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Open Access Research article

Dose and side effects of sublingual misoprostol for treatment of postpartum hemorrhage: what difference do they make?

Wilfrido León1, Jill Durocher2*, Gustavo Barrera1, Ernesto Pinto2 and Beverly Winikoff2

Author Affiliations

1 Hospital Gineco–Obstétrico Isidro Ayora, Quito, Ecuador

2 Gynuity Health Projects, New York, NY, USA

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BMC Pregnancy and Childbirth 2012, 12:65  doi:10.1186/1471-2393-12-65

Published: 7 July 2012

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.

Trial Registration

Clinical trials.gov, Registry No. NCT01080846

Keywords:
misoprostol; postpartum hemorrhage; PPH; fever