Support program for pregnant women using community doulas
Enhancing Perinatal Care Support to Improve Maternal Mortality Disparities
This study is testing if a new support program using community doulas can help pregnant and new mothers from BIPOC communities get better access to care and support during and after pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 576 (estimated) |
| Ages | 15 Years to 49 Years |
| Sex | Female |
| Sponsor | Northwestern University Academic / other |
| Locations | 2 sites (Baton Rouge, Louisiana and 1 other locations) |
| Trial ID | NCT05179369 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and evaluate the Well-Mama intervention, which involves Community Doula Navigators providing support to pregnant and postpartum BIPOC women. Participants will be randomly assigned to receive either standard perinatal care or the Well-Mama intervention, which includes in-person and telehealth check-ins on key health areas, virtual support groups, and labor support. The goal is to assess whether this intervention improves access to prenatal and postpartum care for these women, who face significant health disparities.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals aged 15-49 years who are uninsured or have public insurance and are less than 32 weeks gestation.
Not a fit: Patients who are already enrolled in another perinatal care program or have their own doula may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve maternal health outcomes for BIPOC women by enhancing their access to necessary prenatal and postpartum care.
How similar studies have performed: Other studies have shown promising results with community-based interventions for maternal health, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baton Rouge, Louisiana and 1 other locations
- Woman's Hospital — Baton Rouge, Louisiana, United States (Recruiting)
- University Hospital — Newark, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Melissa A Simon, MD, MPH — Center for Health Equity Transformation Northwestern University
- Study coordinator: Anastasia Harris, MPH, CHES
- Email: anastasia.harris@northwestern.edu
- Phone: (312) 503-8780
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.