CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 564 enrolled
Drug / intervention
Cystoinflationprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04302545
NCT04302545N/ACompleted

Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery Part 1-Cystoinflation in Repeat C-section Part 2- Cystoinflation in Abdominal Hysterectomy Part3- Cystoinflation in Placenta Accreta Spectrum Management

Shazia Saaqib·interventional·Posted Mar 10, 2020·Updated Sep 4, 2024

In Brief

A clinical study evaluating Cystoinflation for Bladder Injury and 2 related conditions. Completed, enrolled 564 participants across 1 site.

Detailed Summary

Part1: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. Part2\&3:Summary of Part 2 and 3 will be provided after publication

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPakistan

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 10, 2020
Enrollment StartAug 1, 2017
Primary CompletionApr 30, 2021
Study CompletionApr 30, 2022
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 6.3 years ago

Interventions

Cystoinflationprocedure

Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline