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No catheter needed? new study tests simpler C-Section

NCT ID NCT06357546

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether women having a planned C-section can safely skip the routine bladder catheter. Instead, they will urinate on their own just before surgery. The goal is to see if this approach avoids the need for a catheter after birth, while also improving comfort. About 550 pregnant women will take part, and researchers will compare those who urinate beforehand with those who get the standard catheter.

What this could mean

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

Active substance
No drug; the procedure is either spontaneous urination before surgery or standard bladder catheterization during surgery.
What this could lead to
If successful, this could make planned C-sections more comfortable by avoiding routine bladder catheters, without raising the risk of needing a catheter afterward.
What could go wrong
This is a relatively small, early-stage trial (550 participants). The approach may not work for all women, and there is a risk of urinary retention requiring emergency catheterization.

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 550 people

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

Started

Jan 2025

Expected to finish

Nov 2029

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 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: * Adult patient * Patient admitted for a planned cesarean section after 34 weeks under spinal anesthesia * Single or twin pregnancy * Unscarred or with one or two scars of the uterus Exclusion Criteria: * Positive urine test strip showing a presence of nitrites or leukocytes, the day before the surgery suggesting asymptomatic bacteriuria * Emergency Caesarean * Scheduled Caesarean section with intervention delayed beyond 3 p.m. for service organization reasons * Epidural anesthesia * Contraindication to spinal anesthesia (uncorrected hypovolemia; blood coagulation disorders; sepsis or severe inflammation at the puncture site; neurological deficit; migraine pattern; spinal cord disease; spinal malformation; febrile syndrome) * ASA (American Society of Anesthesiologists) score ≥ 4 * Placental insertion abnormality (placenta previa and/or accreta) * Medical indication for monitoring of diuresis * Oliguria or renal failure * Indication for use of intrathecal clonidine during scheduled cesarean section * History of bladder surgery or surgical urological pathology during pregnancy (JJ catheter in place) * History of complex abdominal surgery * Impossibility or absence of obtaining free, informed and written consent, after a period of reflection * Patient not affiliated or beneficiary of a national health insurance system * Patient under legal protection, under guardianship or under curatorship * Patient having participated in interventional research on a drug within 3 months before inclusion * Patient participating in another interventional research * Patient in exclusion period determined by another study

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As listed by the trial registrant

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

How to take part

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  1. The places running it

    2 sites. 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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Montpellier University Hospital

    RECRUITING

    Montpellier, 34295, France

  • Nîmes University Hospital

    RECRUITING

    Nîmes, 30029, France

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