oxytocin in that period. When the data for health centers was further disaggregated into rural and urban health centers, the mean duration of oxytocin stock-‐outs was less at the three urban health centers (11 days) when compared to RHCs (57 days) (data not shown).
19
Table 9: Oxytocin availability and stock outs according to facility level at baseline (September 2011 – February 2012)
Rural Health Center (n=51)
Rural Hospital
(n=8)
Mission Hospital
(n=5)
District Hospital
(n=3)
Provincial Hospital
(n=1)
Total (n=68)
Oxytocin stocked at facility
47 (92.2%)
7 (87.5%)
4 (80.0%)
3 (100.0%)
1 (100.0%)
62 (91.2%)
Oxytocin stock-‐outs occurred in last 6 months
29 (61.7%)
4 (57.1%)
3 (75.0%)
2 (66.7%) 0 38
(61.3%)
Mean duration of oxytocin stock-‐outs in days (min; max)
52.0 (0; 240)
7.7 (2; 14)
14.3 (6; 30)
8 (2; 14)
N/A
42.2 (0; 240)
Only four facilities reported offering blood transfusions at baseline (one mission hospital, one rural hospital, one district hospital and the provincial hospital) (data not shown). It is important to note that the cost of blood transfusions can be very high; based on interviews with providers at the provincial hospital, blood transfusions could cost as much as $273.
7.2 OPERATIONS RESEARCH FINDINGS: PPH PREVENTION One key objective of the OR was to increase uterotonic coverage at the third stage of labor at facility deliveries. Figure 6 illustrates the number of women who delivered at a facility during the OR, and the type of uterotonic they received for PPH prevention. For women who had vaginal deliveries and for whom uterotonic information was recorded, the majority received oxytocin (88%), followed by misoprostol (9%) and ergometrine (3%). Overall, only 1% of women who delivered at a facility (n=82) did not receive any uterotonic. Of the 259 women who had a cesarean section, almost all (n=258) were given oxytocin, and one was given ergometrine. Figure 6: Flow chart illustrating women delivering at a facility during the operations research and the uterotonic they received for PPH prevention (January – June 2013)
Of the 528 women who delivered at home or on the way to the health facility, only 214 women (41%) received a uterotonic for PPH prevention once they arrived at the facility. A total of 307 women (58%) who delivered at home were recorded as receiving no uterotonic, and uterotonic data was missing for seven women. The majority of the 214 women who received a uterotonic were
Women who delivered at a facility n = 7,659
Vaginal Delivery n = 7,400
Oxytocin n = 6,492
Misoprostol n = 625
Ergometrine n = 195
No uterotonic n = 82
Uterotonic informacon not recorded
n = 6
Cesarean seccon n = 259
Oxytocin n = 258
Ergometrine n = 1
20
administered oxytocin (n=143; 67%), while 37 received misoprostol (17%) and 34 received ergometrine (16%) (data not shown). The type of uterotonic administered for PPH prevention varied by district (Table 10). Among women who had vaginal deliveries and for whom data was recorded on uterotonic and district (n=7,392), Umguza had the highest proportion of deliveries receiving oxytocin (94%), followed by Mutare district (91%). Chimanimani and Matobo districts reported use of misoprostol for PPH prevention for slightly over 10% of all deliveries (11% and 12% respectively). Very low rates of ergometrine were recorded in every district except for Chimanimani, where 10% of deliveries received ergometrine. Misoprostol and oxytocin was supplied regularly to OR districts during data collection, and Chimanimani district was the only district during the OR to report two oxytocin stock-‐outs; one in February 2012 and another in May 2012 (data not shown). Table 10: Uterotonic used for PPH prevention among women who had a vaginal delivery at a facility according to district (January – June 2013)
Chimanimani (n=1,512)
Matobo (n=678)
Mutare (n=4,833)
Umguza (n=369)
Total* (n=7,392)
Oxytocin 1,166 (77.1%)
596 (87.9%)
4,382 (90.7%)
348 (94.3%)
6,492 (87.8%)
Misoprostol 160 (10.6%)
80 (11.8%)
366 (7.6%)
19 (5.2%)
625 (8.5%)
Ergometrine 150 (9.9%)
1 (0.2%)
42 (0.9%)
1 (0.3%)
194 (2.6%)
No uterotonic 36 (2.4%)
1 (0.2%)
43 (0.9%)
1 (0.3%)
81 (1.1%)
Total women receiving a uterotonic for PPH prevention
1,476 (97.6%)
677 (99.9%)
4,790 (99.1%)
368 (99.7%)
7,311 (98.9%)
*Of the total 7,400 women who had a vaginal delivery, information was missing on district for two women, and on uterotonic used for 6 women. Uterotonic administered for PPH prevention amongst women who had vaginal deliveries also varied by facility level (Table 11). Overall, RHCs (including the three urban health centers) reported the highest level of usage of misoprostol for PPH prevention, for approximately one-‐fifth (21 %) of all vaginal deliveries (for which data was available on the facility level and uterotonic used). When further analysis was conducted to disaggregate the RHCs from the 3 urban health centers, the role of misoprostol for PPH prevention was even higher, with 28% of deliveries at RHCs receiving misoprostol, as compared to 0.4% (n=2) at urban health centers (data not shown). At rural hospitals, misoprostol was used for PPH prevention for 16% of deliveries. At the mission, district, and provincial hospitals, the majority of women (ranging from 92% -‐ 99%) received oxytocin, while misoprostol use for PPH prevention was minimal. The highest number of women receiving no uterotonic (n=61) delivered at RHCs.
