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UNIVERSITEIT GENT
Faculteit Geneeskunde en Gezondheidswetenschappen
Academiejaar 2013-2014
WORLDWIDE UPDATE OF THE AVAILABILITY, EFFECTIVENESS,
EFFICIENCY AND ACCEPTABILITY OF MISOPROSTOL ON A COMMUNITY
LEVEL - A qualitative approach
Masterproef voorgelegd tot het behalen van de graad van
Master in de Verpleegkunde en de Vroedkunde
Door Cherlet Melanie
Promotor: Prof. Dr. Olivier Degomme
Co-promotor: Dr. Els Duysburgh
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ABSTRACT
Introduction: Postpartum haemorrhage still is one of the leading causes of maternal
death worldwide. Misoprostol is considered to be a good alternative therapy when
oxytocin is not available. Recent studies showed evidence concerning the effectiveness,
feasibility, safety and acceptability of misoprostol, distributed on a community level by
community health workers or traditional birth attendants.
Objective: This study aimed to examine understandings of national policies for
community based use of misoprostol to prevent PPH. It was intended to provide
answers why misoprostol isn’t globally approved as an alternative therapy for PPH, by
gaining insides in the attitudes towards community based misoprostol of policymakers
from different African countries.
Methods: Eighteen qualitative in-depth interviews were conducted with a cohort of
purposefully selected policymakers originating from eleven different African countries.
Interviews were transcribed and analyzed for key concepts with the software program,
Nvivo 10.
Results: Misoprostol has found its way in obstetrics, although mainly for abortion and
induction of labour. Community based distribution is not without concerns. There is
some ambiguity about the current role of the TBA in this process. The main obstacles
related to the implementation of this project are the fear for misuse for illegal abortion,
fear for promoting homebirths and lack of resources, both human and financial.
Conclusion: Overall, there is a relative positive attitude towards the use of community
based misoprostol for the prevention of PPH. Increasing facility based remains the
golden standard but in the meantime, community based distribution of misoprostol is a
fine interim solution.
“Number of words thesis: 15,433 (attachments and references excluded)”
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CONTENT
ABSTRACT .......................................................................................................................................... 3
CONTENT ............................................................................................................................................ 4
FOREWORD & AKNOWLEDGMENTS ........................................................................................... 7
LIST OF ABBREVIATIONS & ACRONYMS ................................................................................... 8
INTRODUCTION ................................................................................................................................ 9
PART ONE: LITERATURE REVIEW ............................................................................................. 11
1. PPH: GENERAL BACKGROUND ........................................................................................... 12
1.1. DEFINITION ................................................................................................... 12
1.2. ETIOLOGY ..................................................................................................... 12
1.3. PREVENTION .................................................................................................. 13
1.3.1. Expectant Management of the Third Stage of Labour ................................................... 14
1.3.2. Active Management of the Third Stage of Labour ......................................................... 14
1.4. TREATMENT .................................................................................................. 16
2. THE ROLE OF MISOPROSTOL IN PREVENTING PPH ..................................................... 17
2.1. BACKGROUND ............................................................................................... 17
2.1.1. Misoprostol as an abortifacient.................................................................................... 18
2.2. GLOBAL AVAILABILITY .................................................................................. 19
2.3. MISOPROSTOL AT COMMUNITY LEVEL ............................................................ 20
2.3.1. The three delay model .................................................................................................. 21
3. METHOD ................................................................................................................................... 23
3.1. LITERATURE REVIEW STRATEGY ..................................................................... 23
3.2. INCLUSION/EXCLUSION CRITERIA ................................................................... 23
3.3. DATA EXTRACTION ........................................................................................ 24
4. RESULTS ................................................................................................................................... 25
4.1. CHARACTERISTICS OF THE STUDIES INCLUDED ................................................ 25
4.2. EFFECTIVENESS/ FEASIBILITY......................................................................... 25
4.3. SAFETY ......................................................................................................... 26
4.4. ACCEPTABILITY ............................................................................................. 27
5. CONCLUSION .......................................................................................................................... 27
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PART TWO: QUALITATIVE RESEARCH .................................................................................... 28
6. PROBLEM AND OBJECTIVE ................................................................................................. 29
7. METHOD ................................................................................................................................... 31
7.1. DESIGN ......................................................................................................... 31
7.2. SETTING AND SAMPLE .................................................................................... 31
7.3. RECRUITMENT ............................................................................................... 32
7.4. DATA COLLECTION ........................................................................................ 33
7.5. DATA ANALYSIS ............................................................................................ 34
7.6. ETHICS .......................................................................................................... 35
8. RESULTS ................................................................................................................................... 36
8.1. CURRENT POLICY FOR THE PREVENTION OF PPH ............................................. 36
8.1.1. Misoprostol ................................................................................................................. 37
8.1.2. Role of the CHW/TBA .................................................................................................. 38
8.2. FEASIBILITY AND ACCEPTABILITY OF COMMUNITY BASED MISOPROSTOL ......... 40
8.2.1. Feasibility ................................................................................................................... 40
8.2.2. Acceptability ............................................................................................................... 41
8.3. IMPLEMENTATION OF COMMUNITY BASED DISTRIBUTION OF MISOPROSTOL ...... 44
8.3.1. Safety & risks .............................................................................................................. 44
8.3.2. Preparation & challenges of implementation ............................................................... 45
9. DISCUSSION ............................................................................................................................. 48
9.1. CURRENT POLICY FOR THE PREVENTION OF PPH ............................................. 48
9.2. SAFETY AND RISKS......................................................................................... 49
9.3. CHALLENGES ................................................................................................. 50
9.4. LIMITATIONS OF THE STUDY ........................................................................... 51
10. CONCLUSION AND RECOMMENDATIONS FOR THE FUTURE ................................. 53
11. SUMMARY IN DUTCH ........................................................................................................ 54
11.1. INLEIDING ..................................................................................................... 54
11.2. LITERATUURONDERZOEK ............................................................................... 55
11.3. KWALITATIEF ONDERZOEK ............................................................................. 56
11.3.1. Methodologie .............................................................................................................. 56
11.3.2. Resultaten ................................................................................................................... 56
11.4. CONCLUSIE .................................................................................................... 57
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REFERENCES ................................................................................................................................... 59
LIST OF FIGURES ............................................................................................................................ 67
ANNEXES: ......................................................................................................................................... 68
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FOREWORD & AKNOWLEDGMENTS
“At times our own light goes out and is rekindled by a spark from another person. Each of us
has cause to think with deep gratitude of those who have lighted the flame within us.” (A.
Schweitzer). To accomplish this thesis, I have been supported by several people. By this,
I would like to express my gratitude to them.
First of all, I would like to thank my promoter Prof. Dr. Olivier Degomme. He was
willing to become my new promoter halfway this year, deputizing for Prof. Dr. Marleen
Temmerman. Then I would also like to thank my co-promoter Dr. Els Duysburgh, who
assisted me during this two-and-half year process. Thank you for sharing your
experience, the useful feedback and providing interesting literature.
Subsequently I would like to express my gratitude to my parents. First of all for giving
me the opportunity to follow this master course but moreover, for always standing by
my side and supporting me in the choices I make. I also want to thank my brother, sister
and other members of the family for their continuous support.
A special word of gratitude to my boyfriend, Michiel. I can imagine I wasn’t the most
pleasant person to live with from time to time. Thank you for having the patience of a
saint and never losing faith in me. My friends I would like to thank as well, for
encouraging me, for the literary advice and for the highly necessary breaks.
Then, a word of gratitude towards my colleagues of the operation theatre may not lack.
Secretly, they allowed me to work in a empty room when it was not busy. And they
were always very understanding and willing to switch shifts when I had a meeting with
my promoters.
Finally, I would also like to thank all the people who agreed to participate in this
qualitative research. Without their cooperation it would never have been possible to
achieve this thesis.
Ghent, August 2014
Melanie Cherlet
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LIST OF ABBREVIATIONS & ACRONYMS
AMTSL active management of the third stage of labour
ANC ante natal care
ANM auxiliary nurse midwife
BEmONC Basic Emergency Obstetric and Newborn Care
BMI body mass index
CCT controlled cord traction
CEmONC Comprehensive Emergency Obstetric and Newborn Care
CHW community health worker
DRC Democratic Republic of Congo
FIGO International Federation of Gynecology and Obstetrics
HEW Health extensional worker
IM intra muscular
IU international units
LRC low resource country
MaNHEP Maternal Health in Ethiopia Partnership
MDG millennium development goal
MMR maternal mortality ratio
NDHSA national department of health South Africa
NSAID non steroidal anti-inflammatory drug
ORS oral rehydration solution
PPH post partum haemorrhage
RCT randomized controlled trial
SBA skilled birth attendant
TBA traditional birth attendant
UN United Nations
WHO World Health Organization
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INTRODUCTION
Postpartum haemorrhage (PPH) is a major cause of maternal mortality, morbidity and
long term disability (World Health Organization [WHO], 2012). An estimated 287,000
maternal deaths occurred in 2010 worldwide (United Nations [UN], 2012). More than
25% of these deaths were caused by PPH (WHO, 2012; Khan, Wojdyla, Say,
Gülmezoglu & Van Look, 2006). The contribution of PPH to maternal death is
disproportionally higher in developing countries due to poverty, malnutrition and lack
of access to healthcare services, although it is largely preventable and manageable
(Mobeen et al., 2010; Tsu, Langer & Aldrich, 2004).
Active management of the third stage of labour (AMTSL) is an evidence based
intervention for the prevention of PPH deaths due to atony (WHO, 2006). The first step
of AMTSL is the use of an uterotonic immediately after childbirth among which
oxytocin (Intramuscular [IM], 10 International Units [IU]) is preferred (WHO, 2012;
WHO, 2009). The downside of this drug is that it requires a cold-chain and certain skills
to be administered since it is an injectable drug (Derman et al., 2006). In developing
regions overall, the proportion of deliveries attended by skilled health personnel is 65%
(United nations, 2012). This means that at least 35% of births in low resource countries
occur outside health facilities without a skilled attendant. In Sub-Saharan Africa, the
region with the highest maternal mortality ratio (MMR: 500 maternal deaths per 100
000 live births [United Nations, 2012]), less than half of births are attended by skilled
health personnel (United Nations, 2012).
The goal of Millennium Development Goal 5 (MDG5) is to reduce by three quarters the
maternal mortality ratio between 1990 and 2015. As the deadline for the MDGs draws
near, the persistently high burden of maternal mortality in low- and middle-income
countries demands a revision of strategies to improve maternal health (Oladapo, 2012).
Misoprostol, an E1 prostaglandin analogue, has been suggested as an important
alternative to oxytocin in low resource settings or home births. It acts as an effective
uterotonic agent, is inexpensive, can be taken orally, does not need a cold chain, and has
a long shelf-life (Derman et al., 2006; The International Federation of Gynecology and
Obstetrics [FIGO], 2012). These factors enable programs for the prevention of PPH
using misoprostol to potentially achieve high coverage and use, particularly among
women who live at a distance from a health facility (Mobeen et al., 2010). “WHO
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endorses the important role of misoprostol in low resource settings by including it in the
WHO Model List for Essential Medicines in 2011.” (WHO, 2013). Secondly WHO
included a recommendation for the distribution of misoprostol by community health
workers in the guidelines for the prevention and management of PPH (WHO, 2012).
The CHWs are non-skilled birth attendants, including auxiliary nurse or nurse assistants
and traditional birth attendants (TBA’s). Generally these women are semi-literate and
haven’t received proper education. They have learned ‘midwifery’ from previous
generations or out of their own experiences but they are widespread and accepted in the
community.
Recently published studies confirm that the drug can be used safely at the community
level through either administration by health providers or distribution by community
health workers directly to pregnant women for self-administration at home (Derman, et
al., 2006; Mobeen et al., 2010; Rajbhandari et al., 2009; Sanghvi et al., 2010).
The main goal of this thesis is to find answers why misoprostol isn’t globally approved
as an alternative therapy for PPH. It consist of a literature review and a qualitative
research.
This literature review aims to synthesize the safety, acceptability, effectiveness and
feasibility of oral misoprostol, administered by community health workers, in home
birth settings in low resource countries by summarizing results of trials and
implementation experiences. The objective is to describe different administration
strategies on a community level and to summarize the apparent success of these
approaches by determining certain variables, being the rates of distribution, coverage,
correct use, and serious adverse events (including perceived PPH and maternal
death),… associated with different distribution and administration methods.
The qualitative part includes the analysis of semi structured interviews of policymakers
of LRCs, Like this a global overview of the attitude towards, the availability, the
effectiveness, efficiency and sustainability of misoprostol use, is provided.
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PART ONE: LITERATURE REVIEW
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1. PPH: general background
1.1. Definition
Postpartum hemorrhage is defined as excessive (≥ 500 ml.) bleeding from the genital
tract occurring any time from the birth of the child to the end of the puerperium
(Henderson & Macdonald, 2004).
