Health Economics Evaluation of the Management of Severe Postpartum Hemorrhage: Comparison of Recombinant Activated Factor VII Strategy to the Reference Strategy

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Health Care Cost; Post Partum Haemorrhage

Study type: Observational

Funder types: Other

Identifiers

NCT02900690

AOI/2009/GL

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

84 participants in 2 patient groups

recombinant activated factor VII (NovoSeven®)

Description:

Group using the Novoseven

Standard care

Description:

without use of the Novoseven