Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean S… (NCT06357546) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section
France550 participantsStarted 2025-01-20
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Necessity of heterocatheterization within 24 hours following the cesarean section.
Timeframe: Between Hour 0 (time of surgical closure) and Hour 24