Study of Birth Control Use After Childbirth

June 26, 2012 updated by: Jennifer H. Tang, WakeMed Health and Hospitals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • WakeMed Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LARC script
Received routine postpartum counseling and LARC script.
Behavioral: LARC Script
The LARC Script is a one-minute educational script that describes long-acting reversible contraceptive methods.
No Intervention: No LARC script
Received only routine postpartum counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-reported use of LARC method
Time Frame: After six-week postpartum visit
After six-week postpartum visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-reported interest in use of a LARC method
Time Frame: After six-week postpartum visit
After six-week postpartum visit
Self-reported use of any contraceptive method
Time Frame: After six-week postpartum visit
After six-week postpartum visit
Self-reported reasons for not using the contraceptive method of choice
Time Frame: After six-week postpartum visit
After six-week postpartum visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WakeMed Health and Hospitals

Collaborators

University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

September 27, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (Estimate)

September 29, 2011

Study Record Updates

Last Update Posted (Estimate)

June 28, 2012

Last Update Submitted That Met QC Criteria

June 26, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WakeMed 864

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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