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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS35429 | Registry Identifier | EU PAS Register | |
| U1111-1248-2816 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NovoSeven | Women with severe postpartum haemorrhage treated with NovoSeven |
| |
| Standard of care | Women with severe postpartum haemorrhage treated with standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Women with severe postpartum haemorrhage (sPPH) who were treated with NovoSeven® or other standard of care
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Bern | CH-3010 | Switzerland |
"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D005167 | Factor VII |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
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| Standard of care | Other | The women included in the study population have been treated according to local routine clinical practice at the discretion of the treating physician. |
|
| 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 |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |