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New home device could let moms track Baby's heartbeat

NCT ID NCT07223996

Knowledge-focused Sponsor: Nestmedic Spolka Akcyjna 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 device called PregnaOne that lets pregnant women monitor their baby's heart rate and their own contractions from home. About 71 women in their third trimester used the device during a single visit and compared it to an already-approved monitor. The goal was to see if the new device works just as well and is easy for women to use on their own.

What this could mean

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

Active substance
PregnaOne System (device)
What this could lead to
If successful, this device could offer a convenient way for pregnant women to monitor their baby's heart rate and contractions from home, potentially reducing hospital visits.
What could go wrong
This is a small, early-stage study focused on comparing the device to an existing one, not on health outcomes. The device may not be as accurate or easy to use in real-world settings.

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

71 people

The number who actually took part.

Started

Sep 2025

Finished

Jan 2026

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

22 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Able to independently read and understand written and spoken English and willing to provide written informed consent and comply with all instructions required by the study protocol. * Female aged 22 years or older. * Estimated gestational age between 32 and 41 weeks. * Singleton gestation. * Pre-pregnancy or first prenatal visit BMI \< 40 kg/m². * Able and willing to undergo fetal monitoring sessions in a simulated home environment at the study site. * Women who do not meet the gestational age criterion at the screening visit but will meet it by the study visit (within two weeks) may be enrolled. Exclusion Criteria: * In active labor or in the delivery room during labor. * Requires hospitalization or life support. * Any contraindications for cardiotocography (CTG) monitoring. * Severe hypertension (≥160/110 mmHg measured twice, 15 minutes apart). * Known allergy to latex, ultrasound (US) gel, or ECG gel. * Skin conditions (e.g., edema, erythema, irritation, infection, lesions, or open wounds) at contact points for the Pregnabit Pro or comparator devices. * Implanted electronic devices (e.g., pacemaker, stimulator, defibrillator, pump). * Members of vulnerable populations other than pregnant women (e.g., minors, wards of the state, cognitively impaired individuals, prisoners, or institutionalized persons).

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As listed by the trial registrant

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

Fetal monitoring Pregnancy

Contacts and locations

Locations

  • Christie Clinic, LLC

    Champaign, Illinois, 61820, United States

  • The Iowa Clinic, P.C.

    West Des Moines, Iowa, 50266, United States

  • Wilmington Health, PLLC

    Wilmington, North Carolina, 28401, United States

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