21
Table 11: Uterotonic used for PPH prevention among women who had a vaginal delivery at a facility according to facility level (January – June 2013)
Rural Health Center
(n=2,147)
Rural Hospital (n=730)
Mission Hospital (n=1,064)
District Hospital (n=2,308)
Provincial Hospital (n=1,134)
Total* (n=7,383)
Oxytocin 1,515 (70.6%)
584 (80.0%)
976 (91.7%)
2,292 (99.3%)
1,120 (98.8%)
6,487 (87.9%)
Misoprostol 451 (21.0%)
114 (15.6%)
41 (3.9%)
12 (0.5%)
3 (0.3%)
621 (8.4%)
Ergometrine 120 (5.6%)
24 (3.3%)
39 (3.7%)
1 (0.0%)
9 (0.8%)
193 (2.6%)
No uterotonic 61 (2.8%)
8 (1.1%)
8 (0.8%)
3 (0.1%)
2 (0.2%)
82 (1.1%)
Total women receiving a uterotonic for PPH prevention
2,086 (97.2%)
722 (98.9%)
1,056 (99.2%)
2,305 (99.9%)
1,132 (99.8%)
7,301 (98.9%)
* Of the total 7,400 women who had a vaginal delivery, 11 women were missing facility level information, five were missing method of PPH prevention, and one woman was missing both facility level information and method of PPH prevention. Uterotonic coverage at facility deliveries increased at RHCs and rural hospitals after the inclusion of misoprostol during the OR (Figure 7). Rural health centers saw a 16% increase in uterotonic coverage from the baseline assessment, where 81% of deliveries received a uterotonic, to 97% coverage during the OR. At rural hospitals, uterotonic coverage increased from 78% at baseline to 99% during the OR. Where uterotonic coverage was high at baseline (99% to 100% at mission, district and provincial hospitals), the coverage remained stable. While the numbers of deliveries recorded at district and provincial hospitals varied between the baseline assessment and the OR, the uterotonic coverage recorded at these facility levels remained high throughout both periods.
Figure 7: Proportion of facility deliveries receiving a uterotonic for PPH prevention, at baseline and during the operations research*
*Of the total 7,659 women who had a vaginal delivery during the OR, 11 women were missing facility level information, five were missing method of PPH prevention, and one woman was missing both facility level information and method of PPH prevention.
81% 78%
96% 100% 100%
92% 97% 99% 99% 100% 100% 99%
50%
60%
70%
80%
90%
100%
Uterotonic coverage at Rural Health Centers
Uterotonic coverage at
Rural Hospitals
Uterotonic coverage at Mission Hospitals
Uterotonic coverage at District Hospitals
Uterotonic coverage at Provincial Hospital
Total uterotonic coverage
Baseline (Sept 2011-‐Feb 2012) Operacons Research (Jan-‐June 2013)
22
Near universal uterotonic coverage (99%) for PPH prevention at facility deliveries was achieved during the OR, which was a substantial increase from 92% uterotonic coverage at baseline. Misoprostol contributed to this high coverage (Figure 8). Figure 8: Total uterotonic coverage at facility deliveries during the operations research (January – June 2013)
The majority of women who received misoprostol for PPH prevention delivered at RHCs. Misoprostol use at RHCs increased fourfold between January and May (Figure 9). Figure 9: Trends in cumulative number of women receiving misoprostol for PPH prevention according to facility level (January -‐ June 2013)
When uterotonic use data was analyzed to identify trends during the OR, it was found that oxytocin use for PPH prevention at RHCs ranged from 61% to 82% (Figure 10). On the other hand, the proportion of misoprostol use for PPH prevention at RHC deliveries was approximately 9% in January, increased to 30% in March, and stabilized between 22-‐26% for the following three months of data collection. Misoprostol contributed significantly to increasing uterotonic coverage at RHCs.
Received a uterotonic!
Did not receive a uterotonic!
!"#
$$"#
0
100
200
300
400
500
January February March April May June
Cumulac
ve num
ber o
f wom
en
District Hospital Mission Hospital Provincial Hospital
Rural Health Center Rural Hospital
23
Figure 10: Trends in the uterotonic used for PPH prevention for vaginal deliveries at rural health centers (January – June 2013)
* Of the 2,148 women who delivered at a rural health center and had a vaginal delivery, one woman is missing PPH prevention method information and eleven are missing moth information. Misoprostol also contributed to increasing uterotonic coverage at rural hospitals (Figure 11). The highest proportion of misoprostol use at rural hospitals was seen in February (25%) and April (19%).With the addition of misoprostol, the proportion of women receiving no uterotonic remained extremely low throughout the OR, and during the last month of the OR all women having a vaginal delivery at rural hospitals received a uterotonic for PPH prevention. Figure 11: Trends in the uterotonic used for PPH prevention for vaginal deliveries at rural hospitals (January – June 2013)*
* Of the 730 women who delivered at a rural hospital and had a vaginal delivery, nine women are missing PPH prevention method information, two are missing month information, and one woman is missing both.
74% 82%
67% 73% 67% 61%
9% 10%
30% 22% 26%
26%
10% 7% 2% 3% 6%
8% 7% 1% 1% 2% 1% 5%
0%
20%
40%
60%
80%
100%
January (n=336)
February (n=270)
March (n=326)
April (n=436)
May (n=498)
June (n=270)
Oxytocin Misoprostol Ergometrine No uterotonic
77% 71% 87%
77% 79% 90%
14% 25%
12% 19% 14%
9% 8% 1% 4% 5% 1% 3% 1% 2%
0%
20%
40%
60%
80%
100%
January (n=132)
February (n=126)
March (n=137)
April (n=109)
May (n=123)
June (n=101)
Oxytocin Misoprostol Ergometrine No uterotonic
24
Among the 625 women who were administered misoprostol for PPH during the OR, data on misoprostol route and dosage was available for 591 and 606 women, respectively. For all women for whom the route and/or dosage was recorded, correct route (oral) and correct dose (600 mcg) of misoprostol was used (data not shown).
7.3 OPERATIONS RESEARCH FINDINGS: PPH CASES During the OR, PPH was diagnosed through visual estimation of blood loss, for which providers were trained to strengthen their observational skills to improve estimations. There were a total of 244 PPH cases reported during the OR for vaginal deliveries at facilities, and the proportion of women reported to develop PPH varied by the type of uterotonic they received for PPH prevention (Figure 12). Reported PPH cases at vaginal facility deliveries ranged from 3% for women who had received oxytocin to 4% for women who had received misoprostol or ergometrine. Figure 12: Flow chart illustrating location of delivery, type of delivery and the number of women who were reported to develop PPH (June – January 2013)
Treatment methods for reported PPH cases varied by facility level (Table 12). Of the 241 PPH cases after a facility delivery (for women for whom data was recorded for facility level and uterotonic for PPH treatment), the majority (86%) were treated with oxytocin, followed by misoprostol (10%) and ergometrine (3%). Misoprostol had the greatest influence at RHCs and rural hospitals, where it was used to treat 19% and 27% of reported PPH cases, respectively. The uterotonic used for PPH treatment was not recorded for three women who developed PPH at a facility delivery.
