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CTRI Number  CTRI/2022/05/042453 [Registered on: 11/05/2022] Trial Registered Prospectively
Last Modified On: 08/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to evaluate the safety and efficacy of two different doses of oxytocin bolus doses in elective caesarean sections. 
Scientific Title of Study   A comparative study to evaluate the safety and efficacy of two different doses of oxytocin boluses in elective caesarean sections. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Noorjit Sidhu 
Designation  Second year Anaesthesia Resident 
Affiliation  MM Institute of Medical Sciences 
Address  Department of Anaesthesia, MM Institute of Medical Sciences and Research Centre, Mullana, Ambala

Ambala
HARYANA
133207
India 
Phone  9478722088  
Fax    
Email  noorjitsidhu94@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sapna Bansal 
Designation  Professor 
Affiliation  MM Institute of Medical Sciences 
Address  Department of Anaesthesia, MM Institute of Medical Sciences and Research Centre, Mullana, Ambala

Ambala
HARYANA
133207
India 
Phone  8168381441  
Fax    
Email  drsapna10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sapna Bansal 
Designation  Professor 
Affiliation  MM Institute of Medical Sciences 
Address  Department of Anaesthesia, MM Institute of Medical Sciences and Research Centre, Mullana, Ambala

Ambala
HARYANA
133207
India 
Phone  8168381441  
Fax    
Email  drsapna10@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, MM Institute of Medical sciences and Research Centre, Mullana, Ambala 
 
Primary Sponsor  
Name  Department of Anaesthesia 
Address  MM Institute of Medical Sciences and Research Centre, Mullana, Ambala 
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 
Noorjit Sidhu  MM Institute of Medical Sciences and Research Centre  Department of Anaesthesiology, MM Institute of Medical Sciences and Research Centre, Mullana, Ambala
Ambala
HARYANA 		 09478722088

noorjitsidhu94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, MMIMSR, Mullana, Ambala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnancy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparision of the safety and efficacy of two different doses of oxytocin boluses in elective caesarean sections.  Group 1 : patients will receive 1 unit of oxytocin bolus followed by regular oxytocin infusion of 10 units/hour  
Comparator Agent  Comparision of the safety and efficacy of two different doses of oxytocin boluses in elective caesarean sections.  Group 2: patients will receive 3 unit of oxytocin bolus followed by regular oxytocin infusion of 10 units/hour  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  ASA grade II, Elective LSCS under Spinal Anaesthesia, Singleton pregnancy
 
 
ExclusionCriteria 
Details  • Refusal of patient
• Emergency LSCS
• History of allergy to oxytocin
• Placenta previa/accreta
• Polyhydramnios
• >2 Previous Caesarean sections
• Multifetal Pregnancy
• Contra-indications for Spinal Anaesthesia
• Inadequate Spinal Anaesthesia or conversion to General Anaesthesia
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
● To compare changes in HR and MAP (hemodynamic changes) that occur after administration of 1 and 3 units of iv oxytocin bolus.   Intra operative period after spinal anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
● To study the adequacy of utrerine contractions achieved by two different doses of oxytocin boluses.
● Adverse effects that occur.
● Requirement of additional uterotonic agents.



 		 Intra operative period after spinal anaesthesia 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   15/05/2022 
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    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary                      Oxytocin is given to women during Caesarean section to decrease the blood loss and to prevent postpartum bleeding which is one of the major causes of maternal deaths all over the world. Bolus dosing of oxytocin during C-section might lead to some hemodynamic variations such as hypotension and tachycardia, ST segment depression in ECG independent of anesthesia and Cardiovascular collapse. Other adverse effects are water retention, hyponatraemia, nausea and vomiting, feeling of warmth, palpitations, flushing, nasal congestion, xerostomia, metallic taste, headache, shivering and pruritus. 
                   Administering the appropriate amount of oxytocin maximizes its benefits and minimizes its side effects. The bolus causes detachment of placenta by constricting venous sinuses as well as homeostasis of placental bed, in contrast the infusion sustains the contraction of uterus during the surgical procedure and the postpartum period that follows. But repetitive doses of oxytocin to attain adequate uterine contractility in elective caesarean section needs to be re-evaluated, because they have significant adverse effects when given as a rapid high-dose bolus.
                  Hence the optimal dose of oxytocin in caesarean section is not clear. Thus, this study will be carried out to compare the efficacy & safety of two different bolus doses of oxytocin in terms of adequate Uterine Tone, hemodynamic effects and adverse effects during caesarean delivery.
 
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