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. 2021 Jun 29;2021(6):CD004011. doi: 10.1002/14651858.CD004011.pub4

NCT03668535.

Study name Filling of the urinary bladder during difficult cesaerean section
Methods Allocation: randomised
Intervention model: parallel Assignment
Intervention model description: 2 groups of women with difficult CS 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 envelope will be used for randomisation. The patient and the investigator will be blinded.
Primary purpose: prevention
Participants Patients and Methods
Inclusion criteria: pregnant women at gestation from 20‐ 41 weeks who have any of the following risk factors: previous CS 3 times; previous history of bladder injury during CS; operative report of extensive adhesions in the last CS; CS for placenta accreta spectrum
No exclusion criteria reported
Methods: this is a RCT done at the department of Obstetrics & Gynaecology unit, South Valley University from 1 August 2017‐30 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 envelope is used to randomise patients to either group. Group A: are cases of CS who have the intervention. Group B: are cases of CS who do not have the intervention.
Interventions Group A: bladder filling: participants have a triple‐way IUC insertion before establishment of anaesthesia. Evaluation of the drained urine is done (including: amount, character, and 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.
Group B: bladder deflation: participants have Foley's catheter inserted as usual. The catheter is connected freely to urinary bag
Outcomes Intra‐operative rate of urinary bladder injury
Starting date 1 August 2017
Contact information Mohammad AM Ahmed, MD
Notes