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Clinical Trials/NCT03049592
NCT03049592
Completed
Not Applicable

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

University of California, San Diego1 site in 1 country30 target enrollmentJuly 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
University of California, San Diego
Enrollment
30
Locations
1
Primary Endpoint
Utilization of LARC
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
October 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sheila Mody

Assistant Professor

University of California, San Diego

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

Outcomes

Primary Outcomes

Utilization of LARC

Time Frame: 1 year

Utilization of LARC postpartum

Secondary Outcomes

  • Acceptability of contraceptive counseling intervention by patients and clinicians(1 year)

Study Sites (1)

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