Primary hemorrhage refers to the first 24 hours after delivery of the child. This is the
most common and dangerous type of hemorrhage, complicating approximately 2% - 6%
of all deliveries worldwide (Henderson & Macdonald, 2004; WHO, 2012). The
prevalence reaches its highest rates in Africa, where PPH occurs in more than 10% of
all deliveries (Carroli, Cuesta, Abalos & Gülmezoglu, 2008).
The following categories of severity are described (National Department of Health
South Africa, 2010):
- PPH: blood loss ≥ 500 ml
- Severe PPH: blood loss ≥ 1000 ml
- Massive blood loss: blood loss ≥ 2500 ml
Secondary or puerperal hemorrhage occurs after 24 hours and before the sixth postnatal
week and has an incidence of 0,7% - 1,0% (Edwards & Elwood, 2002).
The main focus of this review includes primary postpartum hemorrhage, first of all
because of its higher incidence and mortality rates. And secondly, it wants to investigate
the role of community-based distribution of misoprostol by CHWs to prevent primary
PPH.
1.2. Etiology
The causes of PPH can be classified into four categories, often referred to as the four
“Ts”: tone, trauma, tissue and thrombin (FIGO Safe Motherhood and Newborn Health
Committee, 2012).
The most common cause of PPH is due to failure of the uterus to contract adequately
after birth. Atonic PPH occurs in 90% of all cases and is consequently the leading cause
of maternal mortality worldwide (Carroli et al., 2008; WHO, 2009). In the developing
world, the main risk factors of atonic PPH are pre-eclampsia, prolonged labour and high
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parity (Tsu et al., 2004). Although most women who experience the complications of
PPH have no identifiable clinical or historical risk factors, there are some conditions
that are known to be associated with PPH (WHO, 2012). One factor that increases the
risk of uterine atony is overdistention of the uterus, for example, by multiple pregnancy,
polyhydramnios and fetal macrosomia. Next, we can also ad uterine muscle exhaustion
as a risk factor for uterine atony. This may occur after a prolonged labour, a very rapid
labour, misuse of oxytocin and high parity. The risk for atonic uterine hemorrhage
increases directly with increasing Body Mass Index (BMI). There is a two-fold
increased risk for PPH in obese women (Fyfe, Thompson, Anderson, Groom, &
McCowan, 2012). Other risk factors for atony are fibroids, tocolitical drugs, infection
and retained placenta (Henderson & Macdonald, 2004).
Traumatic PPH occurs when there is a trauma or a laceration in some part of the genital
tract. The incidence of traumatic PPH among all cases of PPH ranges between 7%-20%
(Carroli et al., 2008; Henderson & Macdonald, 2004). Tissue refers to a retained
placenta, membranes or cloths. Unless the uterus is empty, it cannot contract
completely. And finally, thrombin indicates pre-existing or acquired coagulopathy.
Coagulation disorders are a rare cause of PPH, and are usually identified before
delivery.
1.3. Prevention
“Anticipation of risk factors and active management of the third stage of labor,
including the prophylactic application of uterotonics, are considered to be the key points
in the prevention of PPH.” (Rath, Hackethal & Bohlmann, 2012).
During the second half of the 20th century, a cluster of interventions performed during
the third stage of labour became the key component for the prevention of PPH (WHO,
2012). This approach is now known as “Active Management of the Third Stage of
Labour” (AMTSL). The seriousness with which PPH is viewed by professionals is
evidenced in joint policy statements between the International Confederation of
Midwives (ICM), the International Federation of Gynecology and Obstetrics (FIGO)
and the World Health Organization (ICM-FIGO, 2006; WHO, 2003), all of which
recommend AMTSL (Begley, Gyte, Devane, McGuire & Weeks, 2011).
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There are two different approaches to the clinical management of the third stage of
labour: expectant and active management. Although, sometimes a third approach is
used, a combination of certain components of both the active and expectant
management.
1.3.1. Expectant Management of the Third Stage of Labour
The third stage of labour is the timeframe between the delivery of the baby and the
delivery of the placenta. Expectant management of the third stage of labour is also
known as conservative or physiological management. The basic principle of expectant
management is a “hands off” approach. It relies on the natural contractions of the uterus
to separate the placenta from the uterine wall, stimulated by an upsurge of physiological
oxytocin. “The placenta separates as a result of capillary haemorrhage and the sharing
effect of uterine muscle contraction.” (Prendiville, Elbourne, McDonald, 2009). Signs
of placental separation are awaited and the placenta is delivered spontaneously,
sometimes by means of gravity or maternal pushing. Breastfeeding or other ways of
nipple stimulation can be used to increase the level of oxytocin, but are not an essential
component of the expectant management (Begley et al., 2011).
Rogers, et al. (1998) summarizes expectant management as follow:
- No prophylactic uterotonic is administered.
- The umbilical cord is not clamped or cut before the cord pulsation has ceased
but ideally clamping or cutting is performed after the placenta is delivered.
- The placenta is expelled by maternal effort.
1.3.2. Active Management of the Third Stage of Labour
Postpartum haemorrhage may occur in women without identifiable clinical or historical
risk factors. It is therefore recommended that active management of the third stage of
labour is offered to all women during childbirth (WHO, 2009). AMTSL comprises a
number of interventions during the third stage of labour. These interventions are
implemented routinely in an attempt to reduce the blood loss during the third stage of
labour and the risk of PPH. Originally the tree key interventions were:
15
- prophylactic administration of an uterotonic drug;
- early cord clamping en cutting;
- controlled cord traction (Begley et al., 2011).
Recently WHO has reviewed the guidelines concerning AMTSL because of new
evidence (WHO, 2012):
- The use of uterotonics for the prevention of PPH is strongly recommended for all
births. Oxytocin 10 IU, thereby, is the uterotonic of choice and should be
administered intravenous or intramuscular. Secondly, if there is no oxytocin
available, other appropriate injectable uterotonics as ergometrine and
metylergometrine are recommended. And eventually in settings where no skilled
birth attendants (SBA) are present, and oxytocin cannot be administered because of
the lack of required ‘skills’, the administration of 600 µg misoprostol orally by
community health workers is recommended.
- With regard to umbilical cord traction, clamping and cutting, some aspects have
changed. In settings where a skilled birth attendant is available, there is a weak
recommendation of controlled cord traction (CCT) in case of a vaginal birth if the
care provider regards a small reduction in blood loss and a small reduction in the
duration of the third stage of labour as important. In settings where a skilled
attendant is not available, CCT is absolutely contra indicated because of the risks
associated with inaccurate performance. CCT should always be practiced with
applying counter pressure above the pubic bone on a well contracted uterus together
with signs of placental separation. If not, there is an increased risk of partial placental
separation, uterine inversion or rupture of the umbilical cord (FIGO Safe
Motherhood and Newborn Health Committee, 2012).
Early cord clamping, within 1 minute after birth, is not evidence based in the context
of AMTSL unless the neonate is asphyxiated and needs to be removed immediately
for resuscitation (WHO, 2012).
- Uterine massage is also frequently included as part of the active management of the
third stage of labour (FIGO Safe Motherhood and Newborn Health Committee,
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2012). Although, continuous uterine massage is not recommended as an intervention
to prevent PPH in women who have received a prophylactic uterotonic (Abdel-
Aleem et al., 2010). It may disturb the physiological rhythmic pattern of uterine
contraction, cause maternal discomfort and should be performed by a professional.
Moreover continuous massage may not lead to a reduction of blood loss.
Nevertheless, monitoring the uterine tonus by abdominal palpation for early
identification of uterine atony is recommended for all women (WHO, 2012).
Although the effectiveness of Active Management of the Third Stage of Labour is well
documented (Prendiville et al., 2009), there is still a large gap between knowledge and
practice. Other preventive measures related to PPH include reducing the incidence of
prolonged labour, decreasing the trauma associated to instrumental deliveries and
detecting and treating anemia during pregnancy. The consequences of PPH can be
reduced by adequate treatment of antenatal anemia by providing iron and folic acid and
good nutrition prior to delivery (National Department of Health South Africa
(NDHSA), 2011; Tsu, et al., 2004).
1.4. Treatment
Treatment of PPH begins with identifying it. After a vaginal delivery we can speak of
PPH starting from 500 ml of blood loss, after a cesarean delivery the limit is a blood
loss of 1liter. Because there are several causes for PPH and the cause is often not
apparent, management involves a stepwise approach of interventions for all possible
causes applied in rapid sequence until the bleeding stops (NDHSA, 2011).
Generally, PPH requires early recognition of its cause, immediate control of the
bleeding source by medical, mechanical, invasive-non-surgical and surgical procedures,
rapid stabilization of the mother’s condition, and a multidisciplinary approach (Rath, et
al., 2012).
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2. The role of misoprostol in preventing PPH
As mentioned before, AMTSL is an evidence based practice (EBP) and thereby highly
recommended for all births. WHO recommends the use of 10 IU of oxytocin IV of IM.
This requires the presence of a skilled attendant who is capable of giving injections. In
the studies included in this review, at least 50% of all births occurred at home, without
the presence of SBA, cases where oxytocin is not an option.
2.1. Background
There is consensus that misoprostol is a first-line alternative where conventional
uterotonic use is not practicable (Oladapo, 2012). “WHO endorses the important role of
misoprostol by including it in the WHO Model List for Essential Medicines. It is a
prostaglandin E1 analog that was first marketed in the 1980’s to prevent gastric ulcers.”
(Tang, Kapp, Dragoman et al., 2013). Prostaglandins induce strong myometrial
contractions by increasing the uterine tone therefore they are used widely in obstetric
and gynecological practice.
Misoprostol is less effective than injectable uterotonics in preventing severe PPH. It was
associated with a statistically significant higher risk of severe PPH compared to
conventional uterotonics and women who received misoprostol required more
additional uterotonics. But studies show there is a trend towards fewer blood
transfusions with misoprostol (Gülmezoglu, Villar, Ngoc, et al., 2001; Tunçalp,
Hofmeyr & Gülmezoglu, 2012). In comparison to no treatment or a placebo,
misoprostol shows a significant protective effect towards PPH, and a reduced need for
additional uterotonics and blood transfusion (Derman, et al., 2006; Nasreen, et al., 2011;
Mir, Wajid & Gull, 2012; Hoj, et al., 2005; Walraven, et al., 2005; Mobeen, et al., 2011,
…). Therefore misoprostol has attracted considerable attention as an alternative to
oxytocin for the prevention of PPH in resource-poor settings (FIGO, 2012).
Misoprostol is related to a greater risk of adverse effects compared to conventional
uterotonics (Gülmezoglu, et al., 2001). Shivering and/or fever are all commonly
associated with misoprostol. In the WHO multicenter trial, using 600µg oral
misoprostol, shivering was experienced by 18% of women, but temperatures over 38° or
40° were found in only 6% and 0.1%, respectively (Gülmezoglu, et al., 2001). Derman
18
et al. (2006) used 600 µg of misoprostol and shivering occurred in 52.2% of women, but
fever (≥38.5°C) only in 4.2%. Gastrointestinal effects, such as diarrhea, nausea and
vomiting may occur but are rare (FIGO, 2012).
Hofmeyr et al. (2005) analyzed the pharmacokinetics of misoprostol. Sublingual and
oral administration result in the most rapid onset of effects but the sublingual route has
the highest peak concentration. The onset of effects may be slower with rectal and
vaginal route but as with the sublingual route, it has the advantage of prolonged activity
and greater bioavailability.
Most trials used misoprostol 600 µg orally or sublingually. Doses of less than 600 µg
have also been studied in an attempt to reduce the incidence of shivering and fever
because side-effects are shown to be dose-related (Tunçalp, Hofmeyr & Gülmezoglu,
2012; Hofmeyr & Gülmezoglu, 2008). However, results across trials have been
inconsistent. There is some data to suggest that a lower dose of misoprostol may also be
effective and could reduce the incidence of side effects. Hofmeyr, et al. (2009) and
Hofmeyr & Gülmezoglu (2008), in an attempt to compare dose-related effects,
conducted meta-analysis of direct and adjusted indirect data from randomized controlled
trials because data from direct comparisons of different doses were inadequate. Still,
there is a greater body of evidence supporting the administration of a 600 µg dose
(FIGO, 2012). To minimize the risk of potentially dangerous side effects, future
research should aim to identify the minimum dosage which is clinically most effective
by directly comparing 400 µg to 600 µg.
2.1.1. Misoprostol as an abortifacient.
Apart from its role in preventing PPH and gastric indications, misoprostol is also used
for abortion. Its use for medical abortion is actually more profound than for preventing
PPH. “The first report mentioning the potential of misoprostol use for the termination of
pregnancy was published in 1987. Although the investigators recommended not to use
misoprostol in pregnant women, their results must have formed the base for the interest
in the use of misoprostol for termination of pregnancy.” (Chong, Su & Arulkumaran,
2004).
19
Of the 42 million abortions occurring worldwide in 2003, 20 million took place in
countries where abortion is prohibited by law. Every year, approximately 78,000
women die from complications as a result of illegal or unsafe abortions (WHO, 2011).
Misoprostol is widely used as an abortifacient after its introduction in 1986. Because of
its uterotonic and cervical ripening activity, even today it is used for medical abortion or
cervical preparation before surgical abortion.
