"Role of Tranexamic Acid (TXA) to reduce the bleeding in post delivery cases"

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2012/05/002622
• Date of registration: 02-05-2012
• Prospective Registration: Yes
• Primary sponsor: Indian Council of Medical Research ICMR
• Public title: "Role of Tranexamic Acid (TXA) to reduce the bleeding in post delivery cases"
• Scientific title: Tranexamic acid for the treatment of post-partum haemorrhage: An International randomized, double blind placebo controlled trial. - Woman Trial
• Date of first enrolment: 15-05-2012
• Target sample size: 15000
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=3902
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 3

Countries of recruitment

Albania, Bangladesh, Cameroon, Colombia, Egypt, Ethiopia, Ghana, India, Pakistan

Contacts

• Name: Dr Malabika Roy
• Affiliation: Indian Council of Medical Research

• Name: Dr Malabika Roy
• Affiliation: Indian Council of Medical Research

Key inclusion & exclusion criteria

Inclusion criteria: 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.
Exclusion criteria: 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)

Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: 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
Control Intervention1: Placebo (Sodium chloride 0.9%): placebo 1 gram intravenous at a rate of 1mL/minute.

Primary Outcome(s)

The primary outcome is the proportion of women who die or undergo hysterectomy. the primary cause of death will be described.Timepoint: 6 weeks

Secondary Outcome(s)

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 effectivenessTimepoint: 6 weeks

Secondary ID(s)

76912190 version 1 dated 22 may 2009

Source(s) of Monetary Support

London School of Hygiene & Tropical Medicine (LSHTM) and Indian Council of Medical Research (ICMR)

Secondary Sponsor(s)

London School of Hygene Tropical Medicine

Ethics review

Status: Approved
Approval date: 23/06/2010
Contact:

Institute Ethics Committee, JIPMER Pondicherry

Status: Approved
Approval date: 13/10/2010
Contact:

Ethics Committee, Meerut

Status: Approved
Approval date: 16/11/2010
Contact:

Institute Ethics Committee, PGIMER, Chandigarh

Status: Approved
Approval date: 20/11/2010
Contact:

Institute Ethics Committee, CSMMU, Lucknow

Status: Approved
Approval date: 25/11/2010
Contact:

Ethical Committee Patna Medical College

Status: Approved
Approval date: 06/12/2010
Contact:

Ethics Committee Kasturba Hospital Delhi

Status: Approved
Approval date: 22/12/2010
Contact:

Ethics Committee,R.G.Kar Medical College, Kolkata

Status: Approved
Approval date: 25/12/2010
Contact:

Insitute Ethics Committe, Govt Medical College, Jammu

Status: Approved
Approval date: 08/01/2011
Contact:

Insitute Ethics Committe, Eden Medical College, Kolkata

Status: Approved
Approval date: 13/01/2011
Contact:

Ethics Committee, GSVM Medical College, Kanpur

Status: Approved
Approval date: 20/01/2011
Contact:

Institutional Ethics Committee, Sir JJ Group Hospital, Mumbai

Status: Approved
Approval date: 08/02/2011
Contact:

Ethics Committee, KLE University Belgaum

Status: Approved
Approval date: 17/02/2011
Contact:

Institutional Ethics Committee, IOG Chennai

Status: Approved
Approval date: 07/03/2011
Contact:

ICMR Institutional Ethics Committee

Status: Approved
Approval date: 05/04/2011
Contact:

Ethical Committee, KMC Chennai

Status: Approved
Approval date: 14/05/2011
Contact:

Institute Ethics Committee, AIIMS

Status: Approved
Approval date: 03/06/2011
Contact:

Office of Ethics Committee, VSSM and Safdarjung Hospital, Delhi

Status: Approved
Approval date: 06/07/2011
Contact:

Ethical Committee, Madurai