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

NCT01766388 | Completed

• 1 other identifier: 1005
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Abortion in Second Trimester

Outcome Measures

Primary Outcomes (1)

• Rate of successful abortion

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

Secondary Outcomes (8)

• 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

Study Arms (1)

Pregnant women

Pregnant women of 13-22 weeks gestation

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gynuity Health Projects: lead

Study Sites (2)

State Medical University

Yerevan, 0025, Armenia

Location

Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology

Yerevan, 0078, Armenia

Location

Study Officials

• Ruzanna Abrahamyan, MD

  Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Gayane Abrahamyan, MD, PhD

  State Medical University

  PRINCIPAL INVESTIGATOR

• Beverly Winikoff, MD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: January 11, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

AR (2)