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NCT Number: NCT05179369

Well-Mama Community Doula Navigator Study

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pregnancy Related

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Woman's Hospital, Baton Rouge, Louisiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Standard Care with Well-Mama Intervention

Behavioral

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.

Primary outcomes

  1. Number of Recommended Perinatal Care Components Received

    Time frame: 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 outcomes

  1. Level of patient engagement in healthcare management

    Time frame: Baseline through 1 year postpartum

    Patients will complete surveys to measure their level of engagement in their healthcare management .

  2. Level of self-efficacy for dealing with stressful situations

    Time frame: Baseline through 1 year postpartum

    Patients will complete surveys to measure their level of self-efficacy for dealing with stressful situations.

  3. Level of trust in health care system

    Time frame: Baseline through 1 year postpartum

    Patients will complete surveys to measure their level of trust with the health care system.

  4. Rate of experiences of racism and discrimination

    Time frame: Baseline through 1 year postpartum

    Patients will complete surveys to measure their perceived experiences of racism and discrimination while getting health care.

  5. Number of participants with low birth weight newborns

    Time frame: Baseline through 1 year postpartum

    Medical record data extraction will include the number of participants with low birth weight newborns.

  6. Number of participants with NICU admissions

    Time frame: Baseline through 1 year postpartum

    Medical record data extraction will include the number of participants with deliveries resulting in NICU admissions.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Cook County Health & Hospitals System
  • Rutgers University
  • Woman's Hospital, Louisiana

Registry information

Official study title

Enhancing Perinatal Care Support to Improve Maternal Mortality Disparities

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2022
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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