Maternal Non-Stress Testing

Pregnant Women Clinical Trial

Official title:

Wireless Wearable Maternal Fetal Sensors for Non-Stress Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04343482
• Other study ID #: STU00205895
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: September 6, 2022

Study information

• Verified date: January 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: September 6, 2022
• Est. primary completion date: January 13, 2021
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnant Women

Intervention

Device:
• wearable vital signs sensor
vital signs monitoring during maternal non-stress testing

Locations

Country	Name	City	State
United States	Northwestern Medicine Prentice Women's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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