| CTRI Number |
CTRI/2024/02/062430 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing the effectiveness of the drugs between Carbetocin and Oxytocin in the prevention of heavy blood loss during normal vaginal delivery |
|
Scientific Title of Study
|
A Quasi experimental study to compare the efficacy of Carbetocin and Oxytocin in preventing post partum hemorrhage during vaginal delivery in a tertiary care center in Chengalpattu district |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMonisha S |
| Designation |
Junior resident |
| Affiliation |
Shri Sathya Sai Medical College and Research institute |
| Address |
Room No.20,
First floor,
Department of Obstetrics and Gynecology,
Shri Sathya Sai Medical College and Research Institute,
Ammapettai,
Nellikuppam,
Kancheepuram,
Tamilnadu-603108
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9500527523 |
| Fax |
|
| Email |
monisethu3010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ushadevi Gopalan |
| Designation |
Head of the Department |
| Affiliation |
Shri Sathya Sai Medical College and Research institute |
| Address |
Room No.20,
First floor,
Department of Obstetrics and Gynecology,
Shri Sathya Sai Medical College and Research Institute,
Ammapettai,
Nellikuppam,
Kancheepuram,
Tamilnadu-603108
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9940306107 |
| Fax |
|
| Email |
ushag7@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMonisha S |
| Designation |
Junior resident |
| Affiliation |
Shri Sathya Sai Medical College and Research institute |
| Address |
Room No.20,
First floor,
Department of Obstetrics and Gynecology,
Shri Sathya Sai Medical College and Research Institute,
Ammapettai,
Nellikuppam,
Kancheepuram,
Tamilnadu-603108
TAMIL NADU
603108
India |
| Phone |
9500527523 |
| Fax |
|
| Email |
monisethu3010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynecology, Shri Sathya Sai Medical College and Research Institute, Ammapettai, Nellikuppam, Kancheepuram, Tamilnadu-603108 |
|
|
Primary Sponsor
|
| Name |
Dr Monisha S |
| Address |
Room No 1, 3rd floor, A block, Womens hostel Shri Sathya Sai Medical College and Research Institute, Ammapettai, Nellikuppam,Kancheepuram,Tamilnadu-603108 |
| 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 Monisha S |
Shri Sai Medical College and Research Institute |
Department of OBG,1st Floor Labour Room, Shri Sathya Sai Medical College and Research Institute, Ammapettai, Nellikuppam, Kancheepuram, Tamilnadu- 603108
Kancheepuram
TAMIL NADU |
9500527523
monisethu3010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Human Ethics Committee |
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 |
Carbetocin |
Carbetocin, a synthetic analogue of oxytocin, has been recently accepted as an alternative uterotonic in the prevention of Post partum hemorrhage. Carbetocin has been found to have a similar onset of action with longer lasting effect on uterine contractility. The half-life of carbetocin is 40 minutes (4-10 times longer than oxytocin) |
| Intervention |
Oxytocin |
Oxytocin is the drug of choice to prevent and treat Post partum hemorrhage. The half-life of oxytocin ranges from 1-6 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
SINGLETON PREGNANCY
TERM(37 TO 40 WEEKS OF GESTATION)
VAGINAL DELIVERY |
|
| ExclusionCriteria |
| Details |
AGE ABOVE 35 YEARS
PREVIOUS LOWER SEGMENT CAESAREAN SECTION
INSTRUMENTAL VAGINAL DELIVERY INCLUDING FORCEPS OR VACUUM ASSISTED
COMPLETE PERINEAL TEAR DURING NORMAL VAGINAL DELIVERY
HIGH RISK PREGNANCIES INCLUDING
ANTEPARTUM HEMORRHAGE
PLACENTA PREVIA
ABRUPTIO PLACENTA
PIH
PRE ECAMPSIA
ECLAMPSIA
GDM
MULTIPLE PREGNANCIES
POLYHYDRAMNIOS
MACROSOMIA |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of carbetocin with oxytocin in control of post partum hemorrhage |
2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the safety & the additional need of uterotonic agent following carbetocin & oxytocin administration in prevention of post partum hemorrhage in 24 hours |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
15/02/2024 |
| 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="6"
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
|
A QUASI EXPERIMENTAL STUDY TO
COMPARE THE EFFICACY OF CARBETOCIN VS OXYTOCIN IN PREVENTING POST PARTUM HEMORRHAGE
DURING VAGINAL DELIVERY IN A TERTIARY CARE CENTER IN CHENGALPATTU DISTRICT PRIMARY OBJECTIVE:TO ASSESS THE EFFICACY OF CARBETOCIN AND TO
COMPARE IT WITH OXYTOCIN IN CONTROL OF POST PARTUM HEMORRHAGE SECONDARY OBJECTIVE: TO STUDY THE SAFETY OF
CARBETOCIN AND OXYTOCIN FOR USE IN
PREVENTION OF POST PARTUM
HEMORRHAGE.
TO STUDY THE ADDITIONAL NEED OF
UTEROTONIC AGENT FOLLOWING
CARBETOCIN AND OXYTOCIN
ADMINISTRATION. |