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CTRI Number  CTRI/2024/07/071700 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 25/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of effect of two uterotonic drugs on hemodynamics and bleeding after cesarean section under spinal anesthesia. 
Scientific Title of Study   Hemodynamic effects of Oxytocin and Carbetocin during elective lower segment cesarean section under spinal anesthesia: a double blinded randomized controlled study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Silmi N Abraham  
Designation  First year postgraduate student 
Affiliation  St John’s medical college hospital 
Address  Department of Anesthesiology, St John’s medical college hospital, Sarjapur main road, John nager, Koramangala, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  8943205388  
Fax    
Email  srmerinashabraham@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Rashmi Rani 
Designation  Associate Professor 
Affiliation  St John’s medical college hospital 
Address  Department of Anesthesiology St Johns Medical college hospital Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  7760713968  
Fax    
Email  rashmi172007@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mathangi Krishnakumar  
Designation  Assistant Professor 
Affiliation  ST JOHNS MEDICAL COLLEGE HOSPITAL 
Address  Department of Anesthesiology St Johns Medical college hospital Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  97640662212  
Fax    
Email  Mathangidoc@outlook.com  
 
Source of Monetary or Material Support  
St Johns medical college hospital 
 
Primary Sponsor  
Name  Department of Anesthesiology 
Address  St Johns Medical college hospital Sarjapura road Koramangala Bangalore 560034 
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 
SILMI N ABRAHAM  ST JOHN’S MEDICAL COLLEGE HOSPITAL  DEPARTMENT OF ANAESTHESIOLOGY 1ST FLOOR OT COMPLEX ST JOHN’S MEDICAL COLLEGE HOSPITAL ROAD KORAMANGALA BANGALORE 560034
Bangalore
KARNATAKA 		 8943205388

srmerinashabraham@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee St Johns Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Carbetocin  After delivery of baby and clamping of umbilical cord, measurement of hemodynamic parameters will be done and denoted as T0. 100 mcg carbetocin 10 ml dilution with NS/ RL over 10 minutes will be started(group C). After drug administration, heart rate, systolic and diastolic blood pressure, mean arterial pressure, ST index and O2 saturation will be recorded at T1, T3, T5, T10, T15, and T30 min. After surgery, all patients will be transferred to the recovery room. Uterine tone will be assessed by the surgeon after 20 minutes (T20) using a numerical rating scale of 0-10 (where 0 is uterine inertia and 10 is maximal contraction). If uterine tone is not satisfactory inj. Methergin 0.2 mg IV bolus will be given. In group O, another 10 U of oxytocin in 500 ml of NS/RL will be given as infusion. Incidence of feeling of warmth, chest pain, shortness of breath, palpitations, flushing, headache, nausea/ vomiting and chest discomfort will be taken as side effects and noted during the surgery and in the recovery room. Total IV Ephedrine dose and use of any additional uterotonic agent will be noted.  
Comparator Agent  Oxytocin  After delivery of baby and clamping of umbilical cord, measurement of hemodynamic parameters will be done.10 IUs of oxytocin in 100 ml RL/ NS will be started as infusion over 10 minutes (group O). After drug administration, heart rate, systolic and diastolic blood pressure, mean arterial pressure, ST index and O2 saturation will be recorded at 1, 3, 5, 10, 15, and 30 min. After surgery, all patients will be transferred to the recovery room. Uterine tone will be assessed by the surgeon after 20 minutes using a numerical rating scale of 0-10 (where 0 is uterine inertia and 10 is maximal contraction). If uterine tone is not satisfactory inj. Methergin 0.2 mg IV bolus will be given. Incidence of feeling of warmth, chest pain, shortness of breath, palpitations, flushing, headache, nausea/ vomiting and chest discomfort will be taken as side effects and noted during the surgery and in the recovery room. Total IV Ephedrine dose and use of any additional uterotonic agent will be noted.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1. Healthy pregnant woman under going elective lower segment cesarean section at term under spinal anesthesia concerning to be part of study.
2. Patients aged between 18 to 35 years of age. 
 
ExclusionCriteria 
Details  1. Women with known sensitivity to heat-stable carbetocin or oxytocin
2. Pregnancy with high risk of PPH
3. Pregnancy with other comorbidities
 
 
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 changes in maternal hemodynamic parameters (heart rate, systolic and diastolic blood pressure, mean arterial pressure, ST index and O2 saturation) with use of oxytocin and carbetocin in elective lower segment caesarean section.  After drug administration, hemodynamic parameters will be recorded at 0, 1, 3, T5, T10, T15, and T30 mins. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the incidence of intraoperative & postoperative feeling of warmth, chest pain, shortness of breath, palpitations, flushing, headache, nausea/ vomiting & chest discomfort.  Patient will be assessed at 10,20,30, 60 minutes post operatively.  
To compare uterine tone & need of additional uterotonics with use of oxytocin & carbetocin.   Uterine tone will be assessed after 20 minutes of drug administration. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   26/09/2024 
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="2"
Months="0"
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   This study is a randomized, double blinded, parallel group, single centre trial comparing the hemodynamic effects of Oxytocin and Carbetocin in pregnant ladies undergoing an elective lower segment cesarean section under spinal anesthesia that will be conducted in one centre in India. 
Post partum haemorrhage (PPH) due to uterine atony is one of the leading cause of maternal mortality and morbidity globally.  Uterotonics are recommended for use in active management of the third stage of labour to prevent PPH. Oxytocin is the recommended first-line uterotonic for preventing and treating PPH. Carbetocin, a heat stable, long acting oxytocin analogue is also recommended for PPH prevention.
Oxytocin is a synthetic cyclic peptide form of the naturally occurring posterior pituitary hormone. It binds to oxytocin receptors in the uterine myometrium, stimulating contraction of the uterine smooth muscle by increasing the sodium permeability of uterine myofibrils. Intravenous administration of oxytocin has almost immediate action with peak concentration after 30 minutes and has a half-life of 1–6 minutes. Its clinical indications are induction of labour, augmentation of labour and prevention and treatment of PPH.
Carbetocin is a long-acting synthetic analogue of oxytocin with agonist properties. It binds to oxytocin receptors in the uterine smooth muscle, resulting in rhythmic contractions, increased frequency of existing contractions and increased uterine tone. As an intravenous bolus injection it causes sustained uterine contractions within 2 minutes, lasting for about 6 minutes and followed by rhythmic contractions for 60 minutes. It has half-life of 40 minutes. Clinical indication of carbetocin is prevention of PPH.

The hemodynamic effects of oxytocin bolus consist of brief hypotension and tachycardia due to systemic vasodilation. Carbetocin, an oxytocin derivative exerts its effect by same molecular mechanism. Currently carbetocin in dose of 100 mcg bolus is routinely used for prevention of PPH. Clinical trials have been done to compare the adverse effects of bolus administration of both the drugs.

There is limited data available to compare the hemodynamic alteration and adverse effects of oxytocin and carbetocin given as infusion. This study is aimed to compare the hemodynamic alterations and side effects of both drugs when given as infusion over 10 minutes with hypothesis that carbetocin and oxytocin given as infusion will cause less cardiovascular side effects.


 
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