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New fetal heart monitor put to the test in pregnancy study

NCT ID NCT06726343

Diagnosis Sponsor: GE Healthcare Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new fetal monitoring device to see if it works as well as the current standard monitor for tracking a baby's heart rate during pregnancy. Thirty pregnant women with a single baby at 22 weeks or later were monitored. The goal was to compare how often each device successfully recorded the fetal heart rate.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fetal monitoring device
What this could lead to
If successful, this could confirm that the new device is a reliable alternative for monitoring fetal heart rate during pregnancy.
What could go wrong
This is a small, early-stage device comparison study with only 30 participants. It does not test health outcomes, only device performance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Oct 2024

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pregnancy

Contacts and locations

Locations

  • Element Materials Technology

    Louisville, Colorado, 80027, United States

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