Randomized Controlled Trial of Structured Contraceptive Counseling in Adult Women

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Carolyn L. Westhoff, Columbia University

ClinicalTrials.gov Identifier:

NCT00746993

First received: September 2, 2008

Last updated: December 11, 2012

Last verified: December 2012

History of Changes

Purpose

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	Intervention
Contraception	Other: Structured contraceptive counseling


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Structured Contraceptive Counseling--A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

Choice of contraceptive method on day of enrollment. [ Time Frame: Day of enrollment ] [ Designated as safety issue: No ]


Enrollment:	250
Study Start Date:	October 2008
Study Completion Date:	February 2010
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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Eligibility


Ages Eligible for Study:	18 Years and older
Genders 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

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: 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

No publications provided


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
Study First Received:	September 2, 2008
Last Updated:	December 11, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia University:


Contraception Counseling

Additional relevant MeSH terms:


Contraceptive Agents Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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