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

Abortion in Second Trimester Clinical Trial

Official title:

Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Armenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766388
• Other study ID #: 1005
• Status: Completed
• Phase: N/A
• First received: December 6, 2012
• Last updated: July 7, 2014
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2014
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Armenia: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abortion in Second Trimester

Locations

Country	Name	City	State
Armenia	Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology	Yerevan
Armenia	State Medical University	Yerevan

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Armenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful abortion		Every 3 hours after induction with misoprostol commences, up to 30 hours after the first dose	No
Secondary	Total dose of misoprostol		At the time of fetal and placental expulsion, up to 30 hours after the first dose	No
Secondary	Women's satisfaction with the method		At discharge, up to 5 days after enrollment	No
Secondary	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	No
Secondary	Women's acceptability of the side effects, buccal administration of misoprostol, and duration of procedure		At discharge, up to 5 days after enrollment	No
Secondary	Providers' acceptability of the method		After all study procedures complete, at close out, up to 1.5 years after study enrollment commences	No
Secondary	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	No
Secondary	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	No
Secondary	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	No