Reducing Racial Disparities in Severe Maternal Morbidity

NCT04879797 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1538

Last updated 2023-09-13

No results posted yet for this study

Summary

There is a paucity of research examining the intersection of race, ethnicity, maternal safety bundles, doulas, and maternal outcomes in Black women at increased risk of severe maternal morbidity and mortality. The proposed mixed-methods study is the first systematic investigation of pregnancy complications and outcomes among Black women with whom maternal safety bundles are being implemented including racial disparities, hemorrhage, and hypertension. Additionally, through the analysis of secondary state level data, this study will examine perinatal care, maternal outcomes, and healthcare utilization of Black women at increased risk of severe maternal morbidity and mortality compared with non-Latino white women. Finally, through individual interviews with Black women and focus groups with obstetric health providers and doulas, the study will examine disparities and improve care by creating and disseminating a set of practice recommendations for maternity care for Black women at increased risk of morbidity and mortality.

Research has not yet examined the intersection of race/ethnicity, doulas, and quality improvement (QI) interventions, such as maternal safety bundles, on reducing SMM and mortality among non-Hispanic Black (NHB) women. The overall goal of this mixed-methods study is to use analysis of existing big data and the evaluation of two interventions to ultimately develop targeted recommendations for addressing these inequities. Our approach leverages multiple data sources to study maternal outcomes and access to care during the prenatal, birth, and postpartum periods in order to identify commonalities among women who experienced SMM and use those findings to create a risk profile of women who are more likely to experience SMM; examine the implementation of maternal safety bundles on SMM and MM outcomes for women up to 1 year postpartum (Intervention 1); gather in-depth data from obstetric care providers on factors that support or hinder safety bundle implementation (Intervention 1); and gather in-depth data from individual women and doulas on facilitators of barriers to the use of doulas to improve care and address inequities (Intervention 2).

Conditions

  • Maternal Death

Interventions

OTHER

Implementation of Maternal Safety Bundles

In the second phase, implementation of the bundles will take place. During this phase investigators will conduct quarterly surveys with the health facilities to measure implementation progress, including an index of evidence-based practices. Investigators will conduct surveys with postpartum women to measure their patient experience. Surveys will be conducted using RedCap software. Participants will be given the opportunity to complete the survey online or if they prefer, a research assistant can call them to conduct the survey over the phone. Data on SMM will be collected through PELL

OTHER

Doula Services

Investigators are evaluating doula services that are offered by two doula organizations at three hospitals.

Sponsors & Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH
  • Baystate Medical Center

    collaborator OTHER
  • Beth Israel Medical Center

    collaborator OTHER
  • Boston Medical Center

    collaborator OTHER
  • UMass Memorial Health

    collaborator OTHER
  • Steward St. Elizabeth's Medical Center of Boston, Inc.

    collaborator OTHER
  • Brigham and Women's Hospital

    collaborator OTHER
  • Tufts University

    lead OTHER

Principal Investigators

  • Ndidiamaka Amutah Onukagha, PhD · Tufts University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-06-30
Completion
2025-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04879797 on ClinicalTrials.gov