| CTRI Number |
CTRI/2025/04/084848 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
14/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Prospective randomized double blinded study (participant and researcher)] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of effects of Oxytocin and Carbetocin in women undergoing LSCS |
|
Scientific Title of Study
|
A comparative study of hemodynamic effects of Oxytocin and Carbetocin in women undergoing lower segment cesarean section under spinal anaesthesia |
| 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 Mridula Pandey |
| Designation |
Junior Resident Department Of Anaesthesiology |
| Affiliation |
Institute of Medical Sciences, BHU |
| Address |
Department Of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9140413788 |
| Fax |
|
| Email |
mridulapandey7478@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhinay Jayanthi |
| Designation |
Associate Professor Department of Anaesthesiology |
| Affiliation |
Institute of Medical Sciences, BHU |
| Address |
Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7379141929 |
| Fax |
|
| Email |
abhinay2288@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhinay Jayanthi |
| Designation |
Associate Professor Department of Anaesthesiology |
| Affiliation |
Institute of Medical Sciences, BHU |
| Address |
Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7379141929 |
| Fax |
|
| Email |
abhinay2288@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, 1st floor, Sir Sunderlal Hospital, BHU, Varanasi, PIN- 221005 |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Department of Anaesthesiology, 1st floor, Sir Sunderlal Hospital, BHU, Varanasi, PIN-221005 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mridula Pandey |
Institute of Medical Sciences, BHU |
Department of Anaesthesiology,
1st floor, Sir Sunderlal Hospital, BHU
Varanasi
UTTAR PRADESH |
9140413788
mridulapandey7478@gmail.com |
| Dr Mridula Pandey |
Institute of Medical Sciences, BHU |
Department of Obstretics and Gynaecology, Maternal and Child Health building, Sir Sunderlal Hospital, BHU
Varanasi
UTTAR PRADESH |
9140413788
mridulapandey7478@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BANARAS HINDU UNIVERSITY INSTITUTE OF MEDICAL SCIENCES INSTITUTIONAL ETHICS COMMITTEE VARANASI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Comparator Agent |
Carbetocin |
Carbetocin is a synthetic oxytocin analogue with a longer half life compared to oxytocin. Patient will recieve 100 mcg of IV Carbetocin diluted in 10 ml Normal Saline injected over 1 min. |
| Intervention |
Oxytocin |
Oxytocin is a uterotonic with rapid onset of action but relatively shorter acting. Patient will recieve 10 IU of IV Oxytocin diluted in 10 ml Normal Saline, 5 IU will be given as bolus over 1 min and 5 IU will be given as infusion. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Term gestation between 37 weeks to 42 weeks undergoing elective LSCS |
|
| ExclusionCriteria |
| Details |
1- Conditions of fetal distress
2- Patients with systemic diseases
3- Hydramnios (oligo or poly hydramnios)
4- Placenta previa
5- Ecclampsia, pre ecclampsia
6- Gestational diabetes mellitus
7- Prematurity
8- Borderline cephalo pelvic disproportion
9- Previous classical CS or any other major surgery on uterus
10- Patients undergoing LSCS under GA |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the differences in haemodynamic responses using Mean Arterial Pressure (MAP) among both the groups before and after administration of uterotonics after delivery of baby. |
Baseline, 30 sec after, 1 min, 5 min, 10 min, 15 min and 30 min after administration of uterotonic after delivery of baby. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1- Compare other haemodynamic parameters like Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Heart rate (HR), Oxygen saturation (SpO2) and compare need for vasopressor support after administration of uterotonic after delivery of baby,
2- Compare level of uterine contraction achieved and if any additional dose of uterotonics is required,
3- Compare the amount of blood loss and requirement of transfusion if any. |
Baseline, 30 sec after, 1 min, 5 min, 10 min, 15 min and 30 min after administration of uterotonic after delivery of baby |
|
|
Target Sample Size
|
Total Sample Size="174"
Sample Size from India="174"
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)
|
01/05/2025 |
| 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 Yet Recruiting |
| 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
|
A total of 174 pregnant women undergoing elective LSCS under sub arachnoid block will be enrolled and randomly allocated into two groups of 87 each by computer generated randomized table. Study drugs will be administered after the delivery of baby and clamping of cord. Effect of the drugs will be noted on MAP, SBP, DBP, HR and oxygen saturation as baseline and then followed by 30 sec, 1 min, 5 min, 10 min, 15 min and 30 min after administration of drugs. Other parameters like level of uterine contraction achieved, additional dose of uterotonics if required, dose of vasopressors used, amount of blood loss during operation, requirement of transfusion if any and any other adverse effect will also be assessed. Thus, hemodynamic effects of uterotonics oxytocin and carbetocin will be compared. |