At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 448 enrolled
Drug / intervention
Human Fibrinogen concentrate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Laboratoire français de Fractionnement et de Biotechnologies·interventional·Posted Jun 4, 2014·Updated Sep 25, 2020
In Brief
A Phase 4 clinical trial evaluating Human Fibrinogen concentrate and Placebo for Post-Partum Hemorrhage. Completed, enrolled 448 participants across 31 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-Partum Hemorrhage
CountriesFrance, Martinique
Collaborators--
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartApr 2014
First PostedJun 2014
Primary CompletionAug 2018
TodayJul 2026
First PostedJun 4, 2014
Enrollment StartApr 10, 2014
Primary CompletionAug 6, 2018
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 12.1 years ago
Interventions
Human Fibrinogen concentratedrug
Injection as soon as possible and within 30 min following the start of prostaglandin infusion
Placebodrug
As soon as possible and within 30 min following the start of prostaglandin infusion