Through the years it has drawn the attention of the ‘off-label” users, especially of
women living in countries where abortion is illegal or where it is legal only in limited
circumstances such as rape or to save a woman’s life (Chong, Su & Arulkumaran,
2004). The use of misoprostol for self-induced abortion is not without any risks. If
women take the incorrect dose or they take it at the wrong time, there is a chance of
incomplete abortion and required subsequent uterine evacuation.
2.2. Global availability
Misoprostol is approved in more than 80 countries for the prevention and treatment of
gastric ulcers caused by long-term nonsteroidal anti-inflammatory drug (NSAID) use
(Chong, Su & Arulkumaran, 2004). Seventy percent of all the misoprostol sold
worldwide is the combination misoprostol-NSAID drug, which is used for its initially
approved goal: prevention of gastric ulcers. 91% of those sales are to Western Europe,
Canada, and the United States (Fernandez, Coeytaux, Gomez Ponce de León &
Harrison, 2009). Asia consistently had the highest use of misoprostol-only products.
Originally the upsurge was situated in Japan, between 2002-2007. Currently the
population is aging and abortion services have long been accessible. So misoprostol is
being used mainly, as it appears, in the United States, Canada, and Western Europe, as
prophylaxis for NSAID-induced ulcer disease (Fernandez et al., 2009). The real growth
in Asia occurred in India, where sales of misoprostol-only drugs increased by 646%
since 2002, Bangladesh (128% rise) and Indonesia (116% rise). The market growth in
these countries is probably related to the increased use of misoprostol in obstetrics. In
India, for instances, misoprostol is approved for PPH, termination of pregnancy, and
cervical ripening (Fernandez, et al., 2009). Unfortunately, the sales data for Sub-
Saharan Africa are limited. Until recently, misoprostol was registered in few African
20
countries, even for gastrointestinal indications. In the past few years, however,
misoprostol has been registered or approved for obstetric purposes in several countries,
including Ghana, Nigeria, Sudan, Ethiopia, Kenya, South Africa, Tanzania, Uganda,
Zambia, … (cfr. Figure 1). This region has the highest rates of maternal mortality and
morbidity worldwide, mainly resulting from PPH and complications of unsafe abortion
(United Nations, 2012). In this region, increasing the availability and accessibility of
misoprostol could significantly reduce the maternal death rate.
Figure 1: Global approval misoprostol - Gynuity Health projects. Accessed on: http://gynuity.org/downloads/mapmiso_en.pdf
2.3. Misoprostol at community level
Because most life-threatening complications occur during or near birth, access to a
skilled attendant and to emergency obstetric care are seen as essential solutions for
preventing maternal mortality. However, despite the necessity of these strategies, local
conditions in many countries limit the extent to which this care can be made available to
every woman who needs it. (Spangler, Gobezayehu, Getachewmm & Sibley, 2014).
Misoprostol has been proven to be effective in a medical setting, so the question arose
whether it would be feasible, safe, effective and acceptable when distributed on a
community level. “Since misoprostol does not require a skilled provider or cold chain
21
and therefore can be provided or stored where there is no electricity, it enables programs
for the prevention of PPH using misoprostol to potentially achieve high coverage and
use by women who live at a distance from a health facility.” (Smith, Gubin, Hoslton,
Fullerton & Prata, 2013). Besides, training CHWs for the administration of misoprostol
in low-resource setting seems a particularly cost-effective intervention. Rajbhandari et
al., (2010) concluded that the largest gains in the protection against PPH were realized
by the poor, the illiterate and those living in remote areas.
2.3.1. The three delay model
A helpful way to analyze the barriers to utilization is through the “three delays model”
(Thaddeus & Maine, 1994). It is a useful framework to identify the points at which
delays can occur in the management of obstetric complications, and to design programs
to address these delays.
The first delay covers the decision to seek appropriate medical care. This is influenced
by actors involved in decision making e.g. socio-cultural factors, distance from the
health facility and financial aspects.
The second delay is about reaching an appropriate obstetric facility which depends on
how far the nearest facility is in terms of distance, availability and cost of transportation
and road conditions (Thorsen, Sundby & Malata, 2012). So the first and second delay
relate directly to the obstacle of access to care.
Finally the third delay covers, receiving adequate care when a facility is reached. This
includes shortages of supplies, equipment, and trained personnel (Thorsen, Sundby &
Malata, 2012). The third delay relates to factors in the health facility, including quality
of care.
Misoprostol used on a community level could have an impact on each of the three
delays. In case women do not seek care in time, regardless the reason, misoprostol
offers a solution by bringing the care to the women. Making it available and acceptable
in the community by arising the awareness. This is in line with the second delay, which
also covers the problem of access.
Given the fact that misoprostol does not need a cold chain and can just be taken orally,
it covers the problem of the third delay. Misoprostol can be easily stored in the smallest
22
health post and even nurse assistants or community health workers are able to provide
it.
Nevertheless it is important that community-based use of misoprostol for PPH
prevention should not be considered as a replacement for skilled attendants or
emergency obstetric care, but rather as a supplementary intervention for women served
by health systems that are not yet able to make more comprehensive services widely
accessible.
Figure 2: The three delay Model, Accessed on http:// www.unfpa.org/public/mothers/pid/4385
23
3. Method
3.1. Literature review strategy
PubMed, Google Scholar and Science Direct where searched for suitable literature,
using the keywords “misoprostol”, “postpartum hemorrhage” or “postpartum
haemorrhage” and either “home” or “community”. The results of this search were
supplemented by using “the snowball method” and eventually some of the studies were
withheld by an online hand search of the grey literature. This review strategy was
limited to publications ranging from 2005-2014, written in English, French or Dutch
and full-text available.
3.2. Inclusion/exclusion criteria
First the search was limited by study design. Only randomized controlled trials (RCTs)
were included. Secondly quasi-experimental designs as non randomized controlled trials
were included as well to get a better global view on the distribution of misoprostol on
community level.
Next the search strategy took into account the participants and the intervention. Studies
situated in low resource countries (LRCs) were included. LRCs were defined as any
country in the World Bank economy groups of ‘low income’ or ‘lower middle income’.
Only studies of oral misoprostol compared to a placebo or no treatment were included.
Furthermore, these results were limited to homebirth settings. There was no distinction
between sublingual or oral misoprostol. Because either sublingual or oral administration
result in the most rapid onset of effects compared to other routes of administration
(Hofmeyer et al., 2005).
There were no selection criteria used concerning the outcome measures given the focus
of this review. Studies reporting safety, effectiveness, acceptability en feasibility were
all included.
24
3.3. Data extraction
Taking the above mentioned inclusion criteria into account, a first selection was done
based on the title. In a second phase the abstracts were screened. Studies were included
if they were conducted in LRCs, in a home-birth setting and compared oral misoprostol
with a placebo or no treatment. Studies evaluating the use of misoprostol administered
by other routes, in facility settings or for other reasons than the prevention of PPH, were
excluded. Additional studies were identified trough the reference list of the retrieved
trials. This resulted in a total of eight included studies.
25
4. Results
4.1. Characteristics of the studies included
Three of the eight studies were RCTs, two of them were double blinded. The other five
were quasi experimental non randomized trials. All studies, except for one, used the
current WHO recommended dose of 600 µg of misoprostol, manufactured as three
tablets of 200 µg. Nasreen, Nahar, Al Mamun, Afsana & Byass (2011) were the only
one’s using a dose of 400 µg. All studies were conducted in a non-clinical, home-like
setting. Seven of the eight studies were focusing on home birth only. Derman et al.
(2006) also included ‘sub centers’, a village facility with no doctor present. In five
studies misoprostol was distributed and administered by a type of community health
worker (TBA, community health worker [CHW], auxiliary nurse midwife [ANM]) at
time of birth. In the remaining three studies, misoprostol was distributed following
counseling at some point during antenatal care, ranging from ‘at some point during the
third trimester’ to ‘two weeks before the delivery’. In these settings women
administered misoprostol themselves. Self-administration (n = 3; 37.5%) and
administration by TBA’s (n = 3; 37.5%) were the most common methods used for
administration of the drug. Details of the individual study results are available in annex
1.
4.2. Effectiveness/ Feasibility
All eight studies investigated some measure of effectiveness. Six of them investigated
the clinical effectiveness of misoprostol administered on a community level compared
to a placebo or other drug. They demonstrated a reduced risk for PPH and severe PPH.
Also a reduction in the average blood loss was shown. In the two remaining studies,
researchers did not feel the need to demonstrate the clinical effectiveness, given the
previous evidence in either a facility based or community based setting. Those studies
focused on emergency transfer, blood transfusion and other birth complications. For all
of these outcome measures a reduction of incidence was demonstrated in the
intervention groups. Furthermore, misoprostol also appears to grant benefit by reducing
the need for manual placenta removal and a drop in hemoglobin postpartum.
26
There was also interest to which extend community based distribution is feasible. There
are still very high home birth rates in some LRCs which implies a large number of
women to be reached. Based on the expected number of new pregnant women in a
certain time frame, the uterotonic coverage was calculated in three of the studies.
Results were ranging between 70% and 92%, indicating a high feasibility. One study
used the time elapsed from child birth and consumption of misoprostol as an outcome
measure for feasibility. The results showed that CHWs are able to reach 46% of the
parturient within five minutes and 27% within ten minutes. A total of 92% of women
can be reached within thirty minutes after the birth of the baby to administer
misoprostol.
4.3. Safety
All eight studies confirmed a higher incidence of shivering and fever after taking
misoprostol. However, none of these side effects required an additional treatment or
referral. Shivering is also seen in the control groups as a natural consequence of
delivering. There is also a slightly larger chance on nausea, vomiting or diarrhea but in
most of the studies there was no significant increase in the intervention group.
It is shown in four studies that TBAs or CHWs can be trained to safely administer
misoprostol without the presence of a skilled birth attendant. All women, except for
one, took misoprostol at the correct time, being after the birth of the baby. Nevertheless
there is a small percentage who took it after the delivery of the placenta. The woman
who took misoprostol before the birth of the baby was expecting an undiagnosed twin.
She took the tablets after the birth of the first child. The second child was stillborn, but
autopsy demonstrated that the death was not caused by the use of misoprostol.
There occurred some maternal deaths in three of the studies, but none of the cases were
related to PPH or misoprostol. None of the studies were large enough to detect a
difference in maternal mortality due to PPH.
27
4.4. Acceptability
Two studies investigated whether community based distribution of misoprostol is
acceptable for the women. Results showed a positive attitude towards the use after a
home delivery. Firstly, side effects are not seen as a barrier to take misoprostol. The
protective effect against PPH is considered as more important. Subsequently 80% of
women said they would use misoprostol in the future. Almost all of them would
recommend it to a friend. And 74% to 88% of women stated that they are willing to pay
for misoprostol in the future. In general the use of this drug in a home based setting is
relatively well accepted by husbands and mothers-in-law as well. There are very few
cases mentioned where the husband did not agree with taking misoprostol after the
delivery. Other reasons mentioned for not taking it are lack of knowledge, not believing
in the use of misoprostol and the CHW or drug was unavailable at the time of delivery.
Finally, this strategy is experienced as more acceptable by women because it is
supported by the TBA from their community (Mir, Wajid & Gull, 2012).
5. Conclusion
Misoprostol has proven to be an effective, safe and acceptable alternative for oxytocin
in both facility based and home based settings. Semi-literate TBAs or CHWs can be
trained properly to distribute misoprostol in the community. They can reach a high
percentage of women and are able to successfully educate them and provide them with
misoprostol either at time of birth or at some point in the third trimester for self-
administration. Literature shows that community based distribution of misoprostol does
not promote homebirths. “Study results provide positive evidence that pregnant women
are more likely to seek childbirth care and are not inclined to homebirth because they
have a drug that can prevent PPH.” (Sanghvi et al., 2004).
Women feel misoprostol is acceptable and they are able to safely and correctly use the
medicine. For many countries where universal access to a skilled birth attendant is far
from being achieved, this approach offers an effective interim solution to prevent PPH
and possibly reduce maternal mortality.
28
PART TWO: QUALITATIVE RESEARCH
29
6. Problem and objective
Postpartum haemorrhage still is one of the leading causes of maternal death worldwide.
And although it can easily be prevented, still at least a quarter of maternal deaths is
caused by PPH (WHO, 2012). WHO recommends AMTSL for the prevention of PPH
due to atony. This implies the administration of 10 IU of oxytocine immediately after
the delivery of the child. Since oxytocin is an injectable, it should be administered by a
professional.
The ultimate purpose in improving maternal and child health emprises improving the
access to health services and assuring skilled attendance for all deliveries. Despite
global efforts to ensure this, more than half of the deliveries in Sub-Saharan Africa
occurs outside a health facility (Mobeen et al., 2010). This entails that the routine
administration of oxytocin is impossible, given the fact that a skilled birth attendant is
absent.
Misoprostol has been suggested as an interesting alternative to oxytocin in the
prevention of PPH. Several studies have demonstrated the efficacy of this drug in a
medical setting and results are promising (Caliskan et al., 2003; Raghavan, Abbas, &
Winikoff, 2012). Recently the question arose whether misoprostol is as effective and
safe when distributed on a community level by a TBA or CHW? It has been confirmed
by different researchers that misoprostol also has a protective effect against PPH in a
home based setting. Few women need additional treatment or referral. Moreover, it can
be safely administered by semi-literate health workers and is experienced as acceptable
for the community.
In many low resource countries universal access to skilled care at birth is a distant
reality. For these countries the use of misoprostol on a community level could provide
an interesting interim solution (Mir et al., 2012).
“In 2010 the Maternal Health in Ethiopia Partnership (MaNHEP) project developed a
community-based model of maternal and newborn health focusing on birth and early
postpartum care. The model included misoprostol to prevent postpartum hemorrhage.”
(Sibley et al., 2014). Spangler et al. (2014) conducted a qualitative research to
30
understand the attitude towards the national policy for community-based use of
misoprostol in two regions of Ethiopia.
Although the evidence has been shown in the literature, ministries of health in some
countries are still grappling with policy that addresses the implementation of this
targeted intervention in community settings and with communicating this policy
throughout the health care system (Spangler et al. 2014).
The purpose of this qualitative study is to examine understandings of national policies
for community based use of misoprostol to prevent PPH in sub-Saharan Africa. It is
intended to provide answers why misoprostol isn’t globally approved as an alternative
therapy for PPH, by gaining insides in the attitudes towards community based
misoprostol of policymakers from different African countries.
31
7. Method
7.1. Design
In line with the problem and objective a qualitative exploratory approach was chosen to
perform this research.
“Qualitative research methods are gaining in popularity outside the traditional academic
social sciences, particularly in public health and international development research.”
(Mack, Woodsong, MacQueen, Guest & Namey, 2005). “An important added value of
qualitative research is the culturally specific and contextually rich data it produces. Such
data are proving critical in the design of comprehensive solutions to public health
problems in developing countries.” (Mack et al., 2005).
Through qualitative research we aim to understand how people interpret their
experiences, how they construct their worlds and what meaning they attribute to their
experiences (Merriam, 2009).
Qualitative research is especially effective in obtaining culturally specific information
about the values, opinions, behaviors, and social contexts of particular populations
(Mack et al., 2005).
7.2. Setting and sample
The study focuses on policymakers that are active on national and sub national (district)
level, local researchers and people involved in research of maternal care. The choice to
recruit on policy level was made on the one hand because those people have a sufficient
knowledge about the subject and moreover, health policies depend on their decisions.
On the other hand, this decision was made out of practical considerations. Given the
relatively little time and resources, it was not possible to perform face-to-face
interviews. Subsequently, the sample had to be limited to people who possess the
resources to have a long distance conversation. Nevertheless it would have been very
interesting for the outcome of the study to recruit in the field.
Participants in this study were recruited in different low-resource countries with special
attention to sub-Saharan Africa given the high percentage of births not attended by
32
skilled health professionals. An attempt was made to recruit in as many different
countries as possible to guarantee a geographical diversity.
Given the difficulty to be in touch with possible participants, a purposive sampling was
preferred. The sample size was based on theoretical saturation. Every participant was
asked if he/she knew possible candidates for the study. So by the use of a “snowball-
method” an extra amount of participants was found.
A total of 77 possible candidates were asked to participate of which 18 eventually
confirmed. Three of the possible participants showed interest but when the time and
date for the interview drew near, they withdrew. Two participants dropped out because
they did not meet the criteria and three of them answered after the deadline of
recruitment. Eventually 51 of them never gave any response.
The sample consists of five women and thirteen men. The age of the participants varied
between 29 and 64 years. There were no specific limitations included concerning age,
though it was expected from participants to have some knowledge about the policy and
use of misoprostol in their country and to be still active in the field so they could give
relevant information. This was automatically linked to an adult age. Participants
originated from eleven different African countries. Two of them were born in the
Democratic Republic of Congo (DRC) but had their working experience elsewhere.
More information about the participants can be found in annex 2.
7.3. Recruitment
Participants were recruited by one researcher from 18th of March 2014 until the 30
th of
June 2014. Recruitment of possible participants was done by e-mail. A first general
e-mail was sent with limited information about the subject of the study. Originally it
was mentioned as an investigation about the prevention of PPH, without mentioning
the use of misoprostol on a community level. This was done to minimize the risk of a
biased selection. The second purpose was to avoid that possible participants would
review relevant literature and answer accordingly. After 14 days a reminder was sent.
33
When they agreed to participate, an appointment was made to conduct the interview by
phone of by Skype conversation. Simultaneously, the participants received an additional
information letter (annex 5, 6 and 7) about the subject of the study and the informed
consent form (annex 8, 9 and 10). This information letter was the first document
containing information about misoprostol used for the prevention of PPH at a
community level.
A small part of participants was recruited in a Belgian research institution. Due to their
temporary stay in Belgium they were contacted by mail. The same procedure as
mentioned above was applied, only they received an actual letter instead of an e-mail
and the interview was performed face-to-face. New participants were recruited until
saturation of the results was achieved.
7.4. Data collection
Semi-structured in-depth interviews were conducted to receive data from the
participants. This method is very useful to learn about the perspectives of individuals.
Moreover, it’s an effective method for getting people to talk about their personal
feelings, opinions and experiences. It’s a good opportunity to understand how people
interpret the world (Mack et al., 2005). The majority of conversations were held in
English, only three of the interviews were performed in French. The average duration of
an interview was 35 minutes. The interviews were done by one researcher between the
period of the 21st of March and the 3
th of July. The time and date of the interview was
always chosen by the participant, so the conversation could take place at the most
appropriate time for them. Eight conversations were done by Skype, seven over the
phone and three interviews were done face-to-face. Regarding the telephone
conversations it was always very clearly stated in advance that the researcher would
take the initiative to call and cover the costs. For the three interviews who took place
face-to-face, the participant was also given the choice when and where the interview
could proceed. This was done to maximize the convenience of the participants, so
they’d feel comfortable to share information.
34
In order to ensure a more or less simultaneous progress of the interviews a semi-
structured interview guide was used (see annex 3 and 4). Both personal experiences and
opinions were questioned. The interview guide was comprised of seven main questions
with related probes. The conversation always started with collecting some background
information about the participant e.g. age, country of residence and professional
experience.
Secondly, some general information was asked about the current prevention of PPH and
about the organization of obstetric care in the interviewee’s country. Through these
questions, participants already had a first possibility to talk about misoprostol: if it was
implemented in their country, whether or not by community distribution. In this context
there were also some questions about the role of CHW’s in pre- and postnatal care. This
all led to the main focus of the interview: How do you feel about misoprostol being
available at community level and administered by CHWs for the prevention of PPH?
Some additional questions were:
- How do you feel about risks (safety) and use of misoprostol by CHWs?
- Do you have suggestions for the implementation of misoprostol on a community
level to prevent PPH? If so what are your suggestions?
- What do you think are the biggest challenges/obstacles of community-based
distribution?
- How do you think the local population would feel about community based
distribution?
All interviews were recorded on tape to facilitate the natural progress of the
conversation without interruptions. This was also done to support the data analysis in a
later stage.
7.5. Data analysis
Each interview was re-listened and transcribed. To guarantee the accuracy of the
transcription, the interviews were listened again, while reading the transcript and
adapted if necessary. The more interviews were analyzed, the less new data came
forward. Saturation was reached after analyzing 18 interviews. Final transcripts were
35
entered in a qualitative data analysis software program, Nvivo 10, and coded for key
concepts by a single researcher.
7.6. Ethics
Before the start of this study, approval was obtained from the Ethics Committee of the
University of Ghent (EC/2014/0245). All participants who agreed to cooperate, received
a information letter in which the goal of the study was briefly explained. Furthermore,
the letter also clearly explained what the privacy policy was. In the time between
receiving the letter and the actual conversation, participants were given the chance to
contact the interviewer at any time with further questions. Next, it was also clearly
stated that participants had the right to withdraw from the study at any time. No
participants did. Finally, an informed consent form was sent together with the
information letter.
Before the start of the interview the goal and privacy policy of the study were orally
repeated. Participants were asked if they had any questions left about the study. Finally,
oral permission was specifically asked to those participating through Skype or a phone
call. The ones who were able to do a face-to-face interview were asked to sign the
informed consent form. The oral permission was confirmed on tape. All interviews were
recorded on tape and erased after transcription.
36
8. Results
In this chapter the results of the research are described. First, an overview of the current
policies and trends for the prevention of PPH is provided, including the role of
misoprostol in obstetrics. Then, a summary of the attitude towards the feasibility and
acceptability of community based use of misoprostol is given. This part includes
opinions on the use of the drug, distribution by semi-literate CHWs and the association
with abortion. Finally, the last paragraph comprises information about opinions of
actual implementation of misoprostol in the community. A distinction is made between
the safety and risks of this intervention and possible challenges and obstacles that can
be faced during implementation.
8.1. Current policy for the prevention of PPH
Predominant answers to the questions about the current prevention of PPH were
focusing on facility based deliveries and AMTSL, whereby the preferred uterotonic was
oxytocin. A minority of participants stated that ergometrine is still used in their country.
Also misoprostol has found its way in the prevention of PPH in a hospital based setting.
A clear distinction in two different approaches towards community based distribution of
misoprostol appeared. The majority of participants was in favor of the idea, although
some of them not without concerns. A small part of participants did not think
community based distribution is a solution for the maternal mortality problem. They
prefer a broader health system approach rather than implementing PPH prevention as a
vertical approach. A strategy, often stated, to provide this comprehensive care was the
implementation of adequate Basic and Comprehensive Emergency Obstetric and
Newborn Care (BEmONC and CEmONC).
“We need many other things…. We need to work in a comprehensive package…
I strongly suggest for any kind of large scale intervention related to community based
intervention, to take into account we need to have a comprehensive approach, we need
to have the continuity, to work really on the continuity of care.”
37
A few participants are very well aware of the fact that the current obstetric care does not
meet the needs of the population. It is widely agreed that facility based care is a golden
standard. But this is a project on the long term that already has been going on for many
years without progressive results. They state that there is an urgent need for an
intermediate solution. For those people it is clear that misoprostol is not a substitute for
facility based deliveries and skilled attendants but a good alternative awaiting the
improvement of the healthcare system.
“Yeah I think it’s just a matter of being realistic. Being here in Europe, you may
think that it’s not obvious to implement it. But the reality is different. People in the
village are there, they don’t think about going to deliver to the health facility, yeah. Are
we going to let them die? No! We should provide something, by the time we are
improving access to healthcare.”
“… There is a saying in French: le mieux est l’ennemie du bien.[…] It means
that the best is the enemy of the good. So the best in this case is facility based deliveries
with skilled birth attendants with CEmONC,… but in the meantime….”
8.1.1. Misoprostol
Misoprostol has found its way into the hospital setting, although its predominant use is
not for the prevention of PPH. The aim is to have BEmONC services available
everywhere, which means parenteral uterotonics, e.g. oxytocin, should be available.
“It doesn’t state in our protocol that the midwife should give misoprostol,
because you know, with the ‘BEmONC’ they are supposed to give the parenteral
drugs.”
The main use of misoprostol in a hospital setting is for the induction of labour, abortion
and post abortion care. There was only one participant who mentioned the use of
misoprostol outside the context of obstetrics, being for gastric implications.
38
“You know, misoprostol is mainly used for…. In Namibia it’s used mainly for
gastric indications, for stomach acidity… and so on. That has been the main
indication.”
8.1.2. Role of the CHW/TBA
The interviews showed that policies about the role of the TBA are very divergent. Some
countries want to face out the role of the TBAs completely. They believe the solution
for improving maternal health can be found in a more comprehensive approach of care
e.g. by providing sufficient BEmONC and CEmONC facilities, by providing all signal
functions, by increasing the coverage for antenatal care (ANC),…
“Malawi has been pushing for facility based giving birth. So… the government
has banned the TBAs.”
Other countries integrate the TBA in the health system for referral and assistance of
women to the nearest health center. Even within this level of integration there are
differences in the amount of responsibilities they get. In most countries their function
only comprises referring and accompanying the pregnant women, while the minority of
countries also gives them a role inside the health center. They are there to assist the
midwife and to comfort her patient.
“It is not allowed for village midwifes to practice the delivery. But it is allowed
for them to accompany women to health facilities for giving birth.”
“They bring the women to the midwife, they (the midwifes) allow them to be part
of the delivery. So the woman is not left alone and she knows that the women who was
supposed to deliver her, will stay with her. So it makes them comfortable”.
A few countries endorse community based distribution of misoprostol. In Ethiopia, for
instance, this project is already in a well advanced stage. Mozambique has conducted a
pilot project in some districts of community based distribution of misoprostol by CHWs
and TBAs and are now waiting for national implementation. In Ghana, misoprostol is
39
also used by CHWs although there is a difference in the policy. In Ethiopia and
Mozambique the administration of misoprostol is systematically done, whether in
Ghana the CHWs only give misoprostol in case of a bleeding to stabilize their patient,
awaiting the transfer to a higher level of care.
“But at community level, we have done a pilot intervention in 4 districts using
misoprostol distributed in two ways: through the ANC clinics and through the TBAs.
So… and then the result was used as a support of this policy, I mean, to build up the
policy of the country. So now the strategy has been approved, we are in process at
national level to produce action plans at the same time to see the better ways of
implementing it”.
Although facility based deliveries are the norm, most sub-Saharan countries still have a
very high home delivery rate. Some of the participants admitted that, whether they like
it or not, the TBA still is an valuable player in the process of labour and delivery. As
long as there is no universal access to healthcare for everyone, TBAs and CHWs can
help as an interim solution.
“Because to be honest, now, those people (TBAs) are saving lives in some way.
Yeah, they are saving lives,…. They are helping, …. But sometimes their responsibility
can be questionable to people because they are wondering…. Ok they perform
deliveries but what happens if it gets complicated?… But sometimes I think we minimize
their abilities and what they do. I think they do more than what we think….”
“Yes we need deliveries with SBA… Yes we need to improve the care for women
and refer them to the facilities. But the reality on the ground is that the TBAs are the
only ones available and the facilities are far away. This results in the second and third
delay.”
40
8.2. Feasibility and acceptability of community based misoprostol
8.2.1. Feasibility
Overall, the opinions about the feasibility of community based distribution of
misoprostol were quite positive. The most common topics within this subject were the
easy use and conservation, importance of training, uniformity of recommendations and
gradual implementation and evaluation.
All participants agreed on the fact that misoprostol is an ideal drug to use in low
resource settings because it doesn’t require any cold chain. There was only one person
who expressed his concerns about the conservation at very high temperatures, above 35
degrees. Besides that, there was an overall agreement that the oral intake is an important
benefit in settings were skilled personnel cannot always be guaranteed. Especially
where the population is very scattered and lives at a distance from a health facility,
people feel this as an attainable solution.
“And misoprostol is easy because we can give it to the TBAs and they can just
give it or the women can take it themselves. They can take it. So, it doesn’t change in
hot temperature. So, I think, and this is my personnel opinion and of my colleagues here
in my country: we are convinced.”
“If we use misoprostol at a community level, we can at least help those who
cannot reach the hospital!”
None of the participants considered community based implementation as an unrealistic
goal. All of them agreed that it is necessary to be well prepared prior to the actual
implementation. This means in terms of education of either the TBAs and the
community, clear communication on different levels and a good protocol for gradual
implementation and evaluation. If all of these conditions are fulfilled, they feel it is
possible to establish a well working system. These topics will be described more into
details in the chapter concerning implementation.
41
“When we start, we should be humble during implementation. We should start
small to see what are the challenges and growing. So I believe that… not tomorrow, but
maybe in 2-3-4 years we could be able to make sure that all the women living in the
country have access to something to prevent dying from PPH.”
“Well as long as we standardize the message and the steps… which should be
followed, I don’t see it as a big problem. It’s important to have these standardized
criteria before we start because we should make sure that everyone is using the same
materials. Not one using this, another one using that…. And then create at lot of
information circulating in the community and we end up with confusion and with no
other things to happen. ”
8.2.2. Acceptability
The use of misoprostol for the prevention of PPH has always been a controversial
subject because of its use for abortion. In many African countries, with the exception of
South Africa and Tunisia there still is a restricted abortion policy, meaning abortion is
only allowed in case of rape, incest or when it’s explicitly permitted to save a woman’s
life. In the Democratic Republic of Congo, Central African Republic and Gabon for
example, the law does not even make this explicit exception to save a woman’s life.
This results in a very high amount of illegal and unsafe performed abortions, which
often result in maternal mortality and morbidity (WHO, 2011). The use of misoprostol
in a hospital setting is generally accepted for all purposes but when we are talking about
community based distribution policy makers are concerned that misoprostol would end
up being used for illegal abortions. This will be further discussed in the next chapter
about challenges and obstacles.
Another question arising was whether it is acceptable to distribute misoprostol through
TBAs or CHWs, who have a very limited or completely no formal education. Many
African countries are familiar with the cooperation with CHWs but most of the time
their function comprises health promotion and health education. Although, there were
42
some participants who said the CHWs start to have a greater responsibility for example,
by distributing contraception or oral rehydration solutions (ORS).
“So CHWs do a whole range of activities, not just maternal and child health.
But most of them do individual health promotion and prevention, so they don’t really do
interventions to prevent PPH. Apart from doing home visits and encouraging women to
deliver at health facilities or encourage women to visit the health facility after delivery.
They’re also used to distribute family planning. So they distribute contraceptives out in
the community.”
Nobody believed CHWs or TBAs are entirely unsuitable for this job. Moreover a few
participants even considered them to be very appropriate for this job because the
government is already used to work with them. On the other hand, most of the time
these are highly respected people in the community and they earn a lot of trust. There
was an overall agreement that they’ll need a very intensive training but apart from that
there were no remarks about using CHWs or TBAs to distribute misoprostol.
Finally participants were asked what they thought about the acceptability for the
community. How do they think the local population would feel about using a drug that
initially is used for provoking an abortion.
Most of the participants agreed on the fact that initially, there is a chance on
preconceptions given the fact that abortion still is a large taboo in quite a lot of
countries. One participant stated that the attitude towards abortion is a combination of
socio-cultural and religious considerations. People have a ‘pro-life’ mentality. This
could cause some restraints towards this drug. Others were concerned about the
‘internal communication’. People living in rural areas have access to mobile phones and
sometimes to the internet and when you introduce something new it’s only a matter of
time before the news spreads. Like this, they feared false information could be spread in
the community.
However, every participant did agree on the fact that clear communication and
education can resolve these preconceptions. There is a need to make a clear
differentiation between taking the drug to interrupt a pregnancy and taking it when the
43
baby is already born. All participants stated that if people clearly understand what the
use of misoprostol after delivery is, they will use it on a community level.
“And off course you need to increase the awareness of the community that this
drug is available, this drug is effective. To community engagement… to ensure they
understand that this drug is effective for PPH. Because you know, some of our
communities are rural and the level of education is low and because of that there is a
lot of socio-cultural influence. So they have very strong beliefs. They might not take up
that intervention very positively, if they’ve not been engaged.”
The loss of a woman, especially during pregnancy or giving birth, is a big drama for the
entire community. Women are considered as the driving factor of the family. If people
understand that misoprostol can prevent this, they will be likely to accept it. Moreover
as mentioned before, the TBA is a well known and highly respected person within the
community who represents new life. That is why some participants are convinced that
TBAs are the right person to educate their community about the use of misoprostol for
the prevention of PPH.
“I think they would appreciate it, you know, when a mother dies in a village
during pregnancy or delivery, it’s really very shocking! You lose an adult who was
healthy and wanted to give life and who leaves many orphans. And you know, men don’t
know how to take care of children. In most of the households, women also are
supporting the economy of the household. When there is really a maternal death, it is
really a big shock. And for that, nobody would be against that!”
Finally, all participants who already have introduced a similar project, were all giving
positive reactions about how the community feels about it. They all clearly understand
what it’s used for, what are the benefits, when to take it,… Moreover, in Mozambique
they introduced a pilot study to test this approach. When the study was ended, women
were actually disappointed that misoprostol was no longer available.
44
“People were starting to demand for it: “We need it.” But afterwards they
realized it was just short-term thing. And the ones who didn’t know were disappointed
and hope to see it soon.”
8.3. Implementation of community based distribution of misoprostol
Through the answers of the interviewees it became clear that the implementation of
community based distribution of misoprostol would not be a track without obstacles.
8.3.1. Safety & risks
Without any doubt, the fear for misuse of misoprostol was the most predominant issue
mentioned by almost all participants when they were questioned about challenges and
risks. They fear when misoprostol is stocked by CHWs or TBAs, it might end up in the
hands of the wrong persons who will sell it on the black market for illegal abortion.
However, opinions were not consistent and a few participants actually believe in the
responsibility of the TBAs and don’t see them selling misoprostol purposefully for
misuse.
To prevent misuse, they suggest to train TBAs well, provide them with a small stock of
misoprostol and organize a system whereby all pregnant women who receive
misoprostol are registered in a logbook. This all needs to be strictly supervised.
“Misuse of misoprostol would depend on how you train them, yeah. If you give
them a proper training about the use of misoprostol I think, they will use it well. Those
TBAs have a lot of experience.”
Unfortunately, unsafe abortion is commonly present in Africa (WHO, 2011). There was
one participant who stated that since the problem is already there, he even prefers illegal
abortion to happen with misoprostol because it’s safer than using traditional means.
“And even if some of this misoprostol will end up being used for abortion, it’s
better than having these women doing abortion with other kinds of things which happen
at a community level. Because right now, the abortion is there. And people are using
45
means that you can’t imagine, all kinds of means, just to get rid of it. And most of these
women end up dying… .”
Another concern mentioned by a few participants, was the possibility of women taking
misoprostol at the wrong time, i.e. before the delivery of the baby. Still, this is
considered as a risk that can be prevented by education. There was one participant who
expressed her concern about the fact that this intervention might promote homebirths.
Finally, the side effects linked to the use of misoprostol were not seen as a risk factor
but more as a discomfort. Participants who already implemented a pilot of misoprostol
at community level didn’t identify any of the above mentioned problems.
“ I don’t think you can say something like that is a 100% safe. I think there is a
possibility of a problem…. There is always a possibility it might be taken before the
birth of the baby or before the birth of an undiagnosed twin, and that could be
dangerous.”
8.3.2. Preparation & challenges of implementation
Firstly, the education of the TBAs was listed as an important challenge. There was an
overall agreement that this part of the implementation process is inevitable and needs
special attention. All participants are convinced that possible misuse or mistakes can be
minimized by proper education. However, there is no consensus on how long the TBAs
or CHWs should be trained before moving on to practice. Answers varied from two
weeks to two years. But overall they agreed that it is possible to train CHWs or TBAs to
give them the responsibility of distributing misoprostol. It was also reported that
training should be a continuous process and by this assuring that the knowledge is up to
date and they are not forgetting essential information. Topics should involve more than
just the product misoprostol and its indications. It is important to talk about danger signs
and referral, possible side effects of misoprostol, hygiene, the importance of facility
based deliveries,… .
46
“Misuse of misoprostol would depend on how you train them. If you give them a
proper training about the use of misoprostol I think, they will use it well.”
“That was the fast training…. And after that, I think we had every 2-3 weeks
another session or discussion and euh yeah….and refreshment. It was continuous, so
but the first two weeks were just for training, yes we went through different topics and it
was very interesting.”
Secondly, the supervision of the TBAs and the CHWs was considered as a big
challenge. Everybody agreed on the fact that it would be necessary to have a strict
supervision, mainly to avoid mistakes and misuse, as mentioned above. If participants
were asked who should be responsible for the supervision, answers were very divergent,
varying from the government, to the district health center, to NGOs. One thing clearly
emerged: human resources would be an issue.
There is no consensus on what would be the best system to supervise the CHWs or
TBAs. At first glance, some interviewees thought it seemed obvious to give the
responsibility to one of the nurses of the nearest health center in the area. On second
thoughts, there was some doubt whether this would be realistic, taking into account that
all nurses in the health centers are already coping with a very high workload. Most of
the participants, however, considered this to be the most obvious way.
“… because before, we used to say that the nurse at the nearest health facility
should do this (the supervision). But now, we’ve come to the realization that this is not
feasible. These nurses are already ‘full of job’ and they don’t have enough time to go
around and see what these TBAs are doing. So the NGOs will be responsible for doing
this supervision when we start with the implementation.”
“It will be not easy to supervise this project, because one of the biggest
problems is human resources. So, we need to go around and see what are the things
that are needed. Yes, human resources is a big problem, even in the hospitals.”
One participant was involved in a similar project in Haiti and he was working for an
international NGO at that time. Through this experience he is convinced that the
47
supervision preferably is done by an external workforce, who can invest all his energy
in it. Once the project is working, responsibility can be passed on to the government.
“Yes, I stayed there for one year and a half doing the same job and then
afterwards we closed the project and we handed it over to… to the ministry of health,
and I am still in contact with them. They tell me that it’s working…”
Only a few participants were able to give concrete information on how they see this
supervision. The role of the person in charge of this would not only contain the
supervision of the actual distribution by the TBAs but also involve stock management.
By providing a small stock on a regular base they believe it is possible to minimize
misuse. In addition, the TBAs or CHWs should conscientiously register all women who
received misoprostol. Participants agreed also on the fact that regular meetings and
feedback moments with the supervisor are essential.
A final subject that was discussed in the context of preparation was communication.
Good communication on different levels is the key for a fluent implementation. As
mentioned before, on the level of the community, communication is important to avoid
preconceptions and misuse of misoprostol. The importance of good communication
between the supervisor and the CHW is obvious. Still, participants were also talking
about a third level of communication, e.g. communication with the ministry of health
(MOH). The MOH has a considerable role in the context of implementing new health
policies. They have to realize the magnitude of the problem and understand the role of
misoprostol in order to be supportive. Some participants were saying that they don’t
understand what is holding back the MOH. The evidence is there but still they are
waiting to implement it. Nobody could give a clear answer why they are not yet
implementing it, apart from the link with abortion and the fear for misuse.
