Expired Study
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Chapel Hill, North Carolina 27599


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

15-0665


NCT ID:

NCT02438800


Secondary ID:


Study Acronym:


Brief Title:

Video Counseling for Effective Postpartum Contraception


Official Title:

Video Counseling for Effective Postpartum Contraception: a Randomized Clinical Trial


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of North Carolina, Chapel Hill


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

84


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jessica Morse, MD
Principal Investigator
University of North Carolina, Chapel Hill

Study Dates

Start Date:May 2015
Completion Date:October 2016
Completion Type:Actual
Primary Completion Date:October 2016
Primary Completion Type:Actual
Verification Date:May 2017
Last Changed Date:May 16, 2017
First Received Date:May 6, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Proportion of women who attended a postpartum visit
Time Frame:12 weeks postpartum
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Proportion of women using any contraceptive method at 12 weeks postpartum
Time Frame:12 weeks postpartum
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Number of women who received an intrauterine device (IUD) or implant by 12 weeks postpartum
Time Frame:12 weeks postpartum
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:LARC First Video
Description: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.
Arm Name:Video Counseling

Study Arms

Study Arm Type:Experimental
Arm Name:Video Counseling
Description: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.
Study Arm Type:No Intervention
Arm Name:Standard Counseling
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of North Carolina, Chapel Hill

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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