Maternal Non-Stress Testing

• Sponsor: Northwestern University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04343482
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 58.1
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pregnant Women	Device: wearable vital signs sensor

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Wireless Wearable Maternal Fetal Sensors for Non-Stress Testing
• Actual Study Start Date: Apr 1, 2018
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Feb 1, 2023

Outcome Measures

Primary Outcome Measures

1. Device comparison to standard monitoring [3 years]

   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.

Secondary Outcome Measures

1. Qualitative analyses of sensor output [3 years]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Medicine Prentice Women's Hospital	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shuai (Steve) Xu, Principal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT04343482
• Other Study ID Numbers: STU00205895
• First Posted: Apr 13, 2020
• Last Update Posted: Apr 20, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 20, 2022