Research Proposal First Draft (Adamu Moti)
Research Proposal First Draft (Adamu Moti)
DEPARTMENT OF PHARMACY
APRIL 2023
MATTU, ETHIOPIA
ASSESSMENT OF MAGNITUDE OF PRE-ECLAMPSIA AND ASSOCIATED
FACTORS AMONG WOMEN ATTENDING DELIVERY SERVICE IN
MKCSH SOUTHWEST, ETHIOPIA
APRIL 2023
MATTU, ETHIOPIA
i
Acknowledgment
First, I would like to thank the Almighty God for his love and kindness in bestowing my health,
strength, patience, and protection throughout my work. Next, I would like to forward my
gratitude to Mattu University, College of Health Science Department of Pharmacy that
providing me with this opportunity. Furthermore, I would like to express my gratitude to my
teacher and advisor, Mr. X (MSc. In …) for his guidance, support, and his continuous
enthusiasm and encouragement throughout the research proposal. I pay respect and express
appreciation to him because of his guidance, advice, consistent supervision as well as moral
support.
ii
Summary
Introduction: Preeclampsia is a serious medical complication that affects pregnant women and
their unborn babies. Even though preeclampsia is a leading cause of maternal morbidity and
mortality during pregnancy, labor, and delivery little is known about the current prevalence of
preeclampsia, and its associated factors among women attending delivery services in Ethiopia
and particularly in the study areas. Identifying the magnitude and associated risk factors of this
condition is crucial in developing effective preventive and management strategies to reduce the
burden of this life-threatening condition.
Objective: The objective of this study will be to assess the magnitude of pre-eclampsia and
associated factors among women attending delivery services in Mattu Karl Comprehensive
Specialized Hospital, Mattu, Ethiopia, 2023.
Methods: An Institutional based Cross-sectional study will be conducted starting from May 22
to June 18, 2023, at MKCSH in Mattu, Southwest Ethiopia. All women whose ages are between
eighteen and forty-five attending delivery service during the study period will be involved.
The data will be checked for completeness and consistency, and the collected data will code
and entered Epi Info version 7.2.5.0 and will be analyzed by using Statistical package for social
science (SPSS) version 27. The result is going to be compiled with table and frequency and a
conclusion will be made and a recommendation will be forwarded.
Work plan & Budget: The research will be conducted from May 22 to June 18, 2023, G.C.
Total estimated budget required to accomplish my tasks will be ETB 24,828.10 (twenty-four
thousand, eight hundred twenty-eight birr and ten cents).
Keywords: Preeclampsia, Magnitude, Factors, Delivery, Women, Ethiopia
iii
Acronyms
BMI: Body Mass Index
EDHS; Ethiopian Demographic Health Survey
LNMP: Last Normal Menstrual Period
MKCSH: Mattu Karl Comprehensive Specialized Hospital
PHI: pregnancy-induced hypertension
SPSS: Statistical Product and Service Solutions
WHO: World Health Organization
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Table of Contents
Contents Page
Acknowledgment ....................................................................................................................... ii
Summary ................................................................................................................................... iii
Acronyms .................................................................................................................................. iv
List of Tables ............................................................................................................................ vii
1. INTRODUCTION .............................................................................................................. 8
1.1. Background .................................................................................................................. 8
1.2. Statement of the problem ............................................................................................. 9
1.3. Significance of the study ........................................................................................... 10
2. LITERATURE REVIEW ................................................................................................. 11
3. OBJECTIVES ................................................................................................................... 14
3.1. General objective ....................................................................................................... 14
3.2. Specific objectives ..................................................................................................... 14
4. METHODS ....................................................................................................................... 15
4.1. Study Design.............................................................................................................. 15
4.2. Study Area and study period ..................................................................................... 15
4.3. Population .................................................................................................................. 15
4.3.1. Source population .................................................................................................. 15
4.3.2. Study population .................................................................................................... 15
4.4. Sample size and sampling technique ......................................................................... 15
4.4.1. Sample size ............................................................................................................ 15
4.4.2. Sampling technique ................................................................................................ 16
4.5. Inclusion and Exclusion criteria ................................................................................ 16
4.5.1. Inclusion criteria .................................................................................................... 16
