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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-22

Study Completion Date

2010-11-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Health Care Cost Post Partum Haemorrhage

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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recombinant activated factor VII (NovoSeven®)

Group using the Novoseven

No interventions assigned to this group

Standard care

without use of the Novoseven

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No