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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes, Contraception

Intervention / Treatment
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* Other: HIBISCUS counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Latina obstetric women Pre-gestational diabetes Obtaining prenatal care in the high-risk obstetrical clinic - Diabetes in Pregnancy Exclusion Criteria: Desires sterilization

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIBISCUS counseling<br>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. | Other: HIBISCUS counseling<br>* 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.<br>|
| No Intervention: Standard counseling<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utilization of LARC | Utilization of LARC postpartum | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of contraceptive counseling intervention by patients and clinicians | Comparison of rates and reasons for acceptance vs. non-acceptance of contraceptive counseling. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Contraception, Prenatal Counseling