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Randomized Controlled Trial of Structured Contraceptive Counseling in Adult Women

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ClinicalTrials.gov Identifier: NCT00746993
Recruitment Status : Completed
First Posted : September 4, 2008
Last Update Posted : December 12, 2012
Sponsor:
Information provided by (Responsible Party):
Carolyn L. Westhoff, Columbia University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

In the United States, highly effective methods of birth control are often not used. Healthcare providers use birth control counseling and patient education as ways to increase the usage of birth control. However, little evidence exists to show that patient education and birth control counseling changes birth control use.

We want to evaluate the effectiveness of using a uniform set of birth control information to provide birth control education to women having an early pregnancy termination. The counselors will allow the clients to both read as well as hear the information. We propose to evaluate whether this counseling will lead to 1) more women choosing highly effective nonpermanent birth control methods and 2) more women continuing to use these methods for a longer time.

Women in the study will complete a questionaire about their health. Half of them will have the structured counseling and half will have the routine counseling currently offered to women as a part of their routine care. We will contact all study participants with a telephone call three months and six months later to have a 10 minute conversation about what birth control they are using.


Condition or disease Intervention/treatment Phase
Contraception Other: Structured contraceptive counseling Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Structured Contraceptive Counseling--A Randomized Controlled Trial
Study Start Date : October 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 1
Structured contraceptive counseling and routine care.
 Other: Structured contraceptive counseling
Uniform set of visual information about contraception which a counselor will read out loud with each participant and answer questions.
Other Name: Family Planning Decision Making Tool
No Intervention: 2
Routine care.


Outcome Measures
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Primary Outcome Measures :
  1. Choice of contraceptive method on day of enrollment. [ Time Frame: Day of enrollment ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18 years or older
  • seeking contraception
  • Spanish or English speaking
  • has access to a telephone
  • willing to participate in the study

Exclusion Criteria:

  • age less than 18 years
  • not fluent in English or Spanish
  • not able to have access to a phone
  • not seeking contraception
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00746993


Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Carolyn Westhoff, MD, MSc Columbia University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Carolyn L. Westhoff, Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology at the New York-Presbyterian Hospital at the Columbia University Medical Center, Columbia University
ClinicalTrials.gov Identifier: NCT00746993     History of Changes
Other Study ID Numbers: AAAD5101
First Posted: September 4, 2008    Key Record Dates
Last Update Posted: December 12, 2012
Last Verified: December 2012

Keywords provided by Carolyn L. Westhoff, Columbia University:
Contraception
Counseling

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