RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCESKARNATAKA, BANGALORE

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. Name of the candidate and address (in block letters)

ASHLY JOSEI YEAR M. Sc. NURSINGINDIRA NURSING COLLEGEFALNIRMANGALORE - 575002

2. Name of the Institution INDIRA NURSING COLLEGEFALNIRMANGALORE - 575002

3. Course of Study and Subject M. Sc. NURSINGOBSTETRICS AND GYNAECOLOGICAL NURSING

4. Date of Admission to the Course 28.06.2012

5. Title of the study

A STUDY TO ASSESS THE EFFECTIVENESS OF SELF

INSTRUCTIONAL MODULE ON KNOWLEDGE REGARDING

ASSESSMENT AND MANAGEMENT OF ECTOPIC

PREGNANCY AMONG STAFF NURSES IN SELECTED

HOSPITALS AT MANGALORE.

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6. Brief resume of the intended work

6.1 Introduction

“A mother’s joy begins when new life is stirring inside.....when a tiny heartbeat is heard for the very first time, and a playful kick reminds her that she is never alone”.1

It is believed that giving birth to an offspring is the most beautiful experience for a

women. Pregnancy is the fertilization and development of one or more offspring known as

an embryo or foetus, in a woman’s uterus.2

The word ectopic means “in the wrong place” and it is a pregnancy that develop

outside the uterus(womb).It is a potentially fatal condition and remains a leading cause of

pregnancy related death in the first trimester. It constitutes 2% births with recurrence in

more than 20%patients and permanent sterility in 20-60% of cases.3

The survival rate from ectopic pregnancies is improving even though the incidence of

ectopic pregnancies is also increasing. The developing embryo can’t survive, and the

growing placental tissue may destroy important maternal structures. The majority of women

diagnosed, will have to be operated or treated with medication.4

6.1 Need for the study

An ectopic pregnancy put very simply, means “an out of place pregnancy” .It

happens when a woman’s ovum (egg), which has been fertilised by a man’s sperm, becomes

stuck in the fallopian tube or sometimes in other places in the reproductive organs or

abdomen, instead of developing in uterus.5 The incidence of ectopic pregnancy ranges from

1 in every 40 to 1 in every 100 pregnancies. In India, the incidence of ectopic pregnancy

reported by the Indian council of medical research task force was 3.12 per 1000 pregnancies.

In India 75% of ectopic pregnancy occurred in the age group of 21-30 years.6

Ectopic pregnancy may be caused by birth defects in the fallopian tubes, endometriosis,

previous ectopic pregnancy, pregnant while having an intrauterine device, tubal sterilization,

tubal surgery, in-vitro fertilization etc. Women who experience a tubal pregnancy often

experience manifestation of abnormal vaginal bleeding, low back pain, mild cramping on

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one side of pelvis, pain in lower belly or pelvic area. If the area around the abnormal

pregnancy ruptures and bleeds, symptoms get worse. There will be fainting, intense pressure

in rectum, low blood pressure, pain in shoulder and severe sharp sudden pain in lower

abdomen. The nurse must be aware about the symptoms to recognize the ectopic pregnancy

from a normal pregnancy.7 Patient may also express feelings of self-blame and concern for

her child bearing capacity. In addition to providing high quality physical care to patient,

nurse must be sensitive to the sense of loss and grief.3

Because the ectopic pregnancy cannot be diagnosed in the community, the nurse

should be aware that all sexually active women with a history of lower abdominal pain and

vaginal bleeding should be referred to a hospital for early ultrasonography and if necessary,

measurement of serum concentrations of HCG should be done. Nurse should educate the

women with a history of ectopic pregnancy to have early ultrasonography to verify a viable

intrauterine pregnancy in their subsequent pregnancies. Diagnostic laparoscopy is necessary

if the clinical situation cannot be clarified or if the patient’s condition deteriorates.

Expectant and medical management of ectopic pregnancy are effective options in

selected women as long as adequate facilities for monitoring are available. If surgery is

necessary the laparoscopic route, result in shorter hospital stay. The decision should

therefore be made on individual basis. Methotrexate and laparoscopic salpingostomy are

equally successful in treating ectopic pregnancy.4

The nurse caring for a patient experiencing an ectopic pregnancy looks for changes

in the patient’s blood pressure and pulse, which could indicate hypovolaemic shock resulting

from haemorrhage. Regular assessment of vaginal bleeding is also essential. The nurses are

responsible for monitoring and controlling pain levels. If a linear salpingostomy or

salpingectomy is performed, the nurse monitors vital signs, oxygen saturation, intake and

output, and laboratory results according to institutional policies. As with all patients

experiencing a pregnancy loss, it is important for the nurse to recognize the loss and provide

resources to assist the patient in coping with the emotions that accompany experience of an

ectopic pregnancy. Nurses are responsible for ensuring that the patient is aware of signs and

symptoms that require a call to the healthcare provider or a return visit to the emergency

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room following hospital discharge. If methotrexate is used for the treatment of an ectopic

pregnancy, the patient should be educated about the unpleasant side effects (nausea and

vomiting) of methotrexate. The patient should have a clear understanding of the feelings of

anger, sadness or guilt that may arise following an ectopic pregnancy and that these feelings

are a normal part of the grieving process for someone experiencing the loss of pregnancy.8

An exploratory, qualitative, descriptive study was conducted in a Gauteng hospital,

South Africa to explore and describe the experience of midwives and doctors when caring

for mothers with pregnancy loss(miscarriage and ectopic pregnancy). Sample consisted of

doctors and midwives who worked in the maternity unit for a period of two years and was

selected by purposive sampling method. Data was collected by semi-structured individual

interviews. The study result showed that both midwives and doctors lack the knowledge to

support mothers with pregnancy loss and that they were overwhelmed by problems like

shortage of staff and overcrowding. The study concluded that a counselling programme

should be developed to help health professionals to deal with problems in ward situation.

The study also recommended that the institution should develop guidelines, policies and

procedures to help health professionals to cope when a life can no longer be saved.9

A longitudinal retrospective descriptive survey was conducted in Ghana, to find out

the reason for low detection of ectopic pregnancy before its rupture. Data was collected by

using interview method for 1492 patients. The study result showed that the incidence of

tubal ectopic pregnancy was 32.90 per 1000 deliveries and un-ruptured cases formed 5.43%.

It also found that lack of awareness of early pregnancy, late reporting by women to

healthcare facilities when aware of pregnancy and failure of healthcare providers to utilize

the diagnostic aids for detecting un-ruptured ectopic pregnancy were the main reason for low

detection rates. The study concluded that the health education should be provided to

encourage women to attend clinic early in pregnancy, especially when experiencing unusual

symptoms and judicious use of diagnostic aids for detecting un-ruptured ectopic pregnancy

by health care providers should be improved upon the detection rates.10

A case control study was conducted in France to analyse the risk factors of ectopic

pregnancy. Sample consisted of 2486 women (803 cases of ectopic pregnancy and 1683

deliveries). The study result showed that the main risk factors were infectious history

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(adjusted attributable risk=0.33; adjusted odds ratio for previous pelvic infectious

disease=3.4, 95% confidence interval (CI) : 2.4,5.0) and smoking (adjusted attributable

risk=0.35; adjusted odds ratio=3.9,95% CI:2.6,5.9 for >20 cigarettes/day Vs women who

had never smoked).It also showed that other risk factors were age, previous use of an

intrauterine device. Prior medical induced abortion was a risk of ectopic pregnancy (adjusted

odds ratio=2.8, 95% C I: 1.1, 7.2), but no such association was observed for surgical

abortion. The study concluded that increasing public health awareness about the risk factors

of ectopic pregnancy may be useful for its prevention.11

The investigator’s clinical experience revealed that most of the nurses lack

knowledge about assessment and management of ectopic pregnancy. Nurses are in a position

to educate the women regarding the signs and symptoms of ectopic pregnancy that require

an emergency admission to hospital. Nurses are also responsible to assist the patient in

coping with the emotions that arise following an ectopic pregnancy. The investigator

personally felt that there was a need to bring awareness among staff nurses regarding

assessment and management of ectopic pregnancy. Review of literature and discussion with

the experts also prompted the researcher to pursue the study.

6.2 Review of literature

A longitudinal study was conducted regarding incidence, trends and risk of ectopic

pregnancy in a defined population of women aged 15-39 years in Lund. Data was collected

by interview method. The study result showed that the rate of ectopic pregnancy per 1000

diagnosed conceptions increased from 5.8 to 11.1. The mean annual incidence of ectopic

pregnancy per 1000 women increased from 0.6 to 1.2 during this period. It also found that

the number of ectopic pregnancies per 1000 diagnosed conceptions increased with

increasing age of women. The incidence was 4.1 in the teenage group, 6.9 in women aged

