CTRI Number |
CTRI/2012/05/002622 [Registered on: 02/05/2012] Trial Registered Prospectively |
Last Modified On: |
01/05/2012 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
"Role of Tranexamic Acid (TXA) to reduce the bleeding in post delivery cases" |
Scientific Title of Study
|
Tranexamic acid for the treatment of post-partum haemorrhage: An International randomized, double blind placebo controlled trial. |
Trial Acronym |
Woman Trial |
Secondary IDs if Any
|
Secondary ID |
Identifier |
76912190 version 1 dated 22 may 2009 |
ISRCTN |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Malabika Roy |
Designation |
Scientist F |
Affiliation |
Indian Council of Medical Research |
Address |
Ansari Nagar
New Delhi
South DELHI 110029 India |
Phone |
011-26588965 |
Fax |
011-26588755 |
Email |
malaroy69@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Malabika Roy |
Designation |
Scientist F |
Affiliation |
Indian Council of Medical Research |
Address |
Ansari Nagar
New Delhi
South DELHI 110029 India |
Phone |
011-26588965 |
Fax |
011-26588755 |
Email |
malaroy69@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Malabika Roy |
Designation |
Scientist F |
Affiliation |
Indian Council of Medical Research |
Address |
Ansari Nagar
New Delhi
South DELHI 110029 India |
Phone |
011-26588965 |
Fax |
011-26588755 |
Email |
malaroy69@gmail.com |
|
Source of Monetary or Material Support
|
London School of Hygiene & Tropical Medicine (LSHTM) and Indian Council of Medical Research (ICMR) |
|
Primary Sponsor
|
Name |
Indian Council of Medical Research ICMR |
Address |
V. Ramalingaswami Bhavan, Ansari Nagar, New Delhi -110029, India |
Type of Sponsor |
Government funding agency |
|
Details of Secondary Sponsor
|
Name |
Address |
London School of Hygene Tropical Medicine |
Trials coordinating centre Room -180 London School of Hygene & Tropical Medicine Keppel street, London WC1E 7HT |
|
Countries of Recruitment
|
India Albania Bangladesh Cameroon Colombia Egypt Ethiopia Ghana Pakistan |
Sites of Study
|
No of Sites = 20 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Suneeta Mittal |
All India Institute of Medical Sciences |
Room No 3080,3rd floor Teaching Block Department of Obstetrics and Gynecology All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110029 India
New Delhi
DELHI South DELHI |
01126593378 01126588449 suneeta.mittal@gmail.com |
Dr Vineeta Das |
Chhatrapati Shahuji Maharaj Medical University, Lucknow |
Institute of Obstetrics and Gynecology Chhatrapati Shahuji Maharaj Medical University Lucknow- 226003
Lucknow
UTTAR PRADESH Lucknow UTTAR PRADESH |
05222257742 05222257539 das_lko@yahoo.com |
Dr Tapan Kumar Lahiri |
EDEN, KOLKATA |
Institute of Obstetrics and Gynecology Medical College & Eden Hospital Kolkata -700073
Kolkata
WEST BENGAL Kolkata WEST BENGAL |
03322144901 03322144901 ahiritapan@yahoo.co.in |
Dr S Dilshath |
Government Rajaji Hospital, Madurai |
Institute of Obstetrics and Gynecology Government Rajaji Hospital, Madurai - 20 Madurai TAMIL NADU |
04522532535
icmr.grh@gmail.com |
Dr Shashi Gupta |
Govt Medical College, SMGS Hospital, Jammu |
Department of Obstetrics and Gynecology Govt Medical College, SMGS Hospital, Shalimar Road Jammu 180001
Jammu
JAMMU & KASHMIR Jammu JAMMU & KASHMIR |
01912547635 01912584247 drshashi.gupta@yahoo.com |
Dr Rekha G Davar |
Grants Medical College & Sir JJ Group of Hospitals Mumbai |
Balaram Building, 4th floor Department of Obstetrics & Gynecology Grants Medical College and Sir J.J. Group of Hospitals, Byculla, Mumbai - 400008
Mumbai Mumbai MAHARASHTRA |
02223706332 02223735599 rekhagdaver@gmail.com |
Dr Kiran Pandey |
