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Video Counseling for Effective Postpartum Contraception

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ClinicalTrials.gov Identifier: NCT02438800
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contraception Behavioral: LARC First Video Not Applicable

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  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Video Counseling for Effective Postpartum Contraception: a Randomized Clinical Trial
Study Start Date : May 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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.
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.
Behavioral: LARC First Video
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.




Primary Outcome Measures :
  1. Number of women who received an intrauterine device (IUD) or implant by 12 weeks postpartum [ Time Frame: 12 weeks postpartum ]

Secondary Outcome Measures :
  1. Proportion of women using any contraceptive method at 12 weeks postpartum [ Time Frame: 12 weeks postpartum ]
  2. Proportion of women who attended a postpartum visit [ Time Frame: 12 weeks postpartum ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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): NCT02438800


Locations
United States, North Carolina
North Carolina Women's Hospital
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Jessica Morse, MD University of North Carolina, Chapel Hill

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02438800     History of Changes
Other Study ID Numbers: 15-0665
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of North Carolina, Chapel Hill:
Postpartum Period