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PregnancyUNITENCT07799805

Deconstructing Maternal Burdens: Doulas and the Community Unite for Health

A study testing Doula and Standard (non-enhanced) Medicaid doula support in people with Pregnancy and Post Partum, run by University of Florida at 1 site in United States.

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Sites and contacts
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Trial 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… Read more about this study

Who is it for?
Ages 15 to 49 years, women only
Conditions the study is for
Pregnancy, Post Partum, Doula Care
What is being tested?
Doula and Standard (non-enhanced) Medicaid doula support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
516 participants
Where
1 siteUnited States
Study dates
15 Sep 2026to 30 Nov 2029
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 49 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • Severe physical or mental health conditions that Interfere with participation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • University of Florida

    Gainesville, Florida, 32610

    Clinical Research Manager, 352-665-5255, ALJLAB@ad.ufl.edu

    Director of Doula Programs, 352-665-5255, jrainer@ufl.edu

    Recruiting

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About this study

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.

Read the detailed description

Women in the US have not reaped the benefits of the decline in worldwide maternal mortality (MM) rates (maternal deaths per 100,000 live births) as pregnancy-related deaths (death of a woman while pregnant or within 1 year of the end of a pregnancy) have increased steadily for the past 3 decades. The incidence of perinatal depression and anxiety disorders is high in the US. An estimated 1 out of 7 to 10 pregnant women and 1 out of 5 to 8 postpartum women will develop depressive and/or anxiety disorder.

A doula is a non-medical person who provides informational, physical and emotional support to patients and their support persons. The support doulas provide may be instrumental in supporting maternal wellbeing and navigation of the healthcare system to obtain needed medical care. However, research on doulas have focused primarily on pregnancy and birth. Evidence as to the effectiveness of doula care in the postpartum is scant. This proposal will contribute to the sparse high-level evidence to support the use and expansion of doula services to improve health for low-income families.

This is a pragmatic, two-arm, Type 1 Effectiveness-Implementation Hybrid randomized controlled trial evaluating an enhanced doula support model, UNITE, against standard Medicaid covered doula care, in a socially high-risk population. Pregnant individuals in the study catchment area will be randomized to one of two groups: standard Medicaid doula care, or UNITE doula care, 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. UNITE participants will be engaged in clinic or home settings, in person and/or virtually, and will receive emotional and physical support, education, referrals to community resources, and screening for risk factors for adverse outcomes.

The study also builds the doula workforce it depends on. Through the UNITE Doula Collective, doulas are trained, supported to bill Medicaid, and mentored by an experienced doula network.

Participants in both arms will complete surveys at five time points from pregnancy through one year postpartum to assess the intervention's effectiveness. The primary outcome is a composite measure of perinatal depressive and anxiety symptoms. Secondary outcomes include psychosocial measures, maternal morbidity and mortality, clinical and birth outcomes, and knowledge of pregnancy warning signs. Implementation outcomes include reach, adoption, fidelity, and adaptation, will also be assessed.

A nested qualitative component, including doula group debriefings and in-depth interviews with doula-client dyads, will contextualize the RCT findings.

The study is led by two Community Advisory Board (CAB), 1) Service Recipients - Women of childbearing age, partners/ support persons, and 2) Service Providers - doulas, medical personnel (midwifery, obstetrics, primary care, mental health), community representatives, and policy makers. The CABs meet quarterly throughout the study.

Findings are intended to inform a communication campaign and a state-level policy on Medicaid reimbursement and the extension of doula services into the postpartum period.

Being tested
Doula, Standard (non-enhanced) Medicaid doula support
Keywords
Pregnancy, Doula, Medicaid, Post Partum, Pregnancy Support
Medical subject headings
Depression, Postpartum, Pregnancy Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DoulaOther

    Enhanced doula support in the post-partum period.

  • Standard (non-enhanced) Medicaid doula supportOther

    Standard (non-enhanced) Medicaid doula support

Study groups in NCT07799805
Study groupRoleWhat they receive
Enhanced Doula SupportActive comparatorParticipants 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.
Receives: Other: Doula
Standard Medicaid Doula SupportOtherParticipants with Medicaid insurance will receive standard Medicaid doula support only.
Receives: Other: Standard (non-enhanced) Medicaid doula support

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4-6 weeks postpartum

Secondary outcomes (7)
  1. Perinatal Depressive Symptoms

    Depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), the EPDS ranges from 0 to 30, with higher scores indicating greater severity of depressive symptoms. Longitudinal models will allow comparison of trends over time in mean depressive symptom scores and inferences at specific time points.

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

  2. Perinatal Anxiety Symptoms

    Anxiety symptoms will be assessed using the Generalized Anxiety Disorder 7-item Scale (GAD-7), which ranges from 0 to 21, with higher scores indicating greater severity of anxiety symptoms. Longitudinal models will allow comparison of trends over time in mean anxiety scores and inferences at specific time points.

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

  3. Perceived Stress

    Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10), administered at all time points. The PSS-10 ranges from 0 to 40, with higher scores indicating greater perceived stress.

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

  4. Social Support

    The Medical Outcomes Study Social Support Survey (MOS-SSS) is a 19-item self-administered survey, with items rated on a 5-point scale. Scores are transformed to a 0-to-100 scale, where higher scores represent higher, better perceived social support.

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

  5. Medical Mistrust

    Medical mistrust will be assessed using the Group-Based Medical Mistrust Scale (GBMMS), a 12-item scale assessing perceptions of trustworthiness of doctors and healthcare workers toward one's ethnic group, rated on a 5-point scale (Strongly disagree to Strongly agree). Total scores range from 12 to 60, with higher scores indicating greater medical mistrust.

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

  6. Birth Experience

    Birth experience will be assessed using the Childbirth Experience Questionnaire (CEQ), a 22-item measure covering four domains: Own Capacity, Professional Support, Perceived Safety, and Participation. Items are rated on a 4-point scale (1=strongly disagree/most negative to 4=strongly agree/most positive), with 11 items reverse-scored. Each domain is scored as a mean ranging from 1 to 4, with higher scores indicating a more positive childbirth experience.

    Measured: 4-6 weeks postpartum

  7. Breastfeeding Rates

    Breastfeeding practices will be assessed using a study-adapted CDC Breastfeeding questionnaire, capturing participants who ever breastfed or fed pumped breast milk, currently breastfeeding at each assessment, and breastfeeding duration in weeks/months.

    Measured: 4-6 weeks postpartum, 3 months (±2 weeks) postpartum, and 9-12 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2026
  2. Study start15 Sep 2026 (estimated)
  3. Primary completion28 May 2029 (estimated)
  4. Study completion30 Nov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
A pragmatic two-armed Type 1 Effectiveness-Implementation Hybrid Randomized Controlled Trial (RCT)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
516 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07799805
Sponsor's protocol ID
IRB202501743
Other IDs
R01NR021399
Acronym
UNITE
Status last verified
Aug 2026
First submitted
14 Aug 2026
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Research data documenting, supporting, and validating the study findings will be made available after the main findings from the final research dataset have been disclosed through oral or poster presentations at national and international meetings and through publications in scientific journals. All shared data will be stripped of any potentially identifying information. Data will be made available through an NIH-affiliated repository, TBD data repository, in consultation with NINR.

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