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Fibrinogen in Haemorrhage of Delivery

NCT02155725 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2020-09-25

Study results available
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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.

Conditions

  • Post-Partum Hemorrhage

Interventions

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

Sponsors & Collaborators

  • Laboratoire français de Fractionnement et de Biotechnologies

    lead INDUSTRY

Principal Investigators

  • Anne-Sophie DUCLOY-BOUTHORS, Dr · Maternité Jeanne de Flandre - 59037 LILLE

  • Frédéric MERCIER, Pr · Hôpital Antoine Béclère - 92140 CLAMART

  • Alexandre MIGNON, Pr · Hôpital Cochin - 75014 PARIS

  • Cyril HUISSOUD, Pr · Hôpital Croix Rousse - 69004 LYON

  • Jean-Marie GROUIN · Université de Rouen - 76100 ROUEN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-10
Primary Completion
2018-08-06
Completion
2018-08-06

Countries

  • France
  • Martinique

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02155725 on ClinicalTrials.gov