FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/02/049515 [Registered on: 07/02/2023] Trial Registered Prospectively
Last Modified On: 03/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   A STUDY TO FIND OUT THE RELATIONSHIP BETWEEN ABDOMINAL CIRCUMFERENCE AND OCCURENCE OF HYPOTENSION DURING CAESAREAN SECTION UNDER SPINAL ANAESTHESIA  
Scientific Title of Study   RELATIONSHIPN BETWEEN ABDOMINAL CIRCUMFERENCE AND INCIDENCE OF HYPOTENSION DURING CAESAREAN SECTION UNDER SPINAL ANAESTHESIA  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR LIYA ANDREWS 
Designation  JUNIOR RESIDENT 
Affiliation  JSS MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY JSS MEDICAL COLLEGE AND HOSPITAL MAHATHMA GANDHI ROAD MYSURU

Mysore
KARNATAKA
570004
India 
Phone  8825474711  
Fax    
Email  liyaandrews8@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR HARISH P KUMAR 
Designation  ASSOCIATE PROFESSOR  
Affiliation  JSS MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY JSS MEDICAL COLLEGE AND HOSPITAL MAHATHMA GANDHI ROAD MYSURU

Mysore
KARNATAKA
570004
India 
Phone  9686527230  
Fax    
Email  harishkumarp@jssuni.edu.in  
 
Details of Contact Person
Public Query  
Name  DR LIYA ANDREWS 
Designation  JUNIOR RESIDENT 
Affiliation  JSS MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY JSS MEDICAL COLLEGE AND HOSPITAL MAHATHMA GANDHI ROAD MYSURU

Mysore
KARNATAKA
570004
India 
Phone  8825474711  
Fax    
Email  liyaandrews8@gmail.com  
 
Source of Monetary or Material Support  
JSS MEDICAL COLLEGE AND HOSPITAL MYSURU  
 
Primary Sponsor  
Name  JSS MEDICAL COLLEGE AND HOSPITAL  
Address  MAHATMA GANDHI ROAD FORT MOHALLA MYSURU KARNATAKA 
Type of Sponsor  Private 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 
liya andrews  jss medical college and hospital  Department of obstretics and gynaecology Jss medical college and hospital mahathma gandhi road mysuru karnataka
Mysore
KARNATAKA 		 8825474711

liyaandrews8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Term pregnant women of ASA physical status 2 with:
Age: 18 - 40 years,
Height: 150cm - 170cm,
BMI: <30
 
 
ExclusionCriteria 
Details  Multiple pregnancy,Obesity BMI > 30,Systolic Blood Pressure < 100 mm Hg,Cardiovascular Comorbidities,
Polyhydramnios,High risk pregnancy - placenta previa, abruptio placentae, eclampsia, preeclampsia, or gestational diabetes and Contraindications to regional anaesthesia 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
incidence of hypotension  end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Find the critical abdominal circumference above which there is increased incidence of hypotension,
Study the adverse events associated with hypotension like nausea and vomiting,
Study the foetal outcome by assessing the APGAR score at 1 and 5 minutes,
Study the frequency and total dose of mephentermine administered to prevent intraoperative hypotension.
 		 end of surgery 
 
Target Sample Size   Total Sample Size="152"
Sample Size from India="152" 
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)   12/02/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Assessed for eligibility

 

 


152 Patients will be selected based on the Inclusion criteria



Abdominal circumference will be measured

 

 


Record Preoperative baseline parameters

 


SAB Given

 


Parameters to be assessed:

     Intraoperative hypotension

     Intraoperative frequency & dose of mephentermine given

     Foetal APGAR Score at 1 and 5 minutes

     Incidence of adverse events like nausea and vomiting

 
Close