| CTRI Number |
CTRI/2011/091/000045 [Registered on: 17/01/2011] |
| Last Modified On: |
31/12/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the effects of Carbetocin Injection in prevention of uterine atony after cesarean section |
Scientific Title of Study
Modification(s)
|
A Multicentric, Double-blind, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial of the Safety and Efficacy of Injection Carbetocin versus Injection Oxytocin in prevention of uterine atony after cesarean section |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| Precise/Carbetocin/CT/1109, Version 00, 14-11-09 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Manjusha Patankar |
| Designation |
Director |
| Affiliation |
Clinical Medicine Infomatics India Pvt. Ltd. |
| Address |
Clinical Medicine Infomatics (India) Pvt. Ltd.
Bungalow No. 11, Shreesh Society, Hazuri Dargah Road, Thane West
Thane
MAHARASHTRA
586103
India |
| Phone |
918689901144 |
| Fax |
|
| Email |
cmiphase3@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Manjusha Patankar |
| Designation |
Director |
| Affiliation |
Clinical Medicine Infomatics India Pvt. Ltd. |
| Address |
Clinical Medicine Infomatics (India) Pvt. Ltd.
Bungalow No. 11, Shreesh Society, Hazuri Dargah Road, Thane West
Thane
MAHARASHTRA
400604
India |
| Phone |
8689901144 |
| Fax |
|
| Email |
cmiphase3@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Manjusha Patankar |
| Designation |
Director |
| Affiliation |
Clinical Medicine Infomatics India Pvt. Ltd. |
| Address |
Clinical Medicine Infomatics (India) Pvt. Ltd.
Bungalow No. 11, Shreesh Society, Hazuri Dargah Road, Thane West
Mumbai
MAHARASHTRA
400604
India |
| Phone |
8689901144 |
| Fax |
|
| Email |
cmiphase3@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Precise Chemipharma Pvt. Ltd. |
|
Primary Sponsor
Modification(s)
|
| Name |
Precise Chemipharma Pvt Ltd |
| Address |
209, Jhalawar, Patanwala Industrial Estate,L B S Marg, Ghatkopar west,
Mumbai-400086 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Purushottam B Jaju |
B.L.D.E Universitys Shri B.M.Patil Medical College Hospital and R.C. |
Department of Obstetrics and Gynaecology,
BLDE Universitys Shri B.M.Patil Medical College Hospital,
Bijapur - 586103
Bijapur
KARNATAKA |
9845241315
pbjaju@gmail.com |
| Dr Kamalapriya Thiyagarajan |
Bhaktivedanta Hospital and Research Institute |
Department of Obstetrics and Gynecology,
Bhaktivedanta Hospital and Research Institute,
Srishti Complex, Bhaktivedanta Swami Marg,
Mira Road (East), Thane - 401 107
Thane
MAHARASHTRA |
0061401949293
g.sivaprasad@yahoo.com |
| Dr Ratnabali Chakravorty |
ILS Hospital |
AE-768, Salt Lake City,
Sector I, Kolkata - 700064
Kolkata
WEST BENGAL |
9830033958
ratnabalic@yahoo.co.in |
| Dr Tamkin Khan |
J. N. Medical College Hospital, Aligarh Muslim University |
Department of OBGYN, J. N. Medical College
Hospital, A.M.U.
Aligarh-2O2OO2
Aligarh
UTTAR PRADESH
Aligarh
UTTAR PRADESH |
9412485219
tamkinrabbani@gmail.com |
| Dr Rahul Vishwanath Mayekar |
Lokmanya Tilak Municipal Medical College and General Hospital |
Department of Obstetrics and Gynaecology, 1st Floor, College Building,
Sion, Mumbai - 22
Mumbai
MAHARASHTRA |
0222832746
rvmayekar@gmail.com |
| Dr Sunita TS |
S.D.M College of Medical Sciences and Hospital |
Manjushree Nagar,
Sattur
Dharwad 580009
Dharwad
KARNATAKA |
9740420913
srposdm@yahoo.com |
| Dr Anju Kumari Rani |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Gynaecologist,
General Hospital,
S.G.P.G.I.M.S,
Rai Bareli Road,
Lucknow - 226014
Lucknow
UTTAR PRADESH |
9415222085
skanju02@yahoo.co.in |
| Dr Harish Desai |
Sterling Hospital |
Sterling Hospital, 8th floor, Sterling Hospital road, Memnagar, Ahmedabad 380052, Gujarat
Ahmadabad
GUJARAT |
09825773344
harsh.desai@sterlinghospitals.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Bhaktivedanta Hospital Ethics Committee |
Submittted/Under Review |
| Ethics Committee, Bio Ethical Committee, Rajiv Gandhi Center for Diabetes and Endocrinology, Jawaharlal Medical College, Aligarh Muslim University |
Approved |
| ILS Hospital Ethics Committee |
Approved |
| Institutional Ethics Committee Lokmanya Tilak Municipal Medical College |
Approved |
| Institutional Ethics Committee, Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGI) |
Submittted/Under Review |
| Institutional Ethics Committee, SDM College of Medical Sciences and Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Shri BM Patil Medical College, Hospital and Research Center |
Approved |
| Institutional Ethics Committee, Sterling Hospital, 8th Floor, sterling Hospital Road, Memnagar, Ahmedabad 380052, Gujarat |
Submittted/Under Review |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Prevention of uterine atony after cesarean section, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Carbetocin Injection |
For patients in the carbetocin group dose 1 will be 100 µg of carbetocin, and dose 2 will be 2 mL of normal saline solution. |
| Comparator Agent |
Oxytocin injection |
10 IU |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
0.00 Day(s) |
| Gender |
Female |
| Details |
• All subjects with duly filled and signed in ICFs [Informed Consent Forms]
• Female patients >18 years of age with confirmed pregnancy reports and planned for cesarean section through a lower-segment transverse incision under regional anesthesia
• In generally good health
• Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved Informed Consent Form
|
|
| ExclusionCriteria |
| Details |
• Patients unwilling to sign on ICF
• Known hypersensitivity to study drugs
• Diagnosed placenta previa or abruptio placentae
• Use of general anesthesia
• Classic uterine incision for cesarean section
• Previous history of uterine atony and postpartum bleeding
• Twin gestation
• Number of previous cesarean sections
• Grand multiparity (>5 previous deliveries).
• A current or previous history of significant disease including heart disease
• Chronic hypertension requiring treatment
• Liver, renal, or endocrine disorders (other than gestational diabetes)
• History or currently consuming abusing drugs or alcohol
• History of coagulopathy .
• Patients with abnormal clinical chemistry, hematology, urinalysis, or ECG test results that are considered clinically significant by the investigator or the sponsor.
• Patient’s known to be positive for Hepatitis B, Hepatitis C, HIV-1 or HIV-2.
• Patients being treated with any of the excluded medications mentioned in the protocol.
• Participation in other trials or Previous participation in this or any other carbetocin clinical trial
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
On-site computer system |
Blinding/Masking
Modification(s)
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The primary outcome is defined by the need for additional Oxytocic intervention in the 48 hours after delivery to maintain the uterus well contracted, as judged by the investigator, as would be done under usual clinical practice |
48 hours |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
|  Position of the fundus and tone of the uterus |
48 hours |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
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
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
Date Missing |
| 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
Modification(s)
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is A Multicentric, Double-blind, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial of the Safety and Efficacy of Injection Carbetocin versus Injection Oxytocin in prevention of uterine atony after cesarean section that will be conducted in three centres in India |