| CTRI Number |
CTRI/2024/04/065748 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing injection carbetocin and oxytocin in prevention of bleeding during cesarean delivery |
|
Scientific Title of Study
|
Carbetocin and oxytocin in elective cesarean delivery in patients with high risk of postpartum hemorrhage under spinal anesthesia a comparative double blind randomized control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Somnath debnath |
| Designation |
Post graduate trainee |
| Affiliation |
Tezpur medical college and hospital |
| Address |
Department of anaesthesiology, Tezpur medical college,Tumuki,Bihaguri
Sonitpur
ASSAM
784010
India |
| Phone |
8787894148 |
| Fax |
|
| Email |
somnathdebnath07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dilip kumar saloi |
| Designation |
Professor and HOD |
| Affiliation |
Tezpur medical college and hospital |
| Address |
Department of Anaesthesiology, Tezpur medical college,Tumuki,Bihaguri
Sonitpur
ASSAM
784010
India |
| Phone |
9101291318 |
| Fax |
|
| Email |
dilipkumarsaloi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dilip kumar saloi |
| Designation |
Professor and HOD |
| Affiliation |
Tezpur medical college and hospital |
| Address |
Department of Anaesthesiology, Tezpur medical college,Tumuki,Bihaguri
Sonitpur
ASSAM
784010
India |
| Phone |
9101291318 |
| Fax |
|
| Email |
dilipkumarsaloi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tezpur medical college and hospital,tumuki village,bihaguri,tezpur,sonitpur district,Assam,India, pin-784010 |
|
|
Primary Sponsor
|
| Name |
Tezpur medical college and hospital |
| Address |
Tezpur medical college and hospital,Tumuki,Bihaguri,Sonitpur, Assam,India, pin-784010 |
| Type of Sponsor |
Government 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 |
| Somnath debnath |
Tezpur medical college and hospital |
Department of anesthesia and critical care, TMCH
Sonitpur
ASSAM |
8787894148
somnathdebnath07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tezpur medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O720||Third-stage hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
injection carbetocin and injection oxytocin |
Intravenous injection carbetocin 100mcg bolus over 1 minute and oxytocin 20IU in 1000ml Normal saline(0.9%) at 150ml/hr given after delivery of anterior shoulder of the baby |
| Intervention |
injection of uterotonic agents |
intravenous injection carbetocin 100mcg bolus over 1 minute and oxytocin 20IU in 1000ml Normal saline(0.9%) at 150ml/hr given after delivery of anterior shoulder of the baby. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Parturients of the ASA grade 1 and 2 with gestation of 37 weeks or more, who had an elective cesarean delivery under spinal anesthesia with risk factors of postpartum haemorrhage such as multiple pregnancy,two or more previous cesarean section,presence of uterine fibroids,previous myomectomy,past history of postpartum haemprrhage,prolonged labor,fetal macrosomia,BMI 35 and more and fetal malformations with polyhydramnios |
|
| ExclusionCriteria |
| Details |
ASA garde 2, allergy to study drugs,patients contraindicated for spinal anesthesia,Declined to participate,premature rupture of memebrane,pregnancy induced hypertension,antepartum haemorrhage,patients in active labor,inadequate block after apinal anaesthesia,history of epilepsy,diabetes mellitus,ischemic heart disease,cerebrovascular disease,hepatic and renal disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Oxytocin and carbetocin in terms of adequate uterine contractility and prevention of intraoperative blood loss |
To assess the efficacy of Oxytocin and carbetocin in terms of adequate uterine contractility and prevention of intraoperative blood loss in first 24 hrs of delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
compare the heamodynamic effects of carbetocin and oxytocin(HR,MAP,ECG)
to asses the need for additional uterotonics in cesarean section at high risk of PPH
adverse effects of Oxytocin and carbetocin |
heamodynamic stability in each group for 24 hrs |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
24/04/2024 |
| 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="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 Haemorrhage is the most common cause of maternal mortality worldwide and accounts for nearly one-quarter of all maternal pregnancy related deaths. Currently, WHO recommends active management of third stage of labor for prevention of postpartum Haemorrhage which includes administration of uterotonics after delivery of anterior shoulder,i.e, Inj.Oxytocin 20 IU . Carbetocin has been recommended by WHO as an effective uterotonic in its 2018 guidelines for prevention of PPH.100 micrograms (mcg) of Carbetocin, injected as a slow Iv bolus over 1 minute, should be used instead of continuous oxytocin infusion in elective cesarean section to prevent PPH. This study intend to evaluate the efficacy and safety of carbetocin compared to oxytocin in prevention of postpartum haemorrhage in high risk patients of post partum haemorrhage posted for cesarean delivery in Tezpur medical college and Hospital. |