World Maternal Antifibrinolytic Trial-2
Phase 3
Recruiting
- Conditions
- Pregnancy and Childbirth
- Registration Number
- PACTR201909735842379
- Lead Sponsor
- ondon School of Hygiene and Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 10000
Inclusion Criteria
Women with moderate or severe anaemia (haemoglobin level <100 g/L or packed cell volume <30%),
and who have given birth vaginally
and for who the responsible clinician is substantially uncertain whether to use TXA.
Exclusion Criteria
Women who are not legally adult (<18 years) and permission not provided by a guardian.
Women with a known allergy to TXA or its excipients.
Women who develop PPH before umbilical cord is clamped/cut.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postpartum Haemorrhage (cause will be described) - Clinical assessment: This may be an estimated blood loss of more than 500 mL or any blood loss sufficient to compromise haemodynamic stability within 24 hours of delivery. Haemodynamic instability is based on clinical judgement and assessed using clinical signs (low systolic blood pressure, tachycardia, reduced urine output).
- Secondary Outcome Measures
Name Time Method