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CTRI Number  CTRI/2023/08/056162 [Registered on: 04/08/2023] Trial Registered Prospectively
Last Modified On: 27/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluating the contractile effect of two medicines, namely carbetocin and oxytocin, on the uterus, in patients undergoing cesarean surgery 
Scientific Title of Study   Evaluation of the uterotonic effect of Carbetocin vs Oxytocin 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  Dr Palomi Shah 
Designation  Postgraduate student 
Affiliation  Amrita Institute of medical sciences 
Address  Department of anaesthesiology, Amrita institue of medical sciences, Ernakulam

Ernakulam
KERALA
682041
India 
Phone  9820519944  
Fax    
Email  palomi2603@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dilesh Kadapamannil 
Designation  Assistant Professor 
Affiliation  Amrita Institute of medical sciences 
Address  Department of Anaesthesiology Amrita Institute of medical sciences Ernakulam Kerala

Ernakulam
KERALA
682041
India 
Phone  09994202788  
Fax    
Email  dr.dilesh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dilesh Kadapamannil 
Designation  Assistant Professor 
Affiliation  Amrita Institute of medical sciences 
Address  Department of Anaesthesiology Amrita institute of medical sciences Ernakulam


KERALA
682041
India 
Phone  09994202788  
Fax    
Email  dr.dilesh@gmail.com  
 
Source of Monetary or Material Support  
Amrita institute of medical sciences, Ernakulam Kerala Pin - 682041 
 
Primary Sponsor  
Name  Amrita institute of medical sciences 
Address  Amrita institute of medical sciences, Ponekara ernakulam, Pin 682041 
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 Dilesh  Amrita institute of medical sciences  Department of anaesthesoiology Obstetric theatre
Ernakulam
KERALA 
09994202788

dr.dilesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Amrita institute of medical sciences Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group carbetocin  Patients will receive 100 mcg carbetocin IV after delivery of baby 
Comparator Agent  Group oxytocin  Patients will receive oxytocin 3 units IV followed by oxytocin 3 units per hour infusion 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Parturient between 18 – 40 years undergoing elective caesarean section.

 
 
ExclusionCriteria 
Details  H/o significant Cardiac, renal or liver diseases.
Hypertensive disorder of pregnancy.
Multiple pregnancy.
Abnormal placenta.
Polyhydramnios.
Fibroid complicating pregnancy.
Epilepsy.
General anaesthesia.
Hypersensitivity to study medications and their preservatives 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the uterine tone with prophylactic intravenous oxytocin vs. carbetocin in parturients undergoing elective cesarean section under spinal anesthesia.
 
3 minutes
 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic effects including heart rate, systolic blood pressure & mean arterial pressure after administration of the drug.
Requirement of further uterotonic agents.
Adverse effects.
 
Till 15 minutes after delivery of baby 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 3 
Date of First Enrollment (India)   15/08/2023 
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="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 - NO
Brief Summary  

Post-partum haemorrhage (PPH) is the most important cause of maternal morbidity and mortality. Main cause of PPH is uterine atony. Uterotonic agents and step-wise surgical measures are used for its management. PPH can result in severe anaemia, need for blood transfusion, coagulopathy and end organ damage

Oxytocin and carbetocin are commonly used uterotonic agents. Both the drugs are being used in our institution as part of standard of care during cesarean section.

Oxytocin is the most widely used and available first line uterotonic agent. It brings about its action by binding to the G protein receptors present in the myometrium which will trigger the release of calcium from the sarcoplasmic reticulum. This will further enhance the uterine contractions, which is important in maintaining post- partum haemostasis. Oxytocin is given to the mother as an intravenous (iv) infusion after the delivery of the baby. It is a relatively safe drug with and adverse effect profile consisting of reflex tachycardia, transient decrease in systemic blood pressure, nausea and vomiting. The effect of oxytocin can be limited by its heat susceptible nature and need for cold chain storage.

Carbetocin is an oxytocic analogue with a similar mechanism of action. It acts at the same receptors as that of oxytocin on the myometrium, triggering the release of calcium and further enhancing the uterine contractions. A single dose of this drug is said to be as effective as a continuous infusion of oxytocin and thus it saves the need of an additional iv cannula and the discomfort to the mother in this critical period. The major advantage over the traditionally used oxytocin is a longer duration of action and a heat stable nature which reduces its need for cold chain storage. It has side effects similar to oxytocin - it causes nausea and vomiting, abdominal pain, hyperthermia, tachycardia, hypotension, headache.

Through this study we aim to assess the effect of both these drugs on uterine tone and try and understand if Carbetocin can be a better substitute to oxytocin in our theatres, despite its high cost.

After institutional ethical committee clearance, written informed patient consent and CTRI clearance, parturients undergoing caesarean section under spinal anaesthesia will be randomized to two groups (group O and group C) using computer generated random sequence of numbers. Concealment will be achieved by closed envelope technique. 

After delivery of baby, Group O patients will receive oxytocin 3 units IV bolus over 20 seconds and followed by infusion of 3 units per hour for 4 hours. Group C will receive carbetocin 100 mcg IV over 1 minute followed by saline infusion 3 ml per hour for 4 hrs.

Uterine tone will be assessed by operating surgeon at 3, 6, 9 and 15 minutes after giving study drugs with a 11-point numerical rating scale from 0 to 10, with 0 being no tone and 10 being excellent tone. Further uterotonic agents (oxytocin/methylergometrine/prostaglandin F2α) will be given on demand from the operating surgeon and it will be noted.

Haemodynamic effects including heart rate, systolic blood pressure, mean arterial pressure will be noted during the same time points. Blood loss will be assessed and if it exceeds 1000 ml, PRBC will be transfused.

Any adverse effects associated with the use of study drugs including nausea and vomiting, abdominal pain, hyperthermia and headache will be noted.




 
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