Enhancing Perinatal Care Support to Improve Maternal Mortality Disparities
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pregnancy Related
- Sponsor
- Northwestern University
- Enrollment
- 576
- Locations
- 2
- Primary Endpoint
- Number of Recommended Perinatal Care Components Received
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Melissa Simon
Vice Chair of Research, Professor of Obstetrics and Gynecology
Northwestern University
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Number of Recommended Perinatal Care Components Received
Time Frame: 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 Outcomes
- 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)
- Level of self-efficacy for dealing with stressful situations(Baseline through 1 year postpartum)
- Level of patient engagement in healthcare management(Baseline through 1 year postpartum)
- Level of trust in health care system(Baseline through 1 year postpartum)
- Number of participants with NICU admissions(Baseline through 1 year postpartum)