Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-25 @ 9:02 PM
Study NCT ID:
NCT04444856
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2020-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Study at the University Hospital of Bern
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005167', 'term': 'Factor VII'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D004792', 'term': 'Enzyme Precursors'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2020-06-19', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of invasive procedures (yes/no). (Invasive procedures are defined as: uterine or iliac artery ligation, radiological arterial embolisation, uterine compression sutures, or hysterectomy.)', 'timeFrame': '20 min-24 hours following time 0', 'description': 'Count of participants (yes/no)\n\nTime 0 definition for all endpoints:\n\nTimescale 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.'}], 'secondaryOutcomes': [{'measure': 'Occurrence of thromboembolic events (yes/no)', 'timeFrame': 'From time 0 until 5 days after time 0', 'description': 'Count of participants (yes/no)'}, {'measure': 'Amount of blood products transfused', 'timeFrame': 'From delivery to 24 hours after time 0', 'description': 'Units'}, {'measure': 'Estimated blood loss', 'timeFrame': 'From delivery to 24 hours after time 0', 'description': 'mL'}, {'measure': 'Occurrence of hysterectomy (yes/no)', 'timeFrame': '20 min-24 hours following time 0', 'description': 'Count of participants (yes/no)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Severe Postpartum Haemorrhage']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with severe postpartum haemorrhage (sPPH) who were treated with NovoSeven® or other standard of care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females\n* sPPH, defined as continuous bleeding of more than 1500 mL within 24 hours after delivery\n* Inclusion in one of the four cohorts (historical cohort 1, historical cohort 2, study cohort and new cohort)\n\nExclusion Criteria:\n\n* There are no exclusion criteria'}, 'identificationModule': {'nctId': 'NCT04444856', 'briefTitle': 'Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Study at the University Hospital of Bern', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Retrospective Single-centre Cohort Study at the University Hospital of Bern', 'orgStudyIdInfo': {'id': 'NN7711-4729'}, 'secondaryIdInfos': [{'id': 'EUPAS35429', 'type': 'REGISTRY', 'domain': 'EU PAS Register'}, {'id': 'U1111-1248-2816', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'NovoSeven', 'description': 'Women with severe postpartum haemorrhage treated with NovoSeven', 'interventionNames': ['Drug: Eptacog alfa (activated)']}, {'label': 'Standard of care', 'description': 'Women with severe postpartum haemorrhage treated with standard of care', 'interventionNames': ['Other: Standard of care']}], 'interventions': [{'name': 'Eptacog alfa (activated)', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['NovoSeven']}, {'name': 'Standard of care', 'type': 'OTHER', 'description': 'The women included in the study population have been treated according to local routine clinical practice at the discretion of the treating physician.', 'armGroupLabels': ['Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Clinical Reporting Anchor and Disclosure (1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': '"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}