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.
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
- 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
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.
- Conditions
- Pregnancy, Post Partum, Doula Care, Postpartum Depression (PPD), Perinatal Depression, Perinatal Anxiety
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Doula |
| Standard Medicaid Doula Support | Other | Participants 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.
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)
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
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
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
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
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
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
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.
- First posted2 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion28 May 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
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.