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

Severe Postpartum Haemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04444856
• Other study ID #: NN7711-4729
• Secondary ID: EUPAS35429U1111-
• Status: Completed
• Start date: June 29, 2020
• Est. completion date: January 13, 2021

Study information

• Verified date: January 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: January 13, 2021
• Est. primary completion date: January 13, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Severe Postpartum Haemorrhage

Intervention

Drug:
• Eptacog alfa (activated)
The women included in the study population have been treated with NovoSeven® (eptacog alfa (activated)) according to local routine clinical practice at the discretion of the treating physician.

Other:
• Standard of care
The women included in the study population have been treated according to local routine clinical practice at the discretion of the treating physician.

Locations

Country	Name	City	State
Switzerland	Novo Nordisk Investigational Site	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of invasive procedures (yes/no). (Invasive procedures are defined as: uterine or iliac artery ligation, radiological arterial embolisation, uterine compression sutures, or hysterectomy.)	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.	20 min-24 hours following time 0
Secondary	Occurrence of thromboembolic events (yes/no)	Count of participants (yes/no)	From time 0 until 5 days after time 0
Secondary	Amount of blood products transfused	Units	From delivery to 24 hours after time 0
Secondary	Estimated blood loss	mL	From delivery to 24 hours after time 0
Secondary	Occurrence of hysterectomy (yes/no)	Count of participants (yes/no)	20 min-24 hours following time 0