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Life sciences · Interventional Study
ClinicalTrials.gov · September 28, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Interventional Study.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07799805). This is a study registration, not published results. Lead sponsor: University of Florida. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 516 participants (ESTIMATED). Conditions: Pregnancy, Post Partum, Doula Care, Postpartum Depression (PPD), Perinatal Depression, Perinatal Anxiety, Health Disparities, Pregnancy Complications, Maternal Adverse Outcomes. Interventions: OTHER: Doula; OTHER: Standard (non-enhanced) Medicaid doula support. Primary outcome measures: Evaluating the Effectiveness of UNITE Intervention , 4-6 weeks postpartum. Brief summary: 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.