Well-Mama Community Doula Navigator Study

Last updated: April 7, 2026
Sponsor: Northwestern University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Standard Care with Well-Mama Intervention

Clinical Study ID

NCT05179369
MD016280
  • Ages 15-49
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 576
Treatment Group(s): 1
Primary Treatment: Standard Care with Well-Mama Intervention
Phase:
Study Start date:
May 07, 2023
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Woman's Hospital

    Baton Rouge, Louisiana 70817
    United States

    Site Not Available

  • University Hospital

    Newark, New Jersey 07103
    United States

    Site Not Available

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