| CTRI Number |
CTRI/2024/05/066741 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
the study is comparing two drugs, one called heat stable Carbetocin and the other called Oxytocin, to see which one works better in preventing excessive bleeding after vaginal childbirth by helping the uterus contract properly |
|
Scientific Title of Study
|
Heat stable Carbetocin versus Oxytocin in Active Management of the third stage of Labour to Prevent Postpartum Haemorrhage in women delivering vaginally. |
| 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 Suraj Ashokrao Mokade |
| Designation |
Junior resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR |
| Address |
Room no 3 , First floor B block, Obstetrics and Gynaecology Department Gate No 3 Great Eastern Road opposite Gurudwara AIIMS Campus Tatibandh Raipur
Room no 3 , First floor B block, Obstetrics and Gynaecology Department Gate No 3 Great Eastern Road opposite Gurudwara AIIMS Campus Tatibandh Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9321741018 |
| Fax |
|
| Email |
suraj.mokade1303@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suraj Ashokrao Mokade |
| Designation |
Junior resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR |
| Address |
Room no 3 , First floor B block, Obstetrics and Gynaecology Department Gate No 3 Great Eastern Road opposite Gurudwara AIIMS Campus Tatibandh Raipur
Room no 3 , First floor B block, Obstetrics and Gynaecology Department Gate No 3 Great Eastern Road opposite Gurudwara AIIMS Campus Tatibandh Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9321741018 |
| Fax |
|
| Email |
suraj.mokade1303@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suraj Ashokrao Mokade |
| Designation |
Junior resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR |
| Address |
Room no 3 , First floor B block, Obstetrics and Gynaecology Department Gate No 3 Great Eastern Road opposite Gurudwara AIIMS Campus Tatibandh Raipur
Room no 3 , First floor B block, Obstetrics and Gynaecology Department Gate No 3 Great Eastern Road opposite Gurudwara AIIMS Campus Tatibandh Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9321741018 |
| Fax |
|
| Email |
suraj.mokade1303@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Suraj Ashokrao Mokade |
| Address |
Room no 3 , First floor B block, Obstetrics and Gynaecology Department Gate No 3 Great Eastern Road opposite Gurudwara AIIMS Campus Tatibandh Raipur |
| Type of Sponsor |
Other [selffunded] |
|
|
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 suraj ashokrao mokade |
All India Institute of Medical Sciences Raipur. |
Labour Room , First floor A block, Obstetrics and Gynaecology Department
Raipur
CHHATTISGARH |
9321741018
suraj.mokade1303@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICAL COMMITTEE , AIIMS RAIPUR |
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 carbetocine |
immediately after delivery of baby Heat stable Carbetocin 100mcg IM administered in Active Management of the third stage of Labour to prevent Postpartum haemorrhage |
| Comparator Agent |
injection oxytocine |
Immediately After delivery of the baby 10IU of Oxytocin IM will be administered according to the allotted group of women
The post-delivery blood loss will be measured following placental delivery till 2 hours following delivery by gravimetric methode. also need of other uterotonics
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Age 18 TO 35 years
Pregnant patients with gestational age more than or equal to 37 weeks
Singleton pregnancy with cephalic presentation
Expected to deliver vaginally with cervical dilatation more than or equal to 5 cm
Hemoglobin more than 9gm in recent 3rd trimester report
Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Previous lower segment caesarean section
High risk including antepartum haemorrhage traumatic Postpartum haemorrhage
abruption placenta recurrent pregnancy loss multiple pregnancies polyhydramnios
perineal or cervical tears during Labour and delivery
Medical disorders such as coagulation disorder thrombocytopenia renal disorder hepatic disorder severe cardiac disorder asthma epilepsy
Patients with previous uterine surgery
Patients requiring blood transfusion before delivery
Patient allergy to carbetocin
Patients are not willing to sign informed consent
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| THE PROPERTION OF WOMEN HAVING BLOOD LOSS MORE THAN 500 ML WITH IN 2 HOUR OF DELIVERY . |
THE PROPERTION OF WOMEN HAVING BLOOD LOSS MORE THAN 500 ML WITH IN 2 HOUR OF DELIVERY . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
the proportion of women requiring additional uterotonics in active managment of third stage of labour
the proportion of women requiring blood transfusion
mean hb difference between the two groups
adverse effects of the drug in the two groups after 48 hour .
|
. |
|
|
Target Sample Size
|
Total Sample Size="184"
Sample Size from India="184"
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)
|
17/05/2024 |
| 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="6"
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
|
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Brief Summary
|
The landmark WHO CHAMPION( CarbetocinHAeMorrhagePreventION) trial a double blinded randomized trial concluded Heat-stable carbetocin was not inferior to Oxytocin for the prevention of bloodloss of at least 500 ml or the use of additional uterotonic agents(9). In December 2018, WHO issued new recommendationson uterotonics for PPH prevention.Oxytocin 10 IU I/M or I/V remains the uterotonic of choice for all births, other uterotonics recommended are misoprostol, ergometrine/methylergometrine, and oxytocin plus ergometrine fixed-dose combination. Carbetocin 100ug I/V or I/M is recommended in context based manner .The use of carbetocin (100 μg, IM/IV) is recommended for the prevention of PPH for allbirths in contexts where its cost is comparable to other effective uterotonics(10). However in India oxytocin and misoprostol remain the two most widely used uterotonicsto prevent PPH. The quality of these two may be poor dueto manufacturing or degradation during transport andstorage or exposure to climactic conditions ,oxytocine required cold storage . there by compromising their effectiveness in preventing PPH(11). Though misoprostol not required cold storage , The quality of misoprostol is also adversely impacted by high humidity inresource poor countries and poor packaging. In 2020, a systematic review across 40 Low middle income countries(LMICs) furtherconfirmed that oxytocin and misoprostol are oftenof poor quality with nearly 40% of each failing qualitytests(12). In Addition, ergometrine or the fixed dose combination of oxytocin and ergometrine require screening of hypertension before there use which may not be possible in some healthcare setting especially in the rural areas. As mentioned above the advantages of carbetocin it can cut on cost of the heat sensitive uterotonics in their acquisition, cold chain transport and storage, administration of additional uterotonics, requirement of blood transfusions etc. There are very limited studies in our country which focuses on the comparative efficacy of carbetocin versus oxytocin or other uterotonics and the cost-effectiveness of the drug which has the potential of a good alternative first line drug in prevention of PPH especially in LMICs. Therefore, we aim to compare the effectiveness and side-effect profile of Hs- carbetocin versus oxytocin in prevention of PPH at third stage of labour following vaginal delivery.
There is a difference in the effectiveness of Heat stable Carbetocin as compared to Oxytocin in the prevention of postpartum haemorrhage in vaginal delivery
|