Well-Mama Community Doula Navigator Study

Northwestern University576 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

576

Conditions

Pregnancy Related

Interventions

Standard Care with Well-Mama InterventionBEHAVIORAL

The intervention involves: (1) a Well-Mama checklist on 5 topic areas aligned with leading causes of MM and SMM: (a) mental health/depression; (b) cardiovascular symptoms; (c) safety (e.g., guns at home and intimate partner violence); (d) opioid/substance abuse; and (e) social support, self-agency, and well-being; and (2) Community Doula Navigators (CDNs) who will: (a) conduct biweekly check-ins with pregnant and postpartum women using the Well-Mama List and make appropriate referrals to providers and other resources following check-ins; (b) attend select patient visits; (c) lead virtual pregnancy \& postpartum support groups; and (d) provide labor support.

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Woman's Hospital

Baton Rouge, Louisiana, United States

RECRUITING

University Hospital

Newark, New Jersey, United States

RECRUITING

Outcomes

Primary Outcomes

Number of Recommended Perinatal Care Components Received

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.