Clinical trial NCT01443533: Study of Birth Control Use After Childbirth
Official title: A Randomized Controlled Trial of a Brief Educational Script on Postpartum Contraceptive Uptake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Contraception
Contraception behavior
Postnatal care
Health education
Randomized controlled trial
Lead sponsor: WakeMed Health and Hospitals
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2011-09-29
Enrollment: 800
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Self-reported use of LARC method
timeFrame: After six-week postpartum visit
Secondary outcomes:
measure: Self-reported interest in use of a LARC method
timeFrame: After six-week postpartum visit
measure: Self-reported use of any contraceptive method
timeFrame: After six-week postpartum visit
measure: Self-reported reasons for not using the contraceptive method of choice
timeFrame: After six-week postpartum visit
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: WakeMed Hospital
state: North Carolina
Study officials:
References:
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.
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.
citation: Stanwood NL, Bradley KA. Young pregnant women's knowledge of modern intrauterine devices. Obstet Gynecol. 2006 Dec;108(6):1417-22. doi: 10.1097/01.AOG.0000245447.56585.a0.
citation: Conde-Agudelo A, Rosas-Bermudez A, Kafury-Goeta AC. Birth spacing and risk of adverse perinatal outcomes: a meta-analysis. JAMA. 2006 Apr 19;295(15):1809-23. doi: 10.1001/jama.295.15.1809.
citation: Zerden ML, Tang JH, Stuart GS, Norton DR, Verbiest SB, Brody S. Barriers to Receiving Long-acting Reversible Contraception in the Postpartum Period. Womens Health Issues. 2015 Nov-Dec;25(6):616-21. doi: 10.1016/j.whi.2015.06.004. Epub 2015 Jul 23.