GSVM Medical College, Kanpur |
Department of Obstetrics and Gynecology GSVM Medical College Kanpur 208002
Kanpur Nagar Kanpur Nagar UTTAR PRADESH |
05122543855
dr.kiranpandey@gmail.com |
Dr M Mohanammbal |
Institute of Obstetrics and Gynecology,Chennai |
Institute of Obstetrics and Gynecology Institute of Obstetrics and Gynecology and Hospital for women & Children, Chennai - 600008
Chennai
TAMIL NADU Chennai TAMIL NADU |
04428193094 04428194118 hrrciog@yahoo.com |
Dr Syed Habeebulah |
Jawaharlal Institute of Postgraduate Medical Education & Reserach (JIPMER) |
Jawaharlal Institute of Postgraduate Medical Education & Reserach (JIPMER)Institution of National Importance
Dhanvantri Nagar, Puducherry - 605006 Pondicherry PONDICHERRY |
04132272380 04132272390 oghod@hotmail.com |
Dr B R Desai |
Jawaharlal Nehru Medical College, Belgaum |
Jawaharlal Nehru Medical College Jawaharlal Nehru Medical College Belgaum 590010
Belgaum Belgaum KARNATAKA |
08312473777 08312470759 drbrdesai@yahoo.com |
Dr Asha Aggarwal |
Kasturba Hospital, Delhi |
Department of Obstetrics and Gynecology, Kasturba Hospital Darya Ganj Delhi North DELHI |
01123274376 01123286746 hrrc.khosp@yahoo.com |
Dr Niranjan Mayadeo |
KEM Hospital, Mumbai |
Department of Obstetrics & Gynecology Seth G. S. Medical College and K.E.M. Hospital, Parel, Mumbai - 400012
Mumbai Mumbai MAHARASHTRA |
02224136051 02224143435 nmmkemmumbaihrrc@gmail.com |
Dr A M Famida |
KILPAUK MEDICAL COLLEGE, Chennai |
Institute of Obstetrics and Gynecology KILPAUK MEDICAL COLLEGE, Chennai- 600010 Chennai TAMIL NADU |
04428193094 04428190128 hrrc_oic@yahoo.com |
Dr Abhilasha Gupta |
Lala Lajpat Rai Memorial Medical College, Meerut |
Department of Obstetrics & Gynecology Lala Lajpat Rai Memorial Medical College, Meerut - 250004 Meerut UTTAR PRADESH |
01212769141
hrrcmeerut@yahoo.co.in |
Dr Sushma Pandey |
Patna Medical College, Patna |
Dept of Obstetrics and Gynecology Patna Medical College, Patna - 800004
Patna Patna BIHAR |
06122670132 06122353411 drspandeypnh@yahoo.com |
Dr L K Dhaliwal |
Postgraduate Institute of Medical Education & Research Chandigarh |
Department of Obstetrics and Gynecology Postgraduate Institute of Medical Education and Research, Chandigarh - 160012
Chandigarh Chandigarh CHANDIGARH |
01722756345 01722744401 dhaliwalgynae@yahoo.com |
Dr Joydev Mukherjee |
RG Kar Medical College, Kolkata |
Institute of Obstetrics and Gynecology R.G. Kar Medical College, 1, Belgachia Main Road, Kolkata - 700004
Kolkata
WEST BENGAL Kolkata WEST BENGAL |
03325301673
joydevmukherji@gmail.com |
Dr Shashi Prateek |
Safdarjung Hospital & VMMC |
Room No 162, first floor, OPD Block, Department of Obstetrics and Gynecology Vardaman Mahavir Medical College and Safdarjung Hospital, New Delhi - 110029 India
New Delhi
DELHI South DELHI |
01126707240 01126198108 shashiprateek@yahoo.com |
Dr C Nirmala |
SAT Medical College, Thiruvanathapuram |
Room No 632 Prof and HOD Department of Obstetrics and Gynecology SAT Medical College Thiruvanathapuram - 695011
Thiruvananthapuram
KERALA Thiruvananthapuram KERALA |
04712528362 04712448825 dr.nirmalac@gmail.com |
Dr A K Behra |
SCB Medical College, Cuttack |
Institute of Obstetrics and Gynecology SCB Medical College, Cuttack-753007 Cuttack
Cuttack ORISSA |
06712418841 06712416913 directorhrrc@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 18 |
Name of Committee |
Approval Status |
Ethical Committee Patna Medical College |
Approved |
Ethical Committee, KMC Chennai |
Approved |
Ethical Committee, Madurai |
Approved |
Ethics Committee Kasturba Hospital Delhi |
Approved |
Ethics Committee, GSVM Medical College, Kanpur |
Approved |
