Mifepristone and Misoprostol for Midtrimester Termination of Pregnancy in Uzbekistan

Completed

• Conditions: Abortion in Second Trimester

• Registration Number: NCT02235155
• Lead Sponsor: Gynuity Health Projects

Brief Summary

The primary goal is to examine the efficacy and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Uzbekistan.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-29
• Study Start: 2014-09
• Study First Submitted QC: 2014-09-05
• Study First Posted: 2014-09-09
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 135

Inclusion Criteria

• Meet legal criteria to obtain abortion
• Have an ongoing pregnancy of 13-22 weeks gestation
• Be willing to undergo a surgical completion if necessary
• Have no contraindications to study procedures, according to provider
• Be willing and able to consent to procedure, either by reading consent document or by having consent document read to her
• Be willing 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
• Any contraindications to vaginal delivery, including placenta previa

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of abortions that are complete as a measure of efficacy	At 15 hours after the start of misoprostol administration	It is a proportion that specifies how many abortions out of all initiated abortions are complete without recourse to surgical intervention within 15 hours after the start of misoprostol administration.

Secondary Outcome Measures

Name	Time	Method
Interval of time between induction with misoprostol to complete abortion	Every 3 hours from the start of misoprostol administration until complete abortion	It is the length of time between the administration of the first dose of misoprostol and complete abortion.
Pain experienced by women	At the time of discharge, up to 5 days after enrollment	It is a scale that assesses the acceptability of pain experienced by the woman.
Women's satisfaction with the method	At discharge, up to 5 days after enrollment	It is a scale that assesses the level of a woman's satisfaction with the procedure.
Side effects experienced by women	Every 3 hours from the start of misoprostol administration until complete abortion	It is a brief questionnaire that records all side effects experienced by women.
Provider's perception of acceptability of the method	At study completion, up to 2 years after study enrollment commences	It is a questionnaire that assesses the acceptability of the method for the provider.
Complications during induction and after discharge	Every 3 hours from the start of misoprostol administration, up to 1 month after discharge	It is a record of complications and their treatment during induction and up to 1 month after discharge.
Women's perception of acceptability of the procedure	At discharge, up to 5 days after enrollment	It is a scale that assesses the acceptability of the procedure for the woman.
Total dose of misoprostol administered	Every 3 hours from start of misoprostol administration to complete abortion	Count of the total dose of misoprostol administered from the first dose to complete abortion.

Trial Locations

Locations (3)

Bukhara Maternity House No. 1; 🇺🇿 Bukhara, Uzbekistan

Samarkand Perinatal Center; 🇺🇿 Samarkand, Uzbekistan

Clinic No. 2, Tashkent Medical Academy; 🇺🇿 Tashkent, Uzbekistan