Health Condition 1: O72- Postpartum hemorrhage
Conditions
Interventions
Intervention1: Eptacog Alfa: Eptacog alfa (activated) is authorised under the brand name NovoSeven in India for sPPH (Severe Postpartum Haemorrhage) and is indicated for the treatment of bleeding epi
Sponsors
Novo Nordisk India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Informed consent1 obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study except for blood loss estimation post-partum 2. Adult women aged more than or equal to 18 years at the time of signing the informed consent and who deliver after 27 weeks diagnosed with severe PPH who fail to respond to uterotonics. patients to have uterotonics failure i.e. patients in whom uterotonics were insufficient to attain haemostasis and for definition of severe PPH.
Exclusion criteria
Exclusion criteria: 1 Previous participation in this study. Participation is defined as having given informed consent in this study 2 Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation 3 Patient with a history of thromboembolism2 4 Patient with a history of bleeding disorders3 5 Patient with a history of or ongoing disseminated intravascular coagulation (DIC); haemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome, thrombotic thrombocytopenic purpura (TTP), pre-eclampsia or other severe complication of childbirth apart from severe PPH. 6 Have undergone invasive obstetric procedures for the ongoing haemorrhage prior to trial enrolment (uterine balloon tamponade and external aortic compression not included) 7 Any chronic disorder or severe disease which, in the opinion of the Investigator, might jeopardise patientâ??s safety or compliance with the protocol 8 Participation (i.e., signed informed consent) in any other interventional clinical study prior to screening in the current study 1Note: The patientâ??s legally acceptable representative (LAR) may be approached to obtain the informed consent if the patient is not in an appropriate health condition to provide consent. In a scenario where the LAR has provided informed consent, an additional informed consent will be obtained from the patient as soon as she is able to provide informed consent. Includes arterial and venous thrombosis including myocardial infarction, pulmonary embolism, cerebral infarction/thrombosis, deep vein thrombosis, other clinically significant thromboembolic events, and peripheral artery occlusion. Patient with a history of known inherited or acquired coagulation disorder other than PPH. Factor deficiencies such as haemophilia, acquired haemophilia, von Willebrand disease, other factor deficiencies and platelet disorders. These can also include qualitative and quantitative platelet disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of thromboembolic eventsTimepoint: From baseline (day 0) to end of study (day 30) | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of serious adverse eventsTimepoint: From baseline (day 0) to end of study (day 30);Number of allergic reactionsTimepoint: From baseline (day 0) to end of study (day 30);All medication errorsTimepoint: At the time of administration;Near medication errorsTimepoint: At the time of administration | — |
Countries
India
Contacts
Public ContactVijay Parthasarathy
Novo Nordisk India Private Ltd.
Outcome results
None listed