{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T18:26:22Z","timestamp":1793557582181,"version":"4.5.0"},"reference-count":33,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2021,4,7]],"date-time":"2021-04-07T00:00:00Z","timestamp":1617753600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJOG"],"published-print":{"date-parts":[[2021,10]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess the benefits and safety of early human fibrinogen concentrate in postpartum haemorrhage (PPH) management.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Multicentre, double\u2010blind, randomised placebo\u2010controlled trial. Setting: 30 French hospitals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Population<\/jats:title>\n                    <jats:p>Patients with persistent PPH after vaginal delivery requiring a switch from oxytocin to prostaglandins.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Within 30\u00a0minutes after introduction of prostaglandins, patients received either 3\u00a0g fibrinogen concentrate or placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main outcome measures<\/jats:title>\n                    <jats:p>Failure as composite primary efficacy endpoint: at least 4\u00a0g\/dl of haemoglobin decrease and\/or transfusion of at least two units of packed red blood cells within 48\u00a0hours following investigational medicinal product administration. Secondary endpoints: PPH evolution, need for haemostatic procedures and maternal morbidity\u2013mortality within 6\u00a0\u00b1\u00a02\u00a0weeks after delivery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      437 patients were included: 224 received FC and 213 placebo. At inclusion, blood loss (877\u00a0\u00b1\u00a0346\u00a0ml) and plasma fibrinogen (4.1\u00a0\u00b1\u00a00.9\u00a0g\/l) were similar in both groups (mean\u00a0\u00b1\u00a0SD). Failure rates were 40.0% and 42.4% in the fibrinogen and placebo groups, respectively (odds ratio [OR]\u00a0=\u00a00.99) after adjustment for centre and baseline plasma fibrinogen; (95%\u00a0CI 0.66\u20131.47;\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.96). No significant differences in secondary efficacy outcomes were observed. The mean plasma FG was unchanged in the Fibrinogen group and decreased by 0.56\u00a0g\/l in the placebo group. No thromboembolic or other relevant adverse effects were reported in the Fibrinogen group versus two in the placebo group.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>As previous placebo\u2010controlled studies findings, early and systematic administration of 3\u00a0g fibrinogen concentrate did not reduce blood loss, transfusion needs or postpartum anaemia, but did prevent plasma fibrinogen decrease without any subsequent thromboembolic events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Tweetable abstract<\/jats:title>\n                    <jats:p>Early systematic blind 3\u00a0g fibrinogen infusion in PPH did not reduce anaemia or transfusion rate, reduced hypofibrinogenaemia and was safe.<\/jats:p>\n                  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