Women who delivered at a facility
n = 7,659
Vaginal Delivery n = 7,394
Oxytocin n = 6,492
PPH Cases n = 209
Misoprostol n = 625
PPH Cases n = 24
Ergometrine n = 195
PPH Cases n = 8
No Uterotonic n = 82
PPH Cases n = 3
Cesarean seccon n = 259
Oxytocin n = 258
PPH Cases n = 6
Ergometrine n = 1
Uterotonic informacon not
recorded n = 6
Women who delivered at home or
on the way to a facility N = 528
Vaginal Delivery N = 521
Oxytocin n = 143
PPH Cases n = 5
Misoprostol n = 37
PPH Cases n = 1
Ergometrine n = 34
PPH Cases n = 1
No Uterotonic n = 307
PPH Cases n = 11
Uterotonic informacon not
recorded N = 7
25
Of the 528 women who delivered at home or on the way to the facility, a total of 18 women (4%) were recorded as experiencing PPH. Of these 18 women, 11 ( 61%) were not recorded as receiving a uterotonic, while five received oxytocin, one received misoprostol and one received ergometrine when they arrived at the facility. Table 12: Reported PPH cases* among women with facility or home vaginal deliveries according to facility level and type of uterotonic used for treatment of PPH (January – June 2013)
Rural
Health Center
Rural Hospital
Mission Hospital
District Hospital
Provincial Hospital Total
PPH cases reported at facility deliveries** 79 22 38 80 22 241
Uterotonic used for PPH treatment
Oxytocin 56 (70.9%)
15 (68.2%)
35 (92.1%)
80 (94.1%)
22 (100%)
208 (86.3%)
Misoprostol 15 (19.0%)
6 (27.3%)
2 (5.3%)
0 (0%) 0 23
(9.5%)
Ergometrine 6 (7.6%)
1 (4.6%)
0 (0%) 0 0 7
(2.9%)
Not recorded 2 (2.5%)
0 (0%)
1 (2.6%)
0 (0%) 0 3
(1.2%) PPH cases reported for home deliveries 9 2 1 5 1 18
Uterotonic used for PPH treatment
Oxytocin 3 (33.3%)
1 (50.0%) 0 0 1
(100%) 5
(27.8%)
Misoprostol 0 0 0 1 (20.0%) 0 1
(5.6%)
Ergometrine 1 (11.1%) 0 0 0 0 1
(5.6%)
Not recorded 5 (55.6%)
1 (50.0%)
1 (100%)
4 (80.0%) 0 11
(61.1%) *PPH was diagnosed through visual estimation of blood loss. **For the 244 women who had vaginal facility deliveries and developed PPH, two women were missing facility level information and one woman was missing PPH treatment method. When the proportion of all PPH cases among facility deliveries (including vaginal deliveries and cesarean sections, due to the fact that the baseline data did not distinguish between type of delivery for PPH cases) were compared between the baseline data and the OR data, a total of 249 PPH cases were reported during the OR (accounting for 3% of all facility deliveries), as compared to 173 PPH cases at baseline (2% of all facility deliveries) (Table 13). The difference was not statistically significant.
26
Table 13: Comparison of PPH cases recorded for all facility deliveries, over 6 months, at baseline and during the OR, by the level of facility (January – June 2013)
Rural Health Center
(n=2,824)
Rural Hospital (n=764)
Mission Hospital (n=1,066)
District Hospital (n=1,486)
Provincial Hospital (n=3,411)
Total (n=9,551)
Baseline (September 2011 – February 2012)
19 (0.7%)
9 (1.2%)
125 (11.7%)
10 (0.7%)
10 (0.3%)
173 (1.8%)
Rural Health Center
(n=2,070)
Rural Hospital (n=710)
Mission Hospital (n=1,038)
District Hospital (n=2,228)
Provincial Hospital (n=1,352)
Total* (n=7,647)
Operations research (January – June 2013)
79 (3.7%)
22 (3.0%)
39 (3.6%)
83 (3.6%)
26 (1.9%)
249 (3.3%)
*Of the 252 women who developed PPH at a facility delivery (either after a vaginal or caesarean section delivery) there were three women missing information on facility level.
7.4 MATERNAL DEATHS There were two maternal deaths due to PPH reported in the four districts during the operations research. Neither woman was given misoprostol for PPH prevention or PPH treatment.
7.5 COMMUNITY AWARENESS Focus Group Discussions with Vil lage Health Workers A total of 21 women (nine in Umguza and 12 in Mutare) attended the two FGDs. Table 14 presents the socio-‐demographic characteristics of the women who participated in FGD.
