NCT05179369

Well-Mama Community Doula Navigator Study

Enhancing Perinatal Care Support to Improve Maternal Mortality Disparities

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 576 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 15 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pregnancy Related

Interventions

Type	Name	Description
BEHAVIORAL	Standard Care with Well-Mama Intervention	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.

Timeline

• Start date: 2023-05-07
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2022-01-05
• Last updated: 2026-04-09

Locations

2 sites across 1 country: United States