| CTRI Number |
CTRI/2024/07/069904 [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 |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare two drugs for uterine contraction in patients undergoing Caesarean section |
|
Scientific Title of Study
|
Comparative study of Haemodynamic parameters of Intravenous Oxytocin and Intravenous Carbetocin in patients undergoing Elective Caesarean section-One year Randomised Control Clinical 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 |
Dr Vanshika Saranga |
| Designation |
Junior Resident |
| Affiliation |
KLE Dr Prabhakar Kore Hospital and MRC |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College,Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9000942115 |
| Fax |
|
| Email |
svanshika2022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kedareshvara K S |
| Designation |
Professor |
| Affiliation |
KLE Dr Prabhakar Kore Hospital and MRC |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College,Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9964453463 |
| Fax |
|
| Email |
kedareshvara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kedareshvara K S |
| Designation |
Professor |
| Affiliation |
KLE Dr Prabhakar Kore Hospital and MRC |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College,Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9964453463 |
| Fax |
|
| Email |
kedareshvara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
Jawaharlal Nehru Medical College
Belagavi
590010 |
|
|
Primary Sponsor
|
| Name |
Dr Vanshika Saranga |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Medical College
Belagavi
Karnataka 590010 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vanshika Saranga |
KLE Dr Prabhakar Kore Hospital and MRC |
Department of Anaesthesiology, Jawaharlal Nehru Medical College,Belagavi
Belgaum
KARNATAKA |
9000942115
svanshika2022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC 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 |
Intravenous Carbetocin |
Intravenous Carbetocin 100mcg given over 1minute after delivery of the baby |
| Comparator Agent |
Intravenous Oxytocin |
Intravenous oxytocin 20 units in 500ml normal saline given over 45min at a drip of 12ml/min after delivery of the baby |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
American Society of Anaethesiologists physical status II
Patients undergoing elective caesarean section under subarachnoid block
provides consent
|
|
| ExclusionCriteria |
| Details |
Presence of hypertension,preeclampsia,cardiac,renal or liver diseases, epilepsy and dearranged coagulation profile
patients undergoing general anaesthesia and emergency LSCS
patient who are unable or unwilling to give consent
women with history of hypersensitivity to carbetocin
patients who do not fulfil inclusion criteria
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the maternal hemodynamic changes for oxytocin and carbetocin(effect on heart rate and blood pressure)during elective Caesarean section |
0min,3min,6min,9min,12min,15min,18min,21min,24min,27min,30min,33min,36min,39min,42min,45min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effective uterotonic action of oxytocin & carbetocin in terms of estimation of preoperative & postoperative HB estimation |
48hours after delivery |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="1"
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 to compare haemodynamic responses following intravenous injection of oxytocin and carbetocin in patients undergoing elective caesarean section under subarachnoid block |