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Costly drug may save money in severe childbirth bleeding, but study cut short

NCT ID NCT02900690

Knowledge-focused Sponsor: Centre Hospitalier Universitaire de Nīmes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the costs of treating severe postpartum hemorrhage with a drug called NovoSeven compared to standard care. Researchers wanted to see if the higher drug cost could be offset by avoiding expensive procedures. The trial was terminated early and included 84 women with severe bleeding after childbirth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
recombinant activated factor VII (NovoSeven)
What this could lead to
If successful, it could show whether using NovoSeven is cost-effective for severe bleeding after childbirth, potentially guiding hospital policies.
What could go wrong
The trial was terminated early, so results are limited. It only looked at costs, not whether NovoSeven improves survival or reduces complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

84 people

The number who actually took part.

Started

Apr 2010

Finished

Nov 2010

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Postpartum Hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Health care cost Post partum haemorrhage

Contacts and locations

Locations

  • CHU de Nîmes

    Nîmes, Gard, 30029, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.