“Yes you know, sometimes you have people in MOH who work just
mechanically. They don’t understand what is really the problem. That is sometimes a
big deal… yeah. You need to have a clear understanding of the problem. People are
dying, it’s obvious.”
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9. Discussion
The aim of this research was to gain insides in the attitudes towards community based
misoprostol of policymakers from different African countries and by this trying to
understand why misoprostol is not globally used as an alternative therapy for the
prevention of PPH when oxytocin is not available.
PPH is one of the leading causes of maternal death worldwide. All participants in this
study agree this condition is completely preventable and something has to be done
urgently.
9.1. Current policy for the prevention of PPH
Misoprostol is accepted in most countries, though its principal use is not for the
prevention of PPH. In a facility based setting oxytocin is the preferred drug and
misoprostol is mainly used for induction of labour and abortion. This is in accordance
with the current recommendations (WHO, 2009; WHO, 2012).
The use of misoprostol on a community level distributed by a CHW or TBA is
associated with some concerns. By analyzing the interviews a clear distinction appeared
between two different approaches towards this strategy for the prevention of PPH.
A large minority was absolutely not in favor of the idea to train TBAs to distribute
drugs in the community. For them the focus to improve maternal health lies in providing
universal access to facility based care and providing a comprehensive health care
system. It is likely this point of view is influenced by the latest recommendations of the
WHO concerning the role of TBAs. “WHO’s position on where and with whom women
should deliver has shifted from emphasis on training of traditional birth attendants in
developing countries in the late 1950’s and 1960’s, to a recommendation that TBAs
work with the health-care system, and that they be integrated into the health system via
training and supervision, to today’s position of promoting professionally skilled
attendance at all births.” (Sibley & Sipe, 2006).
Prata et al. (2011) analyzed the latest trends documenting the proportion of births
accompanied by a skilled attendants in different countries over the last fifteen years. An
insufficient change has occurred. In Sub-Saharan Africa less than half of the deliveries
49
occur in a health facility. So the recent efforts to reduce maternal mortality by training
skilled attendants and providing emergency obstetric facilities are good strategies for
future population-level benefits (Prata et al, 2011). However, it does not address the
immediate needs of 45 million women who still deliver at home.
Despite the recommendation of the WHO concerning TBAs, the majority of participants
share the above mentioned opinion. Community based interventions through TBAs are
considered as complementary to the long-term strategies. This is in accordance with
what is shown in the literature (Mir et al., 2012; Prata et at, 2011).
The fact that participants repeatedly highlight the importance of improving facility
based delivery rates, can be an expression of the underlying fear for promoting
homebirths trough community based misoprostol. Spangler et al. (2014) found similar
results in the qualitative report covering two regions in Ethiopia where misoprostol was
already implemented on a community level. However, literature shows where
misoprostol is used for the prevention of PPH at the level of the community, there is a
higher facility based delivery rate (Sanghvi et al., 2004). A possible explanation could
be that prior to the distribution of the drug, a period of intensive health promotion and
education has taken place. By this the awareness in the community rises about the
dangers of PPH and the importance of facility based deliveries.
9.2. Safety and risks
Another concern regarding community based distribution of misoprostol is the safety of
this project. Participants believe CHWs or TBAs are suitable people for this because
they are generally accepted, they live close to the community and are very respected.
There is consensus, however, that the they will need a profound training to minimize the
risk of misuse and abuse.
Then, the question rose to which extend women are capable to take the tablets correctly
after education of the CHW. Literature has shown it is feasible to train TBAs or CHWs
so they can safely distribute misoprostol in the community and cover a high percentage
of women. In addition, there is evidence women are able to take the tablets at the
50
appropriate time without experiencing major side effects (Derman et al., 2006; Sanghvi
et al., 2010, Prata et al., 2009; Mir et al., 2012; Mobeen et al., 2010,…).
9.3. Challenges
The most discussed topic across all interviews is the fear of abuse of misoprostol.
People fear when misoprostol is available at a community level, it will be used to
provoke illegal abortions. Almost half of the abortions occurring worldwide are illegally
performed in countries where this is still prohibited by law (WHO, 2011). Abortion is
still considered as a taboo and in most African countries it is only allowed in case of
rape, incest and sometimes to safe a mother’s life. In the countries where there is a
restricted policy for abortion there also seems to be a restrained position towards
misoprostol. There are concerns that the drug might end up in the hands of the wrong
persons and will be sold on the black market. In contrast, people in favor of community
based implementation believe CHWs or TBAs are trustworthy and will not purposefully
misuse the drug. Moreover, some participants prefer illegal abortion is done with
misoprostol instead of the traditional means. Every year, about 78,000 women die from
complications of unsafe abortions (WHO, 2011). However, self-induced abortion with
misoprostol is not without risks either. It is remarkable, though, none of studies
investigating the safety and acceptability of misoprostol have mentioned misuse for
illegal abortion. All distributed tablets were registered and postpartum all remaining
tablets were collected again (Sanghvi et al., 2010). One should consider this result
within the context of a controlled study environment, but it gives an idea of the
feasibility to prevent misuse. There is an overall agreement community based
distribution of misoprostol should be well organized and strictly supervised.
As for many developing countries, it is stated there is a problem of resources, both
financial and human resources. Misoprostol is not expensive, the price is in line with the
one of oxytocin. There should be a remuneration provided for the CHWs or TBAs to
keep them motivated, this can be in kinds or in money. It is possible that this is seen as a
important cost for the government. Rajbhandari et al., (2010) concluded training CHWs
for the administration of misoprostol in low-resource setting seems a particularly cost-
51
effective intervention. On the long term a significant sum of money can be saved by
preventing PPH, emergency transfers and additional treatments. The lack of human
resources is a known problem in many LRCs. So given the fact that the TBAs are still
there, they might as well be integrated an a healthcare system. Moreover, there are
countries where community based distribution of misoprostol already is implemented
and where it is working well. So the threshold of resources can be overcome.
Generally, there is a relative positive attitude towards community based distribution of
misoprostol to prevent PPH. Apart from the concerns mentioned before, most
participants agree it provides an effective, feasible and acceptable interim solution,
awaiting better healthcare systems in low resource countries. The evidence is available.
So now it is up to the policymakers to convince the ministry of health, so they can
provide financial and human resources to improve maternal health all over the world.
9.4. Limitations of the study
The sample is recruited in different African countries, therefore all communication is
done by e-mail. This contributes some disadvantages. Firstly, the internet connection in
some areas is not always guaranteed. This caused a delay in the communication and
eventually three possible participants were refused because they responded after the
deadline. Secondly, it is an impersonal way of communication, so for participants who
are not really interested, it was easy to refuse participation. Three participants withdrew
from the study after having received all information, including the subject of
misoprostol. It is possible they have a restraint attitude towards community based
distribution of misoprostol and therefore refused participation after all. This might have
influenced the results in a positive way. Finally, it was inevitable to prevent participants
from doing some research about the subject and answer accordingly.
There has not been interviewed on a micro level. The attitude of the local population
was asked through the policymakers. People in rural areas are very hard to get in touch
with and mostly they are not able to have a Skype or Phone conversation. Although
their contribution might have an added value for the study results. It would be
52
interesting for future research to go in the field and conduct a qualitative research on
micro level.
Finally, there has not been done a pre-post test of the interview guide in order to verify
the expected answers were given on the prepared questions. Instead, the interview guide
was adapted if needed during the interview.
53
10. Conclusion and recommendations for the future
Postpartum haemorrhage still is one of the leading causes of maternal death worldwide,
although it is largely preventable and treatable. Misoprostol, an E1 prostaglandin
analogue, has been recommended as a good alternative for preventing PPH when
oxytocin is not available. Furthermore, literature has shown that it is effective, safe and
acceptable to distribute misoprostol at a community level by a CHW or TBA to prevent
postpartum haemorrhage in case of deliveries without a skilled birth attendant. This
qualitative research shows that the overall attitude of policymakers originating from
different African countries towards community based use of misoprostol is quite
positive. The fear for misuse of misoprostol to perform illegal abortion is identified as
the biggest obstacle for the implementation of this project. However, this concern does
not outweigh the overall agreement that something has to be done to prevent maternal
mortality. Everybody agrees increasing facility based deliveries and providing AMTSL
with oxytocin is the golden standard. In the meantime, community based distribution of
misoprostol is a fine interim solution.
Community based distribution of misoprostol is a suitable intervention for countries
where a large proportion of births are not attendant by skilled providers. It is important
to review the latest evidence supporting this strategy to prevent PPH. If the intervention
is successful at a small level, approval of the ministry of health can be received and
commitment can be obtained at a national level. It might not be feasible anymore to
achieve MDG 5 by 2015, but every little step towards the right direction helps.
54
11. Summary in Dutch
11.1. Inleiding
In 2010 deden zich wereldwijd ongeveer 287000 gevallen van maternele sterfte voor
(United Nations [UN], 2012). Postpartumbloedingen zijn nog steeds één van de
belangrijkste oorzaken voor maternele sterfte. Ze zijn vernatwoordelijk voor meer dan
25% van de gevallen van maternele sterfte. Het percentage sterfgevallen in
derdewereldlanden ligt uitermate hoger dan in ontwikkelde gebieden. Dit is te verklaren
door verschillende factoren zoals armoede, ondervoeding en gebrek aan universele
toegang tot gezondheidszorg.
AMTSL is aangeraden door de WHO om atonische bloedingen te vermijden (WHO,
2006). Eén van de handelingen binnen het proces van AMTSL bestaat uit het toedienen
van een uterotocicum vlak na de geboorte van het kind. Bij voorkeur wordt gebruik
gemaakt van oxytocine (10 IU, intra musculair) (WHO, 2012; WHO, 2009). Oxytocine
is het geneesmiddel bij uitstek maar draagt ook een aantal nadelen met zich mee. Het
moet bewaard worden in de koeling en toediening via injectie kan alleen uitgevoerd
worden door een professional die over de nodige competenties beschikt (Derman et al.,
2006).
In ontwikkelingsgebieden bedraagt het aandeel aan bevallingen dat plaatsvindt in een
medische setting slechts 65%. Dit impliceert dat minstens 35% van alle bevallingen in
ontwikkelingslanden plaats heeft zonder enige assistentie van medisch geschoold
personeel. In Sub-Saharisch Afrika, de regio met het hoogste aantal maternele sterftes,
vinden minder dan de helft van de bevallingen plaats binnen een medische setting
(United nations, 2012). Het doel van Millenium Doelstelling 5 omvat de reductie van
maternele sterfte met 75% tegen 2015. De deadline komt met rasse schreden dichterbij
en het aantal maternele sterftes persisteert. Hierdoor rees de vraag als de strategieen en
protocollen om maternele gezondheid te verbeteren niet moeten herzien worden om dit
probleem in de kiem te snoeren.
Misoprostol is een prostaglandine E1 analoog en wordt gezien als een belangrijk
alternatief voor oxytocine in ontwikkelingsgebieden. Het is een goedkoop uterototicum
dat per os genomen kan worden en het hoeft niet in de koelkast bewaard te worden.
55
Hierdoor is het uitermate geschikt in programma’s die vrouwen willen bereiken in
afgelegen gebieden (Mobeen et al., 2010).
WHO heeft zijn richtlijnen ter preventie van PPH recent aangepast en raadt aan om
community health workers in te schakelen voor de distributie van misoprostol (WHO,
2012). Er zijn heel wat studies uitgevoerd die aantonen dat CHW’s of TBA’s
misoprostol veilig en efficient kunnen verspreiden in de gemeenschap (Derman, et al.,
2006; Mobeen et al., 2010; Rajbhandari et al., 2009; Sanghvi et al., 2010). Daarenboven
wordt het gebruik van dit medicijn op dergelijke manier ook als aanvaardbaar ervaren
door de vrouwen in de gemeenschap. Op deze manier kan misoprostol bescherming
bieden aan zij die niet de kans of middelen hebben om in een medische setting te
bevallen.
Het doel van deze masterproef bestaat eruit een aantwoord vinden op de vraag waarom
misoprostol niet gebruikt wordt als alternatieve therapie voor postpartum bloedingen in
derdewereld landen.
11.2. Literatuuronderzoek
Het eerste deel van deze masterproef omvat een literatuurstudie over ‘community
based’ gebruik van misoprostol in ontwikkelingslanden. Via verschillende databanken
werd de huidige literatuur systematisch onderzocht naar RCT’s en quasi experimentele
studies over het gebruik van misoprostol in thuissituaties ter preventie van
postpartumbloedingen. De effectiviteit van dit medicijn in een medische setting werd
reeds aangetoond (Gülmezoglu et al., 2001). De resultaten werden geordend volgens
haalbaarheid & effectiviteit, veiligheid en aanvaardbaarheid.
Misoprostol blijkt een doeltreffend, veilig en aanvaardbaar alternatief voor oxytocine te
zijn zowel in de ziekenhuissetting als in thuissituaties.
