HIPAA Compliant
ISO 27001 CertifiedActively Recruiting
Led by University of North Carolina, Chapel Hill · Updated on 2026-04-17
60000
Participants Needed
1
Research Sites
4 weeks
Total Duration
This research aims to reduce Black-White maternal health disparities by using interventions to decrease bias in prenatal care, improve care coordination, and increase social support. Known as ACURE4Moms, this pragmatic 4-arm cluster randomized controlled trial involves 39 prenatal practices across North Carolina. The study focuses especially on reducing pregnancy complications and low birthweight deliveries among Black patients, who face higher risks related to institutional racism and discrimination. The study compares four groups standard care with Medicaid care management for high-risk pregnancies care management plus Data Accountability and Transparency interventions including electronic warning systems, disparities dashboards, and racial equity training care management plus Community-Based Doula support providing culturally relevant care during pregnancy, labor, and postpartum and a combination of both Data Accountability and Transparency and Doula Support interventions. Each practice participates for two years, initiating prenatal care for approximately 750 to 1,500 patients, with outcomes tracked through delivery and one year after birth. Participants include patients who self-identify as Black or African American receiving prenatal care at participating clinics. Researchers collect data from electronic health records on low birthweight and other pregnancy outcomes and gather patient experiences of discrimination through internet surveys at four time points from the first prenatal visit to three months postpartum. Additional interviews with staff, doulas, and facilitators help assess intervention fit. The study is led by a Stakeholder Advisory Board focusing on patient-centered outcomes and policy advocacy.
CONDITIONS
Accountability for Care Through Undoing Racism & Equity for Moms
J
Jennifer H Tang, MD, MSCR
R
Rabab S Husain, MA
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University of North Carolina, Chapel Hill
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Data Accountability & Transparency Intervention | Standard Care (no intervention) | Community-Based Doula Support Intervention | Combined DAT + Doula Support | Enhanced Standard‑of‑Care Model |
|---|---|---|---|---|---|
| What it is | Practice‑level intervention including data dashboards, equity training, early warning systems, and facilitation | Usual prenatal care in participating practices without added interventions | Provision of community‑based doula support along with racial equity training for high‑risk patients | Combined data accountability with community‑based doula support | Enhanced prenatal practices integrating community‑based doula support are emerging to reduce racial disparities |
| Role in trial | Intervention arm focusing on systemic data accountability and equity | Control arm providing baseline comparison | Intervention arm offering culturally matched doula support | Intervention arm combining both approaches | Not a trial arm; represents emerging models integrating doula support into standard practice |
| Primary use | To evaluate the effect of systemic equity tools on low birthweight outcomes | Baseline measure of routine prenatal care outcomes | To assess impact of doula‑based support on birth outcomes | To test combined effect of both systemic and doula support interventions | Represents current equity‑oriented care models increasingly adopted |
| How it is given or performed | Practice facilitation, dashboards, equity training, early warning tools delivered at clinic level | Usual prenatal practice without added components | Trained doulas embedded to support Black patients alongside equity training | Both systemic equity tools and doula support delivered together | Structured program embedding community‑based doulas into standard prenatal care |
| Evidence status | Effectiveness still under investigation in this trial | Baseline outcomes documented in trial registry; routine care outcomes vary | Emerging evidence supports doula support improving outcomes for Black birthing people | Combined effect is under study, not yet established | Community‑based doula interventions have been shown to reduce cesarean rates and improve breastfeeding initiation among Black patients |
| Important risks | No known safety concerns; intervention is behavioral/system‑level | Not specifically assessed for added harms | No known safety risks; service is non‑clinical doula support | No safety concerns expected from combining behavioral and doula support | No safety risks identified for community‑based doula integrated care |
| Important limitations | Requires clinic infrastructure and staff buy‑in; effects yet unproven | Does not address systemic racial inequities or offer additional support | May face resource, training, and sustainability challenges in practice settings | Complex to implement both clinic‑level and doula components together | Limited large‑scale data; findings from single‑site RCT may not generalize across systems |
| Patient impact | Potential to reduce low birthweight through systemic interventions; outcomes under evaluation | Baseline outcomes for low‑birthweight rates to be compared | Associated with reduced cesarean rates and improved breastfeeding during delivery for Black patients | Impact under study; combined benefit unestablished | May improve birth experience and breastfeeding initiation in equity‑focused care models |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From first prenatal visit until delivery (up to approximately 9 months)
Participants receive prenatal care with interventions depending on their assigned study group. This includes routine care management, community-based doula support with up to 4 prenatal visits, labor support, and postpartum home visits, as well as clinic-level interventions such as use of Maternal Warning Systems, Data Dashboards, and racial equity training for healthcare staff.
Up to 4 doula visits during pregnancy, labor support, and 1 to 2 postpartum home visits
Duration - From 24 weeks of gestation until 3 months after delivery
Participants complete surveys at multiple time points including during pregnancy and up to 3 months after delivery to assess experiences such as discrimination and depression during prenatal care.
4 survey time points completed online
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
4
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Rachel Peragallo Urrutia, Angela Tatum Malloy, Cindy McMillan...
https://pubmed.ncbi.nlm.nih.gov/41731539/University of North Carolina, Chapel Hill
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
