| 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
|
|
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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
|
|
|
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 |
|
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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 |
|
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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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