Clinical trial NCT03049592: High-risk Obstetrical Patient Intervention Utilizing the Contraceptive CHOICE Project Script
Official title: High-risk Obstetrical Patient Intervention to Promote Birth Interval Spacing Utilizing the Contraceptive CHOICE Project Script to Reduce Unintended Subsequent Pregnancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Contraception
Keywords: Diabetes
Contraception
Prenatal Counseling
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2017-02-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High-risk obstetrical patient Intervention to promote Birth Interval Spacing utilizing the Contraceptive CHOICE project script to reduce Unintended Subsequent pregnancies (HIBISCUS) is a collaborative study utilizing qualitative methods to assess the acceptability including a family planning specialist's postpartum contraception counseling during and after prenatal care among Latina obstetric women with pre-gestational diabetes. The investigators will compare the effectiveness of HIBISCUS versus usual contraceptive counseling on Long-Acting Reversible Contraception (LARC) use at 3 months postpartum.

Detailed description: The purpose of this research is to address this gap in long-acting reversible contraception (LARC) counseling among Latinas who have pregnancies complicated by pre-gestational diabetes in order to promote optimal birth-to-pregnancy spacing and planned pregnancies with optimal glucose control. The investigators will utilize Contraceptive CHOICE project which was LARC focused counseling script and removed the cost of contraception. This study had a LARC utilization of 75% compared to the national use of LARC of 7.2% The investigators will conduct a pilot randomized controlled trial among Latina obstetrics patients with pre-gestational diabetes involving a prenatal and postpartum visit with a family planning specialist versus usual contraceptive counseling. The family planning specialist counseling will utilize the Contraceptive CHOICE Project script promoting LARC, 18 month birth-to-pregnancy recommendation and preconception counseling. The intervention's name is HIBISCUS.

Eligibility criteria: Inclusion Criteria:

* Latina obstetric women
* Pre-gestational diabetes
* Obtaining prenatal care in the high-risk obstetrical clinic - Diabetes in Pregnancy

Exclusion Criteria:

* Desires sterilization

Primary outcomes:
measure: Utilization of LARC
timeFrame: 1 year
Secondary outcomes:
measure: Acceptability of contraceptive counseling intervention by patients and clinicians
timeFrame: 1 year
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UC San Diego Health System
state: California
Study officials:
affiliation: UC San Diego Health System
name: Sheila Mody, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peipert JF, Madden T, Allsworth JE, Secura GM. Preventing unintended pregnancies by providing no-cost contraception. Obstet Gynecol. 2012 Dec;120(6):1291-7. doi: 10.1097/aog.0b013e318273eb56.
citation: Daniels K, Daugherty J, Jones J. Current contraceptive status among women aged 15-44: United States, 2011-2013. NCHS Data Brief. 2014 Dec;(173):1-8.
citation: World Health Organization. Report of a WHO Technical Consultation on Birth Spacing, Geneva, Switzerland, June 13-15, 2005. Report Geneva, Switzerland: World Health Organization, 2006.
citation: Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
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: Hardy E, Santos LC, Osis MJ, Carvalho G, Cecatti JG, Faundes A. Contraceptive use and pregnancy before and after introducing lactational amenorrhea (LAM) in a postpartum program. Adv Contracept. 1998 Mar;14(1):59-68. doi: 10.1023/a:1006527711625.