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Deconstructing Maternal Burdens: Doulas and the Community Unite for Health

NCT07799805 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 516

Last updated 2026-09-02

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

Doula

Enhanced doula support in the post-partum period.

OTHER

Standard (non-enhanced) Medicaid doula support

Standard (non-enhanced) Medicaid doula support

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2029-05-28
Completion
2029-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07799805 on ClinicalTrials.gov