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CTRI Number  CTRI/2022/01/039378 [Registered on: 13/01/2022] Trial Registered Prospectively
Last Modified On: 12/01/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   The study of body measurements on incidence of reduced blood pressure in pregnant patients undergoing cesarean section after giving spinal anaesthesia. 
Scientific Title of Study   The study of anthropometric measurements on incidence of hypotension in parturient’s undergoing cesarean 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 Priyanka Y Kanni 
Designation  Assistant Professor 
Affiliation  ESIC Medical College, Gulbarga 
Address  ESIC Medical college, Sedam road, 585105 B-414, Bharat Pride Park apartments, Humnamad road, Gulbarga
ESIC Medical college, Sedam road, 585105 B-414, Bharat Pride Park apartments, Humnamad road, Gulbarga
Gulbarga
KARNATAKA
585105
India 
Phone  9908290999  
Fax  08472265545  
Email  priyankakanni@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priyanka Y Kanni 
Designation  Assistant Professor 
Affiliation  ESIC Medical College, Gulbarga 
Address  ESIC Medical college, Sedam road, 585105 B-414, Bharat Pride Park apartments, Humnamad road, Gulbarga
ESIC Medical college, Sedam road, 585105 B-414, Bharat Pride Park apartments, Humnamad road, Gulbarga
Gulbarga
KARNATAKA
585105
India 
Phone  9908290999  
Fax  08472265545  
Email  priyankakanni@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priyanka Y Kanni 
Designation  Assistant Professor 
Affiliation  ESIC Medical College, Gulbarga 
Address  ESIC Medical college, Sedam road, 585105 B-414, Bharat Pride Park apartments, Humnamad road, Gulbarga
ESIC Medical college, Sedam road, 585105 B-414, Bharat Pride Park apartments, Humnamad road, Gulbarga
Gulbarga
KARNATAKA
585105
India 
Phone  9908290999  
Fax  08472265545  
Email  priyankakanni@gmail.com  
 
Source of Monetary or Material Support  
ESIC Medical College, Gulbarga 
 
Primary Sponsor  
Name  ESIC Medical College Gulbarga 
Address  ESIC Medical College Sedam road Gulbarga 
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 
Dr Priyanka Y Kanni  ESIC Medical College, Gulbarga  ESIC Medical College, Sedam Road, Gulbarga 585105
Gulbarga
KARNATAKA 		 9908290999
08472-265545
priyankakanni@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: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1 Term pregnant women aged between 18-45 years
2 ASA PS grade 1-111 undergoing cesarean section under spinal anaesthesia
 
 
ExclusionCriteria 
Details  1 Multiple pregnancy
2 Morbid Obesity (BMI >40)
3 Height <145 cms & >170cms
4 Patients with spinal deformities and those who have undergone previous spine surgeries.
5 Contraindication to spinal anesthesia
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of maternal anthropometric parameters like abdominal circumference, vertebral column length and symphysiofundal height and incidence of hypotension   To assess the effect of maternal anthropometric parameters like abdominal circumference, vertebral column length and symphysiofundal height and incidence of hypotension during the study period.  
 
Secondary Outcome  
Outcome  TimePoints 
-The level of sensory blockade achieved .
-Baseline fetal parameters – APGAR score at 1 and 5 minutes , birth weight.
 		 -After giving spinal anaesthesia.
-After the baby delivery. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   14/01/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [priyankakanni@gmail.com].

  6. For how long will this data be available start date provided 15-10-2022 and end date provided 15-10-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Spinal Anaesthesia is the most preferred anaesthetic method for elective cesarean section in parturient’s with low risk pregnancy. And hypotension following spinal anaesthesia is one of the most common complication that may lead to poor maternal and fetal outcomes. In most of the studies different variables have been suggested as influencing the ultimate spread of sensory blockade such as height, weight, body mass index of the patient and fetal weight, but the roles of these are controvertial and had little predictive value for the spread of spinal anaesthesia and incidence of hypotension. Various studies based on parameters like age, height, weight, body mass index, abdominal girth, vertebral column length, symphysiofundal height, waist to hip ratio,etc have been studied for assessing mainly the level of sensory blockade and dosage of drug in parturient’s, however none of the studies have been studied correlating the parameters like abdominal circumference, vertebral column length and symphysiofundal height and incidence of hypotension in parturient’s undergoing cesarean section under spinal anaesthesia. Therefore this study is designed to assess the association between anthropometric parameters like abdominal circumference, vertebral column length and symphysiofundal height and incidence of hypotension in parturient’s undergoing cesarean section under spinal anaesthesia. 
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