Well-Mama Community Doula Navigator Study

Pregnancy Related Clinical Trial

Official title:

Enhancing Perinatal Care Support to Improve Maternal Mortality Disparities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05179369
• Other study ID #: MD016280
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Northwestern University
• Contact: Anastasia Harris, MPH, CHES
• Phone: (312) 503-8780
• Email: anastasia.harris[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 576
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Behavioral:
• Standard 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.

Locations

Country	Name	City	State
United States	Woman's Hospital	Baton Rouge	Louisiana
United States	University Hospital	Newark	New Jersey

Sponsors (4)

Lead Sponsor	Collaborator
Northwestern University	Cook County Health & Hospitals System, Rutgers University, Woman's Hospital, Louisiana

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Recommended Perinatal Care Components Received	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.	Baseline through 1 year postpartum
Secondary	Level of patient engagement in healthcare management	Patients will complete surveys to measure their level of engagement in their healthcare management .	Baseline through 1 year postpartum
Secondary	Level of self-efficacy for dealing with stressful situations	Patients will complete surveys to measure their level of self-efficacy for dealing with stressful situations.	Baseline through 1 year postpartum
Secondary	Level of trust in health care system	Patients will complete surveys to measure their level of trust with the health care system.	Baseline through 1 year postpartum
Secondary	Rate of experiences of racism and discrimination	Patients will complete surveys to measure their perceived experiences of racism and discrimination while getting health care.	Baseline through 1 year postpartum
Secondary	Number of participants with low birth weight newborns	Medical record data extraction will include the number of participants with low birth weight newborns.	Baseline through 1 year postpartum
Secondary	Number of participants with NICU admissions	Medical record data extraction will include the number of participants with deliveries resulting in NICU admissions.	Baseline through 1 year postpartum