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.
Reversible cerebral vasoconstriction syndrome (RCVS) is characterized by acute and usually severe headache related to multifocal vasoconstriction of cerebral arteries, reversible within 3 months. About 10% of RCVS are pregnancy-related, but only three cases of antepartum RCVS have been described. We report the case of a 26-year-old pregnant woman who presented at 36 weeks gestation with antepartum RCVS. Delivery was managed by cesarean section under general anesthesia. Though she developed focal neurologic deficits on the first postoperative day, these resolved at hospital discharge. This case highlights pre-and post-partum multidisciplinary management including cesarean section under general anesthesia.
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