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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01902485
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : March 4, 2016
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contraception Other: Timing of Contraceptive Initiation in Medical Abortion Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 937 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immediate Initiation of Progestin Contraceptives in First Trimester Medical Abortion: A Randomized Controlled Trial
Study Start Date : July 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

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

Primary Outcome Measures :
  1. Medical Abortion Failure [ Time Frame: One month after enrollment ]
  2. Repeat Pregnancy [ Time Frame: 6 months after enrollment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01902485

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gynuity Health Projects Identifier: NCT01902485    
Other Study ID Numbers: 1009
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016
Keywords provided by Gynuity Health Projects:
Medical Abortion
Additional relevant MeSH terms:
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Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists