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

[Alpha-blockers or phytotherapy as first-line treatment of LUTS/BPH in general medicine: The PERSAT non-interventional study]. / Alpha-bloquants ou phytothérapie en traitement de première intention des SBAU/HBP en médecine générale : l'étude non interventionnelle PERSAT.

PURPOSE: The objective of the PERSAT study was to evaluate first-line treatment of BPH-associated LUTS in real-life conditions. METHODS: This prospective observational study was conducted in France by general practitioners (GP) on patients with moderate to severe LUTS (IPSS ≥12). GPs freely decided to prescribe either an alpha-blocker (AB) or phytotherapeutic treatment (PT). The main criterion was the percentage of responding patients (decrease in total IPSS score ≥3) at 6 months. RESULTS: Of the 849 patients included, 759 were analysed (381 treated with AB and 378 with PT); 718 were followed up at 6 months, 90% of which had no treatment modification. Their inclusion characteristics were similar between the AB and PT groups (mean IPSS: 18.6±4.5 and 17.8±4.1, respectively). Treatment response rates at 6 months were 94.2% [91.2%; 96.4%] in AB and 92.5% [89.2%; 95.1%] in PT. The IPSS decreased by 10.0±5.6 points, with no difference between groups. The proportion of patients bothered by their LUTS (IPSS-QoL ≥4) evolved from 88.5% to 6.5% at 6 months. The improvement of LUTS was perceived by more than 94% of patients (PGI-I) and doctors (CGI-I), 93% of patients were satisfied with the treatment at 6 months, regardless of the treatment initiated. The most reported adverse reactions were ejaculation disorder (3.9% for AB and 0.9% for PT). CONCLUSION: PERSAT confirms in current practice the effectiveness of AB and PT treatments, recommended as first-line treatment in LUTS/BPH. LEVEL OF PROOF: 3.

[Knowledge, practices and expectations in the management of overactive bladder in general practice and gynecology in France]. / Connaissances, pratiques et attentes pour la prise en charge de l'hyperactivité vésicale en France.

INTRODUCTION: Overactive bladder (OAB) is a clinical syndrome characterized by urgency to urinate, with or without urinary incontinence, often associated with nycturia and pollakiuria. The aim of this practice survey is to identify diagnostic modalities and treatment circuits according to the patient's clinical profile and to practitioner's specialty. MATERIAL AND METHODS: A cross-sectional survey was conducted among 262 physicians practicing in France: 181 general practitioners (GPs) and 81 gynecologists. RESULTS: Urinary disorders were more easily addressed with patients by gynecologists than GPs. Behavioral therapy was the most widely used therapeutic measure, however half of the patients abandoned it. In oldest women and men of all ages, drugs were commonly prescribed, nevertheless only 4 out of 10 patients continued the treatment beyond 6months, according to the physicians. Incontinence was the symptom for which patients were in most need of relief. GPs and gynecologists expressed a need for training, practical tools and recommendations related to OAB. CONCLUSION: Patients and doctors are reluctant to talk about urinary disorders. Non-urologist physicians such as GPs and gynecologists, as health professionals best placed to detect and diagnose OAB, are in demand for training, practical tools and recommendations. LEVEL OF EVIDENCE: 3.