20-29 years and 12.9 in women aged 30-39 years. The study result also showed that ectopic

pregnancy increased sevenfold after acute salpingitis. The study concluded that the ectopic

pregnancy increased after salpingitis and the increased incidence partly accounted for the use

of intrauterine copper devices.12

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A retrospective study was conducted in Rajasthan to assess the frequency of ectopic

pregnancy and to evaluate the relevance of known risk factors. Data was collected from case

record of patients. The study result showed that incidence of ectopic pregnancy was 2.46 per

thousand deliveries. Maximum (72.5%) cases were in the age group of 21 to 30 years and

most of cases (40%) were nulliparous. About half ( 47.5 %) of cases were suffering from

pelvic inflammatory disease. The commonest site of ectopic pregnancy was in ampullo-

isthmic region(82.5%). It also showed that almost all patients underwent exploratory

laparotomy, majority (45%) underwent total salpingectomy, while fallopian tubes were

conserved in a few (7.5%) of cases. The study concluded that by identifying the risk factors

and catching the patient by ultrasonography examination at the earliest of 6 weeks, it is

possible to improve the prognosis to reduce the morbidity and mortality associated with

ectopic pregnancy.13

A case control study was conducted in university medical centre to evaluate the

association between ectopic pregnancy and clinical and historical factors among women

presenting with pain and or bleeding in early pregnancy. Sample consisted of women with

symptomatic early pregnancy of unknown location presenting for care. The study result

showed that the risk of ectopic pregnancy is: prior ectopic pregnancy (odds ratio, 2.98[95%

confidence interval, 1.88-4.73] for one prior ectopic pregnancy and 16.04[5.39-47.72] for

two or more), pelvic inflammatory disease history (1.5[1.11-2.05]),pain at presentation

(1.42[1.06-1.92]),vaginal bleeding at presentation (1.42[1.04-1.93]) and HCG value 501-

2000 ml u/ml (1.73[1.24-2.42]). It also showed that age younger than 25 years (0.59[0.41-

0.85]) and history of abortion were protective from ectopic pregnancy (0.58[0.38-0.90]).

Prior non-tubal pelvic surgery, past intrauterine device use, prior caesarean section and

current cervical infection demonstrated no association with ectopic pregnancy. The study

concluded that knowledge of historical and clinical factors associated with ectopic

pregnancy may aid in early diagnosis.14

A retrospective study was conducted in Tseung Kwano Hospital, Hong Kong to

evaluate the success rates of expectant and medical management of ectopic pregnancy.

Sample consisted of 121 women with ectopic pregnancy identified by computer database.

The result showed that the success rates of expectant and medical management were 63%

and 73% respectively. There were no significant differences in the clinical characteristics

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such as presence of abdominal pain, vaginal bleeding, size of adnexal mass, presence of free

fluid in the pelvis, pre-treatment levels of serum beta –human chorionic gonadotropin

between the responders and non responders in the expectant and medical management

group. The study concluded that both expectant and medical management are reasonable

options in selected women with ectopic pregnancy. It also concluded that the non surgical

management options allow the use of more conservative treatment especially for those

women who want to preserve their fertility or those who have high surgical risk.15

A study was conducted in Montreal QC to identify risk factors of ectopic pregnancy

after in-vitro fertilization treatment. Sample consisted of 365 women, who had undergone in-

vitro fertilization. The study result showed that, out of 365 women, 18 women had an

ectopic pregnancy and 347 others had an intrauterine pregnancy. The incidence of IVF

ectopic pregnancy was 4.9%. It also showed that the tubal factor infertility and previous

surgery for endometriosis were risk factors for IVF ectopic pregnancy. The study concluded

that tubal factor infertility and previous surgery for endometriosis appear to be risk factors

for ectopic pregnancy after IVF treatment.16

A cross sectional study was conducted in Pakistan Institute of medical sciences for a

period of 2 years to determine the modes of treatment of ectopic pregnancy and their

outcome. Sample consisted of 52 patients with ectopic pregnancy. The result showed that the

rate of ectopic pregnancy was 1in 100 deliveries. Emergency laparotomy was performed in

30(57.9%) women,15(28.8%) received methotrexate injection. Seven women(13.3%)were

managed conservatively. It also showed that twelve out of fifteen (80%) cases of medical

treatment were successful, while one(6.7%) proceeded to emergency laparotomy, one(6.7%)

to operative laparoscopy and one (6.7%) to laparoscopy preceding laparotomy. Five out of

seven patients(71.4%)on conservative treatment did not require any further intervention

while two(28.6%)of them resolved with methotrexate injection. Study concluded that more

than half of all women with ectopic pregnancy presented with acute abdomen and required

emergency laparotomy and about 40% of women could be managed with non surgical

modalities with 80% success for methotrexate injection and 71% for conservative

treatment.17

The above studies shows that there is a need for bringing an awareness among the

staff nurses about the assessment and management of ectopic pregnancy to facilitate an early

diagnosis and management for a good prognosis.

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6.3 Statement of the problem

A study to assess the effectiveness of self instructional module on knowledge

regarding assessment and management of ectopic pregnancy among staff nurses in selected

hospitals at Mangalore.

6.4 Objectives of the study

The objectives of the study were:

To assess the existing knowledge of staff nurses regarding assessment and

management of ectopic pregnancy using structured knowledge questionnaire.

To evaluate the effectiveness of self instructional module on knowledge regarding

assessment and management of ectopic pregnancy in terms of gain in post test

knowledge score.

To find the association between mean pre-test knowledge score regarding assessment

and management of ectopic pregnancy among staff nurses and selected demographic

variables.

6.5 Operational definitions

Effectiveness: In the present study, it refers to enhancement of knowledge after

administration of self instructional module.

Self instructional module: In this study, it refers to written material regarding the

definition, incidence, types, aetiology, risk factors, diagnosis and management of

ectopic pregnancy.

Knowledge: In this study, it refers to the understanding and awareness of staff nurses

regarding assessment and management of ectopic pregnancy.

Assessment: In this study, it refers to identifying signs and symptoms of ectopic

pregnancy and utilising diagnostic measures to detect ectopic pregnancy.

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Management: In this study, it refers to treatment modalities for ectopic pregnancy.

Ectopic pregnancy: In this study it refers to a complication of pregnancy in which

the fertilized egg attaches itself outside the cavity of the uterus (womb).

Staff Nurses: In this study, it refers to the registered nurse either with B. Sc. nursing

or diploma certificate programme in nursing and midwifery, working in maternity

units of selected hospital, Mangalore.

Hospitals: In this study, hospital is an organised institution where maternity services

are available.

6.6 Assumptions

Staff nurses may have some knowledge regarding assessment and management of

ectopic pregnancy.

Self instructional module is an accepted strategy to improve knowledge.

Failure in early diagnosis and management of ectopic pregnancy may result in

rupture of surrounding structures and heavy bleeding which may be fatal.

6.7 Hypotheses

The hypothesis will be listed at 0.05 level of significance.

H1: The mean post-test knowledge score regarding assessment and management of

ectopic pregnancy among staff nurses will be significantly higher than mean pre-test

knowledge score regarding assessment and management of ectopic pregnancy among

staff nurses.

H2: There will be significant association between mean pre-test knowledge score

regarding assessment and management of ectopic pregnancy among staff nurses and

selected demographic variables.

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6.8 Delimitations

The study will be delimited to staff nurses who are working in selected maternity

hospitals in Mangalore.

7. Material and methods

7.1 Source of data

Data will be collected from staff nurses working in selected hospitals at Mangalore.

7.1.1 Research design

Pre-experimental design will be used for the study.

One group pre-test-post test will be selected for the study.

Subject Pre-test Treatment Post-test

Staff nurses working in selected maternity hospitals at Mangalore

O1 X O2

R = O1 X O2

R = Sample.

O1 Pre-test assessment of staff nurses knowledge regarding assessment and management

of ectopic pregnancy.

X Treatment (self-instructional module regarding assessment and management of

ectopic pregnancy).

O2 Post-test knowledge of staff nurses regarding assessment and management of ectopic

pregnancy.

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7.1.2 Setting

The study will be conducted in selected hospitals at Mangalore that provide

maternity services.

7.1.3 Population

Staff nurses in the age group of 22-49 years who are working in selected hospitals at

Mangalore.

7.2 Method of data collection

7.2.1 Sampling procedure

Purposive sampling technique will be used to collect the sample.

7.2.2 Sample size

Sample size consists of 50 staff nurses.

7.2.3 Inclusion criteria for sampling

Staff nurses who are willing to participate in the study.

Staff nurses in the age group of 22–49 years.

Staff nurses who are available at the time of data collection.

7.2.4 Exclusion criteria for samplings

The study excludes:

Nursing superintendents.

Staff nurses who are not available at the time of data collection.

Staff nurses who were not willing to participate in the study.

7.2.5 Instruments intended to be used

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Following tool will be prepared and used for data collection.

Section A: Demographic variables.

Section B: Structured knowledge questionnaire regarding assessment and management of

ectopic pregnancy.

