Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
576 participants
INTERVENTIONAL
2023-05-07
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Standard Care
Participants randomized to standard care will be offered prenatal and postpartum care in accordance with site-specific procedures based on AAP and ACOG Guidelines for Perinatal Care. The initial intake appointment, involving a comprehensive visit with physical exam, medical and psychosocial history, laboratory testing, and education would optimally occur in the 1st trimester. Subsequent prenatal visits, per ACOG, is monthly for the first 28 weeks, biweekly for weeks 28-36, and weekly after 36 weeks. More frequent visits may be offered to women at high risk. In addition, some sites may offer supports such as nutritional counseling, childbirth education, and case management. A comprehensive postpartum care visit would typically occur within the first 6 weeks of birth, involving a physical examination, lab tests, and immunizations.
No interventions assigned to this group
Standard Care with Well-Mama Intervention
Participants will receive standard perinatal care plus the Well Mama intervention, including the Well Mama Checklist, assistance from a Community Doula Navigator, and virtual support groups.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
15 Years
49 Years
FEMALE
Yes
Sponsors
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Woman's Hospital, Louisiana
OTHER
Rutgers University
OTHER
Cook County Health & Hospitals System
OTHER
Northwestern University
OTHER
Responsible Party
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Melissa Simon
Vice Chair of Research, Professor of Obstetrics and Gynecology
Principal Investigators
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Melissa A Simon, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Center for Health Equity Transformation Northwestern University
Locations
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Woman's Hospital
Baton Rouge, Louisiana, United States
University Hospital
Newark, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Elizabeth Sutton, PhD
Role: primary
Mark Einstein, MD, MS
Role: primary
Other Identifiers
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MD016280
Identifier Type: -
Identifier Source: org_study_id