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Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery

NCT04302545 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 564

Last updated 2024-09-04

Study results available
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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

Conditions

  • Bladder Injury
  • Complications; Cesarean Section
  • Adhesions Pelvic

Interventions

PROCEDURE

Cystoinflation

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

Sponsors & Collaborators

  • King Edward Medical University

    collaborator OTHER

  • Institute of Public Health, Pakistan

    collaborator OTHER

  • Shazia Saaqib

    lead OTHER

Principal Investigators

  • Munazza Naheed, MBBS · King Edward Medical University

  • Tayyaba Saeed, MBBS · King Edward Medical University

  • Mohammad Khalid, MBBS, MHM · Institute of Public Health, Pakistan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2021-04-30
Completion
2022-04-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04302545 on ClinicalTrials.gov