7.2.6 Data collection method

Prior permission will be obtained from the higher authorities of the selected

hospitals. The purpose and need for the study will be explained to the women.

Confidentiality of the collected data will be assured to the women and written consent will

be obtained. A structured knowledge questionnaire regarding assessment and management

of ectopic pregnancy will be distributed and requested to be filled by the respondents. The

filled tool will be collected and self instructional module will be given to the respondents.

After 7 days, post test will be conducted to the same subjects using the same structured

knowledge questionnaire.

7.2.7 Plan for data analysis

The data will be analysed using both descriptive (mean, median, mean percentage

and standard deviation) and inferential statistics (chi-square test, paired ‘t’ test).

7.3 Does the study require any investigations or interventions to be conducted on patients, or other animals? If so please describe briefly.

Yes. In the present study, the investigator plan to use structured knowledge

questionnaire to evaluate the effectiveness of self instructional module regarding assessment

and management of ectopic pregnancy.

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

Yes. Ethical clearance is obtained from the ethical committee of the institution.

8. References

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1. http://www.finestquotes.com/select-category-pregnancy-page-o.htm.

2. http://en.wikipedia.org/wiki/pregnancy.

3. Swarna, Padmavathy K. Ectopic pregnancy. The Nursing Journal of India 2004

Aug;XCV(8):174-5.

4. Subhashini P, Nimisha RK, Kavimani S, Balu V. Ectopic pregnancy. Nightingale

Nursing Times 2009 Jan;4(10).

5. http://www.ectopic.org.uk/index.php/patients/frequently-asked-questions-faqs/

6. http://www.gulfmd.com/parenting_pregnency/ectopic%20pregnancy.asp?id=27

7. http://www.whattoexpect.com/pregnancy/pregnancy-health/complications/ectopic-

pregnancy.aspx

8. http://www.nursingceu.com/courses/curriculum_all.html

9. Experiences and perceptions of midwives and doctors when caring for patients with

ectopic pregnancy. [online]. Available from: URL:http://www.thefreelibrary.com/

10. Bed SA. Diagnosis of unruptured ectopic pregnancy is still uncommon in Korle Bu

Teaching Hospital. Ghana Medical Journal 2006 Mar;40(1).

11. Bouyer J, Coste J, Shojaei T, Pouly JL, Fernandez H, Gerbaud L, Job-Spira N. Risk

factors for ectopic pregnancy. American Journal of Epidemiology 2000;157(3).

12. Westrom L, Bengtsson LP, Mardh PA. Incidence, trends, and risks of ectopic

pregnancy in a population of women. Br Med J 1981 Jan;282(15).

13. Gupta R, Porwal S, Swarnkar M, Sharma N, Maheshwari P. Incidence, trends and

risk factors for ectopic pregnancies in a tertiary care hospital, Rajasthan. Journal of

Pharmaceutical and Biomedical Sciences 2012;16(16).

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14. Barnhart KT, Sammel MD, Gracia CR, Chittams J, Hummel AC, Shaunik A. Risk

factors for ectopic pregnancies. Fertility and Sterility 2006 Jul;86(1):36-43.

15. Cheng EOL, To WWK, Tsang SW, Mok KM, Sit CY. Success rates of expectant and

medical management of ectopic pregnancy. Hong Kong J Gynaecol Obstet

Midwifery 2008;8(1):35.

16. Malak M, Tawfeeq, Holzer H, Tulandi T. Risk factors for ectopic pregnancy after in-

vitro fertilization treatment. J Obstet Gynaecol Can 2011 Jun;33(6):617.

17. Mahaboob U, Mazhar SB. Ectopic pregnancy. [online]. Available from:

URL:http://www.ayubmed.edu.pk/JAMC/

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9. Signature of the candidate

10. Remarks of the guide

11. Name and designation of (in block letters)

11.2 Guide MRS. LIZZIE D’COSTAPROFESSOR AND HODOBSTETRICS AND GYNAECOLOGICAL

NURSINGINDIRA NURSING COLLEGEFALNIR, MANGALORE – 575 002.

11.2 Signature

11.3 Co-guide (if any)

11.4 Signature

12 12.1 Head of the department MRS. LIZZIE D’COSTAPROFESSOR AND HODOBSTETRICS AND GYNAECOLOGICAL

NURSINGINDIRA NURSING COLLEGEFALNIR, MANGALORE – 575 002.

12.2 Signature

13. 13.1 Remarks of the Chairman and Principal

13.2 Signature

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