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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  
Status 
Approved/Obtained 
 
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. 
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