Mifepristone and Misoprostol for Midtrimester Termination of Pregnancy in Uzbekistan

January 13, 2016 updated by: Gynuity Health Projects

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uzbekistan
      • Bukhara, Uzbekistan
        • Bukhara Maternity House No. 1
      • Samarkand, Uzbekistan
        • Samarkand Perinatal Center
      • Tashkent, Uzbekistan
        • Clinic No. 2, Tashkent Medical Academy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pregnant women of 13-22 weeks gestation
Pregnant women of 13-22 weeks gestation will receive 200 mg mifepristone followed 24-48 hours later by 400 mcg sublingual misoprostol every three hours until complete expulsion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of abortions that are complete as a measure of efficacy
Time Frame: 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.
At 15 hours after the start of misoprostol administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interval of time between induction with misoprostol to complete abortion
Time Frame: 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.
Every 3 hours from the start of misoprostol administration until complete abortion
Women's satisfaction with the method
Time Frame: At discharge, up to 5 days after enrollment
It is a scale that assesses the level of a woman's satisfaction with the procedure.
At discharge, up to 5 days after enrollment
Side effects experienced by women
Time Frame: 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.
Every 3 hours from the start of misoprostol administration until complete abortion
Pain experienced by women
Time Frame: 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.
At the time of discharge, up to 5 days after enrollment
Complications during induction and after discharge
Time Frame: 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.
Every 3 hours from the start of misoprostol administration, up to 1 month after discharge
Women's perception of acceptability of the procedure
Time Frame: At discharge, up to 5 days after enrollment
It is a scale that assesses the acceptability of the procedure for the woman.
At discharge, up to 5 days after enrollment
Provider's perception of acceptability of the method
Time Frame: 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.
At study completion, up to 2 years after study enrollment commences
Total dose of misoprostol administered
Time Frame: 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.
Every 3 hours from start of misoprostol administration to complete abortion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynuity Health Projects

Investigators

  • Principal Investigator: Dilfuza Kurbanbekova, PhD, MD, Women's Wellness Center, Uzbekistan
  • Principal Investigator: Tamar Tsereteli, PhD, MD, Gynuity Health Projects

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 29, 2014

First Submitted That Met QC Criteria

September 5, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 1017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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