NN7711-4729 Clinical outcomes of NovoSeven® treatment in severe postpartum haemorrhage – a retrospective single-centre cohort study at the University Hospital of Bern

Study identification

• EU PAS number:
  EUPAS35429
• Study ID:
  44949
• Official title and acronym:
  NN7711-4729 Clinical outcomes of NovoSeven® treatment in severe postpartum haemorrhage – a retrospective single-centre cohort study at the University Hospital of Bern
• DARWIN EU® study:
  No
• Study countries:
  Switzerland
• Study description:
  This non-interventional study will compare the clinical outcomes in women with an event of severe postpartum haemorrhage treated with NovoSeven® to clinical outcomes in women with an event of severe postpartum haemorrhage not treated with NovoSeven®. The study will be a single centre retrospective cohort study of women with an event of severe postpartum haemorrhage, defined as 1.5 L of blood loss within 24 hours of delivery, in the period of 2005-2016.
• Study status:
  Finalised

Research institutions and networks

Institutions

Novo Nordisk

Study timelines

Date when funding contract was signed

Actual: 20/05/2020

Study start date

Planned: 22/06/2020

Actual: 29/06/2020

Date of final study report

Planned: 13/01/2022

Actual: 02/09/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

WHO UTN: U1111-1248-2816