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.

Epidural analgesia with 0.15% ropivacaine plus sufentanil 0.5 microgram ml-1 versus 0.10% bupivacaine plus sufentanil 0.5 microgram ml-1: a double-blind comparison during labour.

BACKGROUND: Ropivacaine has been claimed to produce less motor block than bupivacaine during epidural analgesia. However, this advantage has not been clearly confirmed in obstetric studies using low analgesic concentrations in a ratio close to that suggested to be equianalgesic. METHODS: This double-blind, randomized, prospective study was performed in 140 parturients who requested epidural analgesia. After a lumbar epidural catheter had been placed, patients received either 0.10% bupivacaine plus sufentanil 0.5 microgram ml-1 or 0.15% ropivacaine plus sufentanil 0.5 microgram ml-1 followed by a continuous infusion. Additional boluses were used for inadequate levels of analgesia. Visual analogue pain scores, motor block, level of sensory block, supplementary boluses and main characteristics of labour were recorded. RESULTS: No differences were observed between the two groups for pain scores, total volume of anaesthetic solution used [59 (23) and 57 (24) ml in the bupivacaine and ropivacaine groups respectively], duration of labour, mode of delivery, side-effects or satisfaction score. The incidence of motor block was not statistically different between the groups (54 and 69% in the bupivacaine and ropivacaine groups respectively, P = 0.07). However, when motor block occurred, survival analysis showed that it occurred sooner in the course of labour with ropivacaine compared with bupivacaine (log rank test, P = 0.012). CONCLUSION: Combined with sufentanil 0.5 microgram ml-1, 0.10% bupivacaine and 0.15% ropivacaine produce effective and equivalent analgesia during labour, with similar incidences of motor block.