Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06357546

Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section: Multicenter Non-inferiority Randomized Controlled Trial

Led by University Hospital, Montpellier · Updated on 2026-03-12

550

Participants Needed

2

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether skipping the routine use of a bladder catheter during planned cesarean sections under spinal anesthesia affects the need for bladder catheterization due to postpartum urinary retention within 24 hours after surgery. This study compares two methods: avoiding catheterization when the patient urinates spontaneously before surgery versus using systematic catheterization during the operation. The trial aims to assess the benefits and risks of skipping catheter use, addressing concerns about urinary infections and patient discomfort related to catheterization. Participants will be divided into two groups randomly. One group will urinate spontaneously before surgery and receive a bladder catheter during the cesarean section. The other group will also urinate before surgery but will not have a catheter placed during the procedure. Ultrasound bladder scans will be done before and after surgery to measure urine retention. Post-surgery monitoring includes checking for urinary retention, infections, pain, and discomfort, as well as collecting urine samples and assessing complications. Follow-up lasts up to six weeks after surgery. During the study, patients will undergo bladder scans before surgery to ensure adequate urination and several ultrasound checks after surgery to monitor urine volume. Pain and discomfort scores during first urination or catheterization are recorded, along with urine tests for infection. Researchers will track surgical complications, painkiller use, hospital stay length, and patients’ childbirth experience. Data collection continues for six weeks to observe recovery and urinary function. The main outcome is whether bladder catheterization is needed within 24 hours after surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient
  • Patient admitted for a planned cesarean section after 34 weeks under spinal anesthesia
  • Single or twin pregnancy
  • Unscarred uterus or with one or two uterine scars
Not Eligible

You will not qualify if you...

  • Positive urine test strip showing nitrites or leukocytes the day before surgery
  • Emergency cesarean section
  • Scheduled cesarean delayed beyond 3 p.m. for organizational reasons
  • Epidural anesthesia
  • Contraindications to spinal anesthesia such as uncorrected hypovolemia, blood clotting disorders, sepsis, neurological deficits, spinal conditions, or febrile syndrome
  • ASA score of 4 or higher
  • Placental insertion abnormalities like placenta previa or accreta
  • Medical indication requiring urine output monitoring
  • Oliguria or kidney failure
  • Use of intrathecal clonidine during scheduled cesarean
  • History of bladder surgery or urological pathology during pregnancy
  • History of complex abdominal surgery
  • Inability to give free, informed, and written consent
  • Not affiliated with national health insurance
  • Under legal protection, guardianship, or curatorship
  • Participation in another interventional drug research within past 3 months
  • Participation in another interventional study
  • In exclusion period of another study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Preoperative Preparation

Duration - Up to a few hours on the day of surgery

Participants will be asked to spontaneously urinate in the hour before their planned cesarean section. An ultrasound bladder scan is performed before surgery to check post-void residue volume.

1 visit (in-person, on the day of surgery)

Surgery

Duration - Duration of the cesarean section procedure

Participants undergo a planned cesarean section under spinal anesthesia, with or without intraoperative bladder catheterization depending on their assigned group.

1 visit (in-person, surgery day)

Postoperative Follow-up

Duration - Up to 24 hours following surgery

After surgery, participants are monitored for urinary retention and other complications with bladder scans and urine tests. Pain and discomfort during first urination or catheterization are assessed. Additional clinical data and adverse events are collected.

Multiple assessments within 24 hours post-surgery

Extended Follow-up

Duration - 6 weeks after cesarean section

Participants are followed up to 6 weeks after surgery to assess recovery, painkiller use, urinary function, and any complications or adverse events.

1 visit at 6 weeks post-surgery

Trial Site Locations

Total: 2 locations

1

Montpellier University Hospital

Montpellier, France, 34295

Actively Recruiting

2

Nîmes University Hospital

Nîmes, France, 30029

Actively Recruiting

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Research Team

A

Audrey LAMOUROUX, MD

L

Laura CRANTELLE, CRA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Indwelling bladder catheterisation as part of intraoperative and postoperative care for caesarean section.

Hany Abdel-Aleem, Mohamad Fathallah Aboelnasr, Tameem M Jayousi...

https://pubmed.ncbi.nlm.nih.gov/24729285