Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section
NCT ID: NCT06357546
Last Updated: 2025-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
500 participants
INTERVENTIONAL
2025-01-20
2027-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery
NCT06242756
Caesarean Delivery With or Without an Indwelling Bladder Catheter. A Randomised Trial.
NCT03479931
Duration of Urinary Catheter Treatment After Cesarean Delivery Under Spinal Anesthesia
NCT05396430
Caesarean Delivery With or Without an Indwelling Bladder Catheter
NCT03672214
Evaluation of the Efficacy of the Addition of Magnesium Sulfate to Morphine on the Occurrence of Acute Urinary Retention Following Epidural Anesthesia for Cesarean Section.
NCT06442995
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A: Intraoperative bladder catheterization
Patients will have spontaneous urination in the hour preceding the caesarean section and will have a systematic intraoperative bladder catheterization.
Spontaneous urination during the hour before caesarean section.
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.
Systematic bladder catherization during caesarean section.
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.
Arm B: Absence of intraoperative bladder catheterization
Patients will have spontaneous urination in the hour preceding the caesarean section but will not have intraoperative bladder catheterization.
Spontaneous urination during the hour before caesarean section.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Spontaneous urination during the hour before caesarean section.
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.
Systematic bladder catherization during caesarean section.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Montpellier
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Audrey LAMOUROUX, MD
Role: STUDY_DIRECTOR
Montpellier University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Montpellier University Hospital
Montpellier, , France
Nîmes University Hospital
Nîmes, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Sentilhes L, Schmitz T, Madar H, Bouchghoul H, Fuchs F, Garabedian C, Korb D, Nouette-Gaulain K, Pecheux O, Sananes N, Sibiude J, Senat MV, Goffinet F. [The cesarean procedure: Guidelines for clinical practice from the French College of Obstetricians and Gynecologists]. Gynecol Obstet Fertil Senol. 2023 Jan;51(1):7-34. doi: 10.1016/j.gofs.2022.10.002. Epub 2022 Oct 11. French.
Hou D, Jia Y, Han A, Hu Q, Li J, Liang W. Effect of urinary catheter removal at different times after caesarean section: A systematic review and network meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2023 Jan;280:160-167. doi: 10.1016/j.ejogrb.2022.12.002. Epub 2022 Dec 5.
Senanayake H. Elective cesarean section without urethral catheterization. J Obstet Gynaecol Res. 2005 Feb;31(1):32-7. doi: 10.1111/j.1447-0756.2005.00237.x.
Ghoreishi J. Indwelling urinary catheters in cesarean delivery. Int J Gynaecol Obstet. 2003 Dec;83(3):267-70. doi: 10.1016/s0020-7292(03)00144-9.
Acharya S, Uprety DK, Pokharel HP, Amatya R, Rai R. Cesarean section without urethral catheterization: a randomized control trial. Kathmandu Univ Med J (KUMJ). 2012 Apr-Jun;10(38):18-22. doi: 10.3126/kumj.v10i2.7337.
Pandey D, Mehta S, Grover A, Goel N. Indwelling Catheterization in Caesarean Section: Time To Retire It! J Clin Diagn Res. 2015 Sep;9(9):QC01-4. doi: 10.7860/JCDR/2015/13495.6415. Epub 2015 Sep 1.
Abdel-Aleem H, Aboelnasr MF, Jayousi TM, Habib FA. Indwelling bladder catheterisation as part of intraoperative and postoperative care for caesarean section. Cochrane Database Syst Rev. 2014 Apr 11;2014(4):CD010322. doi: 10.1002/14651858.CD010322.pub2.
Li L, Wen J, Wang L, Li YP, Li Y. Is routine indwelling catheterisation of the bladder for caesarean section necessary? A systematic review. BJOG. 2011 Mar;118(4):400-9. doi: 10.1111/j.1471-0528.2010.02802.x. Epub 2010 Dec 23.
Fuchs F, Benhamou D. [Post-partum management after cesarean delivery. Guidelines for clinical practice]. J Gynecol Obstet Biol Reprod (Paris). 2015 Dec;44(10):1111-7. doi: 10.1016/j.jgyn.2015.09.020. Epub 2015 Oct 31. French.
Wei G, Harley F, O'Callaghan M, Adshead J, Hennessey D, Kinnear N. Systematic review of urological injury during caesarean section and hysterectomy. Int Urogynecol J. 2023 Feb;34(2):371-389. doi: 10.1007/s00192-022-05339-7. Epub 2022 Oct 17.
Bartzen PJ, Hafferty FW. Pelvic laparotomy without an indwelling catheter. A retrospective review of 949 cases. Am J Obstet Gynecol. 1987 Jun;156(6):1426-32. doi: 10.1016/0002-9378(87)90012-3.
