High-risk Obstetrical Patient Intervention Utilizing the Contraceptive CHOICE Project Script
HIBISCUS
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 23, 2016
CompletedFirst Posted
Study publicly available on registry
February 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedMarch 15, 2018
March 1, 2018
1.3 years
November 23, 2016
March 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Utilization of LARC
Utilization of LARC postpartum
1 year
Secondary Outcomes (1)
Acceptability of contraceptive counseling intervention by patients and clinicians
1 year
Study Arms (2)
HIBISCUS counseling
EXPERIMENTALSubject receives a 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.
Standard counseling
NO INTERVENTIONSubect receives standard high-risk prenatal care and postpartum contraception provision by the referring community clinic. The community clinic offer standard family planning counseling that does not emphasize utilizing of long-acting reversible contraception to promote birth-to-pregnancy spacing of 18 months. This scenario is current the standard practice at the institutions.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Latina obstetric women
- Pre-gestational diabetes
- Obtaining prenatal care in the high-risk obstetrical clinic - Diabetes in Pregnancy
You may not qualify if:
- Desires sterilization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UC San Diego Health System
San Diego, California, 92103, United States
Related Publications (6)
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.
PMID: 23168752BACKGROUNDDaniels 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.
PMID: 25500343BACKGROUNDWorld Health Organization. Report of a WHO Technical Consultation on Birth Spacing, Geneva, Switzerland, June 13-15, 2005. Report Geneva, Switzerland: World Health Organization, 2006.
BACKGROUNDHarris 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.
PMID: 18929686BACKGROUNDThiel 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.
PMID: 24334205BACKGROUNDHardy 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.
PMID: 9587009BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sheila Mody, MD MPH
UC San Diego Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 23, 2016
First Posted
February 10, 2017
Study Start
July 1, 2016
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
March 15, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share