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

Completed

• Conditions: Abortion in Second Trimester

• Registration Number: NCT01766388
• Lead Sponsor: Gynuity Health Projects

Brief Summary

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

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-11
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-07
• Last Update Posted: 2014-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of successful abortion	Every 3 hours after induction with misoprostol commences, up to 30 hours after the first dose

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

State Medical University; 🇦🇲 Yerevan, Armenia

Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology; 🇦🇲 Yerevan, Armenia