Reducing Racial Disparities in Severe Maternal Morbidity

  • End date
    Jun 30, 2025
  • participants needed
  • sponsor
    Tufts University
Updated on 17 September 2023
Accepts healthy volunteers


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).


Background / Literature Review / Rationale for the study:

Black women experience stark disparities in pregnancy complications and outcomes compared to White women. Recognizing, tracking and understanding patterns of severe maternal morbidity (SMM) and associated inequities by race/ethnicity, along with developing and carrying out interventions to improve the quality of maternal care, are essential to reducing SMM and thereby maternal mortality. To date, there has been little research specifically aimed at understanding whether the maternal health inequities as experienced by Black women can be ameliorated through an integrated care model that includes engagement of providers in the planning and implementation of maternal safety bundles or engaging mothers in prenatal, birth and postpartum support from community doulas. The investigators will use the Health Impact Pyramid and CFIR Framework (Consolidated Framework for Implementation) to develop, implement and assess the effectiveness of such a system in reducing disparities in SMM and mortality. The data sources for this study will include state-level and hospital-specific discharge data collected as part of the Alliance for Innovation on Maternal Health (AIM) project and the Pregnancy to Early Life Longitudinal (PELL) data system, which focuses on population-level data needed to examine health inequities among racial and ethnic minorities in Massachusetts. In addition to these existing data sources, the investigators intend to establish a data collection tool to assess doula services as well as analyze qualitative data from interviews with Black women, and focus groups with obstetrical care providers and doulas to explore the effect of implementing safety bundles and incorporating doula-provided services into prenatal, birth and postpartum care.

Condition Maternal Death
Treatment Implementation of Maternal Safety Bundles, Doula Services
Clinical Study IdentifierNCT04879797
SponsorTufts University
Last Modified on17 September 2023


Yes No Not Sure

Inclusion Criteria

PREM PROM (Patient Reported Experience Measure Patient Reported Outcome Measure) Surveys
for Intervention II

Exclusion Criteria

Pregnancies ending prior to 20 weeks and due to ectopic pregnancy not
occurring on labor and delivery units of the four participating hospitals
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