Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT02900690
NCT02900690TerminatedNot Applicable

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

Centre Hospitalier Universitaire de Nīmes1 site in 1 country84 target enrollmentStarted: April 22, 2010Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
84
Locations
1
Primary Endpoint
direct medical cost
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

recombinant activated factor VII (NovoSeven®)

Group using the Novoseven

Standard care

without use of the Novoseven

Outcomes

Primary Outcomes

direct medical cost

Time Frame: day 1

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Study Evaluating the Cost of the Treatments of the Refractory Psoriatic Arthritis to the Conventional TherapyArthritis, Psoriatic, Psoriasis
NCT00303186Pfizer107
Terminated
Not Applicable
Health Economics Evaluation of Percutaneous Vertebroplasty Compared to Radiation Therapy in Patients With Painful Spine Metastases.Spine Metastases
NCT02174107Centre Leon Berard7
Completed
Not Applicable
Observational Study on the Use of IV (Intravenous) Iron Therapy Among Subjects With Iron Deficiency AnemiaIron Deficiency Anemia (IDA)
NCT01984554American Regent, Inc.551
Completed
Not Applicable
Economic Evaluation in Cardiology: Remote Monitoring of PacemakersCardiovascular Disease
NCT02234245Universidad de Almeria83
Recruiting
Not Applicable
Economic evaluation of a therapy for children with Muscular Dystrophy.
CTRI/2021/06/034274Dr Amarjeet Singh