Recruiting

Enhanced Doula Support

Sponsor:

University of Florida

Code:

NCT07799805

Conditions

Pregnancy

Post Partum

Doula Care

Postpartum Depression (PPD)

Perinatal Depression

Eligibility Criteria

Sex: Female

Age: 15 - 49

Healthy Volunteers: Not accepted

Interventions

Doula

Standard (non-enhanced) Medicaid doula support

Study Details

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

Pregnancy

Post Partum

Doula Care

Postpartum Depression (PPD)

Perinatal Depression

Study ID

NCT07799805

Start date

Sep 15, 2026

Status verified date

Aug, 2026

Completion date

Nov 30, 2029

Anticipated

Primary completion date

May 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 15 - 49

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 15-49 years old
  • 14-28 weeks pregnant
  • Medicaid Eligible
  • Resides in North Central Florida

Exclusion Criteria:

  • Severe physical or mental health conditions that Interfere with participation

Study Design

Enrollment

516 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Doula

Enhanced doula support in the post-partum period.

Standard (non-enhanced) Medicaid doula support

Standard (non-enhanced) Medicaid doula support

Primary outcome measure

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

Central Contacts and Locations

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Clinical Research Manager

352-665-5255ALJLAB@ad.ufl.edu

Director of Doula Programs

352-665-5255jrainer@ufl.edu

Principal Investigator:

Adetola Louis-Jacques, MD

More Information

Sponsor

University of Florida

Last update posted

Sep 28, 2026

Last verified

Aug, 2026

Keywords

  • Pregnancy
  • Doula
  • Medicaid
  • Post Partum
  • Pregnancy Support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by University of Florida on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.