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CTRI Number  CTRI/2019/11/021914 [Registered on: 07/11/2019] Trial Registered Prospectively
Last Modified On: 04/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Use of monitoring the pressure in abdominal cavity, in patients undergoing cesarean surgery for baby delivery 
Scientific Title of Study   Intraabdominal Pressure as a Prognostic Marker in Patients scheduled for Cesarean Section: A Prospective Cohort  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ASHA TYAGI 
Designation  DIRECTOR PROFESSOR 
Affiliation  University College of Medical Sciences and GTB Hospital 
Address  Department of Anaesthesiology and Critical Care, Dilshad Garden, Shahdra,

East
DELHI
110095
India 
Phone    
Fax    
Email  drashatyagi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ASHA TYAGI 
Designation  DIRECTOR PROFESSOR 
Affiliation  University College of Medical Sciences and GTB Hospital 
Address  Department of Anaesthesiology and Critical Care, Dilshad Garden, Shahdra,


DELHI
110095
India 
Phone    
Fax    
Email  drashatyagi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sachidananda Das 
Designation  Postgraduate student 
Affiliation  University College of Medical Sciences and GTB Hospital 
Address  Department of Anaesthesiology and Critical Care, Dilshad Garden, Shahdra,

East
DELHI
110095
India 
Phone    
Fax    
Email  sachidananda94@gmail.com  
 
Source of Monetary or Material Support  
University College of Medical Sciences and GTB Hospital 
 
Primary Sponsor  
Name  University College of Medical Sciences and GTB Hospital 
Address  Dilshad Garden, Shahdra, Delhi-110095 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sachidananda Das  University College of Medical Sciences and GTB Hospital  Doctors duty room, Main ICU complex, 2nd floor, OT complex, Department of Anaesthesiology and Critical Care
East
DELHI 
9438851937

sachidananda94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-Human Research, University College of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  All pregnant patients with period of gestation of >32 weeks and posted for cesarean section including those with complicated pregnancies will be enrolled. 
 
ExclusionCriteria 
Details  Those in labour, with pre-existing organ dysfunction or failure not related to pregnancy, or any contraindication to intravesical pressure measurement such as bladder surgery, haematuria, neurogenic bladder etc. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
normalization of (intraabdominal pressure) IAP to 12 mmHg  At end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Intraabdominal volume estimated by Abdominal Volume Index; and Abdominal Compliance  Just before and after cesarean delivery 
 
Target Sample Size   Total Sample Size="81"
Sample Size from India="81" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/11/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
  1. There is limited data evaluating role of intraabdominal pressure (IAP), especially after delivery of fetus, for determining outcome of pregnant patients. This is despite IAPs to be increased to the range conventionally defined for IAH i.e. ≥ 12 mmHg in previous evidence.
  2. No studies estimating or evaluating abdominal compliance in these patients (pregnant) with IAP. Measuring abdominal compliance/its relationship with IAP in parturients may help in triage of these patients for postoperative care and type of interventions required in postoperative period.


Aim:To evaluate the normalization of IAP to <12 mmHg as well as change in IAP after fetal delivery following cesarean section, as prognostic markers for predicting in-hospital mortality, need of admission to ICU, and length of stay therein.

Also, the intraabdominal volume and abdominal compliance in these patients will be estimated, and then assessed for correlation with the IAP.

 Inclusion Criteria:

All pregnant patients with period of gestation of >32 weeks and posted for cesarean section including those with complicated pregnancies will be enrolled. The usual complications of pregnancy likely to be encountered will include preeclampsia, maternal haemorrhage, gestational diabetes, multiple gestation or previous cesarean section.

 Exclusion Criteria:

Those in labour, with pre-existing organ dysfunction or failure not related to pregnancy, or any contraindication to intravesical pressure measurement such as bladder surgery, haematuria, neurogenic bladder etc. will be excluded from the study.

 Methodology: IAP measurement technique

Foley bladder catheter will be inserted under all aseptic precautions if not already in situ. The bladder catheterisation is an essential requirement for cesarean section as well.

 

 

The IAP will be measured using the recommended intravesical technique via the indwelling Foley catheter with a manometer connected to the it. The manometer will be zeroed at the level of mid-axillary line, at the iliac crest for all IAP measurements. The pressure will be measured after injecting 25 ml of saline into bladder, at end-expiration, without any active abdominal contractions. For checking that the pressure signal is correctly transduced, gentle compressions of the abdomen and respiration will be seen to cause oscillations in the manometer saline column. The observed height of column in the manometer will be expressed as cmH2O pressure and converted to mmHg.

The IAP will be measured (a) just prior to administration of spinal block/general anesthesia (IAPantepartum); and then (b) after completion of surgery (but prior to reversing muscle relaxation in patients administered general anesthesia) (IAPpostpartum). 

The IAPwill be measured with patient in supine position.

Intraabdominal Volume and Abdominal Compliance estimation

We will estimate the intraabdominal volume by calculating the AVI (in litres). AVI is calculated by a previously validated formula: The AVI will be calculated at the time of measurement of IAPantepartumas well as IAPpostpartum by measuring the waist and hip circumference in at these times. Compliance will be calculated as change in AVI/change in IAP at antepartum and postpartum times. 

Anesthetic management

The anaesthetic management, whether neuraxial block or general anesthesia, will be standardized as per routine practice. 

Sample Size: 

Taking into consideration the mortality of 100% associated with lack of normalization of postpartum IAP in a previous study, to detect a 20% decrease 27 patients with and without failure of postpartum IAP normalization will be required. Since only 33% patients had evidence of failure of IAP normalization in the previous data,to get 27 such subjects, total of 81 would have to be enrolled. Thus enrollement will continue till 27 patients each with and without normalization of IAP or a minimum of 81 patients overall are enrolled (depending on time constraints of the thesis). 

Statistical Analysis:

Statistical tests will be applied using the SPSS software. A P-value < 0.05 will be considered significant. The correlation between incidence of normalization of postpartum IAP/∆IAP and outcome measures; or intraabdominal volume/compliance with IAP, will be analysed using correlation test or Receiver Operating Characteristic (ROC) analysis with corresponding area under the curve as appropriate. Correlation of hypotension with IAP will also be assessed using ROC analysis. Qualitative data will be represented as percentage and quantitative data will be reported as mean Â±SD for normally distribution data, or median [IQR] for non-normally distributed data.

 
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