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

Phase 3

Not yet recruiting

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.

Recruitment & Eligibility

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).

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.	6 weeks

Secondary Outcome Measures

Name	Time	Method
a) Death	b) surgical interventions: including hysterectomy, brace suture (b-lynch/cho), selective arterial

Locations (20): All India Institute of Medical Sciences
🇮🇳
South, DELHI, India
Chhatrapati Shahuji Maharaj Medical University, Lucknow
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Lucknow, UTTAR PRADESH, India
EDEN, KOLKATA
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Kolkata, WEST BENGAL, India
Government Rajaji Hospital, Madurai
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Madurai, TAMIL NADU, India
Govt Medical College, SMGS Hospital, Jammu
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JAMMU, & KASHMIR, India
Grants Medical College & Sir JJ Group of Hospitals Mumbai
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Mumbai, MAHARASHTRA, India
GSVM Medical College, Kanpur
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Nagar, UTTAR PRADESH, India
Institute of Obstetrics and Gynecology,Chennai
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Chennai, TAMIL NADU, India
Jawaharlal Institute of Postgraduate Medical Education & Reserach (JIPMER)
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Pondicherry, PONDICHERRY, India
Jawaharlal Nehru Medical College, Belgaum
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Belgaum, KARNATAKA, India
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All India Institute of Medical Sciences
🇮🇳South, DELHI, India
Dr Suneeta Mittal
Principal investigator
01126593378
suneeta.mittal@gmail.com