4.5.2. Exclusion criteria ................................................................................................... 16
4.6. Study variables .......................................................................................................... 16
4.7. Data collection ........................................................................................................... 17
4.8. Data quality Control .................................................................................................. 17
4.9. Data processing and analysis ..................................................................................... 17
4.10. Operational definition ............................................................................................ 17
4.11. Ethical consideration .............................................................................................. 18
v
4.12. Dissemination of results ......................................................................................... 18
5. Work plan and Budget Plan .............................................................................................. 19
5.1. Work Plan ...................................................................................................................... 19
5.2. Budget Plan ................................................................................................................... 20
References ................................................................................................................................ 21
ANNEXES ............................................................................................................................... 23
vi
List of Tables
Table 1: Gantt Chart showing the activities that will be performed and the responsible body
with the schedule. ..................................................................................................................... 19
Table 2: List of Budgets That will be required to accomplish the task (Stationary, personal
cost, and another budget) ......................................................................................................... 20
vii
1. INTRODUCTION
1.1. Background
Preeclampsia, sometimes referred to as toxemia or pregnancy-induced hypertension (PIH), is a
disorder that occurs during pregnancy and affects both the mother and the fetus. It is a rapidly
progressive condition characterized by elevated blood pressure, swelling, and protein in the
Urine, and one of the driving causes of maternal and perinatal horribleness and mortality (1).
Preeclampsia may develop from 20 weeks gestation. Its progress differs among patients; most
cases are diagnosed pre-term. Preeclampsia may also occur up to six weeks postpartum. Apart
from a cesarean section or induction of labor, there is no known cure. It is the most common
dangerous pregnancy complication; it may affect both the mother and the unborn child (2).
It is a syndrome characterized by the new onset of elevated blood pressure (>140/90) plus
proteinuria in a previously normotensive woman. If preeclampsia is undetected early and left
untreated, it may advance into severe life-threatening condition eclampsia characterized by the
development of convulsion, which is one of the top five direct causes of maternal mortality and
infant adverse outcome (2).
Preeclampsia refers to a set of symptoms rather than any causative factors, and there are many
different causes for the condition. It appears likely that there are substances from the placenta
that can cause endothelial dysfunction in the maternal blood vessels of susceptible women.
While blood pressure elevation is the most visible sign of diseases, it involves generalized
damage to the maternal endothelium, kidney, and liver, with the release of vasoconstrictive
factors being secondary to the original damage (3; 4).
The exact cause of preeclampsia is not fully understood, but it is believed to be related to the
abnormal development of the blood vessels in the placenta, which can lead to reduced blood
flow to the fetus and inadequate oxygen and nutrient delivery. This can cause damage to organs
such as the liver, kidneys, and brain, and lead to complications such as eclampsia (seizures),
HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), placental
abruption, fetal growth restriction (5).
Preeclampsia can develop suddenly and progress rapidly, which is why regular prenatal care
and monitoring are crucial. It is usually diagnosed through regular blood pressure and urine
tests during prenatal visits, as well as other tests such as blood tests, ultrasounds, and fetal
monitoring (3).
8
Treatment for preeclampsia typically involves close monitoring of the mother and fetus,
medications to lower blood pressure and prevent seizures, and delivery of the baby if the
condition becomes severe or the pregnancy has reached full term. Early detection and
management of preeclampsia can significantly reduce the risk of complications for both the
mother and the baby (5).
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1.3. Significance of the study
Preeclampsia is a major public health concern that contributes significantly to maternal and
fetal morbidity and mortality globally. Identifying the magnitude and associated risk factors of
this condition is crucial in developing effective preventive and management strategies to reduce
the burden of this life-threatening condition. Understanding the epidemiology of preeclampsia
and its associated factors is particularly important in low- and middle-income countries where
the prevalence of the condition is high, and resources for maternal and fetal healthcare are often
limited.
The government of Ethiopia has implemented multi-pronged approaches to reducing maternal
and newborn morbidity and mortality by improving access to and strengthening facility-based
maternal and newborn services. However, maternal morbidity and mortality due to hypertensive
disorders are still on an alarming trend (14).
