Background: Shivering and fever are common side effects of misoprostol. An unexpectedly high rate of fever\r\nabove 40�°C was documented among Ecuadorian women given treatment with 800mcg of sublingual misoprostol\r\nto manage postpartum hemorrhage (PPH) (36%). Much lower rates have been reported elsewhere (0-9%).\r\nMethods: From February to July 2010, an open-label pilot study was conducted in Quito, Ecuador to determine\r\nwhether a lower dose--600mcg sublingual misoprostol--would result in a lower incidence of high fever (=40�°C).\r\nRates of shivering and fever with 600mcg sublingual regimen were compared to previously documented rates in\r\nEcuador following PPH treatment with 800mcg sublingual misoprostol.\r\nResults: The 600mcg dose resulted in a 55% lower rate of high fever compared with the 800mcg regimen (8/50;\r\n16% vs. 58/163; 36%; relative risk 0.45 95% CI 0.23-0.88). Only one woman had severe shivering following the\r\n600mcg dose compared with 19 women in the 800mcg cohort (2% vs. 12%; relative risk 0.17 (0.02-1.25)). No cases\r\nof delirium/altered sensorium were reported with the 600mcg dose and womenâ��s assessment of severity/tolerability\r\nof shivering and fever was better with the lower dose.\r\nConclusions: 600mcg sublingual misoprostol was found to decrease the occurrence of high fever among\r\nEcuadorian women when given to treat PPH. This study however was not powered to examine the efficacy of this\r\ntreatment regimen and cannot be recommended at this time. Future research is needed to confirm whether other\r\npopulations, outside of Quito, Ecuador, experience unusually high rates of elevated body temperature following\r\nsublingual administration of misoprostol for treatment of PPH. If indeed similar trends are found elsewhere, larger\r\ntrials to confirm the efficacy of lower dosages may be justified.
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