Heavy bleeding after giving birth is globally a leading cause of death in new mothers
The European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recently adopted a positive opinion recommending an extension of the NovoSeven® label to treat women suffering from severe post-birth bleeding when uterine contractions anti-bleeding medications (uterotonics) are insufficient to stop the bleeding.
Postpartum haemorrhage (PPH) is the most common major childbirth-related haemorrhage. PPH is defined as blood loss of 1500 mL or more within 24 hours of delivery, regardless of the delivery route (vaginal or caesarean). Dizziness, shaking, increased heartbeat, and confusion is all symptoms of severe PPH. The global incidences of PPH and severe PPH are estimated to be 6-11% and 1-3% of all births, respectively, with substantial variations across regions.
Uterotonics failed to control the bleeding in a prospective randomised clinical trial of women with severe PPH. In the primary analysis, fewer women in the NovoSeven® arm (21 vs 35) needed additional medical procedures to stop bleeding, resulting in a 40% relative risk reduction.
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