High-risk Obstetrical Patient Intervention Utilizing the Contraceptive CHOICE Project Script

Diabetes Clinical Trial

— HIBISCUS  

Official title:

High-risk Obstetrical Patient Intervention to Promote Birth Interval Spacing Utilizing the Contraceptive CHOICE Project Script to Reduce Unintended Subsequent Pregnancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03049592
• Other study ID #: 160020
• Status: Completed
• Phase: N/A
• First received: November 23, 2016
• Last updated: March 13, 2018
• Start date: July 2016
• Est. completion date: October 2017

Study information

• Verified date: March 2018
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Latina obstetric women

• Pre-gestational diabetes

• Obtaining prenatal care in the high-risk obstetrical clinic - Diabetes in Pregnancy

Exclusion Criteria:

• Desires sterilization

Related Conditions & MeSH terms

• Contraception
• Diabetes

Intervention

Other:
• HIBISCUS counseling
Third trimester prenatal appointment with a family planning specialist for contraceptive counseling utilizing the Contraceptive CHOICE counseling script - emphasizing the WHO birth-to-pregnancy recommendation of 18 months, and a follow up postpartum contraception visit with a family planning specialist.

Locations

Country	Name	City	State
United States	UC San Diego Health System	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

Hardy E, Santos LC, Osis MJ, Carvalho G, Cecatti JG, Faúndes A. Contraceptive use and pregnancy before and after introducing lactational amenorrhea (LAM) in a postpartum program. Adv Contracept. 1998 Mar;14(1):59-68. — View 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. — View 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: http://10.1097/AOG.0b013e318273eb56. — View 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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Utilization of LARC	Utilization of LARC postpartum	1 year
Secondary	Acceptability of contraceptive counseling intervention by patients and clinicians	Comparison of rates and reasons for acceptance vs. non-acceptance of contraceptive counseling.	1 year