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New study monitors Baby's heart to improve C-Section safety

NCT ID NCT07333729

Knowledge-focused Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how spinal anesthesia, commonly used in planned C-sections, affects the baby's nervous system. Researchers will monitor the baby's heart rate and the mother's vital signs in 50 pregnant women. The goal is to better understand and prevent complications like low oxygen levels in the baby.

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 help doctors better monitor fetal well-being during C-sections and reduce risks like low oxygen levels.
What could go wrong
This is a small pilot study with only 50 participants, so results may not apply to all pregnancies. It is observational and does not test a new treatment.

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 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2026

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

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 scheduled for elective cesarean delivery * Age: over 18 and under 45 years * Gestational age ≥ 37 weeks of amenorrhea * Singleton pregnancy * Proficient in the French language * Participant has provided written informed consent to take part in the study * Affiliated with a national health insurance scheme Exclusion Criteria: * Requirement for general anesthesia or combined epidural-spinal analgesia * Fetal malformation * Intrauterine fetal demise * Maternal and/or fetal cardiac rhythm disorders * History of heart transplantation * Open wound in an area covered or enclosed by one of the study devices * Risk of viral or infectious contamination of any component of the device * Hospitalization for medical termination of pregnancy * Sensory disorders resulting in lack of pain perception on the skin * Ongoing treatment that may alter autonomic nervous system activity (e.g., beta-blockers, anticholinergics, atropine) * Participant with an implanted medical device (e.g., pacemaker) * Known allergy to any component of the devices: polyamide, polyester, elastane, silver, or other synthetic materials * Participant whose anatomical area intended for ClearSight sensor placement is insufficient to allow proper application * Concurrent participation in another interventional research study

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Conditions

The condition(s) this trial relates to.

hypotensive disorder

As listed by the trial registrant

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

Obstetrics: elective caesarean delivery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • CHU de Lille

    RECRUITING

    Lille, 59037, France