Filling of the Urinary Bladder During Difficult Cesarean Section

Cesarean Section Complications Clinical Trial

Official title:

Filling of the Urinary Bladder During Difficult Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03668535
• Other study ID #: OBGYN 004
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: February 2019
• Source: South Valley University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: November 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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:

Related Conditions & MeSH terms

• Cesarean Section Complications
• Urinary Tract Injury

Intervention

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

Locations

Country	Name	City	State
Egypt	South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department	Qina	Qena

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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;(4):CD010322. doi: 10.1002/14651858.CD010322.pub2. Review. — View Citation

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. — View Citation

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. — View Citation

Özcan HÇ, Balat Ö, 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. — View Citation

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. — View Citation

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. — View Citation

Senanayake H. Elective cesarean section without urethral catheterization. J Obstet Gynaecol Res. 2005 Feb;31(1):32-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bladder injury	the intra-operative rate of urinary bladder injury	3 months
Secondary	Operative time	Operative time in minutes	3 months
Secondary	post-operative voiding dysfunction	post-operative voiding dysfunction in the form of dysuria or retention	3 months
Secondary	operative blood loss	estimated blood loss in mL	3 months
Secondary	Urinary bladder fistulae	development of bladder fistulae	3 months