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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02900690

Enrollment

Registered

2016-09-14

Start date

2010-04-22

Completion date

2010-11-05

Last updated

2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Care Cost, Post Partum Haemorrhage

Brief 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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
direct medical cost	day 1

Countries

France

Outcome results