Objective To assess the efficacy and safety of sublingual misoprostol for preventing postpartum haemorrhage.
Method MEDLINE, Embase, CRD, CENTRAL, mRCT, LILACS, SciELO, ProQuest and ISI Web of Knowledge databases were searched. There were no language, accessibility, or publication date restrictions. Randomised clinical trials of sublingual misoprostol in comparison with placebo or other uterotonics were eligible. The primary outcome was postpartum haemorrhage (blood loss ≥500 ml). Other outcomes were considered (see below). The heterogeneity was evaluated and, when possible, the data grouped into a meta-analysis using a random-effects model.
Results Of 682 references identified, only 15 were included in the analysis (5109 patients). Most of the studies were of low methodologic quality. Sublingual misoprostol, at any dose, was not more effective for reducing postpartum haemorrhage in comparison with standard treatment. Sublingual misoprostol, however, is effective for reducing haemorrhage greater than 1000 ml [600 mcg vs placebo; RR=0.66 (95% CI 0.45 to 0.98)] as well as the use of additional uterotonics [600 mcg vs methylergometrine; RR=0.04 (0.00 to 0.72)] and the duration of the third stage of delivery [50 mcg vs methylergometrine; MD=4.16 min (2.20; 6.12) or 600 mcg vs methylergometrine; RR=0.04 (0.00 to 0.72)]. The drug presented a worse safety profile, causing tremors and fever, especially at higher doses.
Conclusion Sublingual misoprostol aimed at preventing postpartum haemorrhage presents no benefits compared with the standard uterotonics. Its use should be restricted to clinics with adequate medical support, as a complement to other uterotonics.
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Funding MCT/CT-Saúde, MS/SCTIE/DECIT.