Trial Outcomes & Findings for Electrode-Based Sensor for Non-Invasive Fetal Heart Rate Monitoring With Improved Reliability (NCT NCT02024165)

NCT ID: NCT02024165

Last Updated: 2015-05-12

Results Overview

The Fetal Heart Rate (or FHR) of the electrode sensor will be compared to the FHR of the ultrasound when both are compared to the FSE. Percentage of time that signals are interpretable will be compared between devices

• Recruitment status: COMPLETED
• Target enrollment: 71 participants
• Primary outcome timeframe: 2 hours
• Results posted on: 2015-05-12

Participant Flow

Participant milestones

Measure	Electrode Sensor, FSE, Ultrasound Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or FSE and Ultrasound
Overall Study STARTED	71
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Electrode-Based Sensor for Non-Invasive Fetal Heart Rate Monitoring With Improved Reliability

Baseline characteristics by cohort

Measure	Electrode Sensor, FSE, Ultrasound n=71 Participants Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor and/or FSE and Ultrasound
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	71 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	71 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	71 participants n=93 Participants

PRIMARY outcome

Timeframe: 2 hours

The Fetal Heart Rate (or FHR) of the electrode sensor will be compared to the FHR of the ultrasound when both are compared to the FSE. Percentage of time that signals are interpretable will be compared between devices

Outcome measures

Measure	Electrode Sensor, FSE n=71 Participants Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or FSE	Electrode Sensor, Ultrasound n=71 Participants Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or Ultrasound
Fetal Heart Rate Interpretability	83.4 percentage of time the signals are inter Standard Deviation 15.4	62.4 percentage of time the signals are inter Standard Deviation 26.7

Adverse Events

Electrode Sensor, FSE, Ultrasound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Busowski, MD

Winnie Palmer Hospital for Women and Babies

Phone: 407-435-1485

Email: john.busowski@orlandohealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place