Well-Mama Community Doula Navigator Study

NCT05179369 | Active Not Recruiting

• 1 other identifier: MD016280
• Study Type: interventional
• Target: 576
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Level of patient engagement in healthcare management

  Baseline through 1 year postpartum

• Level of self-efficacy for dealing with stressful situations

  Baseline through 1 year postpartum

• Level of trust in health care system

  Baseline through 1 year postpartum

• Rate of experiences of racism and discrimination

  Baseline through 1 year postpartum

• Number of participants with low birth weight newborns

  Baseline through 1 year postpartum

Study Arms (2)

Standard Care

NO INTERVENTION

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.

Standard Care with Well-Mama Intervention

EXPERIMENTAL

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

Interventions

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.

Standard Care with Well-Mama Intervention

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \) 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

You may not qualify if:

• Already receiving/enrolled in another perinatal care program beyond standard care, such as group prenatal care, maternity home, or employing their own doula

Sponsors & Collaborators

• Northwestern University: lead
• Woman's Hospital, Louisiana: collaborator
• Rutgers University: collaborator
• Cook County Health & Hospitals System: collaborator

Study Sites (2)

Woman's Hospital

Baton Rouge, Louisiana, 70817, United States

Location

University Hospital

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Melissa A Simon, MD, MPH

  Center for Health Equity Transformation Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Research, Professor of Obstetrics and Gynecology

Model Details: Hybrid Type 1 randomized effectiveness-implementation trial

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 5, 2022
• Study Start: May 7, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)