Digital Solutions to Reduce Maternal Morbidity and Mortality in Pregnant Refugee Women (NCT06647511) | Clinical Trial Compass
RecruitingNot Applicable
Digital Solutions to Reduce Maternal Morbidity and Mortality in Pregnant Refugee Women
United States75 participantsStarted 2024-09-12
Plain-language summary
The goal of this observational study is to use digital health tracking to improve how high blood pressure and other health issues are detected in pregnant refugee women. The main questions this study aims to answer are are:
* Can a digital monitoring system that checks for high blood pressure in these women be tested and refined, using clinical training and validation?
* Can this digital monitoring system accurately track any related pregnancy health issues and be used to refer participants to care providers?
* Can this system be used to accurately identify risks associated with the contraction of pregnancy-related conditions, such as preeclampsia and high blood pressure?
Participants will:
* Complete baseline and follow-up in-person appointments;
* Complete surveys at these appointment that track their health, stress levels, and comorbidities/risks associated with pregnancy;
* Be given a smartwatch fitness tracker and electronic blood pressure cuffs for at-home measurements.
Who can participate
Age range
18 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:
* Pregnant
* Refugee, asylum seeking, or asylee as designated by the U.S. Government
* Greater than or equal to 18 years of age
* Has a personal smartphone
Exclusion Criteria:
* Unable to provide informed consent
* Determined by the PI to be in an extremely vulnerable position and therefore not suited for research participation
* Planned move from the New York City (NYC) area within the next 24 months
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
1
Digital Sensitivity for detecting gestational hypertension (HTN)
Timeframe: 13 months [maximum duration of enrollment]
Trial details
NCT IDNCT06647511
SponsorWeill Medical College of Cornell University