This study will look at how safe is the medicine eptacog alfa when used in women in India for stopping heavy bleeding after giving birth. If participants have heavy bleeding after giving birth then they will get the medicine eptacog alfa. This study will be conducted to get more knowledge on the safety of the medicine eptacog alfa use in these women. At first participants will receive one dose of medicine eptacog alfa. If the given dose is not helpful to stop the bleeding, participants will get one additional dose. The study will last for about 30-35 days.
Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study except for blood loss estimation post-partum
Adult women aged greater than or equal to (≥) 18 years at the time of signing the informed consent and who deliver after 27 weeks diagnosed with severe postpartum haemorrhage (PPH) who fail to respond to uterotonics
Previous participation in this study. Participation is defined as having given informed consent in this study
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Patient with a history of thromboembolism
Patient with a history of bleeding disorders
Single group
Eptacog alfa (NovoSeven)
DrugParticipants will receive single dose of intravenous bolus injection of eptacog alfa (NovoSeven)
Number of thromboembolic events
Measured as number of events
Number of serious adverse events
Measured as number of events
Number of allergic reactions
Measured as number of allergic reactions
All medication errors
Measured as number of all medication errors
Near medication errors
Measured as number of near medication errors
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