Study of Birth Control Use After Childbirth

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443533
• Other study ID #: WakeMed 864
• Status: Completed
• Phase: N/A
• First received: September 27, 2011
• Last updated: June 26, 2012
• Start date: May 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: WakeMed Health and Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Behavioral:
• LARC Script
The LARC Script is a one-minute educational script that describes long-acting reversible contraceptive methods.

Locations

Country	Name	City	State
United States	WakeMed Hospital	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
WakeMed Health and Hospitals	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (4)

Conde-Agudelo A, Rosas-Bermúdez A, Kafury-Goeta AC. Birth spacing and risk of adverse perinatal outcomes: a meta-analysis. JAMA. 2006 Apr 19;295(15):1809-23. — View Citation

Lopez LM, Hiller JE, Grimes DA. Postpartum education for contraception: a systematic review. Obstet Gynecol Surv. 2010 May;65(5):325-31. doi: 10.1097/OGX.0b013e3181e57127. Review. — View Citation

Secura GM, Allsworth JE, Madden T, Mullersman JL, Peipert JF. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010 Aug;203(2):115.e1-7. doi: 10.1016/j.ajog.2010.04.017. Epub 2010 Jun 11. — View Citation

Stanwood NL, Bradley KA. Young pregnant women's knowledge of modern intrauterine devices. Obstet Gynecol. 2006 Dec;108(6):1417-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported use of LARC method		After six-week postpartum visit	No
Secondary	Self-reported interest in use of a LARC method		After six-week postpartum visit	No
Secondary	Self-reported use of any contraceptive method		After six-week postpartum visit	No
Secondary	Self-reported reasons for not using the contraceptive method of choice		After six-week postpartum visit	No