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OpenTrials
Completed

NCT Number: NCT04343482

Maternal Non-Stress Testing

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

Completed

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Key information

Conditions

Pregnant Women

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Northwestern Medicine Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wearable vital signs sensor

Device

vital signs monitoring during maternal non-stress testing

Primary outcomes

  1. Device comparison to standard monitoring

    Time frame: 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 outcomes

  1. Qualitative analyses of sensor output

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Wireless Wearable Maternal Fetal Sensors for Non-Stress Testing

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Apr 13, 2020
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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