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

Not Applicable

Completed

• Conditions: Diabetes; Contraception
• Interventions: Other: HIBISCUS counseling

• Registration Number: NCT03049592
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-10
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• Desires sterilization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIBISCUS counseling	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.

Primary Outcome Measures

Name	Time	Method
Utilization of LARC	1 year	Utilization of LARC postpartum

Secondary Outcome Measures

Name	Time	Method
Acceptability of contraceptive counseling intervention by patients and clinicians	1 year	Comparison of rates and reasons for acceptance vs. non-acceptance of contraceptive counseling.

Trial Locations

Locations (1)

UC San Diego Health System; 🇺🇸 San Diego, California, United States