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CTRI Number  CTRI/2024/07/069989 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of incidence of decrease in blood pressure between fluid administration before and after spinal anaesthesia in pregnant patients. 
Scientific Title of Study   A comparative evaluation of pre-loading and co-loading of crystalloids in determining the incidence of hypotension in parturients undergoing caesarean section under spinal anaesthesia - a prospective randomized comparative study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vedanshi Singh 
Designation  PG Student 
Affiliation  Deen Dayal Upadhyay Hospital 
Address  Dept Of Anaesthesiology, Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi Shahaed Mangal Pandey Marg, Hari Nagar, New Delhi. 110064 West DELHI 110064 India

West
DELHI
110064
India 
Phone  9958858542  
Fax    
Email  vedanshisingh086@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Puneet Dwivedi 
Designation  Senior Medical Officer 
Affiliation  Deen Dayal Upadhyay Hospital 
Address  Dept Of Anaesthesiology, Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi Shahaed Mangal Pandey Marg, Hari Nagar, New Delhi. 110064 West DELHI 110064 India

West
DELHI
110064
India 
Phone  9999178199  
Fax    
Email  drpuneetdwivedi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mohit Singhal 
Designation  PG student 
Affiliation  Deen Dayal Upadhyay Hospital 
Address  Dept Of Anaesthesiology, Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi Shahaed Mangal Pandey Marg, Hari Nagar, New Delhi. 110064 West DELHI

West
DELHI
110064
India 
Phone  9053808955  
Fax    
Email  mohitsinghal12345@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Deen Dayal Upadhayay Hospital, Hari Nagar, New Delhi-110064 
 
Primary Sponsor  
Name  Deen Dayal Upadhayay Hospital 
Address  Department of Anaesthesiology Deen Dayal Upadhayay Hospital, Hari Nagar, New Delhi-110064 
Type of Sponsor  Research institution and hospital 
 
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 Vedanshi Singh  Deen Dayal Upadhayay Hospital, Delhi  Dept of Anaesthesia (Main OT-1,Obstetrics & Gynaecology Emergency OT)
West
DELHI 		 9958858542

vedanshisingh086@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instutional Ethical Committe Deen Dayal Upadhayay Hospital, Govt. of NCT of Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Co-loading  At the time of identification of cerebro spinal fluid, Co-loading will be done with 15 ml/kg at the rate of 90 ml/min initiated till the end of surgery.  
Intervention  Pre-loading  Pre-loading will be done with Ringers lactate 15 ml/kg at the rate of 90 ml/min before spinal anaesthesia after that, Spinal anaesthesia will be given at L3-L4 inter-vertebral space. 2 ml of 0.5% bupivacaine (hyperbaric) will be administered using 25G Quinkes needle after confirming free and clear flow of cerebrospinal fluid.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Parturients with singleton pregnancy undergoing caeserean delivery under spinal anaesthesia with ASA physical status II and Height more than 150cms.  
 
ExclusionCriteria 
Details  History of allergy to local anaesthetic agent, parturients with cardiovascular, respiratory or hepato-renal disease and coagulopathy , thrombocytopenia or any contraindication to spinal anaesthesia.  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study and compare the systolic blood pressure(SBP) in parturients undergoing caesarean section under spinal anaesthesia with pre-loading or co-loading of crystalloid.  Baseline haemodynamic parameters to be observed before initiation of spinal anaesthesia and haemodynamic parameters to be observed at 0,3,6,9,12,15 minutes till the end of surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess & compare the Mean Arterial Pressure (MAP), Diastolic Blood Pressure (DBP), Heart Rate (HR) in parturients undergoing caesarean delivery under spinal anaesthesia with pre-loading or co-loading of crystalloid, with evaluation & comparison of vasopressor requirement & to assess any comlications, if any.  Baseline haemodynamic parameters to be observed before initiation of spinal anaesthesia & haemodynamic parameters to be observed at 0,3,6,9,12,15 minutes till the end of surgery. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   18/07/2024 
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="0"
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 - 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 - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vedanshisingh086@gmail.com].

  6. For how long will this data be available start date provided 24-02-2026 and end date provided 24-02-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This prospective, randomized clinical comparative study will be conducted after obtaining approval from Scientific Research Committee and the Institutional Ethics Committee and written informed consent of patients. Seventy patients fulfilling the inclusion criteria, scheduled for surgery under spinal anaesthesia with pre-loading or co-loading of crystalloid will be enrolled in the study. Patients will be allocated to one of the two study groups after randomization. In Group A, pre-loading will be done and in Group B ,co-loading will be done with crystalloid. The two will be compared with respect to incidence of hypotension between the two groups, assessment of vasopressor requirement  and complications if any 
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