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Deconstructing Maternal Burdens: Doulas and the Community Unite for Health

Study acronym: UNITE
StatusRecruiting
PhaseNot applicable
Started2026-09-15
View on ClinicalTrials.gov ↗

Amendment history

2026-09-29
notable
Recruitment opened
Start date pushed: 2026-09-01 → 2026-09-15
2,976 trials monitored
See 162 trials at risk
2,229 trials monitored
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This study is a randomized controlled trial comparing two models of doula support for pregnant individuals enrolled in Medicaid: an enhanced doula support model, in which support starts earlier in pregnancy, occurs more frequently, and continues through the first year after birth, versus the standard doula care currently covered by Medicaid in Florida. The study also builds the doula workforce needed to sustain this model of care, training doulas to become eligible to bill Medicaid for their services. The primary goal is to determine whether the enhanced doula model results in significantly lower rates of perinatal depressive and anxiety symptoms compared to standard doula support, while gathering data on real-world implementation. The study also evaluates the effectiveness of Medicaid-covered doula services more broadly, with findings intended to inform state-level policy on Medicaid reimbursement and the extension of doula services into the postpartum period.
Trial Details
NCT Number NCT07799805
Lead Sponsor University of Florida
Collaborators: National Institute of Nursing Research (NINR)
Conditions Pregnancy, Post Partum, Doula Care, Postpartum Depression (PPD), Perinatal Depression, Perinatal Anxiety, Health Disparities, Pregnancy Complications +1 more
Enrollment 516 participants
Start Date 2026-09-15
Primary Completion 2029-05-28 (estimated)
Study Completion 2029-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-28