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Clinical Trials/NCT01443533
NCT01443533CompletedNot Applicable

A Randomized Controlled Trial of a Brief Educational Script on Postpartum Contraceptive Uptake

WakeMed Health and Hospitals2 sites in 1 country800 target enrollmentStarted: May 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
800
Locations
2
Primary Endpoint
Self-reported use of LARC method

Study Overview

Brief Summary

This study is a randomized controlled trial that will evaluate the impact of a brief educational script on the method of birth control that women receive at their 6-week postpartum visit. The one-minute script ("LARC script") is given to women in the hospital during their postpartum admission. It informs patients about long-acting reversible contraceptive (LARC) methods, specifically the contraceptive implant and the intrauterine device. The investigators hypothesize that women who are randomized to receive the LARC script will be more likely to report that they are using a LARC method, when queried immediately after their six-week postpartum visit.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
14 Years to 45 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Women who are admitted to the postpartum unit at WakeMed Hospital
  • Delivery of a live infant >24 weeks gestational age
  • Age 14-45 years
  • Ability to speak either English or Spanish fluently
  • Willing to be contacted by phone until at least 8 weeks after delivery

Exclusion Criteria

  • History of a tubal ligation or hysterectomy
  • Partner has already had a vasectomy
  • History of fertility treatment to conceive this pregnancy
  • Previous randomization into the study

Outcomes

Primary Outcomes

Self-reported use of LARC method

Time Frame: After six-week postpartum visit

Secondary Outcomes

  • Self-reported interest in use of a LARC method(After six-week postpartum visit)
  • Self-reported use of any contraceptive method(After six-week postpartum visit)
  • Self-reported reasons for not using the contraceptive method of choice(After six-week postpartum visit)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jennifer H. Tang

Principal Investigator

University of North Carolina, Chapel Hill

Study Sites (2)

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