Clinical trial NCT06357546: Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section
Official title: Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section: Multicenter Non-inferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnant Women
Cesarean Section
Keywords: Catheterization Urethral
Cesarean Section
Postpartum Urinary Retention
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Introduction:

The recommendations for the clinical practice of cesarean section, published by the National College of French Gynecologists and Obstetricians (CNGOF) in 2022, have led to a standardized surgical technique. During this surgery, urinary catheterization is use and allows to avoid urinary retention and give a better chirurgical exposition. But it presents also risks as urinary infection development or pain and discomfort for the patient. Actually, the CNGOF wonders if for women having a cesarean section, preoperative spontaneous urination would reduce urinary complications compared to the placement of an intraoperative bladder catheter. The current literature does not allow to respond satisfactorily to this question. This is why C2S study proposes a cesarean section without urinary catheterization following a spontaneous miction.

Aim:

The aim of this trial is to evaluate the rate of bladder heterocatheterization in cases of postpartum urinary retention (RUPP) within 24 hours following a planned cesarean section under spinal anesthesia, according to two management methods: the absence of intraoperative catheterization associated with spontaneous urination in the hour preceding the cesarean section versus systematic intraoperative bladder catheterization up to 2 hours postoperatively. Moreover, this trial will allows to evaluate benefits and risks of the urinary catheterization absence.

Methods:

Following the aim of the trial, it is a prospective randomized study comparing these two treatment modalities in a randomized controlled study with a high level of evidence.

In order to meet the objectives of the study, 500 patients will be included.

Patients will be informed by the investigator during the Caesarean section scheduling consultation, and included the day before their cesarean section during their hospitalization. They will be randomized by the investigator the day before their cesarean section or on the morning of their cesarean section.

In the hour before the cesarean section, participants will be asked to urinate spontaneously. Once the patient is installed on the operating table, the investigator will carry out an ultrasound check using bladder scan of the post-void residue. In the event of a post-void residue of more than 150 ml, the participant will be removed from the research.

After the surgical closure of the cesarean section (H0) starts the postpartum follow-up.

* Between 2 and 3 hours after H0 (H2-H3), an ultrasound check by bladder scan will be carried out in the recovery room, and after collecting the first spontaneous urination, the urine will be quantified using a graduated cup.
* After the first urination or between 5 and 9 hours after H0 (H5-H9), an ultrasound check of the remaining bladder volume will be carried out by bladder scan.
* No later than H9, a bladder heterocatheterization will be carried out in the following cases:

  * Complete RUPP: absence of spontaneous urination
  * Partial RUPP: volume urinated less than the post-void residue (only if the volume urinated \> 150 ml)
* After the first urination or the bladder heterocatheterization, a cyto-bacteriological examination of the urine (ECBU) will be carried out.
* Moreover, the patient will evaluate their pain and discomfort felt during their first urination or heterocatheterization using a visual numerical scale (EVN).
* The clinical team will collect complications and adverse events.
* 24 hours after H0 (H24), a ECBU will be realised and the patient's experience of childbirth will be assessed using the Questionnaire For Assessing the Childbirth Experience (QEVA).
* At H24 and at 6 weeks after the caesarean section (W6), the investigator will collect any additional prescriptions for painkillers.
* From the day of the caesarean section to the last visit at 6 weeks after the surgery, potential adverse events will be collected.

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

Primary outcomes:
measure: Necessity of heterocatheterization within 24 hours following the cesarean section.
timeFrame: Between Hour 0 (time of surgical closure) and Hour 24
Secondary outcomes:
measure: Experience of childbirth
timeFrame: Hour 24
measure: Duration of preoperative preparation
timeFrame: Between entering the surgery room and incision during the surgical procedure
measure: Operating time
timeFrame: During surgery (Between incision and surgical closure)
measure: Duration of post-operative hospitalization
timeFrame: Discharge from hospitalization (Maximum 1 month after the cesarean section)
measure: Time to resume ambulation
timeFrame: Discharge from hospitalization (Maximum 1 month after the cesarean section)
measure: First urination
timeFrame: Discharge from hospitalization (Maximum 1 month after the cesarean section)
measure: Pain during the first urination or the first heterocatheterization
timeFrame: Between Hours 6 and 9
measure: Discomfort during the first urination or the first heterocatheterization
timeFrame: Between Hours 6 and 9
measure: Additional prescription for painkillers
timeFrame: Discharge from hospitalization (Maximum 1 month after the cesarean section)
measure: Urinary infection detection
timeFrame: Hour 24
measure: Occurrence of surgical difficulties
timeFrame: During caesarean section procedure
measure: Occurrence of operative complications
timeFrame: Between surgical incision and discharge of hospitalization (Maximum 1 month after the cesarean section)
measure: Amount of bleeding
timeFrame: Between surgical incision and Hour 0, Hour 0 and Hour 3, Hour 3 and Hour 24.
measure: Presence of symptoms suggestive of a urinary infection
timeFrame: Between Hour 24 and the postpartum consultation at 6 weeks +/- 2 weeks
measure: Presence of functional signs (dysuria, incontinence, delayed bleeding or others)
timeFrame: Between Hour 24 and the postpartum consultation at 6 weeks +/- 2 weeks
measure: Time before resuming spontaneous urination
timeFrame: Postpartum consultation at 6 weeks +/- 2 weeks.
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Nîmes
country: France
facility: Nîmes University Hospital
Study officials:
affiliation: Montpellier University Hospital
name: Audrey LAMOUROUX, MD
role: STUDY_DIRECTOR
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