27
Table 14: Socio-‐demographic characteristics of village health workers who participated in FGDs
Total (n=21) Mean age (min; max)
46.6 (26; 70)
Religion
Methodist 2 (9.5%)
Seventh Day Adventist 4 (19.0%)
Catholic 2 (9.5%)
Pentacostal 8 (38.1%)
Anglican 3 (14.3%)
Apostolic 2 (9.5%)
Marital status
Married 11 (52.4%)
Single 2 (9.5%)
Widowed 8 (38.1%)
Employment status
Village Health Worker 21 (100.0%)
Mean years working as a VHW (min; max) 8.9 (0.5; 20)
Traditional Birth Attendant (TBA) 8 (38.1%)
Mean years working as a TBA (min; max) 9.5 (4; 20)
Experience at home deliveries
Ever assisted with home deliveries 10 (47.6%)
Mean number home deliveries assisted during their lifetime (min; max)
35.6 (1; 234)
The majority of VHWs that participated in the FGD understood the risks of delivering at home, citing that they did not have the skills nor equipment to handle complicated deliveries. Despite this, they felt that there are many reasons why women in Zimbabwe continue to deliver at home. These reasons included negative perceptions about delivering at a facility, e.g. fear of exposing their poverty, (for example, some women do not have enough money to buy clothes for their newborn, and may have to use jerseys instead); fear of exposing infidelity; unmarried teenagers worrying about being asked questions about their boyfriends; a preference for traditional birth attendants (TBAs); unwillingness to undergo HIV testing; fear of having a caesarean section; and some access issues such as distance to health facilities and lack of transport. Five VHWs in the FGDs had direct experience in assisting a delivery where a women bled excessively, and three of these five VHWs had experienced the death of a woman from PPH. Searching for transport for women who developed PPH was agreed to be a key challenge at home deliveries, and based on the cases described, either a tractor or a wheelbarrow was used for transport to a health facility. Religious influence was highlighted as a factor in terms of women’s response to PPH. For
28
example, it was reported that in the case of Apostolic women that suffered from excessive bleeding, they would not go or be taken to a health facility, and were sometimes prevented by their husbands from seeking care at a facility. Two women reported that if a woman needed to get to a health facility during a home delivery, it was the sabhuku (a village headman who answers to the village chief) who mobilized funds and resources to get the woman to a facility. Participants said that there were no “home remedies” for managing PPH, but they cited practices such as: 1) giving sugar and salt water as a hydrating solution; 2) rubbing the woman’s stomach; and 3) laying her on a sand bed so that the woman would not be disturbed by how much she was bleeding. Recognizing excessive bleeding at a home delivery was universally agreed to be difficult. While participants said that there were certain “signs” that a woman had too much bleeding (sweating, weakness, dizziness, fainting), the signs were often detected too late to help the woman. The participants had a number of ideas for measuring blood loss at home deliveries, including the use of “cotton” (although they felt many poor women would not have cotton available), old linen, a bed sheet, or a “zambia,” a local cloth that all women own. The focus group facilitators then explained that using a “zambia” to measure excessive blood loss at home deliveries is a method that has been used in a number of other countries (Tanzania, Zambia, and Mozambique). The facilitators demonstrated how two zambias could be used to soak up 500 mls of liquid, which is the amount of blood loss that defines PPH. The participants all felt that this method was very effective in demonstrating how much blood loss was excessive, and they thought that the method would be culturally acceptable to women and families in their communities. They suggested relaying information about this blood loss measurement tool to women through community demonstrations, home visits to pregnant women, group education sessions, community workshops and dramas using “community lead mothers.” They also recommended involving mothers-‐in-‐law, village headmen and “krawl” heads in community education efforts. Community Education Sessions Community education sessions held during the OR incorporated messages from the key findings from the FGDs. Based on feedback from the FGDs, a variety of information channels were used to disseminate community education information, including community demonstrations and dramas, home visits to pregnant women, group education sessions at health facilities and community dramas. Local stakeholders (village headmen, “krawl” heads, mothers-‐in-‐law) were also involved in relaying messages about safe delivery. The key messages of the community education sessions, some of which were based on findings from the FGDs, included: 1) measuring blood loss at home deliveries with two zambias as a culturally acceptable means of blood loss measurement; 2) demonstrations of this method of blood loss measurement for women and their families to know when a woman has bled too much at a home delivery; 3) the importance of birth preparedness and delivering in a health facility; and, 4) safe delivery practices. These key messages were shared with OR staff, providers and VHWs, who incorporated messages into their education sessions and worked to involve local stakeholders in the community education campaign. A total of 364 sessions were conducted and 17,134 community members were reached with messages during the course of the OR (Figure 13). The vast majority of education sessions, both at the facilities and in the communities, were group sessions. The number of education sessions led by
29
health providers increased steadily during the OR. Health providers led the majority of the sessions (54%) and VHWs led 19% of the sessions.
Figure 13: Cumulative number of people reached with community awareness messages, by facilitator and month (January – June 2013)
During the OR, 100 women reported that they experienced excessive bleeding at a home delivery and then self-‐transferred to a health facility. Of those, only 15 women (15%) reported to a provider that they measured blood loss at a home delivery before coming to the health facility; two of them reported using a zambia to measure blood loss at a home delivery.
7.6 PROVIDER PERSPECTIVES ON INTRODUCTION OF MISOPROSTOL FOR PPH PREVENTION AND TREATMENT Providers who had either been trained at the cascade trainings or received feedback from their colleagues about their trainings were invited to complete a Provider Survey. During the last two months of the project, OR monitoring staff visited each facility and explained to providers the purpose of the Provider Survey, which was to gather provider perspectives on using misoprostol for PPH prevention and treatment. OR monitoring staff left Provider Surveys at the facility and asked that staff member(s) who had received training on using misoprostol for PPH prevention and treatment complete the survey, which they would then pick up at their supportive supervision visit the following month. In total, 76 surveys were completed and at least one provider from each OR facility completed a survey. Table 15 presents characteristics of providers who responded to the survey.
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30
Table 15: Selected characteristics of providers who responded to the survey
Level of facility where provider works (n=76)
Rural Health Center 52 (68.4%)
Mission/Rural Hospital 18 (23.7%)
District Hospital 5 (6.6%)
Provincial Hospital 1 (1.3%)
Location of primary work site (n=76)
Rural 71 (93.4%)
Urban 5 (6.6%)
Age (n=74)*
Mean age (min; max) 38 (27;59)
Sex (n=75)**
Male 25 (32.9%)
Female 50 (65.8%)
*Missing data on age for two respondents. **Missing data on sex for one respondent. Almost all (96%) respondents recommended the use of misoprostol to other providers for PPH prevention and treatment (Figure 14). The larger majority (99%) stated that it was easy to learn to use misoprostol for PPH management. However, over half of the providers agreed or strongly agreed that they needed more training to be confident in using misoprostol for PPH prevention and treatment. Figure 14: Provider views on misoprostol training, use and access (n=76)
*Proportion of providers who checked “agree” or “strongly agree” on the survey for these items.
96%
55%
53%
99%
86%
96%
0% 20% 40% 60% 80% 100%
"I am able to access misoprostol when I need to use it for prevencon and/or treatment of
PPH"
“I feel that I need more training to be confident in using misoprostol for PPH
treatment”
“I feel that I need more training to be confident in using misoprostol for PPH
prevencon”
"It was easy to learn how to use misoprostol for PPH management."
“The training I received made me confident in using misoprostol for PPH management.”
