Community-Based Doula (CBD) Support for Maternal Health

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of North Carolina at Chapel Hill, Chapel Hill, NC
Maternal Health+7 More
Community-Based Doula (CBD) Support - Other
Eligibility
Any Age
Female
What conditions do you have?
Select

Study Summary

This trial 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. Community-based doula support is an effective intervention for improving maternal health outcomes. This trial will not include a placebo group.

Eligible Conditions

  • Low; Birthweight
  • Racism
  • Pregnancy Related
  • Maternal Health
  • Implicit Bias
  • Mortality, Maternal

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 1 Secondary · Reporting Duration: 2 years

2 years
Qualitative summaries of practice characteristics, facilitators, and barriers to implementation throughout the study
Week 24
Odds of any discrimination during prenatal care among non-Hispanic Black patients in each study arm
Odds of incidence of depression during prenatal care among non-Hispanic Black patients in each study arm
Week 36
Proportion of patients with high utilization of emergency care (EC) during pregnancy
Upon delivery
Odds of delivery of low-birthweight infants among non-Hispanic Black patients in each study arm

Trial Safety

Trial Design

4 Treatment Groups

Community-Based Doula (CBD) Support
1 of 4
Data Accountability and Transparency + Community-Based Doula Support
1 of 4
Standard Care
1 of 4
Data Accountability and Transparency
1 of 4
Active Control

30000 Total Participants · 4 Treatment Groups

Primary Treatment: Community-Based Doula (CBD) Support · No Placebo Group · N/A

Community-Based Doula (CBD) Support
Other
ActiveComparator Group · 1 Intervention: Community-Based Doula (CBD) Support · Intervention Types: Other
Data Accountability and Transparency + Community-Based Doula SupportActiveComparator Group · 2 Interventions: Community-Based Doula (CBD) Support, Data Accountability and Transparency · Intervention Types: Other, Other
Standard CareNoIntervention Group · 1 Intervention: Standard Care · Intervention Types:
Data Accountability and Transparency
Other
ActiveComparator Group · 1 Intervention: Data Accountability and Transparency · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Closest Location: University of North Carolina at Chapel Hill · Chapel Hill, NC
Photo of University of North Carolina at Chapel Hill 1Photo of University of North Carolina at Chapel Hill 2Photo of University of North Carolina at Chapel Hill 3
1999First Recorded Clinical Trial
1 TrialsResearching Maternal Health
433 CompletedClinical Trials

Who is running the clinical trial?

The Duke EndowmentOTHER
10 Previous Clinical Trials
12,571 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
488 Previous Clinical Trials
29,836,588 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,348 Previous Clinical Trials
3,878,606 Total Patients Enrolled
1 Trials studying Maternal Health
7,500 Patients Enrolled for Maternal Health
UNC Health FoundationUNKNOWN
Rachel P Urrutia, MD, MSCRPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Jennifer H Tang, MD, MSCRPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Eligibility Criteria

Age Any Age · Female Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have delivered at least 180 black babies over 2 years.
You are a patient at one of the 40 clinic groups in this study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.