Well-Mama Community Doula Navigator Study

Enhancing Perinatal Care Support to Improve Maternal Mortality Disparities

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy Related
• Intervention / Treatment: Behavioral: Standard Care with 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 Type: Interventional
• Enrollment (Estimated): 576
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70817
      • Woman's Hospital
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care; Participants randomized to standard care will be offered prenatal and postpartum care in accordance with site-specific procedures based on AAP and ACOG Guidelines for Perinatal Care. The initial intake appointment, involving a comprehensive visit with physical exam, medical and psychosocial history, laboratory testing, and education would optimally occur in the 1st trimester. Subsequent prenatal visits, per ACOG, is monthly for the first 28 weeks, biweekly for weeks 28-36, and weekly after 36 weeks. More frequent visits may be offered to women at high risk. In addition, some sites may offer supports such as nutritional counseling, childbirth education, and case management. A comprehensive postpartum care visit would typically occur within the first 6 weeks of birth, involving a physical examination, lab tests, and immunizations.
Experimental: Standard Care with Well-Mama Intervention; Participants will receive standard perinatal care plus the Well Mama intervention, including the Well Mama Checklist, assistance from a Community Doula Navigator, and virtual support groups.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline through 1 year postpartum

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Rutgers University; Cook County Health & Hospitals System; Woman's Hospital, Louisiana
• Investigators: Principal Investigator: Melissa A Simon, MD, MPH, Center for Health Equity Transformation Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: MD016280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No