Well-Mama Community Doula Navigator Study

Not Applicable

Recruiting

• Conditions: Pregnancy Related

• Registration Number: NCT05179369
• Lead Sponsor: Northwestern University

Brief Summary

This study will develop and test an intervention, called the Well-Mama intervention, which includes the use of a checklist by Community Doula Navigators to support pregnant women. Participants will be randomized to either receive standard perinatal care or standard perinatal care plus the Well-Mama intervention.

Detailed Description

Black, Indigenous, and People of Color (BIPOC) women experience profound maternal health disparities in the US, including rising rates of maternal mortality and severe maternal morbidity. This study will develop a Well-Mama intervention for pregnant and postpartum BIPOC women, centered around Community Doula Navigators conducting in-person and telehealth check-ins on 5 priority areas (mental health, cardiovascular symptoms, safety, opioid/substance abuse, and social support), supplemented with virtual support groups and labor support. The investigators will conduct a randomized trial to test whether the Well-Mama intervention increases BIPOC women's receipt of prenatal and postpartum care.

Study Timeline

• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2022-01-05
• Study Start: 2023-05-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 576

Inclusion Criteria

1. Pregnant individuals that are age 15-49 years; (2) uninsured or have public insurance (i.e., Medicaid); (3) singleton pregnancy <32 weeks gestation; and (4) not cognitively impaired

Exclusion Criteria

Already receiving/enrolled in another perinatal care program beyond standard care, such as group prenatal care, maternity home, or employing their own doula

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Recommended Perinatal Care Components Received	Baseline through 1 year postpartum	The primary outcome will be a composite proportion of perinatal care components across three domains, including prenatal care, postpartum care, and social determinants of health content compared between participants in the intervention and control arms.

Secondary Outcome Measures

Name	Time	Method
Rate of experiences of racism and discrimination	Baseline through 1 year postpartum	Patients will complete surveys to measure their perceived experiences of racism and discrimination while getting health care.
Number of participants with low birth weight newborns	Baseline through 1 year postpartum	Medical record data extraction will include the number of participants with low birth weight newborns.
Level of self-efficacy for dealing with stressful situations	Baseline through 1 year postpartum	Patients will complete surveys to measure their level of self-efficacy for dealing with stressful situations.
Level of patient engagement in healthcare management	Baseline through 1 year postpartum	Patients will complete surveys to measure their level of engagement in their healthcare management .
Level of trust in health care system	Baseline through 1 year postpartum	Patients will complete surveys to measure their level of trust with the health care system.
Number of participants with NICU admissions	Baseline through 1 year postpartum	Medical record data extraction will include the number of participants with deliveries resulting in NICU admissions.

Trial Locations

Locations (2)

Woman's Hospital; 🇺🇸 Baton Rouge, Louisiana, United States

University Hospital; 🇺🇸 Newark, New Jersey, United States