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

Study Overview
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Brief Summary
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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.

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

Conditions
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Severe Postpartum Haemorrhage

Intervention / Treatment
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* Drug: Eptacog alfa (activated)
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NovoSeven<br>Women with severe postpartum haemorrhage treated with NovoSeven | Drug: Eptacog alfa (activated)<br>* 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.<br>|
| Standard of care<br>Women with severe postpartum haemorrhage treated with standard of care | Other: Standard of care<br>* The women included in the study population have been treated according to local routine clinical practice at the discretion of the treating physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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