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

Novo Nordisk A/S225 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

225

Conditions

Severe Postpartum Haemorrhage

Interventions

Eptacog alfa (activated)DRUG

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.

Standard of careOTHER

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

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Bern, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: 20 min-24 hours following time 0

Secondary Outcomes

Occurrence of thromboembolic events (yes/no)

Count of participants (yes/no)

Time frame: From time 0 until 5 days after time 0

Amount of blood products transfused

Units

Time frame: From delivery to 24 hours after time 0

Estimated blood loss

Time frame: From delivery to 24 hours after time 0

Occurrence of hysterectomy (yes/no)

Count of participants (yes/no)

Time frame: 20 min-24 hours following time 0

Data from ClinicalTrials.gov

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