Recruiting

Equity for Moms

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT05484804

Conditions

Pregnancy Related

Maternal Health

Maternal Mortality

Low Birthweight

Racism

Eligibility Criteria

Sex: Female

Age: 12 - 70+

Healthy Volunteers: Accepted

Interventions

Data Accountability and Transparency

Community-Based Doula (CBD) Support

Study Details

Brief summary:

This project-also known as "Accountability for Care through Undoing Racism \& Equity for Moms" or ACURE4Moms-aims to reduce Black-White maternal health disparities using multi-level interventions designed to decrease bias in prenatal care, improve care coordination, and increase social support. ACURE4Moms is a pragmatic 4-arm cluster randomized controlled trial conducted with 39 prenatal practices across North Carolina. Practices have been randomly assigned to receive either: Arm 1 (Standard Care): North Carolina Medicaid Care management for high-risk pregnancies; Arm 2 (Data Accountability and Transparency): North Carolina Medicaid Care Management + Practice-level Data Accountability interventions; Arm 3 (Community-Based Doula Support): North Carolina Medicaid Care Management + Community-Based Doula support intervention for high-risk patients during pregnancy and postpartum; or Arm 4 (Data Accountability and Transparency + Community-Based Doula Support): North Carolina Medicaid Care Management + Both Arms 2 and 3 interventions. During each practice's 2-year intervention period, the practice will initiate prenatal care for \~750-1,500 patients (up to 60,000 patients total), whose outcomes the investigators will follow and compare between arms until all these patients have reached 1-year post-delivery.

Conditions

Pregnancy Related

Maternal Health

Maternal Mortality

Low Birthweight

Racism

Study ID

NCT05484804

Start date

Jun 5, 2023

Status verified date

Apr, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 12 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Practices:

  • Have at least 180 Black patient deliver over 2 years
  • Be willing to be randomized
  • Be willing to adhere to the study protocol

Patient survey participants:

  • Start prenatal care at one of the study clinics during study implementation
  • Self-identify as Black or African American
  • Able to give consent and complete surveys and interviews in English

Practice staff member participants:

  • Employed as either a provider, nurse/medical assistant, or office administrator at one of the clinics in this study

Doula participants:

  • Provide doula care to patients at one the clinics in this study

Exclusion Criteria:

Practices:

  • Already integrated with Community-Based Doulas
  • Already have an Early Warning System or Disparities Dashboard

Study Design

Enrollment

60000 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Standard Care

Pregnant patients with Medicaid insurance are screened for risk factors for low birthweight, and high-risk patients receive intensive care management.

active comparator: Data Accountability and Transparency

Pregnant patients with Medicaid insurance are screened for risk factors for low birthweight, and high-risk patients receive intensive care management. Additionally, practices receive 2 additional patient-level interventions, including: 1) Support from a Practice Facilitator to help implement the interventions and build workflows and quality improvement cycles; 2) Use of a Maternal Warning System for missed visits, elevated blood pressures, and prenatal aspirin eligibility; 3) Use of a Data Dashboard that displays outcome data stratified by race, ethnicity, age, and preferred language; and 4) Maternal Health Equity Education \& Training sessions.

active comparator: Community-Based Doula (CBD) Support

Pregnant patients with Medicaid insurance are screened for risk factors for low birthweight, and high-risk patients receive intensive care management. Additionally, practices receive 2 additional patient-level interventions, including: 1) Shared care of high-risk patients with Community-Based Doulas; and 2) Maternal Health Equity Education \& Training sessions.

active comparator: Data Accountability and Transparency + Community-Based Doula Support

Pregnant patients with Medicaid insurance are screened for risk factors for low birthweight, and high-risk patients receive intensive care management, and practices receive all the Data Accountability and Doula Interventions described in Arms 2 and 3.

Interventions

Data Accountability and Transparency

Collaboration with Practice Facilitators; Maternal Early Warning System; Disparities Dashboard; Racial Equity Training

Community-Based Doula (CBD) Support

Community-Based Doula support for high-risk patients; Racial Equity Training

Primary outcome measure

  • Odds of delivery of low-birthweight infants among non-Hispanic Black patients in each study arm [ Time Frame: Upon delivery ]

Central Contacts and Locations

Central contacts

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-04-17.