Study of Immediate Start of Progestin Contraceptives in Medical Abortion (Quickstart)

March 3, 2016 updated by: Gynuity Health Projects

Immediate Initiation of Progestin Contraceptives in First Trimester Medical Abortion: A Randomized Controlled Trial

This study will compare immediate to post-abortion start of two progestin-based contraceptives (DMPA and etonorgestrel implants) among women having first trimester medical abortion who wish to use that method for post-abortion contraception.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

937

Phase

  • Phase 4

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

  • Mexico
      • Mexico City, Mexico
        • Centro de Salud Beatriz Velasco de Aleman
      • Mexico City, Mexico
        • Centro de Salud Santa Catarina
  • United States
    • California
      • Chula Vista, California, United States
        • Planned Parenthood of the Pacific Southwest
      • Eureka, California, United States
        • Planned Parenthood Northern California
    • Connecticut
      • Stamford, Connecticut, United States
        • Planned Parenthood of Southern New England
    • Maryland
      • Baltimore, Maryland, United States
        • Bayview Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States
        • Boston Medical Center
      • Boston, Massachusetts, United States
        • Planned Parenthood League of Massachusetts

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

Description

Inclusion Criteria:

Women having medical abortion desiring progestin-based contraceptives (injectables or implants)

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Quickstart
Immediate start
Other: Timing of Contraceptive Initiation in Medical Abortion
Active Comparator: Afterstart
Delayed start
Other: Timing of Contraceptive Initiation in Medical Abortion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Medical Abortion Failure
Time Frame: One month after enrollment
One month after enrollment
Repeat Pregnancy
Time Frame: 6 months after enrollment
6 months after enrollment

Collaborators and Investigators

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

Sponsor

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

July 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 15, 2013

First Submitted That Met QC Criteria

July 15, 2013

First Posted (Estimate)

July 18, 2013

Study Record Updates

Last Update Posted (Estimate)

March 4, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1009

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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