NCT03668535

Brief Summary

Risk factors for bladder injury during Cesarean Section are well known. Most of cases of bladder injury occur in presence of previous Cesarean Sections, morbidly adherent placenta, or previous bladder injury. limited evidence suggest that bladder filling may decrease the incidence of bladder injury. n our study, we compared the outcome of urinary bladder filling during Cesarean Section in cases at high risk of bladder injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

1.1 years

First QC Date

September 9, 2018

Last Update Submit

February 6, 2019

Conditions

Urinary Tract InjuryCesarean Section Complications

Keywords

UrinaryBladderInjuryCesarean

Outcome Measures

Primary Outcomes (1)

  • bladder injury

    the intra-operative rate of urinary bladder injury

    3 months

Secondary Outcomes (4)

  • Operative time

    3 months

  • post-operative voiding dysfunction

    3 months

  • operative blood loss

    3 months

  • Urinary bladder fistulae

    3 months

Study Arms (2)

Bladder Filling arm

ACTIVE COMPARATOR

Group A have triple-way urethral catheter insertion before establishment of anaesthesia. Evaluation of the drained urine is done (including: amount, character, and simple for culture and sensitivity). Instillation of 200 ml sterile saline is done by 50 ml syringe through the irrigation way. The irrigation way is closed temporarily by artery forceps. After laparotomy the bladder may be deflated by 50 ml or further inflated by 50 ml if needed to allow comfortable dissection.

Procedure: Bladder Filling

Bladder deflation arm

ACTIVE COMPARATOR

Group B have Foley's catheter is inserted as usual. The catheter is connected freely to urinary bag.

Procedure: Bladder deflation

Interventions

Bladder FillingPROCEDURE

Group A have a triple-way urethral catheter insertion before establishment of anaesthesia. Evaluation of the drained urine is done (including: amount, character, and simple for culture and sensitivity). Instillation of 200 ml sterile saline is done by 50 ml syringe through the irrigation way. The irrigation way is closed temporarily by artery forceps. After laparotomy the bladder may be deflated by 50 ml or further inflated by 50 ml if needed to allow comfortable dissection.

Bladder Filling arm
Bladder deflationPROCEDURE

Group B have Foley's catheter is inserted as usual. The catheter is connected freely to urinary bag.

Bladder deflation arm

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen undergoing Cesarean Section
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Previous Cesarean Section 3 times or more
  • Previous history of bladder injury during Cesarean Section
  • Operative report of extensive adhesions in the last Cesarean Section
  • Cesarean Section for placenta accreta spectrum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department

Qina, Qena Governorate, Egypt

Location

Related Publications (8)

  • Salman L, Aharony S, Shmueli A, Wiznitzer A, Chen R, Gabbay-Benziv R. Urinary bladder injury during cesarean delivery: Maternal outcome from a contemporary large case series. Eur J Obstet Gynecol Reprod Biol. 2017 Jun;213:26-30. doi: 10.1016/j.ejogrb.2017.04.007. Epub 2017 Apr 5.

    PMID: 28411456BACKGROUND

  • Alanwar A, Al-Sayed HM, Ibrahim AM, Elkotb AM, Abdelshafy A, Abdelhadi R, Abbas AM, Abdelmenam HS, Fares T, Nossair W, Abdallah AA, Sabaa H, Nawara M. Urinary tract injuries during cesarean section in patients with morbid placental adherence: retrospective cohort study. J Matern Fetal Neonatal Med. 2019 May;32(9):1461-1467. doi: 10.1080/14767058.2017.1408069. Epub 2017 Dec 3.

    PMID: 29157027BACKGROUND

  • 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.

    PMID: 26500959BACKGROUND

  • 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.

    PMID: 15669989BACKGROUND

  • 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.

    PMID: 23132469BACKGROUND

  • 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.

    PMID: 24729285BACKGROUND

  • Ozcan HC, Balat O, Ugur MG, Sucu S, Tepe NB, Kazaz TG. Use of Bladder Filling to Prevent Urinary System Complications in the Management of Placenta Percreta: a Randomized Prospective Study. Geburtshilfe Frauenheilkd. 2018 Feb;78(2):173-178. doi: 10.1055/s-0044-100039. Epub 2018 Feb 19.

    PMID: 29479114BACKGROUND

  • Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.

    PMID: 34184246DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Mohammad AM Ahmed, MD

    South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department, Qena, Qena, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
closed envelop will be used for randomization. The patient and the investigator will be blinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two groups of women with difficult Cesarean Section at risk of urinary bladder injury. Group A will receive the intervention. Group B will not receive the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 9, 2018

First Posted

September 12, 2018

Study Start

August 1, 2017

Primary Completion

August 30, 2018

Study Completion

November 30, 2018

Last Updated

February 7, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

IPD will be shared in unanonomous manner with the predetermined group of researchers

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
throughout the period of research until end of the study
Access Criteria
IPD will be shared with the predetermined group of researchers as accepted by the local ethical and research committee.

Locations

EG(1)