Clinical trial NCT02380781: Contraceptive Counseling in the Postpartum Period
Official title: Contraceptive Counseling in the Postpartum Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Contraceptive Counseling
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 179
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a prospective randomized control trial in which we propose an intervention in the immediate post-partum period to educate women about contraceptive options, particularly long acting reversible contraception (LARC) methods with an aim of increasing the amount of women who choose a LARC method.

Detailed description: Eligible participants will be identified in the post-partum period and will be randomized to one of two groups. The control group will receive the standard of care contraceptive counseling which includes any prenatal counseling they received as well as information from the nurse practitioner that rounds on them in the post-partum period. The intervention group will also receive the standard of care contraceptive counseling but will also watch a 10 minute video created by the CHOICE project which counsels on different contraceptive options. Both groups will fill out a pre-intervention questionnaire as well as a post-intervention questionnaire 24hrs later. The primary outcome will be which type of contraception each woman chooses. The secondary outcomes will include determining if the women come to their post-partum visits as well as if they get the method of contraception they chose on the post-partum floor.

Eligibility criteria: Inclusion Criteria:

* Women giving birth at University Hospitals Case Medical Center
* Patient of the Women's Health Center
* Women delivering only one child
* Women receiving contraceptive counseling from the nurse practitioner that cares for the postpartum unit

Exclusion Criteria:

* Severe neonatal complication at time of delivery (neonatal death, neonatal admission to the neonatal intensive care unit (NICU) except in cases of chorioamnionitis)
* Severe maternal complication at time of delivery (patient requiring intensive care unit care, patient requiring hysterectomy at time of delivery)
* Preterm delivery \<34 weeks

Primary outcomes:
measure: Choice of contraceptive method
timeFrame: 24 hours post-intervention
Secondary outcomes:
measure: Return to clinic for postpartum visit
timeFrame: 12 weeks post-intervention
measure: Obtained desired method of contraception
timeFrame: 12 weeks post-intervention
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
References:
citation: Finer LB, Zolna MR. Unintended pregnancy in the United States: incidence and disparities, 2006. Contraception. 2011 Nov;84(5):478-85. doi: 10.1016/j.contraception.2011.07.013. Epub 2011 Aug 24.
citation: Conde-Agudelo A, Rosas-Bermudez A, Kafury-Goeta AC. Effects of birth spacing on maternal health: a systematic review. Am J Obstet Gynecol. 2007 Apr;196(4):297-308. doi: 10.1016/j.ajog.2006.05.055.
citation: Thiel de Bocanegra H, Chang R, Howell M, Darney P. Interpregnancy intervals: impact of postpartum contraceptive effectiveness and coverage. Am J Obstet Gynecol. 2014 Apr;210(4):311.e1-311.e8. doi: 10.1016/j.ajog.2013.12.020. Epub 2013 Dec 13.
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: Rose SB, Lawton BA. Impact of long-acting reversible contraception on return for repeat abortion. Am J Obstet Gynecol. 2012 Jan;206(1):37.e1-6. doi: 10.1016/j.ajog.2011.06.102. Epub 2011 Jul 13.
citation: Madden T, Mullersman JL, Omvig KJ, Secura GM, Peipert JF. Structured contraceptive counseling provided by the Contraceptive CHOICE Project. Contraception. 2013 Aug;88(2):243-9. doi: 10.1016/j.contraception.2012.07.015. Epub 2012 Sep 5.
citation: Peipert JF, Zhao Q, Allsworth JE, Petrosky E, Madden T, Eisenberg D, Secura G. Continuation and satisfaction of reversible contraception. Obstet Gynecol. 2011 May;117(5):1105-1113. doi: 10.1097/AOG.0b013e31821188ad.
citation: Finer LB, Jerman J, Kavanaugh ML. Changes in use of long-acting contraceptive methods in the United States, 2007-2009. Fertil Steril. 2012 Oct;98(4):893-7. doi: 10.1016/j.fertnstert.2012.06.027. Epub 2012 Jul 13.
citation: Randel A. Guidelines for the use of long-acting reversible contraceptives. Am Fam Physician. 2012 Feb 15;85(4):403-4. No abstract available.
citation: Zuckerman B, Nathan S, Mate K. Preventing unintended pregnancy: a pediatric opportunity. Pediatrics. 2014 Feb;133(2):181-3. doi: 10.1542/peds.2013-1147. Epub 2014 Jan 27. No abstract available.
citation: American Academy of Pediatrics Committee on Adolescence: Contraception and adolescents. Pediatrics. 1990 Jul;86(1):134-8. No abstract available.
citation: Jones J, Mosher W, Daniels K. Current contraceptive use in the United States, 2006-2010, and changes in patterns of use since 1995. Natl Health Stat Report. 2012 Oct 18;(60):1-25.
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: Cwiak C, Gellasch T, Zieman M. Peripartum contraceptive attitudes and practices. Contraception. 2004 Nov;70(5):383-6. doi: 10.1016/j.contraception.2004.05.010.
citation: Hladky KJ, Allsworth JE, Madden T, Secura GM, Peipert JF. Women's knowledge about intrauterine contraception. Obstet Gynecol. 2011 Jan;117(1):48-54. doi: 10.1097/AOG.0b013e318202b4c9.