“I would recommend the use of misoprostol for prevencon and treatment of PPH to other
qualified health care providers”
Misoprostol Use
Misoprostol Training
Misoprostol Access
31
Three themes emerged from the comments and recommendations provided by the respondents. These themes included misoprostol availability, the effectiveness of misoprostol administration, and the need for additional training. Some of the respondents mentioned that misoprostol should be accessible at all times and that health facilities should be stocked with the drug on a continuous basis. Many of the respondents also mentioned the effectiveness of misoprostol and its ease of use in treating PPH. Some of the respondents noted that the side effects associated with misoprostol are rarely experienced and that the administration of misoprostol helps curb costs by avoiding referrals. The primary theme that emerged was the need for additional training. Many respondents expressed the need for additional training on PPH management with misoprostol for nurses and other health care workers such as nurse aides. Some of the respondents also mentioned that they would feel more confident using misoprostol for PPH management with additional training. Respondents also felt that VHWs should receive additional training on educating women about the availability of misoprostol for PPH management. Box 2: Perspectives from providers
8. Discussion and Conclusions
INTRODUCING MISOPROSTOL INTO THE MIX OF AVAILABLE UTEROTONICS FOR PPH PREVENTION CONTRIBUTES TO NEAR UNIVERSAL COVERAGE AT RURAL HEALTH CENTERS AND RURAL HOSPITALS This OR generated sufficient evidence to inform the scale-‐up of PPH management with misoprostol in Zimbabwe. Misoprostol effectively compensated for the lack of availability of other uterotonics for PPH prevention at rural facilities, increasing coverage at RHCs from 81% to 97% and at rural hospitals from 78% to 99%. Despite the fact that the uterotonic is the most critical component of AMTSL, uterotonic coverage at facility deliveries varies widely, globally. A survey done in 15 tertiary obstetric centers around the world found that administration of a uterotonic occurred in only 44% of vaginal deliveries, making it the least used component of AMTSL (Festin et al., 2003). While data from the OR in Zimbabwe revealed high rates of oxytocic use at tertiary facilities (district and provincial hospitals), uterotonic use at RHCs and rural hospitals was found to be much lower at baseline (81% and 78%, respectively). Including misoprostol as an additional uterotonic for PPH prevention resulted in almost universal (99%) uterotonic coverage at all facility deliveries during the OR, an increase from 92% at baseline.
“Misoprostol was useful in our setting as we sometimes are short of oxytocin. Although we didn’t have PPH patients we feel that could have handled it well.” Primary Care Nurse, Chimanimani District
“Misoprostol can be safely used by non-‐qualified personnel who cannot give injectables.” Primary Care Nurse, Mutare District
“Misoprostol was easy to administer and no problems were encountered in using the drug. We recommend the use of it at areas like outreach points so as to assist the hard to reach clients.” Midwife, Mutare District “Misoprostol is useful in rural setting. It cuts costs and it’s not refrigerated.” Primary Care Nurse
32
MISOPROSTOL MADE THE GREATEST CONTRIBUTION TO INCREASING UTEROTONIC COVERAGE AT RURAL HEALTH CENTERS AND RURAL HOSPITALS During the six months of OR, at RHCs, 21% (n=451) of vaginal deliveries for whom uterotonic data was available received misoprostol for PPH prevention. At rural hospitals, the corresponding figure was 16% (n=114). Without the availability of misoprostol in these facilities, these women may not have received a uterotonic for PPH prevention. Even when oxytocin is available as the drug of choice for PPH management, the additional availability of misoprostol at RHCs and rural hospitals will help to overcome possible challenges with oxytocin, which can include a lack of ideal storage conditions, stock outs, or shortage of providers who are authorized to administer injections. Baseline data revealed that RHCs and rural hospitals are vulnerable to oxytocin stock-‐outs, with approximately three-‐fifths of these facilities reporting at least one oxytocin stock-‐out in the last six months. Refrigeration is recommended for the storage of oxytocin to ensure its stability (Hogerzeil et al. 1993); however, the need to refrigerate oxytocin can compromise its availability. In surveys from 11 sub-‐Saharan African countries, only 28% of health facilities reported reliable electricity supplies (Adair-‐Rohani et al., 2013). Nearly 40% of the RHCs in the OR reported at baseline not having electricity or a power source, which is essential to refrigerate oxytocin and ensure the stability of the drug, especially when stored for over a few months. Misoprostol provides a safe, effective and low-‐cost alternative to oxytocin when the oxytocin supply is interrupted, storage conditions are not maintained, or syringes or staff trained and authorized to administer oxytocin are not available.
RURAL WOMEN, WHO ARE MOST LIKELY TO CONFRONT BARRIERS RELATED TO COST, LACK OF TRANSPORT AND CULTURAL BARRIERS THAT LIMIT THEIR ACCESS TO TIMELY MATERNITY SERVICES, BENEFITTED MOST FROM THE AVAILABILITY OF MISOPROSTOL FOR PPH TREATMENT Almost two-‐fifths of deliveries during the OR took place at RHCs and rural hospitals, which serve primarily rural populations. Increasing the capacity of the staff at these facilities to manage PPH is essential. District and provincial hospitals are mainly located in major urban settings, making it difficult for rural women to access them. Ensuring universal administration of a uterotonic at all levels of facility deliveries will lead to a decrease in PPH cases. Prompt treatment of PPH, when it does occur, will help prevent maternal mortality and morbidity. Providing treatment options at rural facilities is extremely important because if a woman delivers at a rural facility and has to be transferred to a tertiary facility, the woman faces numerous barriers to accessing care. Qualitative data from providers at the provincial hospital revealed that blood transfusions for women cost $273, and that if a woman is unable to pay this amount up-‐front, she will not receive the transfusion. Efforts are currently underway in Zimbabwe to decrease the costs of managing PPH for women; for example, UNFPA is subsidizing a voucher program to allow equitable access to blood transfusion (Taylor et al., 2010). Enabling RHCs and rural hospitals to effectively manage PPH will contribute to decreasing the number of women who have to be transferred to higher-‐level district and provincial hospitals for PPH treatment. This will decrease both costs to the women (in terms of transport and paying for blood transfusions), as well as costs to the health system (physician time to treat PPH cases at the higher-‐level facilities, decrease in bed occupancy, etc.).
33
MISOPROSTOL CAN BE ADMINISTERED CORRECTLY AND SAFELY FOR THE PREVENTION OF PPH AT ALL FACILITY LEVELS Provider adherence to correct dosage protocols was extremely high, and a correct regimen of 600 mcg of oral misoprostol was administered to all women with a facility vaginal delivery for whom data was recorded. Providers received training on dose and route of administration at the cascade trainings, supervisory visits, and they also had access to this information on the misoprostol regimens dosage cards.
