Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial

Objective: To assess the benefits and safety of early human fibrinogen concentrate in postpartum haemorrhage (PPH) management. Design: Multicentre, double‐blind, randomised placebo‐controlled trial. Setting: 30 French hospitals. Population: Patients with persistent PPH after vaginal delivery requiring a switch from oxytocin to prostaglandins. Methods: Within 30 minutes after introduction of prostaglandins, patients received either 3 g fibrinogen concentrate or placebo. Main outcome measures: Failure as composite primary efficacy endpoint: at least 4 g/dl of haemoglobin decrease and/or transfusion of at least two units of packed red blood cells within 48 hours following investigational medicinal product administration. Secondary endpoints: PPH evolution, need for haemostatic procedures and maternal morbidity–mortality within 6 ± 2 weeks after delivery. Results: 437 patients were included: 224 received FC and 213 placebo. At inclusion, blood loss (877 ± 346 ml) and plasma fibrinogen (4.1 ± 0.9 g/l) were similar in both groups (mean ± SD). Failure rates were 40.0% and 42.4% in the fibrinogen and placebo groups, respectively (odds ratio [OR] = 0.99) after adjustment for centre and baseline plasma fibrinogen; (95% CI 0.66–1.47; P = 0.96). No significant differences in secondary efficacy outcomes were observed. The mean plasma FG was unchanged in the Fibrinogen group and decreased by 0.56 g/l in the placebo group. No thromboembolic or other relevant adverse effects were reported in the Fibrinogen group versus two in the placebo group. Conclusions: As previous placebo‐controlled studies findings, early and systematic administration of 3 g fibrinogen concentrate did not reduce blood loss, transfusion needs or postpartum anaemia, but did prevent plasma fibrinogen decrease without any subsequent thromboembolic events

Postpartum hemorrhage: guidelines for clinical practice from the French ă College of Gynaecologists and Obstetricians (CNGOF) in collaboration ă with the French Society of Anesthesiology and Intensive Care (SFAR)

International audiencePostpartum haemorrhage (PPH) is defined as blood loss >= 500 mL after ă delivery and severe PPH as blood loss >= 1000 mL, regardless of the ă route of delivery (professional consensus). The preventive ă administration of uterotonic agents just after delivery is effective in ă reducing the incidence of PPH and its systematic use is recommended, ă regardless of the route of delivery (Grade A). Oxytocin is the first ă line prophylactic drug, regardless of the route of delivery (Grade A); a ă slowly dose of 5 or 10 IU can be administered (Grade A) either IV or IM ă (professional consensus).After vaginal delivery, routine cord drainage ă (Grade B), controlled cord traction (Grade A), uterine massage (Grade ă A), and routine bladder voiding (professional consensus) are not ă systematically recommended for PPH prevention. After caesarean delivery, ă placental delivery by controlled cord traction is recommended (grade B). ă The routine use of a collector bag to assess postpartum blood loss at ă vaginal delivery is not systematically recommended (Grade B), since the ă incidence of severe PPH is not affected by this intervention. In cases ă of overt PPH after vaginal delivery, placement of a blood collection bag ă is recommended (professional consensus). The initial treatment of PPH ă consists in a manual uterine examination, together with antibiotic ă prophylaxis, careful visual assessment of the lower genital tract, a ă uterine massage, and the administration of 5-10 IU oxytocin injected ă slowly IV or IM, followed by a maintenance infusion not to exceed a ă cumulative dose of 40 IU (professional consensus). If oxytocin fails to ă control the bleeding, the administration of sulprostone is recommended ă within 30 minutes of the PPH diagnosis (Grade C). Intrauterine balloon ă tamponade can be performed if sulprostone fails and before recourse to ă either surgery or interventional radiology (professional consensus). ă Fluid resuscitation is recommended for PPH persistent after first line ă uterotonics, or if clinical signs of severity (Grade B). The objective ă of RBC transfusion is to maintain a haemoglobin concentration (Hb) >8 ă g/dL. During active haemorrhaging, it is desirable to maintain a ă fibrinogen level >= 2 g/L (professional consensus). RBC, fibrinogen and ă fresh frozen plasma (FFP) may be administered without awaiting ă laboratory results (professional consensus). Tranexamic acid may be used ă at a dose of 1 g, renewable once if ineffective the first time in the ă treatment of PPH when bleeding persists after sulprostone administration ă (professional consensus), even though its clinical value has not yet ă been demonstrated in obstetric settings. It is recommended to prevent ă and treat hypothermia in women with PPH by warming infusion solutions ă and blood products and by active skin warming (Grade C). Oxygen ă administration is recommended in women with severe PPH (professional ă consensus). If PPH is not controlled by pharmacological treatments and ă possibly intra-uterine balloon, invasive treatments by arterial ă embolization or surgery are recommended (Grade C). No technique for ă conservative surgery is favoured over any other (professional ă consensus). Hospital-to-hospital transfer of a woman with a PPH for ă embolization is possible once hemoperitoneum is ruled out and if the ă patient's hemodynamic condition so allows (professional consensus). (C) ă 2015 Elsevier Ireland Ltd. All rights reserved