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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.

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Background Post-dural puncture headache (PDPH) is one of the most common complications of neuraxial anaesthesia. It limits patients’ general activity and increases length of hospital stay and use of care. It is particularly disabling during the postpartum period, when mothers have to take care of their child. Epidural blood patch is the standard treatment for PDPH. However, it is an invasive procedure that may result in rare but serious complications. Recent evidence has suggested that adrenocorticotropic hormone (ACTH) is effective in the management of PDPH. The aim of this study is to assess the efficacy and safety of tetracosactide (Synacthen ® ), a synthetic analogue of ACTH, for PDPH treatment in patients who receive neuraxial anaesthesia during labour. Method This randomised, double-blind, placebo-controlled, parallel-arm trial, is performed in two French university hospitals. Eligible patients are those suffering from postpartum PDPH, who are randomised to receive either 1 mg of tetracosactide intravenously over 20 min, or 0.9% saline (placebo). The primary endpoint is the rate of epidural blood patch within a 15-day follow-up period. Headache duration, pain intensity, reduction of general activity, increase in length of hospital stay, adverse events, analgesic use (type and duration), and number of blood patches per patient in each group are recorded. Discussion We expect a decrease in the use of epidural blood patch in those receiving tetracosactide, thus indicating a decrease in PDPH symptoms in these patients. This will define the therapeutic success of tetracosactide and the possibility to use this treatment as a non-invasive alternative to blood patch for PDPH treatment.

Background Post-dural puncture headache (PDPH) is one of the most common complications of neuraxial anesthesia. It limits patients’ general activity and increases hospital length of stay and use of care. It is particularly disabling during the postpartum period, when mothers have to take care of their child. Epidural blood patch is the standard treatment of PDPH. However, it is an invasive procedure that may result in rare but serious complications. Recent evidence suggests the effectiveness of adrenocorticotropic hormone (ACTH) in the management of PDPH. The aim of this study is to assess the efficacy and safety of tetracosactide (Synacthen®), a synthetic analogue of ACTH, in the treatment of PDPH in patients who received neuraxial anesthesia during labor. Method This is a randomized, double-blinded, placebo-controlled, parallel-arm trial, performed in two French university hospitals. Eligible patients are those suffering from postpartum PDPH, who are randomized to receive either 1 mg of tetracosactide intravenously over 20 min, or 0.9% saline (placebo). The primary endpoint of the study is the rate of epidural blood patch within a 15-day follow-up period. Duration of headache, intensity of pain, reduction of general activity, increase of hospital length of stay, adverse events, analgesic use (type and duration), and number of blood patches per patient in each group are recorded. Discussion We expect a decrease in the use of epidural blood patch in those who receive tetracosactide, thus indicating a decrease in PDPH symptoms in these patients. This will define the therapeutic success of tetracosactide and the possibility to use this treatment as a noninvasive alternative to blood patch in the treatment of PDPH.