PregnancyNCT06726343

Maternal Fetal Device Performance Singleton

A study testing Fetal Monitoring Device and Investigational Fetal Monitoring Device in people with Pregnancy, run by GE Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pregnancy
What is being tested?: Fetal Monitoring Device and Investigational Fetal Monitoring Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 28 Oct 2024to 23 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Element Materials Technology
Louisville, Colorado, 80027

Other trials in United States

About this study

Official title: Maternal Fetal Device Performance Testing During Antepartum Singleton Monitoring

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.

Read the 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.

Conditions: Pregnancy
Being tested: Fetal Monitoring Device, Investigational Fetal Monitoring Device
Keywords: Pregnancy, Singleton

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fetal Monitoring DeviceDevice
Also called Corometrics 259cx
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.
Investigational Fetal Monitoring DeviceDevice
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.

Study groups in NCT06726343
Study group	Role	What they receive
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 Receives: 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. Receives: 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. Receives: Device: Fetal Monitoring Device; Device: Investigational Fetal Monitoring Device

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 30 minutes with investigational device over the course of 1 visit.
Number of Adverse Safety Events With Investigational Device
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.
Measured: 30 minutes with investigational device over the course of 1 visit.
Number of Adverse Safety Events With Coro259 cx, FDA Approved Device
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.
Measured: 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
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.
Measured: 30 minutes with Coro 259cx, FDA approved device over the course of 1 visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 202423 Dec 2024

First posted10 Dec 2024
Study start28 Oct 2024
Primary completion23 Dec 2024
Study completion23 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PregnancyStudies of the same condition, open and under way.
More trials run by GE HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06726343
Sponsor's protocol ID: SA-000072
Status last verified: Jan 2026
First submitted: 28 Oct 2024
Last updated: 7 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 28392944

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Maternal Fetal Device Performance Testing During Antepartum Singleton Monitoring
ClinicalTrials.gov ID: NCT06726343
Acronym / sponsor ID: SA-000072
Conditions: Pregnancy
Keywords: Pregnancy, Singleton
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Study start: 28 Oct 2024 (actual)
Primary completion: 23 Dec 2024 (actual)
Study completion: 23 Dec 2024 (actual)
First posted: 10 Dec 2024 (actual)
Results: Posted 7 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3
Model description: 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.

Arm	Type	Receives
Group 1: 22 0/7 - 24 6/7 Weeks	Active comparator	Device: Fetal Monitoring Device, Device: Investigational Fetal Monitoring DeviceAll 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
Group 2: 25 0/7 - 31 6/7 Weeks	Active comparator	Device: Fetal Monitoring Device, Device: Investigational Fetal Monitoring DeviceAll 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.
Group 3: Greater than or equal to 32 0/7 Weeks	Active comparator	Device: Fetal Monitoring Device, Device: Investigational Fetal Monitoring DeviceAll 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fetal Monitoring DeviceAlso: Corometrics 259cxFetal 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.	Device	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 DeviceFetal 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.	Device	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

Primary outcome

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.
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.
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.

5 secondary outcomes

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.
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.
Number of Adverse Safety Events With Investigational Device
Time frame: 30 minutes with investigational device over the course of 1 visit.
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 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.

Results and safety

Results posted to the registry on 7 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: 22 0/7 - 24 6/7 Weeks	10	10
Group 2: 25 0/7 - 31 6/7 Weeks	10	10
Group 3: Greater Than or Equal to 32 0/7 Weeks	10	10

Primary outcome: 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.. Mean (95% Confidence Interval). Unit: percentage

Measure	Group 1: 22 0/7 - 24 6/7 Weeks n = 10	Group 2: 25 0/7 - 31 6/7 Weeks n = 10	Group 3: Greater Than or Equal to 32 0/7 Weeks n = 10
Value	85.01 (77.51 to 92.50)	92.27 (86.51 to 98.03)	98.43 (97.3 to 99.57)

Population analysed: The test was performed using two-sided 95% CI of the difference in Mean Success Rate (SR) for each gestational age group. Success rate is defined as percentage of time in which the device gave FHR reading during the study monitoring period.

Primary outcome: 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.. Mean (95% Confidence Interval). Unit: percentage

Measure	Group 1: 22 0/7 - 24 6/7 Weeks n = 10	Group 2: 25 0/7 - 31 6/7 Weeks n = 10	Group 3: Greater Than or Equal to 32 0/7 Weeks n = 10
Value	83.77 (74.41 to 93.13)	89.07 (77.06 to 100)	92.62 (88.27 to 96.96)

Primary outcome: 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.. Mean (95% Confidence Interval). Unit: percentage

Measure	Group 1: 22 0/7 - 24 6/7 Weeks n = 10	Group 2: 25 0/7 - 31 6/7 Weeks n = 10	Group 3: Greater Than or Equal to 32 0/7 Weeks n = 10
Value	1.23 (-7.74 to 10.20)	3.20 (-4.66 to 11.06)	5.82 (2.14 to 9.50)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Duration of monitoring; approximately 60 minutes. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: 22 0/7 - 24 6/7 Weeks	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Group 2: 25 0/7 - 31 6/7 Weeks	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Group 3: Greater Than or Equal to 32 0/7 Weeks	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28392944Euliano 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Monica Rabanal, NP principal investigator

Element Materials Technology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fetal Monitoring Device and Investigational Fetal Monitoring Device in people with Pregnancy, run by GE Healthcare at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06726343, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.