Even though preeclampsia is a leading cause of maternal morbidity and mortality during
pregnancy, labor, and delivery little is known about the current prevalence of preeclampsia, and
its associated factors among women attending delivery services in Ethiopia and particularly in
the study areas. Therefore, this study is intended to assess the magnitude of preeclampsia and
its associated factors among women attending delivery in the Mattu Karl Comprehensive
Specialized Hospital. This study will provide valuable information on the prevalence and
associated risk factors of preeclampsia among pregnant women in a particular setting, which
can be used to inform policy and practice in maternal and fetal healthcare. The findings of this
study can be useful to healthcare providers, policymakers, and stakeholders involved in
improving maternal and fetal health outcomes. Additionally, the study may also provide a
foundation for future research in the area of preeclampsia, especially in similar settings.
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2. LITERATURE REVIEW
2.1. Introduction
Pre-eclampsia is a pregnancy complication characterized by hypertension and proteinuria that
usually arises after 20 weeks of gestation in a previously normotensive and non-proteinuria
woman. It is a leading cause of maternal and fetal morbidity and mortality worldwide (6).
According to the World Health Organization (WHO), pre-eclampsia complicates around 10%
of pregnancies globally (7). The incidence of pre-eclampsia varies among populations and is
influenced by various factors, including maternal age, parity, and body mass index (BMI),
among others. Early detection and management of pre-eclampsia are crucial to reduce maternal
and fetal morbidity and mortality.
Several studies have been conducted to determine the magnitude of pre-eclampsia among
women attending delivery services. A study conducted in Nigeria found that the prevalence of
pre-eclampsia was 8.8% (15). In Tanzania, a study reported a prevalence of 7.3% (16), while
another study in Ethiopia reported a prevalence of 15.7% in Debre Tabor Comprehensive
Specialized Hospital , 12.4% in Mettu (17), 7.9% in Mizan Tepi (18). These findings suggest
that the prevalence of pre-eclampsia varies widely among different populations.
Several socio-demographic factors have been identified as risk factors for pre-eclampsia. A
study conducted in Nigeria found that maternal age above 35 years, low educational level, and
low socio-economic status were significantly associated with pre-eclampsia (15). Similarly, a
study in Ghana reported that low maternal education, low socio-economic status, and nulliparity
were significantly associated with pre-eclampsia (16).
Several obstetric factors have also been identified as risk factors for pre-eclampsia. A study in
Ethiopia found that primigravida, multiple gestation, and history of pre-eclampsia were
significantly associated with pre-eclampsia (19). Another study conducted in Tanzania reported
that twin pregnancy, history of pre-eclampsia, and history of gestational diabetes were
significantly associated with pre-eclampsia (16).
Furthermore, a study conducted in Nigeria found that history of preterm delivery, history of
stillbirth, and history of infertility were significantly associated with pre-eclampsia (15).
11
Similarly, a study in Zanzibar reported that history of pre-eclampsia, history of stillbirth, and
history of preterm delivery were significantly associated with pre-eclampsia (20).
Early detection and management of pre-eclampsia are crucial to reduce adverse outcomes, but
this depends on women's knowledge and awareness of the condition.
Several studies have investigated the knowledge and awareness of pre-eclampsia among
women attending delivery services. In a cross-sectional study conducted in Nigeria, only 28%
of women knew about pre-eclampsia, and only 13% knew its signs and symptoms. Another
study in Ghana reported that only 37.6% of women knew about pre-eclampsia, and only 15.8%
knew its signs and symptoms (21). Similarly, a study in Ethiopia found that only 28.8% of
women had a good knowledge about pre-eclampsia, and 7% knew its signs and symptoms (22).
The low level of knowledge and awareness of pre-eclampsia among women attending delivery
services is a concern. This is because women who are unaware of pre-eclampsia may not
recognize its signs and symptoms and may delay seeking care, which can lead to severe
complications and death. Moreover, women who are not informed about pre-eclampsia may not
take preventive measures or follow recommended management practices.
