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

Post Partum Haemorrhage Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02900690
• Other study ID #: AOI/2009/GL
• Status: Terminated
• First received: September 1, 2016
• Last updated: March 23, 2018
• Start date: April 22, 2010
• Est. completion date: November 5, 2010

Study information

• Verified date: March 2018
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: November 5, 2010
• Est. primary completion date: November 5, 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Care Cost
• Hemorrhage
• Post Partum Haemorrhage
• Postpartum Hemorrhage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	direct medical cost		day 1