Mifepristone and Misoprostol for Midtrimester Termination of Pregnancy in Uzbekistan

Study Overview
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Brief Summary
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The primary goal is to examine the efficacy and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Uzbekistan.

Official Title
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Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Uzbekistan

Conditions
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Abortion in Second Trimester

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet legal criteria to obtain abortion Have an ongoing pregnancy of 13-22 weeks gestation Be willing to undergo a surgical completion if necessary Have no contraindications to study procedures, according to provider Be willing and able to consent to procedure, either by reading consent document or by having consent document read to her Be willing to follow study procedures Exclusion Criteria: Known previous transmural uterine incision Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol Any contraindications to vaginal delivery, including placenta previa
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women of 13-22 weeks gestation<br>Pregnant women of 13-22 weeks gestation will receive 200 mg mifepristone followed 24-48 hours later by 400 mcg sublingual misoprostol every three hours until complete expulsion. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of abortions that are complete as a measure of efficacy | It is a proportion that specifies how many abortions out of all initiated abortions are complete without recourse to surgical intervention within 15 hours after the start of misoprostol administration. | At 15 hours after the start of misoprostol administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interval of time between induction with misoprostol to complete abortion | It is the length of time between the administration of the first dose of misoprostol and complete abortion. | Every 3 hours from the start of misoprostol administration until complete abortion | 
| Women's satisfaction with the method | It is a scale that assesses the level of a woman's satisfaction with the procedure. | At discharge, up to 5 days after enrollment | 
| Side effects experienced by women | It is a brief questionnaire that records all side effects experienced by women. | Every 3 hours from the start of misoprostol administration until complete abortion | 
| Pain experienced by women | It is a scale that assesses the acceptability of pain experienced by the woman. | At the time of discharge, up to 5 days after enrollment | 
| Complications during induction and after discharge | It is a record of complications and their treatment during induction and up to 1 month after discharge. | Every 3 hours from the start of misoprostol administration, up to 1 month after discharge | 
| Women's perception of acceptability of the procedure | It is a scale that assesses the acceptability of the procedure for the woman. | At discharge, up to 5 days after enrollment | 
| Provider's perception of acceptability of the method | It is a questionnaire that assesses the acceptability of the method for the provider. | At study completion, up to 2 years after study enrollment commences | 
| Total dose of misoprostol administered | Count of the total dose of misoprostol administered from the first dose to complete abortion. | Every 3 hours from start of misoprostol administration to complete abortion |