Role of Tranexamic Acid (TXA) to reduce the bleeding in post delivery cases
- Registration Number
- CTRI/2012/05/002622
- Lead Sponsor
- Indian Council of Medical Research ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 15000
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.
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method a) Death <br/ ><br>b) surgical interventions: including hysterectomy, brace suture (b-lynch/cho), selective arterial <br/ ><br>c) blood transfusion- blood or blood component units transfused <br/ ><br>d) health status measured using the EQ-5D <br/ ><br>e) Thromboembolic events (myocardial infarction, strokes, pulmonary emoblism, DVT) <br/ ><br>f) Other releven medical events <br/ ><br>g) lenght of stay at hospital/time spent at an intensive care unit <br/ ><br>h) need for mechanical ventilation <br/ ><br>i) status of breastfed baby/ies <br/ ><br>j) cost effectivenessTimepoint: 6 weeks