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TerminatedNCT02900690Updated Jun 18, 2026

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

An observational study in Health Care Cost and Post Partum Haemorrhage, sponsored by Centre Hospitalier Universitaire de Nīmes. Terminated at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
84
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Health Care Cost
  • Post Partum Haemorrhage

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In context

Postpartum Hemorrhage

446 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.

This study's enrollment of 84 is below the median of 150 across 91 observational studies indexed under Postpartum Hemorrhage.

Browse Postpartum Hemorrhage studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
84 participants (actual)
Patient registry
No

Groups and cohorts

  • recombinant activated factor VII (NovoSeven®)

    Group using the Novoseven

  • Standard care

    without use of the Novoseven

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What researchers measure

Primary outcomes

  1. direct medical cost

    Time frame: day 1

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Study locations

1 site
  • CHU de Nîmes
    Nîmes, Gard 30029, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02900690
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Sep 14, 2016
Start date
Apr 22, 2010
Primary completion
Nov 5, 2010
Completion
Nov 5, 2010
Last update
Jun 18, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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