Well-Mama Community Doula Navigator Study
- Conditions
- Pregnancy Related
- Interventions
- Behavioral: Standard Care with Well-Mama Intervention
- Registration Number
- NCT05179369
- Lead Sponsor
- Northwestern University
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 576
- 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
Already receiving/enrolled in another perinatal care program beyond standard care, such as group prenatal care, maternity home, or employing their own doula
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Care with Well-Mama Intervention 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.
- Primary Outcome Measures
Name Time Method Number of Recommended Perinatal Care Components Received 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 Outcome Measures
Name Time Method Rate of experiences of racism and discrimination Baseline through 1 year postpartum Patients will complete surveys to measure their perceived experiences of racism and discrimination while getting health care.
Number of participants with low birth weight newborns Baseline through 1 year postpartum Medical record data extraction will include the number of participants with low birth weight newborns.
Level of self-efficacy for dealing with stressful situations Baseline through 1 year postpartum Patients will complete surveys to measure their level of self-efficacy for dealing with stressful situations.
Level of patient engagement in healthcare management Baseline through 1 year postpartum Patients will complete surveys to measure their level of engagement in their healthcare management .
Level of trust in health care system Baseline through 1 year postpartum Patients will complete surveys to measure their level of trust with the health care system.
Number of participants with NICU admissions Baseline through 1 year postpartum Medical record data extraction will include the number of participants with deliveries resulting in NICU admissions.
Trial Locations
- Locations (2)
University Hospital
🇺🇸Newark, New Jersey, United States
Woman's Hospital
🇺🇸Baton Rouge, Louisiana, United States