Postpartum Hemorrhage — Management of Postpartum Haemorrhage and Effect of Geographic Region
Citation(s)
Begley CM, Gyte GM, Devane D, McGuire W, Weeks A Active versus expectant management for women in the third stage of labour. Cochrane Database Syst Rev. 2015 Mar 2;(3):CD007412. doi: 10.1002/14651858.CD007412.pub4. Review.
Calvert C, Thomas SL, Ronsmans C, Wagner KS, Adler AJ, Filippi V Identifying regional variation in the prevalence of postpartum haemorrhage: a systematic review and meta-analysis. PLoS One. 2012;7(7):e41114. doi: 10.1371/journal.pone.0041114. Epub 2012 Jul 23. Review.
Carroli G, Cuesta C, Abalos E, Gulmezoglu AM Epidemiology of postpartum haemorrhage: a systematic review. Best Pract Res Clin Obstet Gynaecol. 2008 Dec;22(6):999-1012. doi: 10.1016/j.bpobgyn.2008.08.004. Epub 2008 Sep 25. Review.
Mousa HA, Cording V, Alfirevic Z Risk factors and interventions associated with major primary postpartum hemorrhage unresponsive to first-line conventional therapy. Acta Obstet Gynecol Scand. 2008;87(6):652-61. doi: 10.1080/00016340802087660.
Novikova N, Hofmeyr GJ, Cluver C Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2015 Jun 16;(6):CD007872. doi: 10.1002/14651858.CD007872.pub3. Review.
Shakur H, Roberts I, Edwards P, Elbourne D, Alfirevic Z, Ronsmans C The effect of tranexamic acid on the risk of death and hysterectomy in women with post-partum haemorrhage: statistical analysis plan for the WOMAN trial. Trials. 2016 May 17;17(1):249. doi: 10.1186/s13063-016-1332-2.
WOMAN Trial Collaborators . Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017
Management of Postpartum Haemorrhage and Effect of Geographic Region: A Secondary Analysis of the World Maternal Antifibrinolytic (WOMAN) Trial
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