Fibrinogen in Haemorrhage of Delivery

Phase 4 Completed 448 enrolled LFB

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

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

Publications

Ducloy-Bouthors AS, Mercier FJ, Grouin JM, Bayoumeu F, Corouge J, Le Gouez A, Rackelboom T, Broisin F, Vial F, Luzi A, Capronnier O, Huissoud C, Mignon A; FIDEL working group. Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial. BJOG. 2021 Oct;128(11):1814-1823. doi: 10.1111/1471-0528.16699. Epub 2021 Apr 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fibrinogen Concentrate Human	Protein / enzyme biologic	3 g	Intravenous

Indications

No indication recorded.