| CTRI Number |
CTRI/2024/07/071026 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Carbetocin versus Oxytocin in prevention of postpartum hemorrhage during Caesarean section |
|
Scientific Title of Study
|
Effectiveness of Carbetocin versus Oxytocin in prevention of postpartum hemorrhage during Caesarean section in singleton pregnancy; Randomised clinical trial |
| 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 Aishwarya H K |
| Designation |
PG Trainee |
| Affiliation |
RIMS. |
| Address |
Obstetrics and Gynaecology department ,Room No 1,Regional Institute Of Medical Sciences,Lamphelpat,Imphal,Manipur,India.
795004
Imphal West
MANIPUR
795004
India |
| Phone |
9611819306 |
| Fax |
|
| Email |
aishwaryahk1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laishram Trinity Meetei |
| Designation |
Assistant Professor |
| Affiliation |
RIMS. |
| Address |
Obstetrics and Gynaecology dept ,Room no 2,Regional Institute Of Medical Sciences ,Lamphelpat ,Imphal, Manipur,India
795004
Imphal West
MANIPUR
795004
India |
| Phone |
8729913934 |
| Fax |
|
| Email |
trinitymeetei@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya H K |
| Designation |
PG Trainee |
| Affiliation |
RIMS. |
| Address |
Obstetrics and Gynaecology dept, Room no 1,Regional Institute Of Medical Sciences,Lamphelpat,Imphal,Manipur,India.
795004
Imphal West
MANIPUR
795004
India |
| Phone |
9611819306 |
| Fax |
|
| Email |
aishwaryahk1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynaecology,Regional Institute Of Medical Sciences,Imphal,Manipur,India.795004 |
|
|
Primary Sponsor
|
| Name |
Aishwarya H K |
| Address |
Obstetrics and Gynaecology dept,Room No 1, Regional Institute Of Medical Sciences,Lamphelpat,Imphal,Manipur,India 795004 |
| 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 Aishwarya H K |
Regional Institute Of Medical Sciences |
Obstetrics and Gynaecology dept,Room No 1,Regional Institute Of Medical Sciences,Lamphelpat,Imphal,Manipur,India.795004
Imphal West
MANIPUR |
9611819306
aishwaryahk1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS BOARD RIMS. |
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 |
Inj.Carbetocin |
Study Participants will be randomised into two groups .Intervention group will receive Inj.Carbetocin 100 mcg ,one dose ,IV,after delivery of anterior shoulder of baby during Caeserean section in OT.Duration of action of Inj.Carbetocin is around 1 hr. |
| Comparator Agent |
OXYTOCIN |
Study Participants will be randomised into two groups .Comparator group will receive Inj.Oxytocin 10 units,one dose ,IM(gluteal),after delivery of anterior shoulder of baby during Caeserean section in OT.Duration of action of Inj.Oxytocin is around 2 to 3 hrs.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Age: 18 to 45 years.
2.Period of gestation ≥ 28weeks.
3.Willing to participate in study.
|
|
| ExclusionCriteria |
| Details |
➢ History of epilepsy and coagulation disorders
➢ Eclampsia, HELLP syndrome in present pregnancy
➢ History of classical uterine incision
➢ Patients with Cardiovascular, Renal, Hepatic disorders in present and past pregnancies
➢ Placenta previa
➢ Abruptio placentae
➢ Past h/o PPH |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BLOOD LOSS |
Intra operatively and at 24 hours from OT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.BLOOD PRESSURE
2.UTERINE TONE
3.UTERINE POSITION (according to umblical point )
4.URINE OUTPUT
5.HEMOGLOBIN |
1.BP(INTRA OP AND 2,12,24 HRS POST OP )
2.UTERINE TONE (INTRA OP AND 2,12,24 HRS POST OP)
3.UTERINE POSITION (2,12,24 HRS POST OP )
4.URINE OUTPUT( 2 AND 12 HRS POST OP )
5. HEMOGLOBIN ( 48 HRS AFTER DELIVERY ) |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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 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
|
Postpartum hemorrhage remains the leading cause of maternal mortality in developing countries and a significant proportion of these cases are attributable to uterine atony. In contrast to the advances made in the treatment of postpartum hemorrhage, there has been few novel prophylactic agents. This study will be undertaken to analyze the Effectiveness of carbetocin compared to oxytocin for the prevention of postpartum hemorrhage in caesarean section in singleton pregnancy. With this background, we will be conducting a study to compare the Effectiveness of Carbetocin Versus Oxytocin in Prevention of Postpartum Hemorrhage During Caesarean Section in Singleton Pregnancy : Randomised Clinical Trial This study will be a randomized single blinded, comparative study, to be carried out in 120 participants, undergoing Caesarean section under spinal/general anesthesia/ CESA . The patients will be randomly divided into 2 groups of 60 each. Group A (n=60 ) will receive 100 mcg of Inj. Carbetocin . Group B (n=60 ) will receive 10 IU Inj. Oxytocin. The blood pressure , amount of hemoglobin , need of additional uterotonics , uterine tone , uterine position, urine output, occurrence of adverse effects will be assessed and recorded. All the findings and observations made during the entire study will be tabulated, graphically depicted wherever possible, statistically analysed and inference will be drawn to evaluate and compare the Effectiveness of Carbetocin Versus Oxytocin in Prevention of Postpartum Hemorrhage During Caesarean Section in Singleton Pregnancy. |