title: Dose and side effects of sublingual misoprostol for treatment of postpartum hemorrhage: what difference do they make?
abstract: BACKGROUND
  Shivering and fever are common side effects of misoprostol. An unexpectedly high rate of fever above 40°C was documented among Ecuadorian women given treatment with 800mcg of sublingual misoprostol to manage postpartum hemorrhage (PPH) (36%). Much lower rates have been reported elsewhere (0-9%).
  
  
  METHODS
  From February to July 2010, an open-label pilot study was conducted in Quito, Ecuador to determine whether a lower dose--600mcg sublingual misoprostol--would result in a lower incidence of high fever (≥40°C). Rates of shivering and fever with 600mcg sublingual regimen were compared to previously documented rates in Ecuador following PPH treatment with 800mcg sublingual misoprostol.
  
  
  RESULTS
  The 600mcg dose resulted in a 55% lower rate of high fever compared with the 800mcg regimen (8/50; 16% vs. 58/163; 36%; relative risk 0.45 95% CI 0.23-0.88). Only one woman had severe shivering following the 600mcg dose compared with 19 women in the 800mcg cohort (2% vs. 12%; relative risk 0.17 (0.02-1.25)). No cases of delirium/altered sensorium were reported with the 600mcg dose and women's assessment of severity/tolerability of shivering and fever was better with the lower dose.
  
  
  CONCLUSIONS
  600mcg sublingual misoprostol was found to decrease the occurrence of high fever among Ecuadorian women when given to treat PPH. This study however was not powered to examine the efficacy of this treatment regimen and cannot be recommended at this time. Future research is needed to confirm whether other populations, outside of Quito, Ecuador, experience unusually high rates of elevated body temperature following sublingual administration of misoprostol for treatment of PPH. If indeed similar trends are found elsewhere, larger trials to confirm the efficacy of lower dosages may be justified.
  
  
  BACKGROUND
  Clinical trials.gov, Registry No. NCT01080846.
authors: Hospital Gineco–Obstétrico Isidro Ayora, Quito, Ecuador.
authors: Wilfrido
authors: W
authors: León
authors: Jill
authors: J
authors: Durocher
authors: Gustavo
authors: G
authors: Barrera
authors: Ernesto
authors: E
authors: Pinto
authors: Beverly
authors: B
authors: Winikoff
mesh_terms: D000286:Administration, Sublingual; D000293:Adolescent; D000328:Adult; D004305:Dose-Response Relationship, Drug; D005260:Female; D005334:Fever / Q000139:chemically induced*; D006801:Humans; D016595:Misoprostol / Q000008:administration & dosage* / Q000009:adverse effects*; D010865:Pilot Projects; D006473:Postpartum Hemorrhage / Q000188:drug therapy* / Q000209:etiology; D011247:Pregnancy; D012768:Shivering / Q000187:drug effects*; D014593:Uterine Inertia / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D016595:Misoprostol