MedTrace Logo

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

NCT06647511 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • Gestational Hypertension

Interventions

DEVICE

Smartwatch Devices

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.

DEVICE

Nokia-Withings BPM Connect Blood Pressure Monitor

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.

Sponsors & Collaborators

  • National Academy of Medicine

    collaborator UNKNOWN

  • Cornell University

    collaborator OTHER

  • Apple Inc.

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Gunisha Kaur, MA, MD · Weill Medical College of Cornell University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-12
Primary Completion
2028-09-30
Completion
2028-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06647511 on ClinicalTrials.gov