Traditionele vroedvrouwen zijn in staat na een opleiding misoprostol op een veilige
manier te verspreiden onder zwangere vrouwen in hun gemeenschap. Ze vormen een
ideale sleutelfiguur om een groot percentage vrouwen te bereiken en deze te informeren
over het gebruik van misoprostol. De literatuur toont aan dat deze interventie geen
56
invloed heeft op het ‘hulp zoekend’ gedrag van vrouwen. Het percentage bevallingen
dat in een mediche setting plaatsvindt, blijkt in de interventiegroepen zelf hoger te
liggen (Sanghvi et al., 2004).
Het gebruik van misoprostol in een thuissituatie wordt positief en aanvaardbaar ervaren
door de gemeenschap. Vrouwen zijn in staat de tabletten correct en op een veilige
manier te gebruiken.
Voor veel ontwikkelingslanden waar universele toegang tot gezondheidszorg nog een
groot probleem is, kan deze werkwijze een ideale tussenoplossing bieden om
postpartumbloedingen te vermijden. Daarenboven zijn de resultaten veelbelovend om
maternele sterfte te minimaliseren.
11.3. Kwalitatief onderzoek
Het tweede deel van deze masterproef bestaat uit een kwalitatief onderzoek. Dit deel
omvat de analyses van semi-gestructureerde interviews van beleidsmakers uit
verschillende Afrikaanse landen. Op deze manier wordt gepoogd een globaal overzicht
te presenteren van de attitude ten opzichte van misoprostol gebruik ter preventie van
postpartum bloedingen op het niveau van de gemeenschap.
11.3.1. Methodologie
In het totaal werden 77 mogelijke deelnemers aangeschreven waarvan er uiteindelijk 18
bevestigden. De steekproef bestaat uit vijf vrouwen en dertien mannen. Hun leeftijd
varieert tussen 29 en 64 jaar. De deelnemers zijn afkomstig uit elf Afrikaanse landen.
Gegevens werden verzameld via semi-gestructureerde diepte interviews via telefoon,
Skype of face-to-face, al naargelang de wens van de deelnemer. Vervolgens werden alle
gesprekken uitgeschreven en geanalyseert via het programma Nvivo 10.
11.3.2. Resultaten
Om te beginnen wordt een overzicht weergegeven van de huidige trends en protocollen
omtrend postpartum bloedingen in de verschillende landen. Oxytocine en bevallingen
57
binnen een medische setting zijn de norm, al blijkt de realiteit hier wel niet helemaal
mee in overeenstemming te zijn. Misoprostol heeft zijn weg gevonden in de
ziekenhuissetting maar wordt hoofdzakelijk gebruikt voor abortus.
Binnen dit hoofdstuk wordt de rol van de traditionele vroedvrouw ook besproken.
Afhankelijk van land tot land worden deze vrouwen in verschillende mate betrokken bij
het bevallingsproces. Meningen zijn unaniem dat de TBA een signaalfunctie heeft en
vrouwen tijdig moet begeleiden naar de dichtstbijzijnde medische setting.
Vervolgens wordt een passage binnen dit hoofdstuk gewijd aan de attitude ten opzichte
van de haalbaarheid en aanvaardbaarheid van misoprostol op een ‘community level’.
Het merendeel van de participanten is het eens dat misoprostol een geschikt medicijn is
om in ontwikkelingsgebieden te gebruiken, gezien de orale inname en de
bewaringsmogelijkheid op kamertemperatuur. Verder heerst er wat bezorgheid omtrent
mogelijke vooroordelen omdat misoprostol vooral gekend is voor zijn functie als
abortivum. Daar tegenover staat dat de TBA of CHW als geschikt persoon gezien wordt
om dit middel te verspreiden in de gemeenschap en vooroordelen uit de baan te ruimen.
Tenslotte hebben de participanten er wel vertrouwen in dat eens de gemeenschap
voldoende op de hoogte is, deze methode wel succes kan hebben.
Als laatste worden de deelnemers bevraagd naar hun meningen over de effectieve
implementatie van misoprostol. De antwoorden worden onderverdeel in twee groepen:
veiligheid & risico’s en voorbereiding & uitdagingen.
Het dominerende onderwerp is zonder twijfel de angst voor misbruik van misoprostol
om illegale abortus te plegen. Op vlak van voorbereiding gaat men vooral in op de
training van de TBA’s en de educatie van de gemeenschap en goede communicatie.
11.4. Conclusie
Hoewel postpartum bloeding makkelijk te behandelen en te vermijden zijn behoren ze
nog steeds tot een van de belangrijkste oorzaken van maternele sterfte. Misoprostol
wordt aangeraden als aternative therapie om deze bloedingen te vermijden wanneer
oxytocine niet beschikbaar is. Daarenboven heeft de literatuur aangetoond dat de
58
distributie van misoprostol op een ‘community level’ effectief, veilig en aanvaardbaar is
in de afwezigheid van een professional in thuissituaties in derdewereld landen. Deze
kwalitatieve studie toont aan dat de attitude van beleidsmakers uit verschillende
Afrikaanse landen ten opzichte van het gebruik van misoprostol binnen de gemeenschap
relatief positief is. De schrik voor misbruik van het medicijn om illegale abortus te
plegen werd geïdentificeerd als de grootste hindernis voor de implementatie van
dergelijke interventie. Deze bezorgdheid weegt echter niet op tegenover het feit dat alle
deelnemers overeenstemmen dat er dringend iets moet gedaan worden aan de maternele
sterfte. Er is concensus dat bevallen in een medische setting de gouden standaard is
maar in afwachting kan de distributie van misoprostol een prima tussenoplossing
bieden.
59
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LIST OF FIGURES
Figure 1: Global approval misoprostol ……………………………………………... p 20
Figure 2: The three delay model…………………………………………………….. p 22
68
ANNEXES:
Annex 1: Characteristics of included studies.
Annex 2: Characteristics of participants
Annex 3: Interview guide English
Annex 4: Interview guide French
Annex 5: Information letter Dutch
Annex 6: Information letter English
Annex 7: Information letter French
Annex 8: Informed consent form Dutch
Annex 9: Informed consent form English
Annex 10: Informed consent form French
69
Annex 1: Characteristics of included studies.
70
Annex 2: Characteristics of participants
71
Interview guide
Annex 3: Interview guide English
- General background
o Sex
o Country/residence
o Age
o Can you tell me something more about your job?
Length of service/function
- How is the prevention of PPH currently managed in your country/region/district?
o Who/what kind of health workers cadres/staff are doing it?
o Who is skilled for doing it?
Drugs used for PPH preventions? If yes what drugs?
- Can you tell me something about deliveries by non-skilled attendants in your
country?
o Are there many?
o What is the function of a skilled health worker in a (non-skilled) delivery
outside the hospital.
- What about CHW’s and maternal care in your region?
o What kind of CHW’s are there?
o What are their main tasks (regarding antenatal, perinatal and postnatal care)?
o What about remuneration for CHWs?
o What about CHW training? How long, formal arranges, project based
arranged? Available curriculum for CHWs training?
o What about CHWs supervision?
72
- Can you tell me something more about CHW’s and the management of the
prevention of PPH?
o What about misoprostol use by CHWs for the prevention of PPH.
- How do you feel about misoprostol being available at community level and used by
CHW for the prevention of PPH?
o Why do you feel this way?
o How do you feel about risks (safety) and use of misoprostol by CHWs?
o How do you feel about use of misoprostol by CHWs and feasibility?
o How do you feel about use of misoprostol by CHWs and effectiveness?
o +/-
- Do you have suggestions for the implementation of misoprostol on a community
level to prevent PPH? If so what are your suggestions?
o Needs? Preparation? Supervision?
Training CHW/tba’s
o What do you think are the biggest challenges/obstacles of community-based
distribution?
Safety/risks/side-effects?
o What would make it easier?
Advantages/opportunities
o Effectiveness?
o Feasibility?
o Supervision?
- How do you think the local population would feel about community based
distribution?
o Attitudes/preconceptions?
73
Interview guide Francais
Annex 4: Interview guide French
- Information général
o Sexe
o Vous habitez où ?
o Quel âge aves-vous ?
o Vous pouvez me dire quelque chose de votre travail ?
Que faites vous exactement ?
- Comment est-ce que la prévention de l’hémorragie postpartum est fait chez
vous ?
o Qui est responsable pour ça ?
o Qui est entrainé pour ça ?
Est-ce qu’ils utilisent des médicaments ? les quelles ?
- Vous pouvez me dire quelque chose des accouchements fait par des non-
professionnels ?
o Il y en a beaucoup ?
o Quesque c’est le fonction des professionnels en cas d’un accouchement a
domicile ?
- Il y a des community health workers chez vous ? les travailleurs de la commune ?
vous pouvez me dire quelque chose de ces personnes ?
- Est-ce que ils ont des responsabilités concernant les soins maternelles ?
o Quelles types ?
o Quesque sont ses tâches principales ?
Des responsabilités concernant les soins pré- péri ou post natal ?
o Ils reçoivent un rémunération ?
74
o Ils ont eu un entrainement ? combien de temps ? C’est arrangé
formellement ?
o Qui est responsable pour la surveillance ?
- Vous pouvez me dire quelque chose des travailleurs de la commune et la gestion du
prévention de l’hémorragie postpartum ?
o Qu’ est – ce que vous trouvez de misoprostol utilisez par les CHWs au
niveau de la commune pour la prévention de l’hémorragie postpartum ?
- Comment est-ce que vous sentez vous de misoprostol est disponible au niveaux de
la commune utilisé par les CHWs?
o Pourquoi vous sentez vous comme ça ?
o Que pouvez vous me dire des risques où sécurité de l’utilisation de
misoprostol par les CHW ?
o Que pouvez vous me dire de faisabilité
o Comment vous sentez vous de l’effectivité ?
o Que pouvez vous me dire des avantages et désavantages de l’usage de
misoprostol ?
- Est-ce que vous avez des suggestions pour l’implémentation au niveau de la
commune ?
o Oui ? les quelles ?
o Concernant les besoins, les préparations, la surveillance, l’entrainement ?
o Quesque pensez vous sont les difficultés/obstacles les plus importants ?
Sécurité, risques, les effets,…
o Quesque rendrait plus facile ?
- Comment pensez vous les gens locaux se sentent du distribution de misoprostol au
niveau de la commune ?
o Attitudes ?
o Préconceptions
o Préjuges ?
75
Annex 5: Information letter Dutch
WERELDWIJDE UPDATE VAN DE BESCHIKBAARHEID, EFFECTIVITEIT,
EFFICIËNTIE EN DUURZAAMHEID VAN MISOPROSTOLGEBRUIK: EEN
KWALITATIEVE BENADERING.
Geachte mevrouw/mijnheer,
In het kader van de opleiding tot Master in de Verpleegkunde en de Vroedkunde aan de
Universiteit van Gent, wordt een onderzoek uitgevoerd door Melanie Cherlet over de veiligheid,
aanvaardbaarheid, effectiviteit en haalbaarheid van het gebruik van misoprostol per os om
postpartumbloedingen te vermijden in thuissituaties in low resource landen. Het onderzoek
wordt uitgevoerd in samenwerking met Prof. Dr. Olivier Degomme, wetenschappelijk directeur
van het ICRH België en dr. Els Duysburgh, verantwoordelijke maternele gezondheid, ICRH
België.
Postpartum bloedingen (PPH) vormen nog steeds de nummer 1 oorzaak van maternele sterfte,
wereldwijd. In 2010 deden er zich ongeveer 287000 gevallen van maternele sterfte voor volgens
de United Nations (UN). Actief management van de derde fase van de arbeid wordt gezien als
een evindence based aanpak om PPH te vermijden. Een van de aspecten van actief management
van de derde fase van een arbeid bestaat eruit om Oxytocine toe te dienen onmiddellijk na de
geboorte van het kind. Oxytocine is het eerste keuze oxytonicum in de preventie van PPH,
helaas moet het worden gestockeerd in de koelkast en voor de toediening ervan is de
aanwezigheid van een paramedicus genoodzaakt.
In Sub-Saharan Africa, bijvoorbeeld, worden minder dan de helft van de geboortes bijgewoond
door medisch geschoold personeel. Deze vrouwen kunnen dus niet genieten van de voordelen
van Oxytocine.
76
Misoprostol, een E1 prostaglandine analoog, wordt gezien als een belangrijk alternatief voor
dergelijke situaties.
Dit onderzoek wil nagaan wat lokale onderzoekers/beleidsmakers vinden van het gebruik van
misoprostol door Community Health Worker’s (CHW’s) voor de preventie van PPH. Aan de
hand van interviews van beleidsmakers en lokale onderzoekers hopen we een globaal beeld te
scheppen van o.a. de attitudes ten opzichte van het medicijn, de beschikbaarheid, effectiviteit en
haalbaarheid van het gebruik van misoprostol in thuissituaties, gebruikt door CHW’s in derde
wereldlanden.
