Introduction Clinical outcomes and critical care utilisation associated with Coronavirus Disease 2019 (COVID-19) in obstetric patients remain limited particularly in relation to severe cases. Methods A retrospective multicentre cohort study was conducted during the first wave of COVID-19 in France in 18 tertiary referral maternity units. Consecutive women with confirmed or suspected COVID-19 during pregnancy or the delivery hospitalisation were included between March and July 2020 (17-week period). We report clinical, obstetrical and anaesthetic outcomes of pregnant women with COVID-19 and report the prevalence of severe forms and risk factors for respiratory support in this cohort. Results There were 126 included cases; RT-PCR testing occurred in 82 cases, of which 64 (78%) had a positive test. The caesarean section rate was 52%, and preterm delivery (< 37 weeks) rate was 40%. Neuraxial anaesthesia was performed in 108 (86%) cases with an increasing proportion compared to general anaesthesia over time ( p < 0.0002). Twenty-eight cases received oxygen supplementation (nasal oxygen therapy or mechanical ventilation); the SOFAresp score was associated with gestational age at the time of COVID-19 presentation ( p = 0.0036) and at delivery ( p < 0.0001). Postpartum intensive care unit (ICU) admission occurred in 21 cases (17%) with 17 (13%) receiving invasive or non-invasive ventilation. Pre-delivery factors associated with postpartum ventilation were oxygen support, oxygen saturation and haemoglobin levels. Conclusion In our cohort, COVID-19 was associated with significant maternal morbidity resulting in high ICU admission rates (17%) and invasive or non-invasive ventilation utilisation (10%).
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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