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

July 21, 2016 updated by: Gynuity Health Projects

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

The goal of this study is to examine the effectiveness and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Ukraine.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

172

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

  • Ukraine
      • Odessa, Ukraine
        • Odessa Regional Hospital
      • Poltava, Ukraine
        • Poltava City Maternity Hospital
      • Vinnitsa, Ukraine
        • Vinnitsa Regional Hospital

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

Women with mid-trimester pregnancy seeking abortion

Description

Inclusion Criteria:

  • Having an ongoing pregnancy of 13-22 weeks gestation
  • Be willing to undergo surgical completion if necessary
  • Have no contraindications to study procedures, according to provider
  • Be willing and able to consent to participate in the study
  • Be willing to follow study procedures

Exclusion Criteria:

  • Known allergy to mifepristone or misoprostol/prostaglandin
  • Any contraindications to vaginal delivery, including placenta previa
  • Unable to provide consent

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of successful abortion
Time Frame: 15 hours after start of misoprostol induction
15 hours after start of misoprostol induction

Collaborators and Investigators

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

Sponsor

Gynuity Health Projects

Investigators

  • Study Director: Tamar Tsereteli, MD, PhD, Gynuity Health Projects
  • Study Director: Galina Maistruk, MD, Woman Health and Family Planning Charitable Foundation

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

April 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

April 2, 2015

First Submitted That Met QC Criteria

April 9, 2015

First Posted (Estimate)

April 14, 2015

Study Record Updates

Last Update Posted (Estimate)

July 22, 2016

Last Update Submitted That Met QC Criteria

July 21, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 1025

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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