Maternal Fetal Device Performance Singleton

NCT06726343 | Completed Results FDA Device

• 1 other identifier: SA-000072
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Pregnancy; Singleton

Outcome Measures

Primary Outcomes (3)

• Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Investigational Devices on Subjects Enrolled in Each Gestational Age Group

  Collection of the presence of fetal heart rate rhythm data from the investigational device on subjects enrolled in each gestational age group to evaluate non-Inferiority in terms success rate which was defined as percentage of time in which the device gave FHR reading during the study monitoring period.

  30 minutes with investigational device over the course of 1 visit.

• Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Coro 259cx Devices on Subjects Enrolled in Each Gestational Age Group

  Collection of the presence of fetal heart rate rhythm data from the Coro 259cx device on subjects enrolled in each gestational age group to evaluate non-Inferiority in terms success rate which was defined as percentage of time in which the device gave FHR reading during the study monitoring period.

  30 minutes with Coro 259cx over the course of 1 visit.

• Difference in Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Investigational and Coro 259cx Devices on Subjects Enrolled in Each Gestational Age Group

  Collection of the difference in the presence of fetal heart rate rhythm data sets from the Investigational and Coro 259cx devices on subjects enrolled in each gestational age group to evaluate non-Inferiority in terms success rate which was defined as percentage of time in which the device gave fetal heart rate reading during the study monitoring period. Difference in success rate was calculated as investigation minus Coro 259cx.

  30 minutes with Coro 259cx and 30 minutes of investigational over the course of 1 visit.

Secondary Outcomes (5)

• Number of Raw Datasets of the Presence of Fetal Heart Rate During Continuous Monitoring Data From Investigational Device

  30 minutes with investigational device over the course of 1 visit.

• Number of Raw Datasets of Automated Fetal Movement Detection and Remote Event Marks Data Sets on Investigational Device

  30 minutes with investigational device over the course of 1 visit.

• Number of Adverse Safety Events With Investigational Device

  30 minutes with investigational device over the course of 1 visit.

• Number of Adverse Safety Events With Coro259 cx, FDA Approved Device

  30 minutes with FDA approved device over the course of 1 visit.

• The Number of Raw Datasets of Automated Fetal Movement Detection and Remote Event Marks Data Sets on Coro 259cx Device

  30 minutes with Coro 259cx, FDA approved device over the course of 1 visit.

Study Arms (3)

Group 1: 22 0/7 - 24 6/7 Weeks

ACTIVE COMPARATOR

All subjects will undergo the same interventions as part of the study procedures but will be divided into groups based on gestational age groups. Each study subject will undergo two 30-minute monitoring sessions (60 minutes total). One with FDA approved device and one with the investigational device. During both monitoring sessions, maternal pulse rate (MPR) will be monitored using SpO2 and the investigator shall be present to adjust the transducer placement as needed

Device: Fetal Monitoring Device; Device: Investigational Fetal Monitoring Device

Group 2: 25 0/7 - 31 6/7 Weeks

ACTIVE COMPARATOR

All subjects will undergo the same interventions as part of the study procedures but will be divided into groups based on gestational age groups. Each study subject will undergo two 30-minute monitoring sessions (60 minutes total). One with FDA approved device and one with the investigational device. During both monitoring sessions, maternal pulse rate (MPR) will be monitored using SpO2 and the investigator shall be present to adjust the transducer placement as needed.

Device: Fetal Monitoring Device; Device: Investigational Fetal Monitoring Device

Group 3: Greater than or equal to 32 0/7 Weeks

ACTIVE COMPARATOR

All subjects will undergo the same interventions as part of the study procedures but will be divided into groups based on gestational age groups. Each study subject will undergo two 30-minute monitoring sessions (60 minutes total). One with FDA approved device and one with the investigational device. During both monitoring sessions, maternal pulse rate (MPR) will be monitored using SpO2 and the investigator shall be present to adjust the transducer placement as needed.

Device: Fetal Monitoring Device; Device: Investigational Fetal Monitoring Device

Interventions

Fetal Monitoring Device DEVICE

Fetal monitoring device is a multi-parameter maternal fetal monitor that is intended to monitor, store, display, transmit, and generate alarms for non-invasive and invasive clinical parameters of pregnant women and fetuses (singleton and twin), during the antepartum, intrapartum, and postpartum period.

Also known as: Corometrics 259cx

Group 1: 22 0/7 - 24 6/7 Weeks; Group 2: 25 0/7 - 31 6/7 Weeks; Group 3: Greater than or equal to 32 0/7 Weeks

Investigational Fetal Monitoring Device DEVICE

Fetal monitoring device is a multi-parameter maternal fetal monitor that is intended to monitor, store, display, transmit, and generate alarms for non-invasive and invasive clinical parameters of pregnant women and fetuses (singleton and twin), during the antepartum, intrapartum, and postpartum period.

Group 1: 22 0/7 - 24 6/7 Weeks; Group 2: 25 0/7 - 31 6/7 Weeks; Group 3: Greater than or equal to 32 0/7 Weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide written informed consent.
• Singleton pregnancy.
• Aged 18+.
• Greater than or equal to 22 0/7 weeks gestation.

You may not qualify if:

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

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Element Materials Technology

Louisville, Colorado, 80027, United States

Location

Related Publications (1)

• Euliano TY, Darmanjian S, Nguyen MT, Busowski JD, Euliano N, Gregg AR. Monitoring Fetal Heart Rate during Labor: A Comparison of Three Methods. J Pregnancy. 2017;2017:8529816. doi: 10.1155/2017/8529816. Epub 2017 Mar 14.

  PMID: 28392944 BACKGROUND

Results Point of Contact

• Title: Product Manager
• Organization: GE HealthCare

212612107@gehealthcare.com

+44 (7384) 249324

Study Officials

• Monica Rabanal, NP

  Element Materials Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pregnant women of ≥22 weeks gestation will undergo two 30-minute monitoring sessions (60 minutes total). One with currently approved Corometrics 259cx and one with the investigational device. During both monitoring sessions, maternal pulse rate will be monitored using SpO2 and the investigator shall be present to adjust the transducer placement as needed.

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: December 10, 2024
• Study Start: October 28, 2024
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: January 7, 2026
• Results First Posted: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)