A Research Study to See How Safe is Eptacog Alfa When Used to Stop Heavy Bleeding in Women After Giving Birth in India

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNovo Nordisk A/S

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Eptacog alfa (NovoSeven)

Treatment groups

64 Participants
are divided into 1 treatment group

Sponsors and collaborators