Adverse effect

Administration (probate law)

Biology

Surgery

Placebo-controlled study

Fibrinogen

Anesthesia

Environmental health

Placebo

Alternative medicine

Genetics

Political science

Vaginal delivery

Population

Internal medicine

Clinical endpoint

Obstetrics

Medicine

Postpartum haemorrhage

Double blind

Randomized controlled trial

Pregnancy

Pathology

BJOG An International Journal of Obstetrics & Gynaecology

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. Tweetable abstract Early systematic blind 3 g fibrinogen infusion in PPH did not reduce anaemia or transfusion rate, reduced hypofibrinogenaemia and was safe.

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