Community-based patient navigation for pregnant women
Official title: A Pragmatic Trial of Integrating Community-based Patient Navigation Into the Continuum of Maternal Care for Black Women in a Safety-Net Health System: Effects on Maternal Health, Health Care, Morbidity, and Mortality
Run by Emory University · NCT05588245 · Data updated 2026-11-12
This study tests whether having a patient navigator can help high-risk pregnant women, especially Black women in Georgia, get better care and support during and after pregnancy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 540 (estimated) |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Status | Recruiting |
| Started | January 25, 2024 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | June 23, 2026 |
| Trial ID | NCT05588245 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Black, English-speaking pregnant women aged 18 and older, covered by Medicaid, and identified with unmet social needs.
✕Probably not a fit
Patients who intend to transfer care outside of metro Atlanta or those who are incarcerated may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study tests the effectiveness of a community-based patient navigator intervention for high-risk, medically underserved pregnant women from mid-pregnancy through 12 months postpartum. It involves a randomized controlled trial enrolling 540 women who will be assigned to either standard care or the intervention group receiving support from a patient navigator. The aim is to improve maternal health outcomes and reduce racial disparities in severe maternal morbidities, particularly among Black women in Georgia. The intervention includes prenatal and postpartum contacts to address health assessments, education, and social needs.
Why it matters
Potential benefit: If successful, this intervention could significantly improve maternal health outcomes and reduce disparities for high-risk pregnant women.
How similar studies have gone: Other studies have shown promise in using community-based navigators to improve health outcomes, but this specific approach is novel in the context of maternity care for Black women.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * A pregnant woman or individual (inclusive of all gender identities) who is Black and English-speaking (by self-report), * ≥18 years of age who is capable of consenting for oneself and who presents for prenatal care with a singleton pregnancy ≤ 20 weeks gestation (confirmed by medical record), * covered by Medicaid * for whom the AHC-Health Related Social Needs Tool (administered as part of standard clinical care for prenatal patients) identifies ≥1 unmet social needs * expectation to receive prenatal care and deliver at Grady and be available through 12-months postpartum to assure opportunity for exposure to the intervention, process, and outcome measure ascertainment. Exclusion Criteria: * The intent to transfer care to a health system outside of metro Atlanta * incarceration, which would interfere with intervention provision and outcome ascertainment * adults unable to give consent * individuals who are not yet adults * prisoners * cognitively impaired individuals with impaired decision-making capacity * individuals who are not able to clearly understand and speak English (as the PPP-PN intervention is only available in English at this time)
Where it's running
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Grady Memorial Hospital
Atlanta, Georgia, United States Recruiting
Study contacts
- Principal investigator: Anne L Dunlop, MD — Emory University
- Study coordinator: Anne L Dunlop, MD
- Email: amlang@emory.edu
- Phone: 678-480-5285
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.