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

Gynuity Health Projects120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Abortion in Second Trimester

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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)

Locations (2)

State Medical University

Yerevan, Armenia

Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology

Yerevan, Armenia

Outcomes

Primary Outcomes

Rate of successful abortion

Time frame: Every 3 hours after induction with misoprostol commences, up to 30 hours after the first dose

Secondary Outcomes

Total dose of misoprostol

Time frame: At the time of fetal and placental expulsion, up to 30 hours after the first dose

Women's satisfaction with the method

Time frame: At discharge, up to 5 days after enrollment

Side effects

Time frame: 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

Time frame: At discharge, up to 5 days after enrollment

Providers' acceptability of the method

Time frame: 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

Time frame: 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 frame: 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

Data from ClinicalTrials.gov

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