A Comparison of Continuation Rates for Three Hormonal Contraceptive Methods

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carrie Cwiak, Emory University
ClinicalTrials.gov Identifier:
NCT00253019
First received: November 14, 2005
Last updated: August 10, 2013
Last verified: August 2013
  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 Emory University:

Primary Outcome Measures:
  • Continuation Rates [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   13 Years to 45 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Carrie Cwiak, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00253019     History of Changes
Other Study ID Numbers: 518-2003
Study First Received: November 14, 2005
Results First Received: April 9, 2013
Last Updated: August 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
birth control
continuation
abortion
contraception

Additional relevant MeSH terms:
Contraceptive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014