Fibrinogen concentrate and maternal outcomes in severe postpartum hemorrhage: A population-based cohort study with a propensity score-matched analysis |
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| Institution: | 1. Université Paris Cité, INSERM, INRA, Centre for Epidemiology and Statistics Sorbonne Paris Cité (CRESS), Obstetrical Perinatal and Pediatric Epidemiology Research Team, EPOPé, Maternité Port Royal, 53 avenue de l''Observatoire, F-75014 Paris, France;2. Université Paris Cité, Department of Anesthesia, Louis Mourier Hospital, AP-HP, 178 rue des Renouillers, F-92700 Colombes, France;3. Clinical Research Unit Necker Cochin, AP-HP, Tarnier Hospital, 89 rue d''Assas, F-75006 Paris, France;4. Sorbonne Université, GRC 29, DMU DREAM, Department of Anesthesia and Critical Care, Armand Trousseau Hospital, AP-HP, 26 avenue du Dr Arnold Netter, F-75012 Paris, France;1. Department of Anesthesiology and Pain medicine, Catharina hospital, Michelangelolaan 2, 5623 EJ Eindhoven, the Netherlands;2. Faculty of Health, Medicine and Life Sciences, Department of Epidemiology, CAPHRI School for Public Health and Primary Care, Maastricht University, Universiteitssingel 40, 6229 ER Maastricht, the Netherlands;3. Department of Vascular Surgery, Catharina hospital, Michelangelolaan 2, 5623 EJ Eindhoven, the Netherlands;4. Department of Education and Research, Catharina Hospital, Michelangelolaan 2, 5623 EJ Eindhoven, the Netherlands;5. Department of Electrical Engineering, Eindhoven University of Technology, Groene Loper 19, 5612 AP Eindhoven, the Netherlands;6. Department of Anesthesiology and Pain Medicine, AZ Turnhout, Steenweg op Merksplas 44, 2300 Turnhout, Belgium;1. Department of Anesthesiology & Pain Medicine, Nationwide Children''s Hospital, Columbus, OH, United States of America;2. Department of Anesthesiology, The Ohio State University College of Medicine, Columbus, OH, United States of America;1. Zhengzhou University People''s Hospital, Henan Provincial People''s Hospital, China;2. Department of Anesthesia, Henan Provincial People''s Hospital, Department of Anesthesia of central China Fuwai Hospital, Central China Fu Wai Hospital of Zhengzhou University, Zhengzhou 450003, China;3. Department of Children''s Cardiac Center, Henan Provincial People''s Hospital, Department of Children''s Cardiac Center of Central China Fuwai Hospital, Central China Fu Wai Hospital of Zhengzhou University, Zhengzhou 450003, China |
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| Abstract: | Study objectiveFibrinogen concentrate is used to treat severe postpartum hemorrhage despite limited evidence of its effectiveness in obstetric settings. We aimed to explore the association between its administration and maternal outcomes in women with severe postpartum hemorrhage.Design, setting and patientsThis secondary analysis of the EPIMOMS prospective population-based study, exploring severe maternal morbidity, as defined by national expert consensus (2012–2013, 182,309 deliveries, France), included all women with severe postpartum hemorrhage and transfused with red blood cells during active bleeding.MeasurementsThe primary endpoint was maternal near-miss or death, and the secondary endpoint the total number of red blood cells units transfused.InterventionsWe studied fibrinogen concentrate administration as a binary variable and then by the timing of its administration. We used multivariable analysis and propensity score matching to account for potential indication bias.Main resultsAmong the 730 women with severe postpartum hemorrhage and transfused, 313 (42.9%) received fibrinogen concentrate, and 142 (19.5%) met near-miss criteria or died. The risk of near-miss or death was not significantly lower among the women treated with fibrinogen concentrate than among those not treated, in either the multivariable analysis (adjusted RR = 1.03; 95% CI, 0.72–1.49; P = 0.855) or the propensity score analysis (RR = 0.85; 95% CI, 0.55–1.32; P = 0.477). Among women treated with fibrinogen concentrate, administration more than three hours after red blood cell transfusion started was associated with a higher risk of near-miss or death than administration before or within 30 min after the transfusion began (adjusted RR = 2.07; 95% CI, 1.10–3.89; P = 0.024). Results were similar for the secondary endpoint.ConclusionsThe use of fibrinogen concentrate in severe postpartum hemorrhage needing red blood cell transfusion during active bleeding is not associated with improved maternal outcomes. |
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