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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women | Pregnant women of 13-22 weeks gestation |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of successful abortion | Every 3 hours after induction with misoprostol commences, up to 30 hours after the first dose |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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All women presenting to a study clinic in Yerevan, Armenia for voluntary termination of intrauterine pregnancy with gestational ages of 13-22 weeks
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| Name | Affiliation | Role |
|---|---|---|
| Ruzanna Abrahamyan, MD | Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology | Principal Investigator |
| Gayane Abrahamyan, MD, PhD | State Medical University | Principal Investigator |
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Medical University | Yerevan | 0025 | Armenia | |||
| Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology |
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| 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 |
| Yerevan |
| 0078 |
| Armenia |