CompletedNot Applicable

Labor and Delivery Doula Program to Reduce Perinatal Morbidity and Mortality in Kansas

United States30 participantsStarted 2023-05-12

Plain-language summary

The study was done to learn how doula-enhanced care provided to Black birthing people improved perceived communication and quality care.

Who can participate

Age range

16 Years – 50 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: * Black birthing people * Received care and plan to delivery at the University of Kansas Medical Center * Scored positive to social determinants of health screener * Gestational age between 14-27.6 weeks at enrollment Exclusion Criteria: * Pregnancy not viable or pregnancy not intrauterine on ultrasound * Patients who are not willing to be randomized into not receiving doula enhanced * Patients who do not plan to delivery at the University of Kansas Health System * Non-Black birthing people. * Planned cesarean section * Patients with a known major fetal anomaly * Non-English speaking

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Perceptions of Provider Communication

Timeframe: Study enrollment through 6-weeks postpartum

Perceptions of Maternal Care

Timeframe: Study enrollment through 6-weeks postpartum

Trial details

NCT IDNCT07157059

SponsorUniversity of Kansas Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-01

Results submitted2025-11-24

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