| CTRI Number |
CTRI/2024/05/067030 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| 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 changes in blood pressure following supplementation of either of the two drugs named oxytocin and carbetocin in surgeries done in pregnant mothers following the delivery of the baby. |
|
Scientific Title of Study
|
A prospective randomized study comparing the mean arterial pressure variations following administration of oxytocin and carbetocin in elective cesarean section under subarachnoid blockade |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Noorul Aashika A |
| Designation |
Junior Resident / Postgraduate |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
No.830, B block Operation theatre complex, 8th floor, PSG institute of medical sciences and research, Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
8344854688 |
| Fax |
|
| Email |
noorulaashika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arun Kumar R |
| Designation |
Associate Professor |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
No.830, B block Operation theatre complex, 8th floor, PSG institute of medical sciences and research, Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9944113440 |
| Fax |
|
| Email |
shivaaniarun76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arun Kumar R |
| Designation |
Associate Professor |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
No.830, B block Operation theatre complex, 8th floor, PSG institute of medical sciences and research, Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9944113440 |
| Fax |
|
| Email |
shivaaniarun76@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funded. The study in PSG Institute of Medical Sciences and Research, Operation theatre, PSG Hospitals, Coimbatore |
|
|
Primary Sponsor
|
| Name |
Noorul Aashika A |
| Address |
Operation theatre complex, PSG institute of medical sciences and research, Coimbatore |
| 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 Noorul Aashika A |
PSG IMSR, Coimbatore |
Operation theatre complex, B Block, second floor, Labor OT complex, PSG Institute of Medical Sciences and Research, Peelamedu, Coimbatore - 641004
Coimbatore
TAMIL NADU |
8344854688
914222594400
noorulaashika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Carbetocin |
To intervene the changes in the blood pressure during caeserean surgeries |
| Intervention |
Oxytocin |
Comparing the mean arterial pressure variations in elective LSCS |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1.Parturient acceptance
2.ASA status 2 and 3
3.Age between 20-30 yrs.
4.Parturient of term gestation undergoing elective lower segment cesarean section under spinal anesthesia
|
|
| ExclusionCriteria |
| Details |
1.Absolute contraindications for spinal anesthesia
2.Combined spinal epidural anesthesia
3.Short stature <145cm and BMI > 40
4.Conditions associated with increased level of PPH risk (placenta previa, placentalabruption, multiple gestation)
|
|
|
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 |
| The primary objective of this study is to compare the mean arterial blood pressure variation following administration of oxytocin and carbetocin in lower segment cesarean section. |
Baseline, 1,3,5,10 minutes and every 2nd minute following delivery of baby till 20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary objective focusses on
1.Heart rate variations occurring between oxytocin and carbetocin
2.Requirement of vasopressor - phenylephrine
3.Clinical estimation of blood loss
4.Side effects and complications of oxytocin and carbetocin
|
Baseline, 1,3,5,10 minutes and every 2nd minute following delivery of baby till 20 minutes |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/06/2024 |
| 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
|
80 parturient undergoing elective caesarean section belonging to age group 20 to 30 years will be included in the study. Following the delivery of the fetus either oxytocin or Pitocin will be supplemented, and the hemodynamic parameters will be monitored. The study will be statistically analyzed using the statistical tests. Purpose of the trial: Oxytocin and Carbetocin is recommended as the standard treatment for postpartum hemorrhage. Any one of this uterotonic agents are used following the delivery of the baby. The added advantage of single bolus administration and less cardiovascular side effects are pronounced with more carbetocin when compared to oxytocin which favors the use of carbetocin in clinical practice. Many studies have been done considering the various dose formulations of oxytocin and carebetocni; however, there were not enough clinical information. |