Study of Birth Control Use After Childbirth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01443533
Recruitment Status : Completed
First Posted : September 29, 2011
Last Update Posted : June 28, 2012
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Jennifer H. Tang, University of North Carolina, Chapel Hill

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of a Brief Educational Script on Postpartum Contraceptive Uptake
Study Start Date : May 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Self-reported use of LARC method [ Time Frame: After six-week postpartum visit ]

Secondary Outcome Measures :
  1. Self-reported interest in use of a LARC method [ Time Frame: After six-week postpartum visit ]
  2. Self-reported use of any contraceptive method [ Time Frame: After six-week postpartum visit ]
  3. Self-reported reasons for not using the contraceptive method of choice [ Time Frame: After six-week postpartum visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   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

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 identifier (NCT number): NCT01443533

United States, North Carolina
WakeMed Hospital
Raleigh, North Carolina, United States, 27610
Sponsors and Collaborators
WakeMed Health and Hospitals
University of North Carolina, Chapel Hill

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jennifer H. Tang, Principal Investigator, University of North Carolina, Chapel Hill Identifier: NCT01443533     History of Changes
Other Study ID Numbers: WakeMed 864
First Posted: September 29, 2011    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012

Keywords provided by Jennifer H. Tang, University of North Carolina, Chapel Hill:
Contraception behavior
Postnatal care
Health education
Randomized controlled trial