Cystoinflation to Prevent Bladder Injury in Multiple Caesarean Sections

Not Applicable

Completed

Conditions: Bladder Injury
Complications; Cesarean Section
Adhesions Pelvic

Interventions: Procedure: Cystoinflation

Registration Number: NCT04302545

Lead Sponsor: Shazia Saaqib

Brief Summary: The healthy pregnant women with previous operative deliveries admitted for elective C-section will be counselled and conditioned informed consent will be taken to be included in either study group if dense pelvic adhesions will be found during their operation. Adhesiolysis will be performed using bladder retro-fill with 300cc saline in the cystoinflation group, and without retro-fill in control.Both groups will be observed for bladder injury rate,bloodloss,operativetime,urinary tract infection,micturition problems and fistula formation.

Detailed Description: Investigators will conduct this study to find the effectiveness of cystoinflation to prevent bladder injury in women with adhesions of previous C-sections. This prospective analytic longitudinal study will be conducted in Lady Willingdon Hospital, a tertiary care teaching hospital affiliated with King Edward Medical University Pakistan, from August 2017 to July 2019, after approval by the institutional review board of King Edward Medical University, Pakistan. The subjects will be randomly allocated to cystoinflation and control groups. The healthy pregnant women with previous operative deliveries admitted for elective C-section will be counselled and conditioned informed consent will be taken to be included in either study group if dense pelvic adhesions will be found during their operation. Adhesiolysis will be performed using bladder retro-fill with 300cc saline in the cystoinflation group, and without retro-fill in control. We will assess primary outcome by observing bladder injury rate, blood loss and operative time. The secondary outcome will be assessed by Urinary tract infection, micturition problems and fistula formation during 3month follow up period. The cystoinflation will be considered effective if the proportion of bladder injury in the study group will be less than 50% of the control group.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 214

Inclusion Criteria

• Healthy pregnant women of any age
- Two or more previous C-sections
- Gestational age between 38-40 weeks (confirmed by dating scan)
- Dense Adhesions of Tulandi scores four or more.
- women who give informed consent to participate in the study

Exclusion Criteria

:• Patients with medical disorders

Bladder injury before group assignment
Placenta previa
Subjects experiencing micturition problems (dysuria, frequency, urgency, urinary retention, incontinence) before the study.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cystoinflation group	Cystoinflation	Bladder will be recognized by observing its gradual distension during bladder retro-fill with 300cc saline to perform adhesiolysis.

Primary Outcome Measures

Name	Time	Method
Bladder Injury Rate	From the confirmation of adhesions to adhesiolysis and separation of bladder flap from uterus, before delivery of the baby during cesarean section.This time frame can range between 10-20 minutes.	The bladder injury will be detected by direct visualization in the cesarean section before delivery of the baby during adhesiolysis of dense adhesions of the lower uterine segment, which cover and obscure the bladder. The bladder injury outcome will be measured as the number(percentage) of subjects with injury.
Blood Loss	From the confirmation of adhesions to adhesiolysis and separation of bladder flap from uterus, before delivery of the baby during cesarean section.This time frame can range between 10-20 minutes.	Amount of blood loss during C-section will be increase in weight of sponges used during operation, taking 1gram equal to 1cc.
Operative Time	During Caesarean section	Time from incision till closure of skin

Secondary Outcome Measures

Name	Time	Method
White Blood Cells Count Per High Power Feild	3rd postoperative day	The normal white cell count ranges between 4000-11000 per microlitre. The raised count is an indication of postoperative infection.
Urine Culture Report for Micro-organisms	2nd postoperative day	The outcome measure was the number(percentage) of subjects in which urine culture reports showed the growth of micro-organisms in the urine of the subjects sent for test on the second postoperative day.
Fever	upto 3months	Number of patients who presented with fever during hospital stay
Postmicturition Bladder Volume After C-section	upto 3months	Volume of urine retained in bladder after evacuation. Bladder distension will be diagnosed if volume retained in the bladder will be greater than 50cc measured on 4th postoperative day
Composite Micturition Problems During Hospital Stay	Complaint recorded during hospital stay (range between 4-21 days)	The micturition problems during the hospital stay investigated in this study were dysuria, feeling of incomplete evacuation, frequency, urgency, urethral and extra-urethral incontinence), Dysuria was expressed by the subject as painful micturition using an 11point visual analogue Scale from zero to ten and converted into severity scores from 0-3. Score 0 or no point= 0 point on scale Score1 or mild pain=1-3point Score2 or Moderate Pain=4-6points; Score 3 or Severe Pain=.7-10 Other micturition problems (feeling of incomplete evacuation, frequency, urgency, urethral and extra-urethral incontinence) were measured subjectively on a 4point Likert scale questionnaire according to severity ranging from 0-3 (0-never, 1-rarely, 2-sometimes, and 3-often). The micturition problems of each subject were summed up as composite variables and both groups were compared for the mean value of the composite variable and standard deviation in spss20 statistical software.
Duration of Urinary Catheterization	upto 3months	The time interval for which subject will be kept catheterized postoperatively.
Duration of Hospital Stay	upto 3months	The time interval in days from the date of operation till discharge from the hospital.
Number of Subjects With Urinary Fistula Formation	upto 3months	abnormal communication between genital tract nd urinary tract
Composite Micturition Problems After Discharge	upto 3months	IT is composit Likert score(range from 0-3) of micturition problems recorded by patient after discharge from the hospital to the completion of 3months postoperative(follow up period).The lower value of the score is associated with good outcome while higher value shows a poor outcome.