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Recruiting NCT06357546

NCT06357546 Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section

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Clinical Trial Summary
NCT ID NCT06357546
Status Recruiting
Phase
Sponsor University Hospital, Montpellier
Condition Pregnant Women
Study Type INTERVENTIONAL
Enrollment 550 participants
Start Date 2025-01-20
Primary Completion 2029-09

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Spontaneous urination during the hour before caesarean section.Systematic bladder catherization during caesarean section.

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 550 participants in total. It began in 2025-01-20 with a primary completion date of 2029-09.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The hypothesis of this trial is that the absence of systematic bladder catheterization in patients performing spontaneous urination in the hour preceding the planned cesarean section under spinal anesthesia would not lead to more bladder heterocatheterization for postpartum urinary retention (RUPP) in the 24 hours post-cesarean section than systematic intraoperative bladder catheterization up to 2 hours post-surgery.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Audrey LAMOUROUX, MD

✉ a-lamouroux@chu-montpellier.fr

📞 +334 66 68 37 99

Principal Investigator

Audrey LAMOUROUX, MD

STUDY DIRECTOR

Montpellier University Hospital

Frequently Asked Questions

Who can join the NCT06357546 clinical trial?

This trial is open to female participants only, aged 18 Years or older, studying Pregnant Women. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06357546 currently recruiting?

Yes, NCT06357546 is actively recruiting participants. Contact the research team at a-lamouroux@chu-montpellier.fr for enrollment information.

Where is the NCT06357546 trial being conducted?

This trial is being conducted at Montpellier, France, Nîmes, France.

Who is sponsoring the NCT06357546 clinical trial?

NCT06357546 is sponsored by University Hospital, Montpellier. The principal investigator is Audrey LAMOUROUX, MD at Montpellier University Hospital. The trial plans to enroll 550 participants.

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