Two-Door Doulas: Enhanced vs Standard Medicaid Doula Care in Pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pragmatic randomized trial compares two models of doula support for Medicaid-enrolled pregnant individuals in North Central Florida: an enhanced UNITE doula program with earlier and more frequent visits through the first year postpartum, versus standard Medicaid-covered doula care. The study also trains doulas to be eligible for Medicaid billing to build workforce capacity. Primary outcomes focus on maternal depressive and anxiety symptoms, with additional data on real-world implementation and potential policy implications for postpartum doula reimbursement. The design is an effectiveness-implementation hybrid with real-world applicability in a socially high-risk population. The trial is led by the University of Florida with collaboration from the National Institute of Nursing Research.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Florida
  Gainesville, Florida, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Womb Watch: using a smartphone app to detect fetal movements

  This study tests a smartphone app to help pregnant people track fetal movements and see if it can better detect movement changes that might signal risk.

  Recruiting at 3 sites University of Texas at Austin · Austin, Texas and 2 other locations · NCT07626112

• Personalized mobile health support to prevent maternal depression and anxiety during pregnancy

  A personalized mobile health program added to ordinary care is tested to see if it can prevent depression and anxiety in pregnant people and support partners.

  Recruiting University of Seville · Mairena del Aljarafe, Sevilla · NCT07613008

• Early referral in perinatal mental health approach

  We’re testing a mobile program in routine maternal care to see if early detection and referral for depression and anxiety in pregnant and recently postnatal women is feasible and acceptable, and whether an AI screening tool can help identify those at risk.

  Recruiting University of Seville · Mairena del Aljarafe, Sevilla · NCT07609550

• Parents and Babies: a virtual and hybrid program to support perinatal mood for LGBTQ+ parents

  A pilot program tests a Parents and Babies intervention to see if it’s feasible, acceptable, and potentially helpful for LGBTQ+ people who are pregnant or within a year postpartum and have mild depressive symptoms.

  Recruiting Northwestern University · Chicago, Illinois · NCT07607613

• Virtual forest mindfulness for pregnant women

  A randomized trial tests whether a VR forest mindfulness program helps improve mental health for pregnant women around 20–24 weeks of gestation, compared with standard mindfulness training.

  Recruiting National Taiwan University Hospital · Hsinchu · NCT07606248

• Maternal insulin and fat metabolism in pregnancies at risk for preeclampsia and gestational diabetes

  This project will try to see if insulin resistance and how the body burns fats early in pregnancy predict later preeclampsia or gestational diabetes in people at higher risk.

  Recruiting University of Tennessee Graduate School of Medicine · Knoxville, Tennessee · NCT07565727

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.