Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06357546
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-03-26
Brief Title:
Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section Multicenter Non-inferiority Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
C2S
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
2 hours after H0 H2 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 6 hours after H0 H6 an ultrasound check of the remaining bladder volume will be carried out by bladder scan
At H6 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 patients 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
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
2 hours after H0 H2 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 6 hours after H0 H6 an ultrasound check of the remaining bladder volume will be carried out by bladder scan
At H6 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02424-41 | OTHER | N ID-RCB | None |