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

NCT02900690 | Terminated

• 1 other identifier: AOI/2009/GL
• Study Type: observational
• Target: 84
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Health Care Cost; Post Partum Haemorrhage

Outcome Measures

Primary Outcomes (1)

• direct medical cost

  day 1

Study Arms (2)

recombinant activated factor VII (NovoSeven®)

Group using the Novoseven

Standard care

without use of the Novoseven

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 14, 2016
• Study Start: April 22, 2010
• Primary Completion: November 5, 2010
• Study Completion: November 5, 2010
• Last Updated: March 26, 2018

Record last verified: 2018-03