Studies have identified several factors that influence women's knowledge and awareness of pre-
eclampsia. These include maternal education, age, parity, socioeconomic status, and access to
healthcare. For instance, studies have found that women with higher levels of education, older
women, and women with more pregnancies have better knowledge and awareness of pre-
eclampsia. In contrast, women with low socioeconomic status and limited access to healthcare
are less likely to know about pre-eclampsia (21).
12
2.4. Screening and Management Practices
Several screening and management strategies have been developed and implemented to
improve the care of women with pre-eclampsia. Screening for pre-eclampsia typically involves
measuring blood pressure and proteinuria during antenatal care visits. Some screening tools
also incorporate other clinical and laboratory parameters, such as maternal age, body mass
index, gestational age, and blood tests for biomarkers such as placental growth factor and
soluble films-like tyrosine kinase-1. The choice of screening tool depends on various factors,
including the availability of resources, the local prevalence of pre-eclampsia, and the healthcare
provider's expertise (5).
Management of pre-eclampsia typically involves close monitoring of maternal and fetal status,
administration of medications such as antihypertensives and magnesium sulfate, and timely
delivery. The timing and mode of delivery depend on various factors, including the severity of
pre-eclampsia, gestational age, fetal status, and maternal condition. Women with severe pre-
eclampsia or eclampsia often require hospitalization and close monitoring and may need to be
delivered urgently to prevent further complications (2).
Several guidelines and protocols have been developed to standardize the screening and
management of pre-eclampsia. For instance, the World Health Organization recommends that
all pregnant women have their blood pressure measured at every antenatal care visit, and that
women with suspected pre-eclampsia or eclampsia be referred to a higher-level facility for
appropriate management. The American College of Obstetricians and Gynecologists
recommends that women with severe pre-eclampsia or eclampsia be delivered promptly,
regardless of gestational age (2).
Despite the availability of screening and management guidelines, the implementation of these
strategies in clinical practice remains variable. Studies have identified several barriers to the
uptake of evidence-based practices, including healthcare provider knowledge and attitudes,
limited resources, and patient factors such as lack of awareness or adherence to treatment (21).
Interventions to improve the implementation of screening and management practices for pre-
eclampsia include provider education, use of clinical decision support tools, and quality
improvement initiatives. Provider education can improve healthcare provider knowledge and
attitudes towards pre-eclampsia and increase adherence to guidelines. Clinical decision support
tools can assist healthcare providers in the timely identification and management of pre-
eclampsia. Quality improvement initiatives can improve the overall quality of care and patient
outcomes.
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3. OBJECTIVES
3.1. General objective
✓ To assess the magnitude of pre-eclampsia and associated factors among women
attending delivery service in MKCSH, Mattu, South-west Ethiopia, 2023.
14
4. METHODS
4.1. Study Design
This study will utilize a facility-based cross-sectional study design to assess the magnitude of
pre-eclampsia and associated factors among women attending delivery services in MKCSH,
Mattu, South-west Ethiopia.
4.3. Population
(𝑍𝛼/2)2 𝑃𝑞
𝑛=
𝑑2
Where: -
n= required sample size
α= confidence interval=95%
p= population proportion (15.7%)
15
q=1-p
d= desired precision=5%
Zα/2 =value under the standard normal table for the given value of confidence level=1.96
(1.96)2 (0.157)(0.843)
𝑛=
(0.05)2
(3.8416)(0.1324)
𝑛=
(0.0025)
𝑛 = 203
Considering a 10% nonresponse rate, we calculated the final sample size to be;
Final sample size(nf)=203+ (203*0.1)
Nf=223, So, the total sample size will be=223.
Thus, a simple random sampling technique will be performed to select 223 study participants.
16
4.7. Data collection
A structured questionnaire will be designed to assess the magnitude and associated factors of
preeclampsia among women attending delivery services. Data will be collected via face-to-face
interviews using a structured, and pre-tested questionnaire.
17
4.11. Ethical consideration
Initially, ethical approval will be taken from Mettu University Ethical Review Committee and
a formal permission letter will be obtained from the Department of Pharmacy, College of Health
Science, Mattu University. All participants will be adequately pre-informed regarding the aim
and the implication of the study and, will be assured that the given information will be kept
confidential and only be used for research purposes.
