Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Armenia

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

Detailed Description
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Women who were deemed eligible for the study by the provider gave informed consent. They took 200 mg of mifepristone orally at the study clinic. In 24-44 hours, they returned to the clinic for induction with misoprostol. They were admitted as inpatients at the clinic and took 400 mcg of buccal misoprostol every 3 hours until the fetus and placenta were expelled. If there was no full expulsion after 10 doses of misoprostol, the provider used their discretion to determine the appropriate clinical course of action. After responding to questions about their experience with the procedure, women were discharged from the study.

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

Conditions
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Abortion in Second Trimester

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnancy of 13-22 weeks' gestation Good general health Meeting legal criteria to obtain abortion Presenting with closed cervical os and no vaginal bleeding Live fetus at time of presentation for service Willingness to undergo a surgical completion if necessary No contraindications to study procedures, according to provider Woman willing and able to consent to procedure, either by reading consent document or by having consent document read to her Willingness 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 Parity greater than 5 Any contraindications to vaginal delivery, including placenta previa Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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<br>Pregnant women of 13-22 weeks gestation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful abortion |  | Every 3 hours after induction with misoprostol commences, up to 30 hours after the first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of misoprostol |  | At the time of fetal and placental expulsion, up to 30 hours after the first dose | 
| Women's satisfaction with the method |  | At discharge, up to 5 days after enrollment | 
| Side effects |  | Every 3 hours, starting from the first dose of misoprostol, up to fetal and placental expulsion or 30 hours after the first dose, whichever occurs first | 
| Women's acceptability of the side effects, buccal administration of misoprostol, and duration of procedure |  | At discharge, up to 5 days after enrollment | 
| Providers' acceptability of the method |  | After all study procedures complete, at close out, up to 1.5 years after study enrollment commences | 
| Complications including heavy bleeding, uterine rupture, or infection requiring additional treatment |  | Every 3 hours, starting from the first dose of misoprostol, up to fetal and placental expulsion, or 30 hours after the first dose, whichever occurs first | 
| Induction to fetal expulsion interval |  | Time from administration of first misoprostol dose to expulsion of the fetus, up to 30 hours after the first dose | 
| Induction to fetal and placental expulsion interval |  | Time from administration of first misoprostol dose to expulsion of the fetus and placenta, up to 30 hours after the first dose |