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

March 23, 2018 updated by: Centre Hospitalier Universitaire de Nīmes
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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

84

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The population of this study is the population described in "rhuFVIIa in Post-partum Hemorrhage " NCT00370877

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
direct medical cost
Time Frame: day 1
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2010

Primary Completion (Actual)

November 5, 2010

Study Completion (Actual)

November 5, 2010

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

September 9, 2016

First Posted (Estimate)

September 14, 2016

Study Record Updates

Last Update Posted (Actual)

March 26, 2018

Last Update Submitted That Met QC Criteria

March 23, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOI/2009/GL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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