Clinical trial NCT05179369: Well-Mama Community Doula Navigator Study
Official title: Enhancing Perinatal Care Support to Improve Maternal Mortality Disparities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Woman's Hospital, Louisiana
name: Rutgers University
name: Cook County Health & Hospitals System
First posted: 2022-01-05
Enrollment: 576
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hybrid Type 1 randomized effectiveness-implementation trial
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Number of Recommended Perinatal Care Components Received
timeFrame: Baseline through 1 year postpartum
Secondary outcomes:
measure: Level of patient engagement in healthcare management
timeFrame: Baseline through 1 year postpartum
measure: Level of self-efficacy for dealing with stressful situations
timeFrame: Baseline through 1 year postpartum
measure: Level of trust in health care system
timeFrame: Baseline through 1 year postpartum
measure: Rate of experiences of racism and discrimination
timeFrame: Baseline through 1 year postpartum
measure: Number of participants with low birth weight newborns
timeFrame: Baseline through 1 year postpartum
measure: Number of participants with NICU admissions
timeFrame: Baseline through 1 year postpartum
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Woman's Hospital
state: Louisiana
city: Newark
country: United States
facility: University Hospital
state: New Jersey
Study officials:
affiliation: Center for Health Equity Transformation Northwestern University
name: Melissa A Simon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: