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Pregnant WomenC2SNCT06357546

Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section

A study testing Spontaneous urination during the hour before caesarean section. and Systematic bladder catherization during caesarean section. in people with Pregnant Women and Cesarean Section, run by University Hospital, Montpellier at 2 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnant Women, Cesarean Section
What is being tested?
Spontaneous urination during the hour before caesarean section. and Systematic bladder catherization during caesarean section.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
2 sitesFrance
Study dates
20 Jan 2025to Nov 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Audrey LAMOUROUX, MD contact

+334 66 68 37 99

a-lamouroux@chu-montpellier.fr

Laura CRANTELLE, CRA contact

+334 67 33 54 76

l-crantelle@chu-montpellier.fr

France2 sites, 2 recruiting

  • Montpellier University Hospital

    Montpellier, 34295

    Martha DURAES, MD, +334.67.33.65.32, m-duraes@chu-montpellier.fr

    Martha DURAES, MD

    Recruiting

  • Nîmes University Hospital

    Nîmes, 30029

    Audrey LAMOUROUX, MD, audrey.lamouroux@chu-nimes.fr

    Audrey LAMOUROUX, MD

    Recruiting

Other trials in France

About this study

Official title: Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section: Multicenter Non-inferiority Randomized Controlled 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.

Read the 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.
Being tested
Spontaneous urination during the hour before caesarean section., Systematic bladder catherization during caesarean section.
Keywords
Catheterization Urethral, Cesarean Section, Postpartum Urinary Retention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spontaneous urination during the hour before caesarean section.Procedure or surgery

    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.Procedure or surgery

    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.

Study groups in NCT06357546
Study groupRoleWhat they receive
Arm A: Intraoperative bladder catheterizationActive comparatorPatients will have spontaneous urination in the hour preceding the caesarean section and will have a systematic intraoperative bladder catheterization.
Receives: Procedure: Spontaneous urination during the hour before caesarean section.; Procedure: Systematic bladder catherization during caesarean section.
Arm B: Absence of intraoperative bladder catheterizationExperimentalPatients will have spontaneous urination in the hour preceding the caesarean section but will not have intraoperative bladder catheterization.
Receives: Procedure: Spontaneous urination during the hour before caesarean section.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Between Hour 0 (time of surgical closure) and Hour 24

Secondary outcomes (16)

  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)

    Measured: Hour 24

  2. Duration of preoperative preparation

    The duration of preoperative preparation (min) will be measured from entry into the operating room to the incision.

    Measured: Between entering the surgery room and incision during the surgical procedure

  3. Operating time

    Operating time (in minutes) corresponds to the period between incision and surgical closure (H0).

    Measured: 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.

    Measured: Discharge from hospitalization (Maximum 1 month after the cesarean section)

  5. Time to resume ambulation

    The time to resume ambulation (in hours) corresponds to the period between surgical closure (H0) and resumption of ambulation.

    Measured: Discharge from hospitalization (Maximum 1 month after the cesarean section)

  6. First urination

    The time to the 1st urination (in hours) corresponds to the period between surgical closure (H0) and the 1st urination.

    Measured: Discharge from hospitalization (Maximum 1 month after the cesarean section)

  7. 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.

    Measured: Between Hours 6 and 9

  8. 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.

    Measured: Between Hours 6 and 9

  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).

    Measured: Discharge from hospitalization (Maximum 1 month after the cesarean section)

  10. 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.

    Measured: Hour 24

  11. 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.

    Measured: During caesarean section procedure

  12. 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.

    Measured: Between surgical incision and discharge of hospitalization (Maximum 1 month after the cesarean section)

  13. 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.

    Measured: Between surgical incision and Hour 0, Hour 0 and Hour 3, Hour 3 and Hour 24.

  14. 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.

    Measured: Between Hour 24 and the postpartum consultation at 6 weeks +/- 2 weeks

  15. 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.

    Measured: Between Hour 24 and the postpartum consultation at 6 weeks +/- 2 weeks

  16. 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.

    Measured: Postpartum consultation at 6 weeks +/- 2 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2024
  2. Study start20 Jan 2025
  3. Primary completionSep 2029 (estimated)
  4. Study completionNov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomization list by blocks of random size and stratified by center, by scarred uterus (with or without scar) and Body Mass Index (BMI) at the start of pregnancy (\<30 and ≥30), will be established by a methodologist independent of the study. Patients will be randomized into each group at a ratio of 1:1.
Masking
Single blind
Who is masked
Care provider
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06357546
Sponsor's protocol ID
RECHMPL23_0411
Other IDs
2023-A02424-41
Acronym
C2S
Status last verified
Mar 2026
First submitted
26 Mar 2024
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36228999

  • 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.

    PubMed 36502759

  • 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.

    PubMed 15669989

  • 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.

    PubMed 14643036

  • 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.

    PubMed 23132469

  • 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.

    PubMed 26500959

  • 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.

    PubMed 24729285

  • 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.

    PubMed 21176084

  • 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.

    PubMed 26527019

  • 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.

    PubMed 36251061

  • 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.

    PubMed 3591859

  • 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.

    PubMed 26773243

  • 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.

    PubMed 18257692

  • 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.

    PubMed 12707878

  • 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.

    PubMed 15517675

Questions about this trial

What is this clinical trial studying?

A study testing Spontaneous urination during the hour before caesarean section. and Systematic bladder catherization during caesarean section. in people with Pregnant Women and Cesarean Section, run by University Hospital, Montpellier at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Audrey LAMOUROUX, MD (+334 66 68 37 99, a-lamouroux@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Necessity of heterocatheterization within 24 hours following the cesarean section. (time frame: Between Hour 0 (time of surgical closure) and Hour 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06357546, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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