Study of Birth Control Use After Childbirth

This study has been completed.
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Jennifer H. Tang, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01443533
First received: September 27, 2011
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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 Intervention
Contraception
Behavioral: LARC Script

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of a Brief Educational Script on Postpartum Contraceptive Uptake

Resource links provided by NLM:


Further study details as provided by WakeMed Health and Hospitals:

Primary Outcome Measures:
  • Self-reported use of LARC method [ Time Frame: After six-week postpartum visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported interest in use of a LARC method [ Time Frame: After six-week postpartum visit ] [ Designated as safety issue: No ]
  • Self-reported use of any contraceptive method [ Time Frame: After six-week postpartum visit ] [ Designated as safety issue: No ]
  • Self-reported reasons for not using the contraceptive method of choice [ Time Frame: After six-week postpartum visit ] [ Designated as safety issue: No ]

Enrollment: 800
Study Start Date: May 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   14 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443533

Locations
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
  More Information

Publications:
Responsible Party: Jennifer H. Tang, Principal Investigator, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01443533     History of Changes
Other Study ID Numbers: WakeMed 864
Study First Received: September 27, 2011
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by WakeMed Health and Hospitals:
Contraception
Contraception behavior
Postnatal care
Health education
Randomized controlled trial

ClinicalTrials.gov processed this record on October 23, 2014