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Completed

NCT Number: NCT06726343

Maternal Fetal Device Performance Singleton

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.

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Element Materials Technology

Louisville, Colorado, 80027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Corometrics 259cx

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.

Primary outcomes

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

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

    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.

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

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

    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.

  3. 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

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

    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.

Secondary outcomes

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

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

    Collection of the number of raw data sets of fetal heart rate data sets for each group for internal testing purposes. No additional analysis was performed outside the success rate described in primary outcome.

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

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

    The collection of the number of raw data sets of automated fetal movement detection and remote event marks data sets per subject during continuous fetal monitoring from the investigational device on enrolled subjects for device validation. No analysis was performed on this data and it was collected for future testing purposes.

  3. Number of Adverse Safety Events With Investigational Device

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

    The collection of the number of adverse events, serious adverse events, and/or device deficiencies reported on all enrolled subjects in the study using the investigational device.

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

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

    The collection of the number of adverse events, serious adverse events, and/or device deficiencies reported on all enrolled subjects in the study using the FDA approved device.

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

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

    The collection of the number of raw data sets of automated fetal movement detection and remote event marks data sets per subject during continuous fetal monitoring from the investigational device on enrolled subjects for device validation. No analysis was performed on this data and it was collected for future testing purposes.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study title

Maternal Fetal Device Performance Testing During Antepartum Singleton Monitoring

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2024
Registry last updated
Jan 7, 2026

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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