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

Completed

• Conditions: Severe Postpartum Haemorrhage
• Interventions: Drug: Eptacog alfa (activated); Other: Standard of care

• Registration Number: NCT04444856
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Study Start: 2020-06-29
• Status Verified: 2021-01
• Primary Completion: 2021-01-13
• Study Completion: 2021-01-13
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 225

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NovoSeven	Eptacog alfa (activated)	Women with severe postpartum haemorrhage treated with NovoSeven
Standard of care	Standard of care	Women with severe postpartum haemorrhage treated with standard of care

Primary Outcome Measures

Name	Time	Method
Occurrence of invasive procedures (yes/no). (Invasive procedures are defined as: uterine or iliac artery ligation, radiological arterial embolisation, uterine compression sutures, or hysterectomy.)	20 min-24 hours following time 0	Count of participants (yes/no); Time 0 definition for all endpoints: Timescale for matching is time (in hours and minutes) since onset of sPPH. For exposed women: Time 0 is defined as time of first administration of NovoSeven®. It occurs x minutes after onset of sPPH. For matched controls: Time 0 is derived from the matching process. It is equal to the period from onset of sPPH to time of first administration of NovoSeven® for the patient for which they are a matched control.

Secondary Outcome Measures

Name	Time	Method
Amount of blood products transfused	From delivery to 24 hours after time 0	Units
Occurrence of hysterectomy (yes/no)	20 min-24 hours following time 0	Count of participants (yes/no)
Occurrence of thromboembolic events (yes/no)	From time 0 until 5 days after time 0	Count of participants (yes/no)
Estimated blood loss	From delivery to 24 hours after time 0	mL

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇭 Bern, Switzerland