Pregnancy Related
Conditions
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.
Interventions
BEHAVIORALStandard 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
Northwestern University
Woman's Hospital, Louisiana
Rutgers University
Cook County Health & Hospitals System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Hybrid Type 1 randomized effectiveness-implementation trial
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMelissa A Simon, MD, MPH
Center for Health Equity Transformation Northwestern University
Outcome results
None listed