Ectopic pregnancy of research protocol
Ectopic pregnancy of research protocol
1.Titel :
A prospective observational Study on the diagnosis. Management and outcome of ectopic pregnancy.
2. Abstract:
Ectopic pregnancy is a potentially life- threatened condition in which a fertilized ovum implants outside
the uterine cavity, most commonly in the fallopian tubes. It affects approximately 1-2℅of all
pregnancies and remains a leading cause of maternal morbidity and early pregnancy related mortality.
Risk of factor include previous ectopic pregnancy, tubal surgery, pelvic inflammatory disease, assisted
reproductive techniques and smoking clinical presentation varies but often includes abdominal pain,
vaginal bleeding and amenorrhea. Diagnosis relies on a combination of transvaginal ultrasonography
and serial measurement of serum beta human chronic gonadotropin. Management Strategies depend
on the patient's hemodynamic stability, gestational age, and desire for future fertility, ranging from
expectant management and medical therapy with methotrexate to surgical intervention via laparoscopy
or laparotomy. Early recognition and timely treatment are critical to prevent complications such as tubal
rupture and hemorrhagic shock. Advances in diagnostic imaging and minimally invasive treatment have
significantly improved outcomes, yes ectopic pregnancy remains a significant challenge in reproductive
health.
3.Introduction:
Ectopic pregnancy is defined as the inflammation of a fertilized Ovum outside the uterine cavity. It is a
significant cause of maternal morbidity and motility, particularly during the first trimester of pregnancy.
the most common site of inflammation is the fallopian tube, accounting for over 90% of course,
although information can also occur in the ovary, cervix, abdomen or previous cesarean scar.
The incidence of ectopic pregnancy has been increasing globally, partly due to improved diagnostic
techniques, higher rate of pelvic infection, and the widespread use of assistant reproductive
technologies, Risk factor include a history of pelvic inflammatory disease, previous tuba surgery, piror
topic pregnancy, intrauterine device use, smoking and infertility treatments.
Clinically, ectopic pregnancy often present with abdominal pain, vaginal bleeding and missed menstrual
periods, but symptoms can vary, Making early diagnosis challenging, Delayed recognition many
complications, Advances in imaging, particularly, transvaginal ultrasonography, along with sensitive,
Human chorionic gonadotropin assays, have improved early detection.
Understanding the pathology, risk factor and management options for ectopic pregnancy is crucial for
reducing maternal morbidity and preserving fertility.
4.Background and Rationale:
Ectopic pregnancy (EP) occurs when a fertilized ovum implants outside the uterine cavity, most
commonly in the fallopian tube. It remains a significant cause of maternal morbidity and mortality,
particularly in early pregnancy. Despite advances in diagnostic tools—such as transvaginal ultra sound and serum β- hCG delayed diagnosis is still common in many settings. Understanding local risk factors,
presentation patterns, diagnostic delays, and treatment outcomes is essential to improving clinical
management and reducing complications.
Objectives
1.General Objective:
To determine the clinical presentation, diagnostic methods, management strategies, and outcomes of
ectopic pregnancy at [Hospital/Region].
2 Specific Objectives:
o To describe the demographic and clinical characteristics of women diagnosed with ectopic
pregnancy.
o To identify common risk factors associated with ectopic pregnancy.
o To assess diagnostic modalities used and time intervals to diagnosis.
o To determine predictors of complications such as tubal rupture, hemorrhage, or need for blood
transfusion.
5. Study Design:
Study Type: Retrospective or prospective observational study
Study Period: e.g., July 2025 – December 2025]
6. Study Population:
1.Inclusion Criteria:
All women diagnosed with ectopic pregnancy during the study period
Confirmed by ultrasound, β-hCG trend, or surgical findings
2 Exclusion Criteria:
Incomplete medical records (for retrospective studies).
Patients declining participation (for prospective studies).
7. Sample Size: Can be calculated using prevalence-based formula or include all cases within the study
period (census).
(If you want, provide prevalence and I can compute the sample size.)
8. Sampling Technique:
Retrospective: Consecutive sampling from medical records.
Prospective: Consecutive enrolment of all eligible patients.9. Data Collection:
1. Variables
2. Sociodemographic variables
3. Age
4. Parity
5. Gravidity
6. Marital status
7. Occupation
8. Risk factors
9. Previous ectopic pregnancy
10. PID history
11. Tubal surgery
12. Infertility or ART
13. Contraceptive use (IUD, etc.)
14. Smoking
15. Clinical presentation
16. Abdominal pain
17. Vaginal bleeding
18. Amenorrhea duration
19. Shock symptoms
20. Diagnostic findings
21. β-HCG level
22. Transvaginal ultrasound findings
23. Hemoglobin level
24. Management
25. Medical (methotrexate: dose, criteria)
26. Surgical (salpingectomy, salpingostomy , laparoscopy/laparotomy)
27. Expectant management
28. Outcomes
29. Success of therapy
30. Rupture
31. Hemo peritoneum volume
32. Blood transfusion
33. Length of hospital stay
34. Maternal morbidity or mortality
9.2 Data Collection Tools:
Structured data extraction sheet
Electronic medical record review
Patient interview (for prospective studies)10. Data Analysis:
o Using SPSS, STATA, or R:
o Descriptive statistics: frequencies, means, medians.
o Bivariate analysis: χ² test, t-test.
o Multivariate analysis: logistic regression to identify predictors of complications or
treatment success.
o Significance level: p < 0.05.
11. Ethical Considerations:
o Approval from the Institutional Review Board/Ethics Committee.
o Informed consent for prospective participants.
o Confidentiality ensured by anonymizing data.
o No harm expected as it is an observational study.
o Data stored securely with restricted access.
12. Expected Outcomes:
o Clear understanding of local burden and presentation patterns.
o Evidence-based recommendations for improving early diagnosis.
o Identification of the most effective management strategies.
o Reduced morbidity from ectopic pregnancy.
13. Timeline:
Activity Months Proposal approval (1–2) Data collection (3–8) Data analysis (9–10 )Report writing (11–
12).
14. Budget (Example):
Item Cost Da
Reference:
Cunningham FG, Leven KJ, Bloom SL, et al. Williams obstetrics,26th ed. New York ; McGraw- Hill;2022.
Berek JS. Berek & Novak's Gynecology. 17th ed. Philadelphia Walters Kluwer ;2020.
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