Simplifying First Trimester Medical Abortion Follow-up

November 1, 2017 updated by: Gynuity Health Projects
This study evaluates the usability of the multilevel pregnancy test among women undergoing medical abortion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

250

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

  • Armenia
      • Gyumri, Armenia
        • Gyumri Maternity Hospital
      • Yerevan, Armenia
        • Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology
  • Georgia
      • Batumi, Georgia
        • Batumi International Hospital
      • Tbilisi, Georgia
        • David Gagua Clinic
  • Kazakhstan
      • Almaty, Kazakhstan
        • City Policlinic #17

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

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women seeking medical abortion with pregnancies of 63 days or less.

Description

Inclusion Criteria:

  • Have a first trimester pregnancy with a gestational age of ≤63 days;
  • Desire medical abortion with mifepristone and misoprostol and be medically eligible for that treatment, according to clinic protocol;
  • Be able to read and understand the local language or Russian;
  • Have access to a telephone;
  • Agree to follow all study procedures;
  • Have no contraindication to participation in the study, in the judgment of the site investigator or designee.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Understanding of the instructions for the multilevel pregnancy test
Time Frame: 14 days
14 days
Ability to independently use the multilevel pregnancy tests
Time Frame: 14 days
14 days
Ability to interpret the results of the multilevel pregnancy test
Time Frame: 14 days
14 days

Collaborators and Investigators

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

Sponsor

Gynuity Health Projects

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 (Actual)

January 1, 2017

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

January 5, 2017

First Submitted That Met QC Criteria

January 5, 2017

First Posted (Estimate)

January 9, 2017

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 6009

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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