Severe Postpartum Haemorrhage
Conditions
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.
Interventions
DRUGEptacog 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.
OTHERStandard 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.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of thromboembolic events (yes/no) | From time 0 until 5 days after time 0 | Count of participants (yes/no) |
| Amount of blood products transfused | From delivery to 24 hours after time 0 | Units |
| Estimated blood loss | From delivery to 24 hours after time 0 | mL |
| Occurrence of hysterectomy (yes/no) | 20 min-24 hours following time 0 | Count of participants (yes/no) |
Countries
Switzerland
Outcome results
None listed