Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section
- Conditions
- Pregnant WomenCesarean Section
- Interventions
- Procedure: Spontaneous urination during the hour before caesarean section.Procedure: Systematic bladder catherization during caesarean section.
- Registration Number
- NCT06357546
- Lead Sponsor
- University Hospital, Montpellier
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 500
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Intraoperative bladder catheterization Spontaneous urination during the hour before caesarean section. Patients will have spontaneous urination in the hour preceding the caesarean section and will have a systematic intraoperative bladder catheterization. Arm A: Intraoperative bladder catheterization Systematic bladder catherization during caesarean section. Patients will have spontaneous urination in the hour preceding the caesarean section and will have a systematic intraoperative bladder catheterization. Arm B: Absence of intraoperative bladder catheterization Spontaneous urination during the hour before caesarean section. Patients will have spontaneous urination in the hour preceding the caesarean section but will not have intraoperative bladder catheterization.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Experience of childbirth Hour 24 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)Duration of preoperative preparation Between entering the surgery room and incision during the surgical procedure The duration of preoperative preparation (min) will be measured from entry into the operating room to the incision.
Operating time During surgery (Between incision and surgical closure) Operating time (in minutes) corresponds to the period between incision and surgical closure (H0).
Duration of post-operative hospitalization Discharge from hospitalization (Maximum 1 month after the cesarean section) Duration of post-operative hospitalization (in days and hours) corresponds to the period between surgical closure (H0) and discharge from hospitalization.
Time to resume ambulation Discharge from hospitalization (Maximum 1 month after the cesarean section) The time to resume ambulation (in hours) corresponds to the period between surgical closure (H0) and resumption of ambulation.
First urination Discharge from hospitalization (Maximum 1 month after the cesarean section) The time to the 1st urination (in hours) corresponds to the period between surgical closure (H0) and the 1st urination.
Pain during the first urination or the first heterocatheterization Between Hours 6 and 9 The participant will self-assess her pain felt during the first urination or the first heterocatheterization postpartum, using a visual numerical scale (EVN) between 0 to 10 (0 = absence of pain and 10 = maximum pain imaginable), between surgical closure (H0) and 6 hours after (H6) or no later than 9 hours after (H9) in case of urinary retention.
Discomfort during the first urination or the first heterocatheterization Between Hours 6 and 9 The participant will self-assess her discomfort felt during the first urination or the first heterocatheterization postpartum, using a visual numerical scale (EVN) between 0 to 10 (0 = absence of discomfort and 10 = major discomfort which can be a burning sensation, pain, etc.), between surgical closure (H0) and 6 hours after (H6) or no later than 9 hours after (H9) in case of urinary retention.
Additional prescription for painkillers Discharge from hospitalization (Maximum 1 month after the cesarean section) The additional prescription for analgesics corresponds to the analgesics necessary postpartum, in addition to basic treatment, and until discharge from hospitalization (Yes or No, and if Yes: Level I, II or III).
Urinary infection detection Hour 24 A cyto-bacteriological examination of the urine (CBEU) is realised at the first urination or at the first heterocatheterization postpartum, or 24 hours after surgical closure (H24). The CBEU is positive in case of a bacteriuria ≥ 103 CFU/mL, for Escherichia coli ≥ 104 CFU/mL and for other germs with leukocyturia ≥ 104 CFU/mL.
Occurrence of surgical difficulties During caesarean section procedure The occurrence of surgical difficulties is evaluated by the surgeon during the caesarean section. It can be : bladder distension at the start of the procedure, discomfort during surgical exposure, incision difficulty, uterine splitting line, difficulty in fetal extraction, difficulty in uterine suturing, uterine atony, bladder distension at the end of the procedure, or others.
Occurrence of operative complications Between surgical incision and discharge of hospitalization (Maximum 1 month after the cesarean section) The occurrence of operative complications is evaluated by the surgeon from the start of the intervention (surgical incision) and the discharge of hospitalization. It can be : bladder wound, digestive wound, postpartum hemorrhage defined by bleeding greater than 500 ml within 24 hours after surgical closure, surgical revision, quantity of bleeding in the event of surgical revision, or others.
Amount of bleeding Between surgical incision and Hour 0, Hour 0 and Hour 3, Hour 3 and Hour 24. The measurement of the bleeding quantity (in mL) is done between surgical incision and surgical closure (H0) in the operating room, between H0 and 2 hours after (H2) in recovery room, and between 2 hours (H2) and 24 hours (H24) after surgical closure in hospitalization.
Presence of symptoms suggestive of a urinary infection Between Hour 24 and the postpartum consultation at 6 weeks +/- 2 weeks If the presence of symptoms suggestive of a urinary infection is positive, an authentication of the infection is carried out by CBEU or dipstick. The analysis of this symptoms is done between 24 hours after surgical closure (H24) and the postpartum consultation at 6 weeks +/- 2 weeks.
Presence of functional signs (dysuria, incontinence, delayed bleeding or others) Between Hour 24 and the postpartum consultation at 6 weeks +/- 2 weeks The presence of functional signs (dysuria, incontinence, delayed bleeding or others) is detected between 24 hours between the surgical closure (H24) and the postpartum consultation at 6 weeks +/- 2 weeks.
Time before resuming spontaneous urination Postpartum consultation at 6 weeks +/- 2 weeks. In case of heterocatheterization between surgical closure (H0) and 6 hours after (H6), the time before resuming spontaneous urination is measured (in days) during the postpartum consultation at 6 weeks +/- 2 weeks.
Trial Locations
- Locations (2)
Nîmes University Hospital
🇫🇷Nîmes, France
Montpellier University Hospital
🇫🇷Montpellier, France