18
5. Work plan and Budget Plan
5.1. Work Plan
Table 1: Gantt Chart showing the activities that will be performed and the
responsible body with the schedule.
S.N Activities Responsible Time(Jan, 2023- August, 2023 G.C)
Body
18,
August 21,
August 28-
Jan 17, 2023
May22-June
May17-19,
18, 2023
30, 2023
17, 2023
17, 2023
2023
2023
2023
July
1. Title selection & -----------
Submission
2. Literature
redefining
3. Preparation of -----------
Proposal
4. Ethical clearance -----------
from respective
authorities
5. Pre-test -----------
questionnaire
6. Data Collection -----------
7. Data Cleaning -----------
8. Data processing, -----------
analysis,
and interpreting
9. Submission of the -----------
first Draft to the
Advisor
10. Submission of -----------
final Draft
11. Defense and -----------
Final Report
submission
19
5.2. Budget Plan
Table 2: List of Budgets That will be required to accomplish the task (Stationary, personal
cost, and another budget)
Total 24,828.10
20
References
1. RobertsJM, Redman CW. Pre-eclampsia: more than pregnancy-induced hypertension. s.l. :
Lancet1993;.
2. American College of Obstetricians and Gynecologist. ACOG practice bulletin: Diagnosis and
management of preeclampsia and eclampsia. 2019.
3. Magee, L. A., Pels, A., Helewa, M., Rey, E., von Dadelszen, P.,. Diagnosis, evaluation, and
management of the hypertensive disorders of pregnancy: executive summary. Canada : Canadian
Hypertensive Disorders of Pregnancy Working Group., 2014.
4. RobertsJM, Cooper DW. Pathogenesis and genetics of pre-eclampsia. s.l. : Lancet, 2001.
5. P., Green. Update in the Diagnosis and Management of Hypertensive Disorders in Pregnancy.
Michigan : Wayne State University School of Medicine;, 2014.
6. World Health Organization. WHO recommendations on antenatal care for a positive pregnancy
experience. s.l. : World Health Organization., 2019.
7. L., Duley. The global impact of pre-eclampsia and eclampsia. s.l. : Semin Perinatol, 2009.
9. L., Duley. Maternal mortality associated with hypertensive disorders of pregnancy in Africa, Asia,
Latin America and the Caribbean. s.l. : Br J Obstet Gynaecol, 1992.
10. Igberase GO, Ebeigbe PN. PN. Eclampsia: ten years of experience in a rural tertiary hospital in the
Niger delta. Nigeria : Journal of obstetrics and gynaecology., 2006 Jan 1.
11. WHO U, UNFPA, World Bank Group and the United Nations Population Division. Trends in
Maternal Mortality 2000 to 2017. 2019.
12. ICF, Central Statistical Agency (CSA) [Ethiopia] and. Ethiopia Demographic and Health Survey
2016: Key Indicators Report. Addis Ababa, : Ethiopia, and Rockville, Maryland, USA.CSA and ICF,
2016.
13. World health organization. Recommendations for prevention and treatment of pre-eclampsia
and eclampsia. Geneva : World health organization, 2011.
14. Federal Democratic Republic of Ethiopia Ministry of Health. Health sector development
Programme IV 2010/11 – 2014/15. 2010.
15. Ogunbode, O. O., Fawole, A. A., Adeniran, A. S., & Ogunbode, A. M. Sociodemographic and
obstetric factors associated with pre-eclampsia in a Nigerian tertiary hospital. Nigeria : Nigerian
Journal of Clinical Practice, 2018, Vols. 21(7), 942-947.
16. Mselle, L. T., Pembe, A. B., Hamisi, Y. A., Mbekenga, C. K., & Sam, N. E. Prevalence and
predictors of pre-eclampsia among pregnant women attending antenatal care at Bugando Medical
Centre, Mwanza,. Tanzania : BMC Pregnancy and Childbirth, 2019, Vols. 19(1), 1-.
21
17. Belay AS, Wudad T. Prevalence and associated factors of pre-eclampsia among pregnant women
attending anti-natal care at Mettu Karl referal hospital, Ethiopia: cross sectional study. Clinical
hypertension. 2019.
