Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Study at the University Hospital of Bern

Novo Nordisk

Status: Completed

Conditions: Severe Postpartum Haemorrhage

Treatments: Drug: Eptacog alfa (activated); Other: Standard of care

Study type: Observational

Funder types: Industry

Identifiers

NCT04444856

NN7711-4729

U1111-1248-2816 (Other Identifier)

EUPAS35429 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 225 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females
• sPPH, defined as continuous bleeding of more than 1500 mL within 24 hours after delivery
• Inclusion in one of the four cohorts (historical cohort 1, historical cohort 2, study cohort and new cohort)

Exclusion criteria

• There are no exclusion criteria

Trial design

225 participants in 2 patient groups

NovoSeven

Description:

Women with severe postpartum haemorrhage treated with NovoSeven

Treatment:

Drug: Eptacog alfa (activated)

Standard of care

Description:

Women with severe postpartum haemorrhage treated with standard of care

Treatment:

Other: Standard of care