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Table 1 List of baseline parameters/variables to be assessed for baseline imbalance between treatment groups in the final analysis

From: The FIB-PPH trial: fibrinogen concentrate as initial treatment for postpartum haemorrhage: study protocol for a randomised controlled trial

Baseline parameter/variable
The level of fibrinogen before intervention defined by Clauss method (g/L)
Presence of hypofibrinogenaemia before intervention defined by Clauss method (<2 g/L) and equivalent functional fibrinogen (TEG) MA (< 14 mm or according to validation in this study).
Hypocoagulability prior to intervention measured with standard TEG: R-time >8 min or alpha angle <55° or MA <50 mm or LY30 >8 %
Crystalloids used prior to intervention (ml)
Colloids used prior to intervention (ml)
The use of tranexamic acid prior to intervention (yes/no)
Mode of delivery Caesarean section
Vaginal delivery
Post vaginal procedure Intended manual removal of placenta
Manual exploration of the uterus due to continuous bleeding after the birth of placenta
Estimated blood loss before intervention (ml)*
Primary cause of PPH:
TRAUMA of the birth canal: paravaginal haematoma, cervical laceration, vaginal laceration, perineal laceration, uterine rupture
Retained TISSUE: Retained placental tissue, Percrete or accrete placenta
Impaired THROMBOSIS: disseminated intravascular coagulation, placental abruption, severe pre-eclampsia
Reduced TONE of uterus: uterine atony
Weight of parturient (kg) (because dose of fibrinogen = 2 g/BW kg)
Units of allogenic blood transfusion transfused prior to intervention (numbers of units)
Bleeding duration (from start of bleeding to intervention) (min.)
Time from birth to intervention (min.)
Baseline haemoglobin (measured before intervention) (mmol/L or g/dL)
Method of anaesthesia: general versus regional anaesthesia
  1. Adjusted analysis will be provided and results may guide further research in this field.