A Community Health Worker Intervention to Address Adverse Pregnancy Outcomes (NCT06353256) | Clinical Trial Compass
CompletedNot Applicable
A Community Health Worker Intervention to Address Adverse Pregnancy Outcomes
United States61 participantsStarted 2024-09-03
Plain-language summary
United States maternal mortality and preterm birth rates are among the highest among high-income countries due in part to a combination of racial, regional and socioeconomic disparities in access to care and overall health. The research proposed focuses on adapting and expanding a perinatal community health worker intervention for Black postpartum patients with preeclampsia (PE) and other adverse pregnancy outcomes (APOs). Investigators will partner with a community-based organization that trains and deploys community health workers. Investigators will test an intervention for urban and rural Black postpartum patients with APOs to 1) enhance blood pressure control postpartum and 2) promote long-term cardiovascular disease prevention for this underserved population. This pilot study will determine if randomizing and implementing a community health worker intervention tailored to pregnant people experiencing preeclampsia is feasible and found to be acceptable by participants.
Who can participate
Age range
16 Years – 56 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:
* Self Identifies as Black
* Between 16-56 years old
* Experiencing adverse pregnancy outcomes defined as hypertensive disorders of pregnancy, preterm birth, placental abruption, pregnancy loss (loss at greater or equal to 14 weeks gestation), gestational diabetes, delivering a small for gestational age infant
* Planning to deliver at UAB Hospital
* Speaks and writes in English
Exclusion Criteria:
* Declines Randomization
* Speaks or writes in languages other than English
* Currently incarcerated
* Previously enrolled in P3OPPY
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 trial focused on community health worker support after delivery to address things like postpartum preeclampsia — based on what it found about participant satisfaction, does my doctor think this kind of support program is available or recommended for me after I give birth?
2Since the trial has already been completed and was measuring how satisfied participants were with postpartum support rather than clinical outcomes like blood pressure control, what do the results actually tell us about whether this approach reduced risks for people with preeclampsia or adverse pregnancy outcomes?
3Given that this study used community health workers specifically for postpartum care, would my doctor suggest I work with a community health worker or care navigator after delivery, and is that something my hospital or clinic currently offers?
4Because postpartum preeclampsia can be dangerous and is sometimes missed after discharge, what postpartum monitoring plan would my doctor put in place for me regardless of whether a program like this one is available to me?
5Are there other completed or ongoing studies my doctor is aware of that looked at harder clinical outcomes — like blood pressure readings or hospital readmission rates — for postpartum preeclampsia, so we can compare what's known beyond just satisfaction scores?
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
Participant Satisfaction With Postpartum Support
Timeframe: Assessed once at the study postpartum follow-up, which occurred approximately 12 to 20 weeks postpartum.