Mifepristone and Misoprostol for Midtrimester Termination of Pregnancy in Uzbekistan

Abortion in Second Trimester Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235155
• Other study ID #: 1017
• Status: Completed
• Phase: N/A
• First received: August 29, 2014
• Last updated: January 13, 2016
• Start date: September 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uzbekistan: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abortion in Second Trimester

Locations

Country	Name	City	State
Uzbekistan	Bukhara Maternity House No. 1	Bukhara
Uzbekistan	Samarkand Perinatal Center	Samarkand
Uzbekistan	Clinic No. 2, Tashkent Medical Academy	Tashkent

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Uzbekistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of abortions that are complete as a measure of efficacy	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.	At 15 hours after the start of misoprostol administration	No
Secondary	Interval of time between induction with misoprostol to complete abortion	It is the length of time between the administration of the first dose of misoprostol and complete abortion.	Every 3 hours from the start of misoprostol administration until complete abortion	No
Secondary	Women's satisfaction with the method	It is a scale that assesses the level of a woman's satisfaction with the procedure.	At discharge, up to 5 days after enrollment	No
Secondary	Side effects experienced by women	It is a brief questionnaire that records all side effects experienced by women.	Every 3 hours from the start of misoprostol administration until complete abortion	No
Secondary	Pain experienced by women	It is a scale that assesses the acceptability of pain experienced by the woman.	At the time of discharge, up to 5 days after enrollment	No
Secondary	Complications during induction and after discharge	It is a record of complications and their treatment during induction and up to 1 month after discharge.	Every 3 hours from the start of misoprostol administration, up to 1 month after discharge	No
Secondary	Women's perception of acceptability of the procedure	It is a scale that assesses the acceptability of the procedure for the woman.	At discharge, up to 5 days after enrollment	No
Secondary	Provider's perception of acceptability of the method	It is a questionnaire that assesses the acceptability of the method for the provider.	At study completion, up to 2 years after study enrollment commences	No
Secondary	Total dose of misoprostol administered	Count of the total dose of misoprostol administered from the first dose to complete abortion.	Every 3 hours from start of misoprostol administration to complete abortion	No