Well-Mama Community Doula Navigator Study (NCT05179369) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Well-Mama Community Doula Navigator Study
United States576 participantsStarted 2023-05-07
Plain-language summary
This study will develop and test an intervention, called the Well-Mama intervention, which includes the use of a checklist by Community Doula Navigators to support pregnant women. Participants will be randomized to either receive standard perinatal care or standard perinatal care plus the Well-Mama intervention.
Who can participate
Age range
15 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
1\) Pregnant individuals that are age 15-49 years; (2) uninsured or have public insurance (i.e., Medicaid); (3) singleton pregnancy \<32 weeks gestation; and (4) not cognitively impaired
Exclusion Criteria:
Already receiving/enrolled in another perinatal care program beyond standard care, such as group prenatal care, maternity home, or employing their own doula
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is measuring how many recommended perinatal care components participants actually receive — can you walk me through which specific prenatal and postpartum care steps are considered 'recommended,' and whether I'm currently on track to receive all of them?
2This trial pairs pregnant people with community doula navigators — how might having a doula navigator work alongside my existing care team, and do you think that kind of support could be helpful given my specific situation?
3The study is no longer actively recruiting, so I can't enroll — but are there similar doula support programs or care coordination resources available to me locally that could provide the same kind of help?
4Since this is a community-based navigation study rather than a drug or procedure trial, what does the evidence currently say about whether doula support actually improves perinatal outcomes, and is that something worth pursuing for my pregnancy?
5Are there any gaps in my current prenatal care plan — like mental health check-ins, postpartum visits, or social support — that a program like this was designed to address, and how can we make sure those bases are covered for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Recommended Perinatal Care Components Received