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

NCT06357546 | Recruiting

• 2 other identifiers: RECHMPL23_04112023-A02424-41
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 2

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.

Conditions

Cesarean Section; Pregnant Women

Keywords

Catheterization Urethral; Cesarean Section; Postpartum Urinary Retention

Outcome Measures

Primary Outcomes (1)

• Necessity of heterocatheterization within 24 hours following the cesarean section.

  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.

  Between Hour 0 (time of surgical closure) and Hour 24

Secondary Outcomes (16)

• Experience of childbirth

  Hour 24

• Duration of preoperative preparation

  Between entering the surgery room and incision during the surgical procedure

• Operating time

  During surgery (Between incision and surgical closure)

• Duration of post-operative hospitalization

  Discharge from hospitalization (Maximum 1 month after the cesarean section)

• Time to resume ambulation

  Discharge from hospitalization (Maximum 1 month after the cesarean section)

Study Arms (2)

Arm A: Intraoperative bladder catheterization

ACTIVE COMPARATOR

Patients will have spontaneous urination in the hour preceding the caesarean section and will have a systematic intraoperative bladder catheterization.

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

Arm B: Absence of intraoperative bladder catheterization

EXPERIMENTAL

Patients will have spontaneous urination in the hour preceding the caesarean section but will not have intraoperative bladder catheterization.

Procedure: Spontaneous urination during the hour before caesarean section.

Interventions

Spontaneous urination during the hour before caesarean section. PROCEDURE

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.

Arm A: Intraoperative bladder catheterization; Arm B: Absence of intraoperative bladder catheterization

Systematic bladder catherization during caesarean section. PROCEDURE

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.

Arm A: Intraoperative bladder catheterization

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

Montpellier University Hospital

Montpellier, 34295, France

RECRUITING

Nîmes University Hospital

Nîmes, 30029, France

RECRUITING

Related Publications (24)

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Related Links

• National perinatal survey: Births, two-month follow-up and establishments - Situation and evolution since 2016
• Birth rate - Fertility - Tables of the French economy \| Insee
• Analysis and improvement of practices: planned cesarean sections at term
• What are the main principles of RAC for planned cesarean section?

Study Officials

• Audrey LAMOUROUX, MD

  Montpellier University Hospital

  STUDY DIRECTOR

Central Study Contacts

Audrey LAMOUROUX, MD

CONTACT

+334 66 68 37 99; a-lamouroux@chu-montpellier.fr

Laura CRANTELLE, CRA

CONTACT

+334 67 33 54 76; l-crantelle@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The care provider carrying out the heterocatheterization will be blinded to the participant's randomization group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomization list by blocks of random size and stratified by center, by scarred uterus (with or without scar) and Body Mass Index (BMI) at the start of pregnancy (\<30 and ≥30), will be established by a methodologist independent of the study. Patients will be randomized into each group at a ratio of 1:1.

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 10, 2024
• Study Start: January 20, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)