Maternal Fetal Device Performance Singleton

Not Applicable

Completed

• Conditions: Pregnancy

• Registration Number: NCT06726343
• Lead Sponsor: GE Healthcare

Brief Summary

Maternal Fetal Monitoring devices assist the health care professional in acquiring, monitoring, and storing fetal and maternal physiologic data which supports the decision making for pregnant women and the overall fetal health status during pregnancy and delivery. This study aims to support a new maternal fetal monitoring device with clinical data to demonstrate the equivalent performance against the currently marketed Corometrics 259cx. The fetal heart rate and will be collected during antenatal monitoring using standard of care Doppler ultrasound.

Detailed Description

This study aims to compare a maternal fetal monitoring device to the currently marketed Corometrics 259cx. Fetal heart rate and Fetal Movement Detection data will be collected during antenatal monitoring using standard of care Doppler Ultrasound transducers.

The new Maternal/Fetal Monitor is capable of monitoring heart rates (maternal/ fetal), maternal uterine contractions, as well as maternal blood pressure and maternal pulse oximetry. This study will compare clinical data between the current and the new monitor on non-laboring singleton gestation women.

Funding for this study will be provided by GE HealthCare. This study does not include patient advisors.

Study Timeline

• Study Start: 2024-10-28
• Study First Submitted: 2024-10-28
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-06
• Study First Posted: 2024-12-10
• Primary Completion: 2024-12-23
• Study Completion: 2024-12-23
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

1. Able and willing to provide written informed consent.
2. Singleton pregnancy.
3. Aged 18+.
4. Greater than or equal to 22 0/7 weeks gestation.
5. Patient has none of the exclusion criteria.

Exclusion Criteria

1. Multiple pregnancy.
2. Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study.
3. Medical or obstetric problem that in investigator's opinion would make the patient incapable of taking part in the study.
4. Inability to understand the consent information due to medical illness, diminished intellectual capacity, or insurmountable language barrier.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
FHR Success Rate	60 minutes	To determine whether the FHR data from the investigational device is non-inferior to Doppler US from the Coro 259cx by collecting 30 minutes of continuous monitoring on both devices individually. Success rate measures the percentage of time each device generates a value for fetal hear rate and will be computed per subject. Overall success rate across all subjects will be summarized and is defined as a less than 10% difference in mean success rate between the two devices.

Secondary Outcome Measures

Name	Time	Method
Safety Analysis	4 months	Analysis of adverse events will be listed per subject, summarized with counts and percentages of events, and summarized with counts and percentages of subjects with events.
Collection of Raw Parameter Data	30 minutes	Collection of raw parameter data from the investigational device on 30 subjects over 30 minutes of continuous fetal monitoring.
Collection of Automated Fetal Movement Detection and Remote Event Marks	60 minutes	Collection of automated fetal movement detection and remote event marks data from the investigational device and Corometrics device on 30 subjects over 60 minutes of continuous fetal monitoring.

Trial Locations

Locations (1)

Element Materials Technology; 🇺🇸 Louisville, Colorado, United States