Sentilhes L, Vayssiere C, Deneux-Tharaux C, Aya AG, Bayoumeu F, Bonnet MP, Djoudi R, Dolley P, Dreyfus M, Ducroux-Schouwey C, Dupont C, Francois A, Gallot D, Haumonte JB, Huissoud C, Kayem G, Keita H, Langer B, Mignon A, Morel O, Parant O, Pelage JP, Phan E, Rossignol M, Tessier V, Mercier FJ, Goffinet F. Postpartum hemorrhage: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF): in collaboration with the French Society of Anesthesiology and Intensive Care (SFAR). Eur J Obstet Gynecol Reprod Biol. 2016 Mar;198:12-21. doi: 10.1016/j.ejogrb.2015.12.012. Epub 2015 Dec 21.
Vincent A, Ayzac L, Girard R, Caillat-Vallet E, Chapuis C, Depaix F, Dumas AM, Gignoux C, Haond C, Lafarge-Leboucher J, Launay C, Tissot-Guerraz F, Fabry J; Mater Sud-Est Study Group. Downward trends in surgical site and urinary tract infections after cesarean delivery in a French surveillance network, 1997-2003. Infect Control Hosp Epidemiol. 2008 Mar;29(3):227-33. doi: 10.1086/527512.
Yip SK, Sahota D, Chang AM. Determining the reliability of ultrasound measurements and the validity of the formulae for ultrasound estimation of postvoid residual bladder volume in postpartum women. Neurourol Urodyn. 2003;22(3):255-60. doi: 10.1002/nau.10112.
Demaria F, Amar N, Biau D, Fritel X, Porcher R, Amarenco G, Madelenat P, Benifla JL. Prospective 3D ultrasonographic evaluation of immediate postpartum urine retention volume in 100 women who delivered vaginally. Int Urogynecol J Pelvic Floor Dysfunct. 2004 Jul-Aug;15(4):281-5. doi: 10.1007/s00192-004-1159-3.
Laterza RM, Sievert KD, de Ridder D, Vierhout ME, Haab F, Cardozo L, van Kerrebroeck P, Cruz F, Kelleher C, Chapple C, Espuna-Pons M, Koelbl H. Bladder function after radical hysterectomy for cervical cancer. Neurourol Urodyn. 2015 Apr;34(4):309-15. doi: 10.1002/nau.22570. Epub 2014 Feb 12.
Lim JL. Post-partum voiding dysfunction and urinary retention. Aust N Z J Obstet Gynaecol. 2010 Dec;50(6):502-5. doi: 10.1111/j.1479-828X.2010.01237.x. Epub 2010 Nov 2.
de Boer HD, Detriche O, Forget P. Opioid-related side effects: Postoperative ileus, urinary retention, nausea and vomiting, and shivering. A review of the literature. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):499-504. doi: 10.1016/j.bpa.2017.07.002. Epub 2017 Jul 8.
Hernandez NS, Wang AY, Kanter M, Olmos M, Ahsan T, Liu P, Balonov K, Riesenburger RI, Kryzanski J. Assessing the impact of spinal versus general anesthesia on postoperative urinary retention in elective spinal surgery patients. Clin Neurol Neurosurg. 2022 Nov;222:107454. doi: 10.1016/j.clineuro.2022.107454. Epub 2022 Sep 27.
Baldini G, Bagry H, Aprikian A, Carli F. Postoperative urinary retention: anesthetic and perioperative considerations. Anesthesiology. 2009 May;110(5):1139-57. doi: 10.1097/ALN.0b013e31819f7aea.
Neron M, Fatton B, Monforte M, Mares P, de Tayrac R, Letouzey V. [Evaluation of urine postvoid residuals in post-partum period: a prospective and descriptive clinical study]. Prog Urol. 2015 Mar;25(4):211-6. doi: 10.1016/j.purol.2014.09.043. Epub 2014 Oct 22. French.
Neron M, Allegre L, Huberlant S, Mousty E, de Tayrac R, Fatton B, Letouzey V. Impact of systematic urinary catheterization protocol in delivery room on covert postpartum urinary retention: a before-after study. Sci Rep. 2017 Dec 18;7(1):17720. doi: 10.1038/s41598-017-18065-8.
Nasr AM, ElBigawy AF, Abdelamid AE, Al-Khulaidi S, Al-Inany HG, Sayed EH. Evaluation of the use vs nonuse of urinary catheterization during cesarean delivery: a prospective, multicenter, randomized controlled trial. J Perinatol. 2009 Jun;29(6):416-21. doi: 10.1038/jp.2009.4. Epub 2009 Feb 12.
Basbug A, Yuksel A, Ellibes Kaya A. Early versus delayed removal of indwelling catheters in patients after elective cesarean section: a prospective randomized trial. J Matern Fetal Neonatal Med. 2020 Jan;33(1):68-72. doi: 10.1080/14767058.2018.1487394. Epub 2018 Jul 18.
Related Links
Access external resources that provide additional context or updates about the study.
National perinatal survey: Births, two-month follow-up and establishments - Situation and evolution since 2016
Birth rate - Fertility - Tables of the French economy \| Insee
Analysis and improvement of practices: planned cesarean sections at term
What are the main principles of RAC for planned cesarean section?
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-A02424-41
Identifier Type: OTHER
Identifier Source: secondary_id
RECHMPL23_0411
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.