Om dit onderzoek mogelijk te maken, willen we uw medewerking vragen. Deelname aan het
onderzoek betekent dat u akkoord gaat om deel te nemen aan een interview over de telefoon of
via Skype met de onderzoeker. U bent volledig vrij deel te nemen of niet. Het interview zal
plaatsvinden op een voor u geschikt ogenblik, u kunt hiervoor een afspraak maken met de
onderzoeker. Deelname aan het interview zal ongeveer 40 minuten van uw tijd in beslag nemen.
Het gesprek dat we in het kader van dit onderzoek met u willen hebben, willen we het liefst op
band opnemen. Zo hoeven we niet te noteren tijdens het gesprek en kan de verwerking van het
gesprek correcter gebeuren. Na het onderzoek worden alle opnames gewist. Wat op band
opgenomen is, wordt nadien uitgetypt. Daarbij laten we alle namen en alle verwijzingen weg,
waaruit iemand zou kunnen opmaken over wie het gaat. Alleen de onderzoekers krijgen de
uitgeschreven gesprekken te lezen. In overeenstemming met de Belgische wet van 8 december
1992 en de Belgische wet van 22 augustus 2002, zal uw persoonlijke levenssfeer worden
gerespecteerd. Als de resultaten van de studie worden gepubliceerd, zal uw anonimiteit aldus
verzekerd zijn.
U kunt ook op ieder ogenblik uw deelname aan het onderzoek beëindigen of uw toestemming
om deel te nemen intrekken. Vooraleer het onderzoek van start kon gaan, hebben we, zoals dat
in België wettelijk geregeld is, het onderzoek aan het Ethische Comité van het UZ Gent
voorgelegd. Dit comité heeft het project goedgekeurd. In geen geval dient de goedkeuring van
het Ethisch Comité een aanzet te zijn tot deelname.
De onderzoeker voorziet in een vergoeding en/of medische behandeling in het geval van schade
en/of letsel tengevolge van deelname aan de klinische studie. Voor dit doeleinde is een
verzekering afgesloten met foutloze aansprakelijkheid conform de wet inzake experimenten op
de menselijke persoon van 7 mei 2004. Op dat ogenblik kunnen uw gegevens doorgegeven
worden aan de verzekeraar.
77
Als u bereid bent deel te nemen aan het onderzoek, zullen we u vragen, zoals de wet dit
voorziet, een toestemmingsformulier te ondertekenen. Ook na de ondertekening daarvan bent u
vrij om op ieder ogenblik te beslissen niet langer aan het onderzoek deel te nemen.
Als u aanvullende informatie wenst over het onderzoek of over uw mogelijke deelname, kunt u
nu of in de loop van het onderzoek steeds contact opnemen met Melanie Cherlet, student Master
in de Verpleegkunde en de Vroedkunde. ([email protected]). Zij is de onderzoeker die
het gesprek met u zal voeren.
We danken u omdat u aan onze vraag aandacht hebt willen geven.
Met vriendelijke groeten,
- Prof. Dr. Olivier Degomme, Scientific director of ICRH Belgium; +32 (0)9 332 35 64;
- Dr. Els Duysburgh, Team Leader Maternal Health ICRH Belgium; +32 (0)9 332 35 64;
- Melanie Cherlet, midwife, student Master in Science of Nursing and Midwifery Email:
78
Annex 6: Information letter English
WORLDWIDE UPDATE OF THE AVAILABILITY OF MISOPROSTOL AND THE
EFFECTIVENESS, EFFICIENCY AND SUSTAINABILITY OF MISOPROSTOL USE:
A QUALITATIVE APPROACH..
Dear Sir/Madam
In the context of a thesis to accomplish the degree of Master of Nursing and Midwifery at the
University of Ghent, Melanie Cherlet conducts an investigation about the safety, acceptability,
effectiveness and feasibility of oral misoprostol in reducing postpartum hemorrhage (PPH) in
homebirth settings/ births by unskilled health professionals. This research is performed in
collaboration with Prof. Dr. Olivier Degomme, Scientific director of ICRH Belgium and Dr. Els
Duysburgh, Team Leader Maternal Health, ICRH Belgium.
PPH still is the main cause of maternal death worldwide. An estimated 287,000 maternal deaths
occurred in 2010 according to the United Nations (UN). Active management of the third stage
of labour (AMTSL) is considered an evidence based approach to prevent PPH. One of the
aspects of AMTSL is the administration of Oxytocin. Oxytocin is the first choice uterotonic for
the prevention of PPH but it requires a cold chain and a skilled birth attendant to administer it.
In Sub-Saharan Africa, for example, less than half of births is attended by skilled health
professionals. These women cannot benefit the advantages of oxytocin. Misoprostol, an E1
prostaglandin analogue, has been suggested as an important alternative to oxytocin in this case.
The main goal of this study is to find out what health policy makers, managers and researchers
think/feel about on the use of misoprostol by Community Health Workers(CHW’s) to prevent
PPH. By interviewing policymakers and local researchers, we would like to find out the attitude
towards, the availability and use of misoprostol by CHW in home birth settings and get an idea
79
about their thoughts on the effectiveness, safety and feasibility of misoprostol use by CHW in
home birth settings.
In order to make this research possible we would like to ask your cooperation. Participation in
this research implies a private interview by phone/Skype with you and the investigator. You are
completely free to decide whether you participate in this research or not.
The interview will be recorded in function of processing the conversation more easily
afterwards. After the study all of the tapes will be erased. The interview will take place when it
suites you best. An appointment can be made with the investigator. Participation in the
interview will take about 40 minutes.
This study was approved by an independent Commission for Medical Ethics, Faculty of
Medicine University of Ghent and UZGhent. If you agree to participate in this study, everything
you say is strictly anonymous. In accordance with the Belgian law of December 8, 1992 and the
Belgian Law of 22 August 2002, your privacy will be respected. If the results of the study are
published, your anonymity is guaranteed. The recorded interview will be transcribed afterwards
but only the investigators mentioned above, have access to your file.
The researcher provides a compensation and / or medical treatment in case of damage and / or
injury resulting from participation in the clinical study. Therefore a no-fault-insurance is
provided in accordance with the law concerning experiments on the human person from May 7,
2004.
If you are prepared to participate in this investigation, please feel free to contact Melanie
Cherlet, student Master in Science of Nursing and Midwifery ([email protected]), for
further information about participating or in case of any questions during the study. She will be
the interviewer during the study.
Thanks for your attention and time,
Yours Faithfully,
- Prof. Dr. Olivier Degomme, Scientific director of ICRH Belgium +32 (0)9 332 35 64;
- Dr. Els Duysburgh, Team Leader Maternal Health ICRH Belgium +32 (0)9 332 35 64;
- Melanie Cherlet, midwife, student Master in Science of Nursing and Midwifery Email:
80
Annex 7: Information letter French
Informations pour les participants à l'étude qualitative de la sécurité,
l’acceptabilité, l’efficacité et la faisabilité de misoprostol oral, dirigée par
community health workers pour diminuer l’incidence de l'hémorragie postpartum
en cas de l’accouchement à domicile en pays en développement.
Madame/Monsieur
Dans le cadre des études en sciences infirmières et des sages-femmes à l'Université de
Gand, Melanie Cherlet mène une étude de la sécurité, l'acceptabilité, l'efficacité et la
faisabilité de l'utilisation de misoprostol par voie orale pour la prévention de
l'hémorragie postpartum en cas de l’accouchement à domicile en pays en
développement. La recherche est menée en collaboration avec Prof. Dr. Olivier
Degomme, le directeur scientifique de l'ICRH Belgique et Dr Els Duysburgh,
responsable de la santé maternelle, ICRH Belgique.
Hémorragie post-partum (HPP) reste toujours la première cause de mortalité maternelle dans le
monde. En 2010, il s'est produit 287 000 cas de mortalité maternelle, selon les Nations Unies.
‘La gestion active de la troisième phase du travail est considérée comme une approche
evidence-based pour éviter l’hémorragie post-partum. L’un des aspects de la gestion active de la
troisième phase du travail est l’administration de l’Oxytocine directement après la naissance du
bébé.
Oxytocine est le médicament préféré pour la prévention de HPP mais malheureusement il doit
être conservé dans le réfrigérateur et l’administration oblige la présence d’une personne
médicalement compétente. En Afrique sub-saharienne, par exemple, moins de la moitié des
naissances est assistée par un professionnel. Alors, ces femmes ne peuvent pas profiter des
avantages d’Oxytocine. Misoprostol, un E1 prostaglandine analogue, est considéré comme une
81
alternative importante pour l’utilisation d’ Oxytocine en cas de l’accouchement à domicile en
pays en développement.
Cette étude vise à vérifier qu’est-ce que les politiciens et les scientifiques locaux pensent de
l’utilisation de Misoprostol par des CHW’s pour prévenir le HPP. A partir des interviews avec
eux, nous aimerions créer une image globale de l’attitude concernant le médicament,
l’acceptabilité, l’efficacité et la faisabilité de misoprostol en cas d’ un accouchement à
l’extérieur d’un cadre médical dans des pays en développement.
Pour réaliser cette recherche, je voudrais vous demander votre coopération. Participer signifie
que vous vous déclarez prêt à faire une interview par téléphone ou par Skype avec la
chercheuse. Vous êtes entièrement libre de participer ou non à cette recherche. L’interview aura
lieu à un moment de votre préférence et durerait environ 40 minutes. Nous aimerions
enregistrer la conversation de sorte qu’on ne doit pas prendre des notes pendant l’interview. De
cette façon, après la conversation, on pourra traiter d’une manière plus correcte les données de
la conversation. Après l'étude, tous les enregistrements seront supprimés.
Ce qui est enregistré, sera rédigé après. On efface tous les noms et des références, de sorte qu’il
n’en est pas question des données où on peut tracer des données des personnes interviewées.
Seulement les rechercheurs ont accès aux conversations.Toutes les données de la recherche sont
traitées selon les règles de la protection de la vie privée, comme dans la loi du 22 août 2002 est
défini. A tout moment vous pouvez finir votre participation à la recherche ou retirer votre
consentement à la participation.
Avant d’avoir démarré la recherche, on a soumis la recherche au Comité éthique de l’hôpital
universitaire de Gand (UZ Gent), comme la loi belge (légalement) oblige. Ce comité a
approuvé le projet. Cette approbation ne doit pas être vue comme une obligation de la
participation de votre part. Si vous acceptez de participer à cette étude, nous vous demandons,
comme la loi oblige, de signer le formulaire de consentement. Même après avoir signé le
formulaire, vous êtes libre de vous retirer de la recherche à tout moment.
Si vous voulez des informations supplémentaires de cette recherche ou de votre participation,
vous pouvez toujours contacter Melanie Cherlet, étudiante en sciences infirmières et des sages-
femmes à l'Université de Gand ([email protected]). Elle sera l’intervieweuse
pendant la recherche.
82
Merci beaucoup pour votre attention
Cordialement,
- Prof. Dr. Olivier Degomme, directeur scientifique de l'ICRH Belgique, +32 (0)9 332
35 64; [email protected]
- Dr Els Duysburgh, la santé maternelle responsable, ICRH Belgique. +32 (0)9 332
35 64; [email protected]
- Melanie Cherlet, sage-femme, étudiante en sciences infirmières et des sages-
femmes. Email: [email protected]
83
Geïnformeerde toestemming tot medewerking.
Annex 8: Informed consent form Dutch
Ik ben bereid op vrijwillige basis deel te nemen aan dit onderzoek onder de
voorwaarden die in de informatiebrief zijn vermeld. Ik bevestig ingelicht te zijn omtrent
de aard en het doel van het onderzoek, kon vragen stellen en kreeg hierop de nodige
antwoorden. Tevens ben ik op de hoogte dat ik mij op elk ogenblik kan terugtrekken uit
het onderzoek.
Naam van de deelnemer: …………………………………………………………….
Datum: …………………………………………………………….
Handtekening: …………………………………………………………….
Naam van de onderzoeker door wie uitleg werd verstrekt: ………………………………
Datum: …………………………………………………….............
Handtekening: ………………………………………………………….....
84
Informed consent
Annex 9: Informed consent form English
I am prepared to participate in this research under the conditions mentioned in the
information letter. I confirm being informed of the purpose of the study and I have been
able to ask questions. My participation is completely voluntary and I am also aware of
the fact that I have the right to withdraw from the study at any point.
Name participant: ……………………………………………………………………..
Date: ……………………………………………………………………..
Signature: ……………………………………………………………………..
Name investigator: …………………………………………………………………….
Date: …………………………………………………………….............
Signature: …………………………………………………………………….
85
Formulaire de consentement
Annex 10: Informed consent form French
Je veux participer à cette recherche aux conditions précisées dans la lettre
d’information. Je confirme que je suis conscient de l’objective du recherche, je pourrait
demander mes questions et j’ai reçu t les réponds nécessaires. Enfin, je sais que je peux
me retirer au tout moment si je veux.
Nom participant: ………………………………………………………………………
Date: ……………………………………………………………………….
Signature: ………………………………………………………………………
Nom intervieweur: ……………………………………………………………………
Date: ………………………………………..…………………………...
Signature: ……………………………………………………………………..
86
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