Ireland
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Recruiting Not applicable

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

NCT06357546 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-01-20
Last updated
2026-03-12

Condition(s) studied

Pregnant WomenCesarean Section

Investigational drug(s) / intervention(s)

Spontaneous urination during the hour before caesarean section.Systematic bladder catherization during caesarean section.

Spontaneous urination during the hour before caesarean section.: Patients will be asked to urinate by spontaneous urination in the hour before the cesarean section with a cytobacteriological urine examination (ECBU) carried out. An ultrasound check by Bladderscan of the post-void residue will be carried out as soon as the patient will be installed on the intervention table. In the event of post-void residue of more than 150 ml, favoring urinary infections, the patient will be excluded from the research.

Systematic bladder catherization during caesarean section.: After implementation of loco-regional analgesia by spinal anesthesia, the patient will be positioned, with a perineal toilet and installation of a bladder catheter type Foley ch. 16.

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Necessity of heterocatheterization within 24 hours following the cesarean section. — Between Hour 0 (time of surgical closure) and Hour 24
    Heterocatheterization is indicated in cases of Complete postpartum urinary retention (RUPP-C) or in cases of Partial postpartum urinary retention (RUPP-P) with a post-void residue (measured by Bladder scan) greater than the volume urinated (measured in a graduated jar), provided the volume urinated exceeds 150 ml.

Trial sites (2)

FacilityCityRegionStatus
Montpellier University Hospital Montpellier France Recruiting
Nîmes University Hospital Nîmes France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06357546 on ClinicalTrials.gov ↗ ← All trials in France