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

Tranexamic acid for the treatment of post-partum haemorrhage: An International randomized, double blind placebo controlled trial. - Woman Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/05/002622

Enrollment

15000

Registered

2012-05-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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 chl

Eligibility

Inclusion 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

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

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

Contacts

Public ContactDr Malabika Roy

Indian Council of Medical Research

malaroy69@gmail.com011-26588965

Outcome results