INCLUDING AN INDICATOR FOR UTEROTONIC USED FOR PPH TREATEMENT CONTRIBUTES TO HIGH-QUALITY DATA COLLECTION ON PPH MANAGEMENT Monitoring the use of uterotonics for the prevention of PPH is recommended as a process indicator for programmatic evaluation, and the suggested Prophylactic Uterotonic Coverage Indicator is calculated as the number of women receiving prophylactic uterotonic drugs after birth divided by all women giving birth (WHO, 2012). While the Delivery Registry used by the ZMoHCC collects data on prophylactic uterotonic use, the revised Delivery Registry used for the OR added a column to collect data on 1) whether a woman developed PPH and 2) what uterotonic was given for PPH treatment. Despite the fact that PPH is relatively rare, it is important to document PPH cases, as well as their treatment, in order to ensure that proper PPH management protocols are being followed. Consequently, the continued use of the revised Delivery Registry may allow the ZMoHCC to better capture data on PPH management practices. Additionally, as providers during the OR were trained to visually estimate blood loss to diagnose PPH, it is plausible that they diagnosed more PPH cases. As the ZMoHCC plans to continue training providers on PPH management with misoprostol, it can be expected that providers will continue to see an increase in PPH diagnoses, and it will be increasingly important to accurately capture PPH management practices.
A CULTURALLY APPROPRIATE METHOD FOR MEASURING POSTPARTUM BLOOD LOSS WAS IDENTIFIED Focus group discussions with VHWs identified a culturally acceptable method for measuring blood loss at home deliveries. Two soaked zambias, a widely available local cloth in Zimbabwe, were identified as a threshold for when a woman had experienced excessive bleeding and needed to go to a health facility for emergency treatment. Using a local cloth, similar to a zambia, to measure excessive blood loss at home deliveries has been piloted in other countries (Prata et al., 2012) and data from the literature suggests that increasing community knowledge about how to identify excessive bleeding after childbirth can increase the proportion of women who self-‐refer to a facility after developing PPH at a home delivery.
PROVIDERS AND VILLAGE HEALTH WORKERS INTEGRATED MESSAGES ABOUT THE IMPORTANCE OF FACILITY DELIVERIES, THE AVAILABILITY OF DRUGS AT THE FACILITY TO PREVENT BLEEDING, AND HOW TO RECOGNIZE EXCESSIVE BLOOD LOSS, INTO THEIR EXISTING EDUCATIONAL ACTIVITIES Community sensitization activities were an important component of the OR, and 17,134 community members were reached with messages about the importance of facility deliveries, misoprostol, and how to recognize excessive blood loss at delivery. Health providers led the majority of education sessions (54%), indicating that providers are able to incorporate messages about misoprostol into already-‐existing education sessions. Village health workers led 19% of the sessions. However, it is important to note that the population of the four OR districts was 762,481, meaning that only 2% of the population was reached with these messages. As the ZMoHCC works to ensure that all women
34
deliver in a health facility, it will be increasingly important to continue to educate communities on the importance of delivering in a health facility and that drugs are available at facilities to prevent bleeding during childbirth. Simultaneously, it will be critical to ensure that communities understand how to recognize excessive blood loss after delivery. During the OR, 100 women reported that they experienced excessive bleeding at a home delivery, and then self-‐referred to a facility for treatment. Only 15 of these women reported to a provider that they measured blood loss at a home delivery before coming to the health facility; two of these women reported that they used a zambia to measure blood loss at a home delivery. While this number is very small, not all women who had home deliveries were captured in the Delivery Registry. Thus, there may have been women who delivered at home and used a zambia to measure blood loss, for whom data was not captured during the OR. With 6% of recorded deliveries during the OR taking place at home, it is necessary to ensure that these women have the knowledge to know when they are bleeding excessively and must go to a health facility for treatment. UTEROTONIC COVERAGE WAS LOWEST IN WOMEN WHO DELIVERED AT HOME During the OR, data on home deliveries was captured in the Delivery Registry for women who delivered at home and then came to a facility immediately after delivery for postnatal care. The registries, as such, did not capture the totality of home deliveries, as many women who deliver at home do not immediately come to a facility afterwards. Despite this, home delivery rates were relatively high in some districts during the OR: 17% of recorded deliveries in Umguza district and 9% of recorded deliveries in Chimanimani district took place at home. For women who were recorded as delivering at home and for whom uterotonic data was recorded, only 41% (n=214) were recorded as receiving a uterotonic for PPH prevention when they reached a facility. PROVIDERS FIND MISOPROSTOL HIGHLY ACCEPTABLE, BUT RECOMMEND ADDITIONAL TRAINING Over half of respondents to the Provider Survey agreed or strongly agreed that they need more training to be confident in using misoprostol for PPH prevention (53%) and treatment (55%). As providers are regularly relocated to new facilities, some providers initially trained at the cascade trainings moved to different facilities during the OR. It is important to ensure that all of the providers providing delivery services are formally trained with standardized knowledge and skill assessment tools on the appropriate use of misoprostol for PPH management.
9. Programmatic Recommendations
The following recommendations are based both on the results of the OR as well as lessons learned by the ZMoHCC and providers in terms of what is needed to strengthen PPH management in Zimbabwe. As such, the following recommendations go beyond the results presented in this report, and encompass larger programmatic priorities in the country.
INTEGRATE MISOPROSTOL AS AN ADDITIONAL UTEROTONIC FOR PPH MANAGEMENT AT ALL HEALTH FACILITIES THAT CONDUCT DELIVERIES IN ZIMBABWE Misoprostol provided critical uterotonic coverage to women delivering at RHCs and rural hospitals. Misoprostol should continue to be supplied to all health facilities in Zimbabwe that conduct
35
deliveries to ensure that all women delivering in facilities receive a uterotonic, whether they deliver in a rural or urban location.
ENSURE THAT RURAL HEALTH CENTERS AND RURAL HOSPITALS CAN MANAGE PPH IN ORDER TO DECREASE COSTS, BOTH TO WOMEN AND TO THE HEALTH SYSTEM, OF MANAGING COMPLICATED PPH CASES AT HIGHER LEVEL FACILTIES If a woman delivers at a rural facility, develops PPH, and has to be transferred to a higher-‐level facility, she faces numerous challenges: cost of transport to the referral facility; the time it will take to get to the referral facility (particularly given that the average time from development of PPH to death is two hours); and high costs of blood transfusions at referral facility. Consequently, ensuring that rural women can receive high quality maternity care at rural health facilities is essential to achieving the ZMoHCC’s goal of achieving health equity.
