- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02438800
Video Counseling for Effective Postpartum Contraception
May 16, 2017 updated by: University of North Carolina, Chapel Hill
Video Counseling for Effective Postpartum Contraception: a Randomized Clinical Trial
This is a randomized clinical trial to evaluate if the addition of long-acting reversible contraception (LARC) focused video-counseling during prenatal care increases uptake of postpartum LARC.
Study Overview
Detailed Description
Eligible participants will be identified in the prenatal period and will be randomized to one of two groups.
The control group will receive the standard of care contraceptive counseling during prenatal counseling.
The intervention group will also receive the standard of care contraceptive counseling during prenatal care, but will also watch an evidence-based,12 minute LARC First video created by the CHOICE project which provides information on different contraceptive methods.
All participants will receive information regarding access to free LARC methods in the postpartum period.
All participants will be called at 12 weeks postpartum.
Independent of randomization arm, they will all undergo a 5-minute survey by phone about contraceptive method choice and use.
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- North Carolina Women's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- woman presenting for routine prenatal care visit at University of North Carolina (UNC) Resident Continuity Clinic
- least 18 years old
- fluent in English
- able to read to a third-grade reading level
- not planning sterilization for postpartum contraception
- at least 28 weeks gestation at time of enrollment
Exclusion Criteria:
- those who do not meet the previously outlined inclusion criteria
- those who are unable to provide informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard Counseling
Women in this arm will receive standard contraceptive counseling routinely provided during prenatal care.
All participants will receive information regarding access to free LARC methods in the postpartum period.
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Experimental: Video Counseling
Women in this arm will receive LARC First video-based contraceptive counseling in addition to standard contraceptive counseling routinely provided during prenatal care.
All participants will receive information regarding access to free LARC methods in the postpartum period.
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LARC First is an evidence-based, 12-minute video developed by the CHOICE project that features women of all racial and ethnic backgrounds describing LARC methods of contraception in simple, understandable language with summary text when appropriate.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of women who received an intrauterine device (IUD) or implant by 12 weeks postpartum
Time Frame: 12 weeks postpartum
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12 weeks postpartum
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of women using any contraceptive method at 12 weeks postpartum
Time Frame: 12 weeks postpartum
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12 weeks postpartum
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Proportion of women who attended a postpartum visit
Time Frame: 12 weeks postpartum
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12 weeks postpartum
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Proportion of women answering agree or strongly agree to the following statement "I would recommend birth control counseling by video to a friend."
Time Frame: Baseline
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jessica Morse, MD, University of North Carolina, Chapel Hill
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
May 6, 2015
First Submitted That Met QC Criteria
May 6, 2015
First Posted (Estimate)
May 8, 2015
Study Record Updates
Last Update Posted (Actual)
May 18, 2017
Last Update Submitted That Met QC Criteria
May 16, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 15-0665
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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