Clinical trial NCT01766388: Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Armenia
Official title: Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Armenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abortion in Second Trimester
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women presenting to a study clinic in Yerevan, Armenia for voluntary termination of intrauterine pregnancy with gestational ages of 13-22 weeks

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of successful abortion
timeFrame: Every 3 hours after induction with misoprostol commences, up to 30 hours after the first dose
Secondary outcomes:
measure: Total dose of misoprostol
timeFrame: At the time of fetal and placental expulsion, up to 30 hours after the first dose
measure: Women's satisfaction with the method
timeFrame: At discharge, up to 5 days after enrollment
measure: Side effects
timeFrame: 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
measure: Women's acceptability of the side effects, buccal administration of misoprostol, and duration of procedure
timeFrame: At discharge, up to 5 days after enrollment
measure: Providers' acceptability of the method
timeFrame: After all study procedures complete, at close out, up to 1.5 years after study enrollment commences
measure: Complications including heavy bleeding, uterine rupture, or infection requiring additional treatment
timeFrame: 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
measure: Induction to fetal expulsion interval
timeFrame: Time from administration of first misoprostol dose to expulsion of the fetus, up to 30 hours after the first dose
measure: Induction to fetal and placental expulsion interval
timeFrame: Time from administration of first misoprostol dose to expulsion of the fetus and placenta, up to 30 hours after the first dose
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: State Medical University
city: Yerevan
country: Armenia
facility: Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology
Study officials:
affiliation: Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology
name: Ruzanna Abrahamyan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: State Medical University
name: Gayane Abrahamyan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: