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
|
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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 |

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 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Structured contraceptive counseling and routine care.
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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.
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- Choice of contraceptive method on day of enrollment. [ Time Frame: Day of enrollment ]

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

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
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 |
Principal Investigator: | Carolyn Westhoff, MD, MSc | Columbia University |
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 |