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CTRI Number  CTRI/2024/01/061946 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 25/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A clinical trial to check for association of preoperative hand grip strength with perioperative hemodynamic changes in patients undergoing cesarean section under subarachnoid block 
Scientific Title of Study   Association of preoperative hand grip strength with perioperative hemodynamic changes in patients undergoing cesarean section under subarachnoid block 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kamakshi Garg 
Designation  Professor Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  9814444121  
Fax    
Email  drkamakshigarg@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anish Bhatia 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  9988293919  
Fax    
Email  anishbhatia22@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anish Bhatia 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  9988293919  
Fax    
Email  anishbhatia22@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital Tagore Nagar , Civil lines, Ludhiana  
 
Primary Sponsor  
Name  Dayanand Medical College and Hospital 
Address  Tagore Nagar, Civil lines, Ludhiana. 141001 Punjab India 
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 
Dr Kamakshi Garg  Dayanand Medical College and Hospital  Department of Anaesthesia Dayanand Medical College and Hospital Tagore Nagar, Civil Lines Ludhiana 141001 Ludhiana PUNJAB
Ludhiana
PUNJAB 		 9814444121

drkamakshigarg@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethical Committee, Dayanand Medical College and Hospital, Ludhiana  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  ASA 2 and ASA 3 pregnant females aged 18 and above 
 
ExclusionCriteria 
Details  1. Parturients who cannot use the dynamometer
freely or are unable to comprehend the commands.
2. Parturients with movement restriction in upper limbs or having positive history of any neurological disorder.
3. Parturients who are hemodynamically unstable or in severe cardiopulmonary distress.
4. Parturients with history of allergy to local anaesthetics.
5. Parturients with cord prolapse, ruptured uterus, eclampsia, altered sensorium, fetal distress, morbidly adherent placenta or placenta
accreta.
6. Parturients with any contraindication to subarachnoid block. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the association of preoperative hand grip strength testing in parturients posted for lower segment cesarean section with:
1. Episodes of intraoperative and post operative hypotension till 72 hours.
2. Need for inotropes/vasopressors. 		 2 minutes interval after subarachnoid block till the delivery of baby and then at interval of 15 minutes each till 1 hour and then at interval of 30 minutes each till surgery is over. 
 
Secondary Outcome  
Outcome  TimePoints 
Association of preoperative hand grip strength with preoperative hemoglobin, serum albumin, body mass index and post operative hand grip strength.  0,4,8,12,24,36,48 and 72 hours. 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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)   05/02/2024 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Pregnancy leads to many physical, psychological and physiological changes in women, including reduced hand grip strength. Reduced hand grip strength may help us to indicate patient’s health outcomes. Hand grip strength testing might also be an important indicator of cardiovascular function. There is limited data on association of hand grip strength with hemodynamic parameters in pregnant women. Hence, we propose to evaluate association of preoperative hand grip strength with perioperative hemodynamic changes in patients undergoing cesarean section under subarachnoid block. A prospective cross sectional analytical study will be conducted on 140 ASA II, III pregnant females, aged 18 and above posted for cesarean section under subarachnoid block. During pre anaesthetic checkup, hand grip strength will be measured in dominant hand. Preoperative investigations including hemoglobin and serum albumin along with age, height, weight, BMI and gravidity of patient will be noted. Hemodynamic parameters will also be recorded intraoperatively. In the post operative period, hemodynamic parameters will be recorded till 72 hours along with hand grip strength testing on post operative day 3. Data thus obtained will be analyzed statistically.
 
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