CTRI Number |
CTRI/2022/06/043237 [Registered on: 14/06/2022] Trial Registered Prospectively |
Last Modified On: |
28/05/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparison of Carbetocin vs Oxytocin for prevention of haemorrhage after delivery in women undergoing Caesarean section |
Scientific Title of Study
|
Comparison of Carbetocin versus Oxytocin for Prevention of Primary Postpartum Haemorrhage in Women Undergoing Caesarean Section at a Tertiary Care Hospital in West Bengal: A Randomised Recipient Blinded Clinical Trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Isha Sudrania |
Designation |
Associate Professor |
Affiliation |
IQ City Medical College Hospital |
Address |
Department of Obstetrics and Gynaecology
IQ City Medical College Hospital
Sovapur Bijra Road Jemua
Durgapur
Barddhaman WEST BENGAL 713206 India |
Phone |
7502707024 |
Fax |
|
Email |
isha107@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shouvik Das |
Designation |
Assistant Professor |
Affiliation |
IQ City Medical College Hospital |
Address |
Department of Obstetrics and Gynaecology
IQ City Medical College Hospital
Sovapur Bijra Road Jemua
Durgapur
Barddhaman WEST BENGAL 713206 India |
Phone |
8478948603 |
Fax |
|
Email |
drdasshouvik@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Shouvik Das |
Designation |
Assistant Professor |
Affiliation |
IQ City Medical College Hospital |
Address |
Department of Obstetrics and Gynaecology
IQ City Medical College Hospital
Sovapur Bijra Road Jemua
Durgapur
Barddhaman WEST BENGAL 713206 India |
Phone |
8478948603 |
Fax |
|
Email |
drdasshouvik@gmail.com |
|
Source of Monetary or Material Support
|
IQ City medical college Hospital |
|
Primary Sponsor
|
Name |
IQ City Medical College Hospital |
Address |
Sovapur, Bijra Road, durgapur 713206 |
Type of Sponsor |
Private medical college |
|
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 ISHA SUDRANIA |
IQ City Medical College Hospital |
Department of Obstetrics and Gynaecology
Sovapur Bijra Road Jemua
Durgapur 713206 Barddhaman WEST BENGAL |
7502707024
isha107@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IQ City Medical College & Hospital, Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O721||Other immediate postpartum hemorrhage, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Injection Carbetocin |
Injection Carbetocin 100 micrograms intravenous given in active management of third stage of labour |
Comparator Agent |
Injection Oxytocin |
Injection Oxytocin 10 IU intravenous given in active management of third stage of labour |
|
Inclusion Criteria
|
Age From |
21.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Female |
Details |
1.Age 21 to 45 years
2.Emergency or elective Caesarean section
3.Singleton pregnancy |
|
ExclusionCriteria |
Details |
1.Contraindication for carbetocin and oxytocin
known allergy or hypersensitivity to carbetocin or oxytocin
2.Cases of coagulopathy
3.Multifoetal gestation
4.Medical diseases as cardiac, hypertension, liver, renal or endocrine diseases
5.Uterine fibroids
6.Suspected placental pathology (placenta accreta, praevia or abruption)
7.General anaesthesia
8.Classical uterine incision
9.Those who did not give consent
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Volume of blood loss
Use of additional uterotonics |
First 24 hours post-operative |
|
Secondary Outcome
|
Outcome |
TimePoints |
change in blood pressure |
after one hour of drug administration |
change in pulse rate |
after one hour of drug administration |
change in haemoglobin |
24 hours after lscs |
need of blood transfusion |
during first 24 hours post operative |
|
Target Sample Size
|
Total Sample Size="340" Sample Size from India="340"
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)
|
25/06/2022 |
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
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Postpartum haemorrhage (PPH) continues to be the leading cause of maternal mortality in middle and low-income countries including India. Much advancement has been made in the field of treatment of PPH, but not much progress has been made in the field of prevention, where one of its main component is administration of uterotonic, preferably oxytocin, immediately after birth of the baby. In many low- and middle income countries, the efficacy of oxytocin cannot be assured since access to sustained cold-chain is unavailable. Regarding other uterotonics: Ergometrine degrades when exposed to heat or light and Misoprostol degrades rapidly when exposed to moisture. Innovation in the manufacture of carbetocin has met the stability requirements in hot and humid climates. Both Carbetocin and Oxytocin are approved drugs for active managemrent of third stage of labour (AMTSL) and prevention of PPH. This study has been undertaken to evaluate the uterotonic effect of carbetocin compared to oxytocin for the prevention of primary PPH in emergency or elective Caesarean delivery. The purpose of this study is to determine if carbetocin is superior to oxytocin in terms of reduction in the need of additional uterotonic agents and the occurrence of PPH. |