DISSEMINATE AND IMPLEMENT THE BEMOC GUIDELINES, TO ENSURE THAT PROVIDERS CAN CORRECTLY IMPLEMENT PPH MANAGEMENT AND REFERRALS ACCORDING TO PROTOCOLS The BeMOC Guidelines are currently not printed in Zimbabwe, and there is a need for providers to be uniformly educated on correct PPH management protocols. The BeMOC guidelines should be printed and disseminated to all facilities conducing deliveries. Supportive supervision should also be provided to ensure that providers are correctly implementing the protocols.
PROVIDE TRAINING AND JOB AIDS ON THE USE OF MISOPROSTOL FOR PPH MANAGEMENT, FOLLOWING THE SERVICE DELIVERY PROTOCOLS, TO ALL MATERNITY SERVICE PROVIDERS INCLUDING PHYSICIANS, MIDWIVES, NURSES, PRIMARY CARE NURSES, AND NURSE AIDES It is important to keep service providers’ skills and knowledge up to date, and certain components of providers’ training need to be reinforced to assure that the protocol and reporting system are followed correctly. Supplying providers with job aids and reference materials at health facilities will improve the quality of PPH management services. The misoprostol regimen cards developed for the OR should continue to be used as additional providers are trained on using misoprostol for PPH management. The high turnover of staff, as well as other job responsibilities that the providers need to fulfill can make it challenging to ensure that a facility has trained providers available at all times to manage PPH. Training all providers who attend deliveries, including nurse aides, was suggested during the interviews with the providers. Nurse aides were not a part of the cascade trainings for the OR, as attending deliveries is not included in their job description. However, in reality, when PCNs were not available at RHCs to attend deliveries, nurse aides managed the deliveries as the only available facility staff. As nurse aides currently are not authorized to administer injections, misoprostol fills a critical gap in the maternity care that they can provide.
INCORPORATE TRAINING ON MISOPROSTOL FOR PPH MANAGEMENT INTO THE PRE-SERVICE CURRICULA OF THE MEDICAL, NURSING, AND MIDWIFERY SCHOOLS In order to ensure the sustainable dissemination of correct and updated clinical protocols and guidelines, training on misoprostol for PPH management should be incorporated into the pre-‐service curricula of all medical, nursing and midwifery schools in Zimbabwe.
36
INCREASE COMMUNITY AWARENESS THROUGH APPROPRIATE INTERVENTIONS TO ENSURE UTEROTONIC COVERAGE FOR ALL WOMEN GIVING BIRTH Engage providers, VHWs, district health staff, and local administrators in additional community awareness activities to raise awareness of the importance of facility deliveries, the availability of drugs at facilities to prevent bleeding, and how to recognize excessive blood loss at delivery.
REGISTER MISOPROSTOL FOR OBSTETRIC USES IN ZIMBABWE, AS AN IMPORTANT FIRST STEP TO ENSURE THE ONGOING SUPPLY OF A HIGH QUALITY PRODUCT Registration, the process by which a drug is approved by a regulatory agency for importation, distribution and marketing for a specific medical indication, is a key strategy for improving access to misoprostol. Registration is important because it allows for the drug to be marketed for approved indications and to ensure that an insert with proper dosages and instructions for providers and pharmacists is included with the product. It ensures that oversight is provided by a drug regulatory board which oversees product quality. It will be important both to ensure that a misoprostol product is registered for PPH prevention and treatment and that procedures are in place for ongoing procurement, in order to ensure the availability of misoprostol for PPH at all levels of the health care system.
ADOPT AND IMPLEMENT PROCEDURES FOR THE ORDERING AND DISTRIBUTION OF MISOPROSTOL TO ENSURE ITS AVAILABILITY FOR PPH MANAGEMENT IN ALL LEVELS OF HEALTH FACILITIES, WITH SPECIAL ATTENTION TO ENSURING STOCKS IN RURAL FACILITIES WHERE THE NEED IS MOST OFTEN UNMET As misoprostol for PPH management is expanded in Zimbabwe, procedures should be put in place to ensure that stock-‐outs do not occur, particularly at the RHCs and rural hospitals, where misoprostol had the greatest impact on increasing uterotonic coverage.
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10. References
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Adair-‐Rohani H, Zukor L, Bonjoura S et al. Limited electricity access in health facilities of sub-‐Saharan Africa: a systematic review of data on electricity access, sources, and reliability. Global Health Science and Practice 2013;1(2):249-‐61.
Aflaifel N, Weeks AD. Active management of the third stage of labour. British Medical Journal 2012;345:e4546.
Alfirevic Z, Blum J, Walraven G et al. Prevention of postpartum hemorrhage with misoprostol. International Journal of Gynecology and Obstetrics 2007;99:S198-‐S201.
Derman R, Kodkany B, Goudar S et al. Oral misoprostol in preventing postpartum haemorrhage in resource-‐poor communities: a randomised controlled trial. Lancet 2006;368(9543):1248-‐53.
Festin MR, Lumbiganon P, Tolosa JE et al. International survey on variations in practice of the management of the third stage of labour. Bulletin of the World Health Organization 2003;81(4):286-‐91.
Geller SE, Adams MG, Kelly PJ et al. Postpartum hemorrhage in resource-‐poor settings. International Journal of Gynaecology and Obstetrics 2006;92(3):202-‐11.
Gulmezoglu A M, Lumbiganon P, Landoulsi S et al. Active management of the third stage of labour with and without controlled cord traction: a randomised, controlled, non-‐inferiority trial. Lancet 2012;379(9827):1721-‐27.
Hogezeil HV, Walker GJA, de Goeje MJ. Stability of injectable oxytocics in tropical climates Results of field surveys and simulation studies on ergometrine, metholergometrine and oxytocin. WHO Action Programme on Essential Drugs and Vaccines, 1993.
Knight HE, Self A, Kennedy SH et al. Why are women dying when they reach hospital on time? A systematic review of the 'third delay.’ PLoS One 2013;8(5):e63846.
Mobeen N, Durocher J, Zuberi N et al. Administration of misoprostol by trained traditional birth attendants to prevent postpartum haemorrhage in homebirths in Pakistan: a randomized placebo-‐controlled trial. British Journal of Obstetrics & Gynaecology 2011;118(3):353-‐61.
