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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02900690
Recruitment Status : Terminated
First Posted : September 14, 2016
Last Update Posted : March 26, 2018
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease
Health Care Cost Post Partum Haemorrhage

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Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Other
Time Perspective: Retrospective
Actual Study Start Date : April 22, 2010
Actual Primary Completion Date : November 5, 2010
Actual Study Completion Date : November 5, 2010

Resource links provided by the National Library of Medicine

recombinant activated factor VII (NovoSeven®)
Group using the Novoseven
Standard care
without use of the Novoseven

Primary Outcome Measures :
  1. direct medical cost [ Time Frame: day 1 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The population of this study is the population described in "rhuFVIIa in Post-partum Hemorrhage " NCT00370877

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

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Responsible Party: Centre Hospitalier Universitaire de Nīmes Identifier: NCT02900690     History of Changes
Other Study ID Numbers: AOI/2009/GL
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage