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Terminated
NCT02900690
Health Economics Evaluation of the Management of Severe Postpartum Hemorrhage: Comparison of Recombinant Activated Factor VII Strategy to the Reference Strategy
Conditions: Health Care Cost, Post Partum Haemorrhage
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 84
Sponsor: Centre Hospitalier Universitaire de Nīmes
Location: CHU de Nîmes Nîmes Gard
Summary
The main objective of this project is to assess the average cost of the treatment of bleeding postpartum with recombinant activated factor VII (NovoSeven®) and compare it to the reference strategy. Costs related to medicine NovoSeven® can generate surplus, but it also avoids in some cases very costly invasive procedures. It will be interesting to compare the average cost of the complete strategies supported.
Eligibility Criteria
Inclusion Criteria:
* Severe haemorrhage is defined by the following criteria: blood loss greater than 1500 ml graduated measured in the bag and / or hemodynamically unstable and / or requiring transfusion of packed red blood cells (3);
* Sulprostone (Nalador®) ineffective;
* Age over 18 years;
* The term is more than 27 SA (child's viability);
* Without anthropomorphic limit;
* The outcome of the pregnancy is normal or pathological;
* Informed consent "emergency procedure" is signed by the husband or family.
Exclusion Criteria:
* minors, majors in guardianship, with a personal history of venous or arterial thrombosis may cons-indicate treatment with rFVIIa or refuses to sign the consent
Source: ClinicalTrials.gov (NCT02900690). StuddyBuddy aggregates publicly available trial information.