Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Montpellier
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Spontaneous urination during the hour before caesarean section.
Procedure/SurgeryPatients 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.
Procedure/SurgeryAfter 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.
Treatment groups
550 Participants
are divided into 2 treatment groupsGroup A: Arm A: Intraoperative bladder catheterizationActive comparator 2 interventions
Group B: Arm B: Absence of intraoperative bladder catheterizationExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Between Hour 0 (time of surgical closure) and Hour 24Secondary outcomes
1
Experience of childbirth
The participant's experience of childbirth will be assessed using the Questionnaire For Assessing the Childbirth Expérience (QEVA) built in 26 items: Score result: D1: Emotions during childbirth (Items 1, 2, 3, 4 and 24) D2: Interactions with healthcare professionals (Items 5, 6, 7, 8 and 9) D3: First moments with the child (Items 17, 18 and 19) D4: Delayed emotions (Items 20, 21, 22, 23)
Time frame
Hour 242
Duration of preoperative preparation
The duration of preoperative preparation (min) will be measured from entry into the operating room to the incision.
Time frame
Between entering the surgery room and incision during the surgical procedure3
Operating time
Operating time (in minutes) corresponds to the period between incision and surgical closure (H0).
Time frame
During surgery (Between incision and surgical closure)4
Duration of post-operative hospitalization
Duration of post-operative hospitalization (in days and hours) corresponds to the period between surgical closure (H0) and discharge from hospitalization.
Time frame
Discharge from hospitalization (Maximum 1 month after the cesarean section)Sponsors and contacts
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Source ClinicalTrials.gov