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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
500
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.
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.
Montpellier University Hospital
Montpellier, France
RECRUITINGNîmes University Hospital
Nîmes, France
RECRUITINGNecessity 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 24
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 24
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 procedure
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)
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)
Time to resume ambulation
The time to resume ambulation (in hours) corresponds to the period between surgical closure (H0) and resumption of ambulation.
Time frame: Discharge from hospitalization (Maximum 1 month after the cesarean section)
First urination
The time to the 1st urination (in hours) corresponds to the period between surgical closure (H0) and the 1st urination.
Time frame: Discharge from hospitalization (Maximum 1 month after the cesarean section)
Pain during the first urination or the first heterocatheterization
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.
Time frame: Between Hours 6 and 9
Discomfort during the first urination or the first heterocatheterization
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.
Time frame: Between Hours 6 and 9
Additional prescription for painkillers
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).
Time frame: Discharge from hospitalization (Maximum 1 month after the cesarean section)
Urinary infection detection
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.
Time frame: Hour 24
Occurrence of surgical difficulties
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.
Time frame: During caesarean section procedure
Occurrence of operative complications
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.
Time frame: Between surgical incision and discharge of hospitalization (Maximum 1 month after the cesarean section)
Amount of bleeding
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.
Time frame: Between surgical incision and Hour 0, Hour 0 and Hour 3, Hour 3 and Hour 24.
Presence of symptoms suggestive of a urinary infection
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.
Time frame: Between Hour 24 and the postpartum consultation at 6 weeks +/- 2 weeks
Presence of functional signs (dysuria, incontinence, delayed bleeding or others)
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 frame: Between Hour 24 and the postpartum consultation at 6 weeks +/- 2 weeks
Time before resuming spontaneous urination
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.
Time frame: Postpartum consultation at 6 weeks +/- 2 weeks.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.