| CTRI Number |
CTRI/2025/03/081722 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare efficacy of carbetocin versus oxytocin for prevention of post partum hemorrhage. |
|
Scientific Title of Study
|
A randomized controlled, open labelled clinical trial comparing the efficacy of carbetocin versus oxytocin in prevention of post partum hemorrhage. |
| 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 V Bhuvaneshwaran |
| Designation |
Post graduate trainee |
| Affiliation |
|
| Address |
c/o- Dr. Suneeta Dutta ,
Department of anaesthesiology,
Silchar medical college and hospital, Silchar,
Assam.
Cachar
ASSAM
788014
India |
| Phone |
8668122946 |
| Fax |
|
| Email |
bhuvaneshwaranv1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Deepannita sutradhar |
| Designation |
Associate professor |
| Affiliation |
|
| Address |
Department of anaesthesiology,
Silchar medical college and hospital, Silchar,
Assam.
Cachar
ASSAM
788014
India |
| Phone |
7002209146 |
| Fax |
|
| Email |
dipanitasutradhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Deepannita sutradhar |
| Designation |
Associate professor |
| Affiliation |
SILCHAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of anaesthesiology, Silchar medical college and hospital, Silchar, Assam.
Cachar
ASSAM
788014
India |
| Phone |
8668122946 |
| Fax |
|
| Email |
dipanitasutradhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr V.Bhuvaneshwaran, Post graduate trainee, Department of anaesthesiology and critical care, Silchar medical college and hospital, Silchar, Assam. |
|
|
Primary Sponsor
|
| Name |
DR. V. BHUVANESHWARAN |
| Address |
DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE, SILCHAR MEDICAL COLLEGE AND HOSPITAL, GHUNGOOR, MASIMPUR, SILCHAR 788014 |
| 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 V Bhuvaneshwaran |
silchar medical college and hospital |
dept of anaesthesiology and critical care,
Silchar medical college and hospital,
Silchar.
Cachar
ASSAM |
8668122946
bhuvaneshwaranv1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee , Silchar medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patient came for cesarean section having high risk for PPH |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
COMPARISON BETWEEN CARBETOCIN VERSUS OXYTOCIN FOR PREVENTION OF POST PARTUM HEMORRHAGE, HEMODYNAMIC PROFILE |
in this study demographic profile, hemodynamic variable with post operative blood loss untill 24 hrs postpartum period is evaluated. tonicity of uterus in post part period is also considered |
| Intervention |
INTERVENTION DONE IN CASE OF CARBETOCIN VERSUS OXYTOCIN FOR PREVENTION OF POST PARTUM HEMORRHAGE |
AIM
•To assess the efficacy of carbetocin and oxytocin in preventing post-partum haemorrhage.
OBJECTIVES
1.Primary outcome is to compare the efficacy of carbetocin and oxytocin in preventing intraoperative blood loss
2. Secondary outcome to compare the hemodynamic outcome and uterine atony.
TECHNIQUE OF ANAESTHESIA
patients with high risk of PPH posted for elective cesarean section will be selected and divided randomly by simple random sampling and divided into two groups.
Pre- anaesthetic evaluation will be done the day prior to the operation and patient will be premedicated with Inj. Ranitidine 50 mg iv the night before . NPO will be maintained for 6 hours for solids and 4 hours for liquids and all the patients will receive maintenance fluids with I.V RL.
On arrival at the O.T all patients will be connected to standard monitor . After clamping the umbilical cord of baby patient in Group CP will be receive Inj. Carbetocin 100 micrograms diluted in 10 ml RL and injected over 2 mins and patient in Group OP will receive oxytocin 10 U in 1000 ml RL @125ml/ hr. Blood loss will be estimated by weighing the difference in weight of the dry and blood soaked gauge and the amount of blood in suction container.
Uterine tone will be assessed with palpation with the assistance of the surgeon.
Continuous hemodynamic monitoring will be done throughout the perioperative period till 24 hrs starting from the initiation of the surgery.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Women aged 18 yrs to 50 years.
2.Multiple pregnancy.
3.Scheduled for Elective cesarean section under spinal anaesthesia.
4.Prolonged third stage labour.
5.Fetal macrosomia.
6.History of post partum hemorrhage.
7.Grand multiparity.
8.Placenta previa.
9.Placental abruption.
10.Pregnancy induced hypertension.
11.ASA I and II. |
|
| ExclusionCriteria |
| Details |
1.Patient refusal.
2.History of thromboembolic disorder.
3.Patients suffering from other chronic illness like COPD or any active LRTI.
4.Preexisting neuropathy.
5.Eclampsia and HELLP syndrome.
6.Contraindication to Spinal anesthesia.
7.Any known allergy to local anaesthetia or general anaesthesia.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is to compare the efficacy of carbetocin and oxytocin in preventing intraoperative blood loss |
1.(T0) at carbetocin /oxytocin injection.
2.(T1) end of operation procedure.
3. (T3) 2 hr post operative period.
4. (T4) 12 hr post operative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| haemodynamic variable |
after administering two drugs take taken in T1 min
T3min
T5min
T10min
T15min
T45min
T60min
T75min
T90min |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/03/2025 |
| 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
|
To summarise this study, postpartum haemorrhage is a major concern nowadays in high-risk patients for PPH undergoing cesarean section. although oxytocin is a gold standard drug in preventing PPH and carbetocin a novel drug came to the market with flying colours is used to prevent PPH, comparing these two drugs by administering to high risk PPH patients who are all undergoing c section. in this study we can measure the hemodynamic variability in both intra operative as well post operative period. |