Filling of the Urinary Bladder During Difficult Cesarean Section

February 6, 2019 updated by: Mohammad Abdel-Rahman Mohammad Ahmed, South Valley University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In women at risk of bladder injury, such as in presence of previous Cesarean Section(s), there may tough adhesions between the bladder and the lower uterine segment. Trial of separation of the bladder in such circumstances may result in bladder injury. Filling of the bladder will delineate the contour of the bladder and clarify the proper plane of dissection. In a recent randomized clinical trial lower bladder filling resulted in non-significant decrease in the rate of bladder injury in women with placenta percreta. In our study, we compared the outcome of urinary bladder filling during Cesarean Section in cases at high risk of bladder injury.

Patients and Methods Inclusion criteria: Pregnant women at gestation from 20- 41 weeks who have any of the following risk factors

  1. Previous Cesarean Section 3 times or more
  2. Previous history of bladder injury during Cesarean Section
  3. Operative report of extensive adhesions in the last Cesarean Section
  4. Cesarean Section for placenta accreta spectrum Methods This is a randomized controlled trial done at the department of Obstetrics & Gynaecology unit, South Valley University from August 1st, 2017until the 30th of August 2018. The research is approved by the Committee of Ethics for Biomedical Researches, South Valley University at June 2017. All cases have informed consent before inclusion in the research. Closed envelop is used to randomized patients to either group. Group A: are cases of Cesarean section who have the intervention. Group: are cases of Cesarean section who do not have the intervention.

The intervention:

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. All Cesarean sections in both groups are done by the same surgeon supported by the same team in the same hospital. The Cesarean sections are done under spinal or general anaesthesia through pfannenstiel's incision. The catheter is removed 12 hours after Cesarean section. Postoperative follow up is maintained until 3 months from the time of the Cesarean section.

Study Type

Interventional

Enrollment (Actual)

266

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bladder Filling arm
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
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.
Active Comparator: Bladder deflation arm
Group B have Foley's catheter is inserted as usual. The catheter is connected freely to urinary bag.
Procedure: Bladder deflation
Group B have Foley's catheter is inserted as usual. The catheter is connected freely to urinary bag.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bladder injury
Time Frame: 3 months
the intra-operative rate of urinary bladder injury
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: 3 months
Operative time in minutes
3 months
post-operative voiding dysfunction
Time Frame: 3 months
post-operative voiding dysfunction in the form of dysuria or retention
3 months
operative blood loss
Time Frame: 3 months
estimated blood loss in mL
3 months
Urinary bladder fistulae
Time Frame: 3 months
development of bladder fistulae
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

August 30, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

September 9, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

February 7, 2019

Last Update Submitted That Met QC Criteria

February 6, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OBGYN 004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

throughout the period of research until end of the study

IPD Sharing Access Criteria

IPD will be shared with the predetermined group of researchers as accepted by the local ethical and research committee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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