Potts M, Prata N, Sahin-‐Hodoglugil NN. Maternal mortality: one death every 7 min. Lancet 2010;375(9728):1762-‐63.
Prata N, Ejembi C, Fraser A et al. Community mobilization to reduce postpartum hemorrhage in home births in northern Nigeria. Social Science and Medicine 2012;74(8):1288-‐96.
Program for Appropriate Technology in Health (PATH). A Report evaluating the acceptability and feasibility of introducing oxytocin in the Uniject device for AMTSL. PATH, 2010. Accessed 24 July 2013 at: http://www.path.org/publications/files/TS_oiu_amtsl_guat_rpt.pdf
Shah I, Ahman E. Unsafe abortion in 2008: Global and regional levels and trends. Reproductive Health Matters 2010;18(36):90-‐101.
Taylor P, Gomez P et al. Maternal and Child Health Integrated Program: Zimbabwe Situation. 2010. USAID.
Thaddeus S, Maine D. Too far to walk: maternal mortality in context. Social Science and Medicine 1994;38:1091–1110.
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The National Medicine and Therapeutics Policy Advisory Committee [NMTPAC], Zimbabwe Ministry of Health and Child Welfare et al. The Essential Medicines List for Zimbabwe, 6th Edition. Harare: ZMoHCW, 2011.
UN Commission Implementation Planning Meeting. UN Commission, 2012. Accessed 15 July 2013 at: http://www.rhsupplies.org/fileadmin/user_upload/CoLSC/Meeting_Documents/30_Aug_Recommendation_2.pdf
UNFPA. Maternity Waiting Homes Programme: A Summary. UNFPA Zimbabwe, 2013. Accessed 19 June 2013 at: http://countryoffice.unfpa.org/zimbabwe/drive/MATERNITYWAITINGHOMES.SUMMARY.pdf.
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World Bank. Zimbabwe Overview. The World Bank Group, 2012. Accessed 24 July 2013 at: http://www.worldbank.org/en/country/zimbabwe/overview
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APPENDIX A: MISOPROSTOL REGIMENS, POCKET REFERENCE FOR CLINICIANS
CERVICAL RIPENINGDose Route Instructions
400 mcg Vaginal or sublingual Give 3 hours before the procedure.
INTRAUTERINE FETAL DEATHReduce doses in women with not use with previous cesarean section.
Dose Route Instructions13-17 weeks200 mcg Vaginal Every 6 hours, maximum 4 doses.18-26 weeks100 mcg Vaginal Every 6 hours, maximum 4 doses.>26 weeks25 mcg Vaginal Every 6 hours.OR25 mcg Oral Every 2 hours.
MEDICATION ABORTIONUse as permitted within the country’s legal framework.
RegimenMEDICATION ABORTION WITH MIFEPRISTONE AND MISOPROSTOLUp to 9 weeks gestationMifepristone 200 mg oral followed 24 to 48 hours later by misoprostol 800 mcg vaginal, sublingual or buccal. For oral route, 400 mcg misoprostol can be used up to 7 weeks of gestation.9-12 weeks gestationMifepristone 200 mg oral followed 36 to 48 hours later by misoprostol 800 mcg vagi-nal. Subsequent misoprostol 400 mcg vaginal or sublingual can be used every 3 hours until expulsion of the products of conception, up to 4 further doses.12-24 weeks gestationMifepristone 200 mg oral followed 36 to 48 hours later by misoprostol 800 mcg vaginal or 400 mcg oral. Subsequent misoprostol 400 mcg vaginal or sublingual can be used every 3 hours until expulsion of the products of conception, up to 4 further doses.Dose Route InstructionsMEDICATION ABORTION WITH MISOPROSTOL ONLYUp to 12 weeks gestation
800 mcg Vaginal or sublingual Every 3 hours, maximum 3 doses.
12-24 weeks gestation
400 mcg Vaginal or sublingual Every 3 hours, maximum 5 doses.
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APPENDIX B: CONTRACEPTIVE GUIDE, POCKET REFERENCE FOR CLINICIANS
Adapted from: MAQ Exchange: Contraceptive Technology Update
Contraceptive Guide for POSTPARTUM SERVICESPocket Reference for Clinicians
DELIVERY
Condoms/SpermicidesIntrauterine Device (IUD)a
Tubal Ligation
Lactational Amenorrhea Methodb
ALL WOMEN
BREAST-FEEDING WOMEN
NON-BREAST-FEEDING WOMEN
Combined Oral or Injectable Contraceptives (COCs/CICs)c
48 HOURS
3 WEEKS
4 WEEKS
6 WEEKS
6 MONTHS
9 MONTHS
Diaphragm/Cervical Cap
Male Sterilization
Progestin-only Pills or InjectablesCombined Oral or Injectable Contraceptivesc
Progestin-only Pills or Injectables
Emergency Contraception
aIf delivery is in a health care facility, IUD can be inserted immediately postpartum (within 48 hrs).
cDuring the first 6 months postpartum, COCs/CICs may affect the quantity of breastmilk and the healthy growth of the infant. However, if no other methods are available or acceptable, a woman may use COCs/CICs starting 6 weeks postpartum.
bNatural family planning (NFP) may be harder for breastfeeding women as reduced ovarian function makes fertility signs more difficult to interpret. As a result, NFP can require prolonged periods of abstinence during breastfeeding.
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APPENDIX C: UTEROTONICS FOR PPH PREVENTION, POCKET REFERENCE FOR CLINICIANS
MISOPROSTOL
Rural Health Centers: 10 IU intramuscularly (IM)
800 mcg sublingual
ERGOMETRINE0.5 mg IM or intravenously (IV)*Contraindicated when used with certain HIV drugs including HIV protase inhibitor, efavirenz, or delavirdine.
District/Provincial/Central Hospitals: Oxytocin infusion, 40 IU at 30-40 drops per minute
Uterotonics forPostpartum Hemorrhage TREATMENT*
Pocket Reference for Clinicians
*The regimens listed here are from the Zimbabwe PPH treatment protocol developed for operations research.
OXYTOCIN
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APPENDIX D: POSTER FOR PPH PREVENTION
I delivered ata health facility.”
Prevent excessive bleedingafter chilbirth
“I made the Right Choice.“I made the Right Choice.