Ethics Committee, KLE University Belgaum |
Approved |
Ethics Committee, Meerut |
Approved |
Ethics Committee,R.G.Kar Medical College, Kolkata |
Approved |
ICMR Institutional Ethics Committee |
Approved |
Insitute Ethics Committe, Eden Medical College, Kolkata |
Approved |
Insitute Ethics Committe, Govt Medical College, Jammu |
Approved |
Institute Ethics Committee, AIIMS |
Approved |
Institute Ethics Committee, CSMMU, Lucknow |
Approved |
Institute Ethics Committee, JIPMER Pondicherry |
Approved |
Institute Ethics Committee, PGIMER, Chandigarh |
Approved |
Institutional Ethics Committee, IOG Chennai |
Approved |
Institutional Ethics Committee, Sir JJ Group Hospital, Mumbai |
Approved |
Office of Ethics Committee, VSSM and Safdarjung Hospital, Delhi |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Postpartum Haemorrhage (PPH) |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Placebo (Sodium chloride 0.9%) |
placebo 1 gram intravenous at a rate of 1mL/minute. |
Intervention |
Tranexamic Acid (TXA) |
TXA 1 gram intravenous at a rate of 1 mL/minutes. if bleeding does not stop after 1 hour the same dose will be repeated |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Female |
Details |
All legally adult women with clinically diagnosed postpartum haemorrhage following vaginal delivery of a baby or caesarean section; women may have delivered their babies at a participating hospital of outside a participating hospital, with hospital admission following delivery:
Where the responsible clinician is substantially uncertain as to whether or not to use TXA
When consent has been given according to approved procedures.
The clinical diagnosis of PPH may be based on any of the following:
Estimated blood loss after vaginal delivery of a baby >500 mL OR
>1000 mL from caesarean section OR
Estimated blood loss enough to compromise the haemodynamic status of the woman. |
|
ExclusionCriteria |
Details |
Women for whom the responsible clinician considers there is a clear indication for TXA should not be randomized.
Women for whom the responsible clinician considers there is a clear contraindication for TXA should not be randomized (e.g. a known thrombembolic even during pregnancy) |
|
Method of Generating Random Sequence
|
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
The primary outcome is the proportion of women who die or undergo hysterectomy. the primary cause of death will be described. |
6 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
a) Death
b) surgical interventions: including hysterectomy, brace suture (b-lynch/cho), selective arterial
c) blood transfusion- blood or blood component units transfused
d) health status measured using the EQ-5D
e) Thromboembolic events (myocardial infarction, strokes, pulmonary emoblism, DVT)
f) Other releven medical events
g) lenght of stay at hospital/time spent at an intensive care unit
h) need for mechanical ventilation
i) status of breastfed baby/ies
j) cost effectiveness |
6 weeks |
|
Target Sample Size
|
Total Sample Size="15000" Sample Size from India="15000"
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 3 |
Date of First Enrollment (India)
|
15/05/2012 |
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="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The women Trail aims to determine the effect of the early adminstration of Tranexamic acid on mortality, hysterectomy and other morbidities (surgical interventions, blood tranfusion, risk of nonfatal vascular events) in woman with clinically diagonsed postpartum haemorrhage. the use of health services and safety, espically thromoboembolic effect, on brestfeed babies will also be assessed. |