NCT02438800

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 18, 2017

Status Verified

May 1, 2017

Enrollment Period

1.4 years

First QC Date

May 6, 2015

Last Update Submit

May 16, 2017

Conditions

Keywords

Postpartum Period

Outcome Measures

Primary Outcomes (1)

  • Number of women who received an intrauterine device (IUD) or implant by 12 weeks postpartum

    12 weeks postpartum

Secondary Outcomes (3)

  • Proportion of women using any contraceptive method at 12 weeks postpartum

    12 weeks postpartum

  • Proportion of women who attended a postpartum visit

    12 weeks postpartum

  • Proportion of women answering agree or strongly agree to the following statement "I would recommend birth control counseling by video to a friend."

    Baseline

Study Arms (2)

Standard Counseling

NO INTERVENTION

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.

Video Counseling

EXPERIMENTAL

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

Interventions

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.

Video Counseling

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • those who are unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Carolina Women's Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Study Officials

  • Jessica Morse, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 8, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

May 18, 2017

Record last verified: 2017-05

Locations