| CTRI Number |
CTRI/2024/04/065815 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
study of Oxytocin versus Carbetocin for the prevention of primary post partum hemorrhage following caesarean delivery in pregnant women |
|
Scientific Title of Study
|
A comparative study between Oxytocin and Carbetocin for the prevention of primary postpartum hemorrhage following caesarean delivery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Adhi lakshmi |
| Designation |
Post graduate trainee |
| Affiliation |
North Bengal Medical College and Hospital |
| Address |
Department of obstetrics and gynaecology,North bengal medical college and hospital,Sushrut nagar,
Darjeeling,West bengal,India
Darjiling
WEST BENGAL
734012
India |
| Phone |
6303594367 |
| Fax |
|
| Email |
sampathadhilakshmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandip Sengupta |
| Designation |
Assistant Professor |
| Affiliation |
North Bengal Medical College and Hospital |
| Address |
Department of Obstetrics and Gynaecology,North Bengal Medical college and hospital,Sushrut nagar.
Darjiling
WEST BENGAL
734012
India |
| Phone |
6303594367 |
| Fax |
|
| Email |
dr.sandipsengupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Adhi lakshmi |
| Designation |
Post graduate trainee |
| Affiliation |
North Bengal Medical College and Hospital |
| Address |
Department of obstetrics and gynaecology,North bengal medical college and hospital,Sushrut nagar,
Darjeeling,West bengal,India
Darjiling
WEST BENGAL
734012
India |
| Phone |
6303594367 |
| Fax |
|
| Email |
sampathadhilakshmi@gmail.com |
|
|
Source of Monetary or Material Support
|
| North bengal medical college and hospital,Sushrut nagar,darjeeling,west bengal,734012 |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
North bengal medical college and hospital,darjeeling ,West Bengal. |
| Type of Sponsor |
Other [other] |
|
|
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 Adhi lakshmi |
North Bengal medical college and hospital. |
Department of Obstetrics and Gynaecology,operation theatre and post operative ward ,Susruthanagar
Darjiling
WEST BENGAL |
6303594367
sampathadhilakshmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80-O82||Encounter for delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
carbetocin |
carbetocin 100mcg bolus given via intravenous route |
| Comparator Agent |
oxytocin |
therapeutic drug intervention,comparator agent oxytocin 20 IU in 1000ml NS being compared with carbetocin 100mcg bolus given via intravenous route. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
female with singleton, fullterm pregnancy undergoing elective or emergency caesarean section, |
|
| ExclusionCriteria |
| Details |
Hypersensitivity to study drugs,
Cases of coagulopathy,uterine fibroid,suspected placental pathology,
Medical diseases such as hypertension,diabetes mellitus,Cardiac ,renal,liver disorders .
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of hemodynamic effects of carbetocin in terms of blood loss. |
24 hours after ceserean section |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Need of additional uterotonics
2.Need of blood transfusion to compensate the blood loss.
3.The adverse effects encountered by the participants. |
24 hours after ceserean section |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/04/2024 |
| 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="0"
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
|
|
Brief Summary
|
This study is randomised parallel group controlled trial comparing the efficacy of oxytocin and carbetocin for the prevention of primary postpartum hemorrhage following ceserean delivery done in 100 pregnant women in North bengal medical college and hospital,darjeeling. The primary outcome evaluates the hemodynamic effects of carbetocin in terms of blood loss .The secondary outcome evaluates the need of additional uterotonics ,blood transfusion and adverse effects encountered by participants. |