Deconstructing Maternal Burdens: Doulas and the Community Unite for Health

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07799805
Status
Not Yet Recruiting

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Conditions

  • Doula Care
  • Health Disparities
  • Maternal Adverse Outcomes
  • Perinatal Anxiety
  • Perinatal Depression
  • Post Partum
  • Postpartum Depression (PPD)
  • Pregnancy
  • Pregnancy Complications

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • Doula — OTHER
    Enhanced doula support in the post-partum period.
  • Standard (non-enhanced) Medicaid doula support — OTHER
    Standard (non-enhanced) Medicaid doula support

Study Details

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.

Key Dates

First listed
Sep 2, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
May 28, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
516 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Enhanced Doula Support
    Participants with Medicaid insurance will receive an enhanced doula support, which adds more visits starting earlier in pregnancy, more frequent visits near the due date, several extended home visits in the first two months postpartum, and continued check-ins through the first year after birth.
  • Other: Standard Medicaid Doula Support
    Participants with Medicaid insurance will receive standard Medicaid doula support only.

Primary Outcome Measure

Evaluating the Effectiveness of UNITE Intervention [ Time Frame: 4-6 weeks postpartum ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Clinical Research Manager
[email protected]
352-665-5255
Director of Doula Programs
[email protected]
352-665-5255
Adetola Louis-Jacques, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Florida· Gainesville, FL

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