| CTRI Number |
CTRI/2024/03/064722 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs for control of bleeding after vaginal delivery,in one arm drug named carbetocin alone and in other arm combination of carbetocin with methergine. |
|
Scientific Title of Study
|
EFFICACY OF CARBETOCIN ALONE AGAINST CARBETOCIN WITH METHYL ERGOMETRINE MALEATE IN ACTIVE MANAGEMENT OF THIRD STAGE OF LABOUR IN VAGINAL DELIVERIES-A DOUBLE BLINDED RANDOMISED CONTROL TRIAL. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Fathima Najeeb |
| Designation |
DNB post graduate resident |
| Affiliation |
Rajagiri hospital |
| Address |
Department of Obstetrics and gynecology
Rajagiri hospital
Chunangamvely
Aluva
Ernakulam
KERALA
683112
India |
| Phone |
9995210143 |
| Fax |
|
| Email |
getpathu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ambujam k |
| Designation |
HOD and Senior consultatnt |
| Affiliation |
Rajagiri hospital |
| Address |
Department of obstetrics and gynecology
Rajagiri hospital
Chunangamvely
Aluva
Ernakulam
KERALA
683112
India |
| Phone |
9447092467 |
| Fax |
|
| Email |
k.ambujam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ambujam k |
| Designation |
HOD and Senior consultatnt |
| Affiliation |
Rajagiri hospital |
| Address |
Department of Obstetrics and gynecology
Rajagiri hospital
Chunangamvely
Aluva
Ernakulam
KERALA
683112
India |
| Phone |
9447092467 |
| Fax |
|
| Email |
k.ambujam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rjagiri Hospital
Chunangamvely,Aluva
683112 |
|
|
Primary Sponsor
|
| Name |
Dr Fathima najeeb |
| Address |
Rajagiri hospital
Chunangamvely
Aluva,683112 |
| 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 Fathima najeeb |
Rajagiri hospital |
Rajagiri hospital
Department of obstetrics and gynecology
Chunangamvely
Aluva,683112
Ernakulam
KERALA |
9995210143
getpathu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RAJAGIRI HOSPITAL INSTITUTIONAL 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 |
COMBINATION OF CARBETOCIN WITH METHYL ERGOMETRINE MALEATE |
CARBETOCIN 100MCG INTRAVENOUS AFTER DELIVERY OF ANTEROIR SHOULDER OF BABY AND METHYL ERGOMETRINE MALEATE 0.2MG INTRAMUSCULAR AFTER DELIVERY OF PLACENTA .STUDY DURATION IS FOR A PERIOD OF 15 MONTHS. |
| Intervention |
FOR ACTIVE MANAGEMENT OF THIRD STAGE OF LABOUR, A DRUG CARBETOCIN IN ONE ARM |
CARBETOCIN 100MCG SLOW INTRAVENOUSLY GIVEN AFTER DELIVERY OF ANTERIOR SHOULDER OF BABY.STUDY DURATION IS FOR A PERIOD OF 1 YEAR |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
WOMEN EXPECTED TO GIVE BIRTH VAGINALLY
TERM GESTATION
PRIMI AND MUTIGRAVIDA
MUTIPLE PREGNANCIES
RECIEVING ALL MODE OF ANALGESIA |
|
| ExclusionCriteria |
| Details |
PRETERM AND POST DATED PREGNANCIES
WOMEN UNDERGOING CAESAREAN SECTION
ABRUPTIO PLACENTA AND PLACENTA PREVIA
GESTATIONAL HYPERTENSION AND CHRONIC HYPERTENSION
ABNORMAL LIE
KNOWN CASE OF EPILEPSY CARDIAC AND RESPIRATORY DISORDERS |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
COMPARE MEAN BLOOD LOSS IN BOTH GROUPS
USE OF ADDITIONAL UTEROTONICS
OCCURANCE OF POSTPARTUM HEMORRHAGE
REQUIREMENT OF BLOOD TRASFUSION
HEMOGLOBIN DROP
|
FROM TIME OF DELIVERY TO POST NATAL DAY 2
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
BLOOD PRESSURE
PULSE
SIDE EFFECTS OF
NAUSEA
VOMITING
HYPOTENSION
RETAINED PLACENTA |
1 HOUR |
|
|
Target Sample Size
|
Total Sample Size="430"
Sample Size from India="430"
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)
|
01/04/2024 |
| 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="3"
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
|
FOR ACTIVE MANAGEMENT OF THIRD STAGE OF LABOUR,WE ARE COMPARING THE EFFICACY OF CARBETOCIN ALONE AGAINST CARBETOCIN WITH METHYL ERGOMETRINE MALEATE IN VAGINAL DELIVERIES.According to a study conducted in our department ,Efficacy of carbetocin against oxytocin in active management of third stage of labour,states that there is no significant difference in blood loss in both groups.Hence we proposed to combine another cost effective uterotonic methergine for a better outcome for further control of bleeding to ensure adequate patient care and improve the quality of life and to keep a check in postpartum morbidity. |