Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Filling of the Urinary Bladder During Difficult Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03668535
Recruitment Status : Completed
First Posted : September 12, 2018
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Mohammad Abdel-Rahman Mohammad Ahmed, South Valley University

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Injury Cesarean Section Complications Procedure: Bladder Filling Procedure: Bladder deflation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Investigator)
Masking Description: closed envelop will be used for randomization. The patient and the investigator will be blinded.
Primary Purpose: Prevention
Official Title: Filling of the Urinary Bladder During Difficult Cesarean Section
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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.




Primary Outcome Measures :
  1. bladder injury [ Time Frame: 3 months ]
    the intra-operative rate of urinary bladder injury


Secondary Outcome Measures :
  1. Operative time [ Time Frame: 3 months ]
    Operative time in minutes

  2. post-operative voiding dysfunction [ Time Frame: 3 months ]
    post-operative voiding dysfunction in the form of dysuria or retention

  3. operative blood loss [ Time Frame: 3 months ]
    estimated blood loss in mL

  4. Urinary bladder fistulae [ Time Frame: 3 months ]
    development of bladder fistulae



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women undergoing Cesarean Section
Accepts Healthy Volunteers:   No
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668535


Locations
Layout table for location information
Egypt
South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department
Qinā, Qena, Egypt
Sponsors and Collaborators
South Valley University
Investigators
Layout table for investigator information
Principal Investigator: Mohammad AM Ahmed, MD South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department, Qena, Qena, Egypt
Publications:

Layout table for additonal information
Responsible Party: Mohammad Abdel-Rahman Mohammad Ahmed, Doctor, South Valley University
ClinicalTrials.gov Identifier: NCT03668535    
Other Study ID Numbers: OBGYN 004
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared in unanonomous manner with the predetermined group of researchers
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohammad Abdel-Rahman Mohammad Ahmed, South Valley University:
Urinary
Bladder
Injury
Cesarean