Digital Solutions to Reduce Maternal Morbidity and Mortality in Pregnant Refugee Women

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06647511
Status
Recruiting
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Conditions

  • Gestational Hypertension

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Nokia-Withings BPM Connect Blood Pressure Monitor — DEVICE
    At-home blood pressure (BP) measurements will be weekly via a blood pressure cuff (e.g., Nokia-Withings BPM (Beats per Minute) Connect), with measurements being manually entered into the study specific smartphone app.
  • Smartwatch Devices — DEVICE
    Passive continuous collection of digital data (e.g., daily heart rate trends, activity levels, sleep measurements) for exploratory outcomes will occur via Apple Watches and Fitbit Versa 3s, which are synced to a smartphone application.

Study Details

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.

Key Dates

Start date
Sep 12, 2024
Status verified
Apr 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
75 participants (estimated)

Arms

  • Arm: Pregnant Refugees
    Participants will complete validated questionnaires, regular blood pressure measurements, pain and trauma assessments, and clinical monitoring during this study.

Primary Outcome Measure

Digital Sensitivity for detecting gestational hypertension (HTN) [ Time Frame: 13 months [maximum duration of enrollment] ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065
Gunisha Kaur, MA, MD
[email protected]
212-746-2461
Michele Steinkamp, RN
[email protected]
212-746-2953
Lola Berger, BS (SUB_INVESTIGATOR)
Gunisha Kaur, MA, MD (PRINCIPAL_INVESTIGATOR)

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Weill Cornell Medicine· New York, NY

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