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

University of California San Diego

Status: Completed

Conditions: Diabetes; Contraception

Treatments: Other: HIBISCUS counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03049592

160020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Desires sterilization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

HIBISCUS counseling

Experimental group

Description:

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.

Treatment:

Other: HIBISCUS counseling

Standard counseling

No Intervention group

Description:

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.