High-risk Obstetrical Patient Intervention Utilizing the Contraceptive CHOICE Project Script
NCT ID: NCT03049592
Last Updated: 2018-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2016-07-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HIBISCUS counseling
Subject 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.
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.
Standard counseling
Subect 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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Pre-gestational diabetes
* Obtaining prenatal care in the high-risk obstetrical clinic - Diabetes in Pregnancy
Exclusion Criteria
18 Years
45 Years
FEMALE
Yes
Sponsors
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University of California, San Diego
OTHER
Responsible Party
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Sheila Mody
Assistant Professor
Principal Investigators
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Sheila Mody, MD MPH
Role: PRINCIPAL_INVESTIGATOR
UC San Diego Health System
Locations
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UC San Diego Health System
San Diego, California, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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160020
Identifier Type: -
Identifier Source: org_study_id
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