- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04302545
Cystoinflation to Prevent Bladder Injury in Multiple Caesarean Sections
A Randomized Controlled Trial of Cystoinflation to Prevent Bladder Injury in the Adhesive Disease of Multiple Caesarean Sections
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 042
- Lady Willingdon Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cystoinflation group
Bladder will be recognized by observing its gradual distension during bladder retro-fill with 300cc saline to perform adhesiolysis.
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Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline
Other Names:
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NO_INTERVENTION: Control group
Pelvic adhesiolysis will be performed without bladder retrofill.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bladder Injury Rate
Time Frame: 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.
|
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.
|
Blood Loss
Time Frame: 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.
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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.
|
Operative Time
Time Frame: During Caesarean section
|
Time from incision till closure of skin
|
During Caesarean section
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
White Blood Cells Count Per High Power Feild
Time Frame: 3rd postoperative day
|
The normal white cell count ranges between 4000-11000 per microlitre.
The raised count is an indication of postoperative infection.
|
3rd postoperative day
|
Urine Culture Report for Micro-organisms
Time Frame: 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.
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2nd postoperative day
|
Fever
Time Frame: upto 3months
|
Number of patients who presented with fever during hospital stay
|
upto 3months
|
Postmicturition Bladder Volume After C-section
Time Frame: upto 3months
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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
|
upto 3months
|
Composite Micturition Problems During Hospital Stay
Time Frame: 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. |
Complaint recorded during hospital stay (range between 4-21 days)
|
Duration of Urinary Catheterization
Time Frame: upto 3months
|
The time interval for which subject will be kept catheterized postoperatively.
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upto 3months
|
Duration of Hospital Stay
Time Frame: upto 3months
|
The time interval in days from the date of operation till discharge from the hospital.
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upto 3months
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Number of Subjects With Urinary Fistula Formation
Time Frame: upto 3months
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abnormal communication between genital tract nd urinary tract
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upto 3months
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Composite Micturition Problems After Discharge
Time Frame: 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.
|
upto 3months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Munazza Naheed, MBBS, King Edward Medical University
- Study Director: Tayyaba Saeed, MBBS, King Edward Medical University
- Study Director: Mohammad Khalid, MBBS, MHM, Institute of Public Health, Pakistan
Publications and helpful links
General Publications
- O'Hanlan KA. Cystosufflation to prevent bladder injury. J Minim Invasive Gynecol. 2009 Mar-Apr;16(2):195-7. doi: 10.1016/j.jmig.2008.11.011. Epub 2009 Jan 9.
- 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.
- 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.
- Joelsson-Alm E, Nyman CR, Svensen C, Ulfvarson J. Micturition problems after bladder distension during hospitalization in Sweden: "I'm not ill, just damaged for the rest of my life". Nurs Res. 2014 Nov-Dec;63(6):418-25. doi: 10.1097/NNR.0000000000000057.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERB#216/RC/KEMU
- NCT#04302545 (REGISTRY: Clinical trials.gov)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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