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

NCT06647511 | Recruiting

• 1 other identifier: 24-01026913
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

refugee; pregnant; digital

Outcome Measures

Primary Outcomes (1)

• Digital Sensitivity for detecting gestational hypertension (HTN)

  The diagnostic accuracy of the digital blood pressure cuffs will be compared to the measurements taken during in-person visits.

  13 months [maximum duration of enrollment]

Secondary Outcomes (20)

• Number of Participants that Complete All Surveys Between Appointments

  13 months [maximum duration of enrollment]

• Number of Participants That Complete All Surveys at the Baseline Appointment

  13 months [maximum duration of enrollment]

• Number of Participants Referred to Physicians/Care that do not have a designated provider

  13 months [maximum duration of enrollment]

• Number of Participants With No Comorbid Pain as Assessed by BPI-SF

  13 months [maximum duration of enrollment]

• Number of Participants With Mild Comorbid Pain as Assessed by BPI-SF

  13 months [maximum duration of enrollment]

Study Arms (1)

Pregnant Refugees

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

Device: Nokia-Withings BPM Connect Blood Pressure Monitor; Device: Smartwatch Devices

Interventions

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.

Pregnant Refugees

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.

Pregnant Refugees

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is a pregnant refugee, or asylee as designated by the U.S. Government.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Academy of Medicine: collaborator
• Cornell University: collaborator
• Apple Inc.: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gunisha Kaur, MA, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gunisha Kaur, MA, MD

CONTACT

(212) 746-2461; gus2004@med.cornell.edu

Michele Steinkamp, RN

CONTACT

2127462953; mls9004@med.cornell.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 17, 2024
• Study Start: September 12, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)