Advanced Multi-Modal Wearable Sensing for the Prediction of Pre-Term Labor

Pregnancy Preterm Clinical Trial

Official title:

Advanced Multi-Modal Wearable Sensing for the Prediction of Pre-Term Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04362579
• Other study ID #: STU00210698
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2022
• 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

Description:

The primary objective of the Prentice study is to assess and validate EMG performance of the new home-use sensor with extended battery life in detecting continuous EHG in a range of uterine contraction intensities, frequencies, and durations compared to gold-standard FDA-cleared tocodynamometer (GE Corometrics 250cx) in non-stress testing for antepartum surveillance.

An "at-home" study will validate the developed modifications to the wearable sensors system that provides a continuous electrohysterography (EHG) along with other additional physiological parameters (e.g. heart rate, heart rate variability, sleep quality, physical activity, and continuous blood pressure) for longitudinal monitoring in the home setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

• Maternal age >18 years old

• Pregnant mothers >13 weeks (home study only)

• Pregnant mothers >26 weeks undergoing nonstress testing or delivering

• Singleton pregnancy (inpatient or clinic visit patients only)

• History of preterm labor or premature birth, active smoker, chronic condition (ex: HTN or DM), or an interval of less than 6 months between the prior pregnancy

• Singleton pregnancy (home study only)

• No fetal abnormality or chromosomal abnormality

• Subjects willing and able to comply with requirements of the protocol

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

• Obstetric Labor, Premature
• Pregnancy Preterm

Intervention

Device:
• wearable vital signs sensor
vital signs monitoring during maternal non-stress testing or in the home setting

Locations

Country	Name	City	State
United States	Northwestern University	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.	2 years