Smart monitor could spot fetal distress before It's too late
NCT ID NCT07409545
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new device called TOCONAUTE that records fetal and maternal heart rates during labor. Researchers will analyze the recordings to see if a new measure called the Fetal Stress Index can predict acidosis, a condition that can lead to brain damage in newborns. The study involves 760 pregnant women at three French hospitals. If the device works, it could help doctors make better decisions about when to perform a C-section or induce labor.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could provide a more accurate way to monitor fetal distress during labor, helping doctors decide when to intervene to prevent brain damage.
- What could go wrong
- This is an early-stage study that only analyzes recordings after birth, not in real time. The device may not prove reliable enough to change current practices.
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
-
About 760 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Mar 2027
An estimate. Start dates often move.
- Expected to finish
-
Sep 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- 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 Hide 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: * Pregnant woman admitted to the delivery room for childbirth * Fetus in cephalic presentation * Aged 18 to 45 years old * Gestational age greater than 37 weeks * Understanding of the French language * Participant who has given written consent to participate in the study. Exclusion Criteria: * Hospitalization for medical termination of pregnancy * Death in utero * Heart transplant * Twin pregnancy * Open wound in an area covered or wrapped by the medical device * Allergy to a component of the TOCONAUTE device: polyamide, polyester, elastane, silver, other synthetic materials * Sensory disorders rendering the subject insensitive to pain on the skin * Risk of contamination (viral/infectious) of one of the materials constituting the device * Participant wearing an implanted medical device (pacemaker, etc.) * Simultaneous participation in another research study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Obstetrics are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.