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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05179369
Other study ID # MD016280
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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