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

Gynuity Health Projects

Status: Completed

Conditions: Abortion in Second Trimester

Study type: Observational

Funder types: Other

Identifiers

NCT01766388

1005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Female

Volunteers: No Healthy Volunteers

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)

Trial design

120 participants in 1 patient group

Pregnant women

Description:

Pregnant women of 13-22 weeks gestation