18. Tesfaye Abera Gudeta, Tilahun Mekonnen. Pregnancy Induced Hypertension and Its Associated
Factors among Women Attending Delivery Service at Mizan-Tepi University Teaching Hospital, Tepi
and Gebretsadikshawo Hospitals, Southwest. Ethiopia : Ethiop J Health Sci., 2018, Vol. 29 (1):831.
19. Asseffa, N. A., Bukola, F., & Ambaye, M. Prevalence of pre-eclampsia and associated factors
among pregnant women attending antenatal care at the University of Gondar Hospital. northwest
Ethiopia : BMC Pregnancy and Childbirth, 2017, Vols. 17(1), 307.
20. Machano, M.M., Joho, A.A. Prevalence and risk factors associated with severe pre-eclampsia
among postpartum women in Zanzibar: a cross-sectional study. s.l. : BMC Public Health 20,, 2020.
21. Fondjo, L.A., Boamah, V.E., Fierti, A. et al. Knowledge of preeclampsia and its associated factors
among pregnant women: a possible link to reduce related adverse outcomes. s.l. : BMC Pregnancy
Childbirth, 2019.
22. Mekie, M., Addisu, D., Bezie, M. et al. Knowledge and attitude of pregnant women towards
preeclampsia and its associated factors in South Gondar Zone, Northwest Ethiopia: a multi‐center
facility‐based cross‐sectional study. Ethiopia : BMC Pregnancy Childbirth 21, 16, 2021.
23. Fekadu GA, Kassa GM, Berhe AK, Muche AA, Katiso NA. The effect of antenatal care on use of
institutional delivery service and postnatal care in Ethiopia: a systematic review and meta-analysis.
s.l. : BMC Health Serv Res., 2018.
22
ANNEXES
Section 1: Socio-demographic
1. What is your age? _____
2. What is your highest level of education completed?
A. Illiterate B. Read & Write only C. Primary D. Secondary E. Above
3. What is your occupation?
A. Housewife B. Student C. Government workers D. Merchant E. other
4. Address place of residence
A. Urban B. Rural
5. What is your monthly income? _______
6. How many children do you have?________
Section 2: Pre-eclampsia Status
7. Have you ever been diagnosed with pre-eclampsia during any of your pregnancies?
A. Yes B. No
8. If yes, how many times have you had pre-eclampsia?___________
9. Were you diagnosed with pre-eclampsia during your current pregnancy?
_________________
Section 3: Pre-eclampsia Symptoms
10. Did you experience any of the following symptoms during your pregnancy?
A. High blood pressure B. Swelling in the hands and feet C. Headaches
D. Blurred vision E. Abdominal pain F. Decreased urine output
G. Nausea or vomiting
Section 4: Associated Factors
11. Have you ever had any of the following conditions during your pregnancy?
A. Diabetes B. Chronic hypertension C. Kidney disease
D. Thyroid disease E. Lupus or other autoimmune disease
12. Did you receive any antenatal care during your current pregnancy?
A. Yes B. No
13. How many antenatal care visits did you have during your current pregnancy?_____
14. Did your healthcare provider discuss pre-eclampsia with you during your antenatal care
visits?
A. Yes B. No
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15. Did you receive any medications or interventions to prevent pre-eclampsia during your
pregnancy?
A. Yes B. No
16. Did you have any complications during your pregnancy or delivery?
A. Yes B. No
17. If yes, what were the complications? _________________________
18. Did you have a normal delivery or a caesarean section?
A. Normal delivery B. Caesarean section
19. Did your healthcare provider discuss postpartum care with you?
A. Yes B. No
20. Did you receive any postpartum care after delivery?
A. Yes B. No
21. How many days after delivery did you receive postpartum care? _____________
22. Did you experience any complications during the postpartum period?
A. Yes B. No
23. If yes, what were the complications?
24. Did you receive any treatment for postpartum complications?
A. Yes B. No
25. Do you have any suggestions for improving maternal and child health services in your
area? A. Yes B. No
Thank you for participating in this survey. Your responses will be kept confidential and will be
used for research purposes only.
24