Overview

This trial is active, not recruiting.

Conditions health care cost, post partum haemorrhage
Sponsor Centre Hospitalier Universitaire de Nīmes
Start date June 2015
End date July 2017
Trial size 84 participants
Trial identifier NCT02900690, AOI/2009/GL

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective retrospective
Arm
Group using the Novoseven
without use of the Novoseven

Primary Outcomes

Measure
direct medical cost
time frame: day 1

Eligibility Criteria

Female participants at least 18 years old.

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 information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nīmes.