Comparison of Surgical Versus Medical Termination of Pregnancy Between 13-20 Weeks of Gestation in Ethiopia

Study Overview
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Brief Summary
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The purpose of the study is to determine the safety and effectiveness of dilation and evacuation for surgical abortion as compared to medical abortion

Detailed Description
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All patients with a gestational age between 13-20 weeks are fully counseled on the risks and benefits and given the option of medical or surgical abortion. Those who choose medical abortion receive mifepristone 200 mg on day 1 and are appointed to return to SPHMMC 24-48 hours later for admission and misoprostol administration. Those who chose surgical abortion are given mifepristone 200 mg with or without laminaria and appointed to return the next day for surgical abortion.

Official Title
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Comparison of Surgical Versus Medical Termination of Pregnancy Between 13-20 Weeks of Gestation in Ethiopia: A Quasi-experimental Study.

Conditions
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Termination of Pregnancy

Intervention / Treatment
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* Procedure: Dilation and evacuation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age between 13 - 20 weeks confirmed with ultrasound, Age at or more than18 years, Having a working phone and willingness to be contacted for a follow-up questionnaire 2 weeks after the procedure. Exclusion criteria Inability to give consent complicated abortion (missed abortion, septic abortion)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medical arm<br>Those who choose medical abortion receive mifepristone 200 mg on day 1 and are appointed to return to SPHMMC 24-48 hours later for admission and misoprostol administration. | Procedure: Dilation and evacuation<br>* Abortion is termination of pregannacy by evaccuating the uterus using either medical or surgical technique<br>* Other names: Medical abortion;|
| Experimental: Surgical arm<br>Those who chose surgical abortion are given mifepristone 200 mg with or without laminaria and appointed to return the next day for surgical abortion. | Procedure: Dilation and evacuation<br>* Abortion is termination of pregannacy by evaccuating the uterus using either medical or surgical technique<br>* Other names: Medical abortion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite complication rate | Presence of one of the following complications: bleeding requiring observation, genital tract lacerations requiring repair, need for additional intervention to complete the abortion procedure, and one or more symptoms of pelvic infection | During the abortion procedure and within 2 weeks post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other serious maternal complications | Continued bleeding for more than two weeks, additional major surgery (laparotomy), and death. | During the abortion procedure and within 2 weeks post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dilation and evacuation, Second Trimester, Medical abortion, Ethiopia