| CTRI Number |
CTRI/2024/08/072930 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
17/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Carbetocin vs Prostadin in patients- Best drug for postpartum bleeding in cesarean deliveries. |
|
Scientific Title of Study
|
Effectiveness and safety of Carbetocin vs Prostadin in patients with high risk of postpartum hemorrhage undergoing caesarean section - A Randomised control 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 VISHRUTHA SRI S |
| Designation |
DNB (OBGYN) RESIDENT |
| Affiliation |
Dr rangarajan memorial hospital; Sundaram Medical Foundation |
| Address |
Sundaram medical foundation,
Labour room, 2nd floor, Main hospital,Shanti colony,
Anna nagar
Chennai.
Chennai
TAMIL NADU
600048
India |
| Phone |
6379438858 |
| Fax |
|
| Email |
vishrutha30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR K UMA |
| Designation |
MBBS., M.D.(Obst.& Gynaec.)., D.N.B. (Obst.& Gynaec.)., DGO., |
| Affiliation |
Dr rangarajan memorial hospital; Sundaram Medical Foundation |
| Address |
Sundaram Medical Foundation,Labour Room, 2nd floor, Main hospital, Shanti colony, Anna nagar, Chennai
Chennai
TAMIL NADU
600048
India |
| Phone |
9840370004 |
| Fax |
|
| Email |
druma@smfhospital.org |
|
Details of Contact Person
Public Query
|
| Name |
DR VISHRUTHA SRI S |
| Designation |
DNB (OBGYN) RESIDENT |
| Affiliation |
Dr Rangarajan memorial hospital; Sundaram Medical Foundation |
| Address |
Sundaram Medical Foundation,Labour Room, 2nd floor, Main hospital, Shanti colony, Anna nagar, Chennai
Chennai
TAMIL NADU
600048
India |
| Phone |
6379438858 |
| Fax |
|
| Email |
vishrutha30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rangarajan memorial hospital/ Sundaram Medical Foundation
Main hospital,
Shanti colony,
Anna nagar,
Chennai,
Tamilnadu,
600048
India. |
|
|
Primary Sponsor
|
| Name |
Dr Rangarajan memorial hospital/ Sundaram Medical Foundation |
| Address |
Department of Obstetrics and Gynecology Shanthi Colony 4th Avenue Anna Nagar Chennai Tamilnadu 600040 Chennai TAMIL NADU 600040 India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 VISHRUTHA SRI S Post graduate |
Dr Rangarajan Memorial Hospital, Sundaram Medical Foundation |
Labour Room, 2nd floor , Shanti colony, Anna Nagar.
Chennai
TAMIL NADU |
6379438858
vishrutha30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Rangarajan Memorial Hospital, Sundaram Medical Foundation |
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 |
| Intervention |
Injection Carbetocin |
100mcg Carbetocin IV given over 1 minute immediately after delivery. |
| Comparator Agent |
Injection Prostadin |
Injection Prostadin 250mcg IM Stat given immediately after delivery. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Prolonged labour
Multiple pregnancies
Obesity
Anemia
Macrosomia |
|
| ExclusionCriteria |
| Details |
Normal delivery
Hypersensitivity to drugs
Bronchial asthma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Need for additional uterotonics and blood transfusion |
24 hours at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="59"
Sample Size from India="59"
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)
|
28/08/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 assess the effectiveness of Carbetocin vs Prostadin in patients with high risk of postpartum hemorrhage in patients undergoing cesarean section by assessing the need for any further uterotonics or blood transfusion in first 24 hours post LSCS. |