Deconstructing Maternal Burdens: Doulas and the Community Unite for Health

NCT07799805 | Recruiting DMC

• 2 other identifiers: IRB202501743R01NR021399
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pregnancy; Doula; Medicaid; Post Partum; Pregnancy Support

Outcome Measures

Primary Outcomes (1)

• Evaluating the Effectiveness of UNITE Intervention

  The primary outcome is a composite measure of perinatal depressive and/or anxiety symptoms. Depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), with a score greater than 9 indicating clinically significant symptoms; the EPDS ranges from 0 to 30, with higher scores indicating greater severity of depressive symptoms. As well as the Generalized Anxiety Disorder 7-item Scale (GAD-7), ranges from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.

  4-6 weeks postpartum

Secondary Outcomes (7)

• Perinatal Depressive Symptoms

  Baseline (14-28 weeks gestation), 32-36 weeks gestation, 4-6 weeks postpartum, 3 months (±2 weeks) postpartum, and 9-12 months postpartum

• Perinatal Anxiety Symptoms

  Baseline (14-28 weeks gestation), 32-36 weeks gestation, 4-6 weeks postpartum, 3 months (±2 weeks) postpartum, and 9-12 months postpartum

• Perceived Stress

  Baseline (14-28 weeks gestation), 32-36 weeks gestation, 4-6 weeks postpartum, 3 months (±2 weeks) postpartum, and 9-12 months postpartum

• Social Support

  Baseline (14-28 weeks gestation), 32-36 weeks gestation, 4-6 weeks postpartum, 3 months (±2 weeks) postpartum, and 9-12 months postpartum

• Medical Mistrust

  Baseline (14-28 weeks gestation), 32-36 weeks gestation, 4-6 weeks postpartum, 3 months (±2 weeks) postpartum, and 9-12 months postpartum

Study Arms (2)

Enhanced Doula Support

ACTIVE COMPARATOR

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: Doula

Standard Medicaid Doula Support

OTHER

Participants with Medicaid insurance will receive standard Medicaid doula support only.

Other: Standard (non-enhanced) Medicaid doula support

Interventions

Doula OTHER

Enhanced doula support in the post-partum period.

Enhanced Doula Support

Standard (non-enhanced) Medicaid doula support OTHER

Standard (non-enhanced) Medicaid doula support

Standard Medicaid Doula Support

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• weeks pregnant
• Medicaid Eligible
• Resides in North Central Florida

You may not qualify if:

• Severe physical or mental health conditions that Interfere with participation

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum; Pregnancy Complications

Interventions

Doulas

Condition Hierarchy (Ancestors)

Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pragmatic two-armed Type 1 Effectiveness-Implementation Hybrid Randomized Controlled Trial (RCT)

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: September 2, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): May 28, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: September 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available as soon as possible or at the time of associated publication, whichever comes first.
• Access Criteria: Deidentified data will be publicly available through an NIH-affiliated repository, TBD data repository. All data generated through the course of this project will be shared using a Data Use Agreement between the University of Florida and the University of South Florida and University of Virginia. As well as a Data Use Agreement between the University of Florida and the Gainesville Doula Network. The data will be shared with these key personnel to meet the proposed study aims.

Locations

US (1)