MedTrace Logo

Well-Mama Community Doula Navigator Study

NCT05179369 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 576

Last updated 2026-04-09

No results posted yet for this 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.

Conditions

  • Pregnancy Related

Interventions

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.

Sponsors & Collaborators

  • Woman's Hospital, Louisiana

    collaborator OTHER

  • Rutgers University

    collaborator OTHER

  • Cook County Health & Hospitals System

    collaborator OTHER

  • Northwestern University

    lead OTHER

Principal Investigators

  • Melissa A Simon, MD, MPH · Center for Health Equity Transformation Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-07
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05179369 on ClinicalTrials.gov