Maternal Non-Stress Testing

Wireless Wearable Maternal Fetal Sensors for Non-Stress Testing

Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring

Study Overview

• Status: Completed
• Conditions: Pregnant Women
• Intervention / Treatment: Device: wearable vital signs sensor

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine Prentice Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

Description

Inclusion Criteria:

• Maternal age >18 years old
• Pregnant mothers >26 weeks undergoing nonstress testing or delivering
• Singleton pregnancy
• No fetal abnormality or chromosomal abnormality
• Subjects willing and able to comply with requirements of the protocol
• Nurses and clinicians who will be administering the non-stress test to the pregnant subject

Exclusion Criteria:

• Women who refuse to signed the informed consent form
• Maternal age under 18 years old
• Multiple pregnancy
• Known major fetal malformation or chromosomal abnormality
• Medical or obstetric problem that would preclude the use of abdominal electrodes
• Inability to consent to this study due to medical illness, diminished intellectual capacity, or language barrier
• Women using pacemakers

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device comparison to standard monitoring	The primary outcome measure is concordance of FHR tracing assessments from Rogers sensor recordings with those obtained from the current standard of care electronic fetal monitoring systems.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative analyses of sensor output	Qualitative analyses of FHR, MHR, BP, pulse oximetry, and UC data capture from the sensors will be performed for the purpose of optimizing signal-to-noise filtering of raw data collected during the study. Any adverse events will be recorded such as skin irritation (expected to be negligible).	3 years

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): January 13, 2021
• Study Completion (Actual): September 6, 2022

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 13, 2020

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STU00205895

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No