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A Comparison of Continuation Rates for Three Hormonal Contraceptive Methods

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00253019
First Posted: November 15, 2005
Last Update Posted: August 21, 2013
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.
Information provided by (Responsible Party):
Carrie Cwiak, Emory University
  Purpose
This study will assess the continuation rates among women using oral contraceptive pills, Depo-Provera and Ortho Evra following a first trimester abortion.

Condition
Contraception

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparison of Continuation Rates for Three Hormonal Contraceptive Methods (Oral Contraceptive Pills, Depo Provera and Ortho Evra) Among Women Seeking First Trimester Abortion.

Resource links provided by NLM:


Further study details as provided by Carrie Cwiak, Emory University:

Primary Outcome Measures:
  • Continuation Rates [ Time Frame: 3 months ]
    We followed subjects to evaluate the continuation rates for subjects receiving oral contraceptive pills, Depo Provera and Ortho Evra.


Enrollment: 321
Study Start Date: October 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Detailed Description:
Unintended pregnancy rates among women in the United States continue to surpass that of the rest of the developed world at great cost to society. Contraceptive failure has been attributed to poor compliance with contraceptive methods and results in unintended pregnancies. This study will evaluate the 3-month continuation rates among women using the oral contraceptive pill and Depo-Provera. It will also assess the continuation rates of Ortho Evra®, which has not previously been studied in the adolescent population. This study will provide information with regard to pregnancy rates and 3-month patterns of use of contraception among women seeking first-trimester abortion. It will also assess other factors contributing to successful contraception such as the use of emergency contraception and concomitant condom use. The results of this study will be used to inform the practice of providers who provide reproductive health care to women and add to the sparse body of literature available comparing the success of different contraceptive methods used by women.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants were recruited from a indigent, urban, African American population.
Criteria

Inclusion Criteria:

  • Age 13-45 women presenting at the ambulatory surgery at Grady Memorial Hospital who want to use either oral contraceptive pills, ortho evra or depo provera?

Exclusion Criteria:

  • Leaving the Atlanta area within 6 months?
  • Desires pregnancy within the next 6 months?
  • Unable to provide contact information?
  • Contraindications to hormonal contraceptive?
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00253019


Locations
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Carrie Cwiak, MD, MPH Emory University
  More Information

Responsible Party: Carrie Cwiak, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00253019     History of Changes
Other Study ID Numbers: 518-2003
First Submitted: November 14, 2005
First Posted: November 15, 2005
Results First Submitted: April 9, 2013
Results First Posted: August 9, 2013
Last Update Posted: August 21, 2013
Last Verified: August 2013

Keywords provided by Carrie Cwiak, Emory University:
birth control
continuation
abortion
contraception

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs