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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02438800
Other study ID # 15-0665
Secondary ID
Status Completed
Phase N/A
First received May 6, 2015
Last updated May 16, 2017
Start date May 2015
Est. completion date October 2016

Study information

Verified date May 2017
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States North Carolina Women's Hospital Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of women who received an intrauterine device (IUD) or implant by 12 weeks postpartum 12 weeks postpartum
Secondary Proportion of women using any contraceptive method at 12 weeks postpartum 12 weeks postpartum
Secondary Proportion of women who attended a postpartum visit 12 weeks postpartum
Secondary Proportion of women answering agree or strongly agree to the following statement "I would recommend birth control counseling by video to a friend." Baseline
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