Trials / Completed
CompletedNCT02155725
Fibrinogen in Haemorrhage of Delivery
Study on the Efficacy and Safety of a Therapeutic Strategy of PPH Comparing Early Administration of Human Fibrinogen vs Placebo in Patients Treated With IV Prostaglandins Following Vaginal Delivery
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 448 (actual)
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to assess the benefits of a therapeutic strategy that associates an early administration of human fibrinogen concentrate in the management of PPH on the reduction of bleeding after the initiation of prostaglandins intravenous infusion, following vaginal delivery.
Detailed description
Randomised, double-blind,multicenter, placebo-controlled study
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Human Fibrinogen concentrate | Injection as soon as possible and within 30 min following the start of prostaglandin infusion |
| DRUG | Placebo | As soon as possible and within 30 min following the start of prostaglandin infusion |
Timeline
- Start date
- 2014-04-10
- Primary completion
- 2018-08-06
- Completion
- 2018-08-06
- First posted
- 2014-06-04
- Last updated
- 2020-09-25
- Results posted
- 2020-09-25
Locations
31 sites across 2 countries: France, Martinique
Source: ClinicalTrials.gov record NCT02155725. Inclusion in this directory is not an endorsement.