Improving maternal health outcomes for Black women
Reducing Racial Disparities in SMM: Assessing the Integration of Maternal Safety Bundles and Community Based Doulas to Improve Outcomes for Black Women
This study is trying to find ways to improve pregnancy and postpartum care for Black women to help reduce serious health problems and deaths during childbirth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1538 (estimated) |
| Sex | Female |
| Sponsor | Tufts University Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04879797 on ClinicalTrials.gov |
What this trial studies
This study investigates the severe maternal morbidity and mortality disparities faced by Black women compared to non-Latino white women. It employs a mixed-methods approach, utilizing both quantitative data from state-level health records and qualitative insights from interviews and focus groups with Black women and healthcare providers. The study aims to implement maternal safety bundles and community doula services to enhance care and outcomes for Black women during pregnancy and postpartum. By analyzing existing data and gathering new insights, the research seeks to develop actionable recommendations for improving maternity care.
Who should consider this trial
Good fit: Ideal candidates for this study are Black women who are at increased risk of severe maternal morbidity and have given birth at the participating hospital sites.
Not a fit: Patients who are not Black or who do not meet the criteria for increased risk of severe maternal morbidity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce maternal morbidity and mortality rates among Black women.
How similar studies have performed: Other studies have shown success in addressing maternal health disparities through targeted interventions, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Intervention I (Maternal Safety Bundles) AIM Bundle Structure, Process and SMM 21 Outcome Measures • Inclusion criteria: Births at the five participating hospital sites for Intervention 1, collecting data one year prior to, during and one year after the study period. PREM PROM (Patient Reported Experience Measure ( PREM) Patient Reported Outcome Measure (PROM) Surveys for Intervention I • Inclusion criteria for Pre- and post- surveys for Maternal Safety Bundles Implementation: Birthing individuals who have delivered six weeks to one year prior to the interview at the five participating sites in Intervention 1 Focus groups for Intervention I • Inclusion criteria: Obstetrical care providers including nurses, midwives, family practitioners, attending obstetricians and trainee obstetricians employed at the five participating hospital sites will be invited to participate in focus groups. Intervention II (Community doula support) Severe Maternal Mortality (SMM) 21 Outcome Measures • Inclusion criteria: Live births among birthing individuals who identify as Black or African American and who are offered community doula-support at one of the participating four hospitals, either through a hospital-based program or a payer navigation program. The study will include in the intervention arm 340 pregnant women who (1) live in the state of MA, (2) identify as Black or African American, (3) are offered doula care by either their provider or their payer-based navigation program and (4) deliver at one of the four delivering hospitals (Beth Israel Lahey, Boston Medical Center, St. Elizabeth's Medical Center, and Baystate Medical Center). Concurrently, the 340 birthing individuals who were offered doula care in the intervention arm will be matched with birthing individuals who identify as Black or African American, have a live birth, and deliver at one of four hospitals and have similar demographics such as age, comorbidities, payer status, etc. Focus groups for Intervention II • Inclusion criteria: Persons who practice or identify as community doulas and work with clients who deliver in the state of Massachusetts and have assisted a client in pregnancy, birth, or postpartum within the past 12 months prior to the focus group discussion; obstetrical care provider including nurses, midwives, family medicine practitioners, attending obstetricians, and obstetricians employed at the four participating hospital sites as well as community doula programmatic staff who are employed at participating hospitals sites, or participating community doula organizations, or payers PREM PROM (Patient Reported Experience Measure Patient Reported Outcome Measure) Surveys for Intervention II • Inclusion criteria: Live births among birthing individuals who identify as Black or African American and who are offered community doula-support at one of the participating four hospitals, either through a hospital-based program or a payer navigation program. Intervention I (Maternal Safety Bundles) AIM Bundle Structure, Process and SMM 21 Outcome Measures • Exclusion criteria: Pregnancies ending prior to 20 weeks and due to ectopic pregnancy not occurring on labor and delivery units of the five participating hospitals PREM PROM (Patient Reported Experience Measure Patient Reported Outcome Measure) Surveys for Intervention I • Exclusion criteria: Pregnancies ending prior to 20 weeks and due to ectopic pregnancy not occurring on labor and delivery units of the five participating hospitals Focus groups for Intervention I • Exclusion criteria: Staff who have contact with patients but do not identify in the provider types listed in the inclusion criteria Intervention II (Community doula support) SMM 21 Outcome Measures • Exclusion criteria: Pregnancies ending prior to 20 weeks and due to ectopic pregnancy not occurring on labor and delivery units of the five participating hospitals Focus groups for Intervention II • Exclusion criteria: Staff who have contact with clients but do not identify in the provider types listed in the 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
Where this trial is running
Boston, Massachusetts
- Tufts University — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Ndidiamaka Amutah Onukagha, PhD — Tufts University
- Study coordinator: Ndidiamaka Amutah Onukagha, PhD
- Email: ndidiamaka.amutah_onukagha@tufts.edu
- Phone: (617) 636-3809
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.