Comparison of 400 mcg buccal and 400 mcg sublingual misoprostol after mifepristone medical abortion through 63 days' LMP: a randomized controlled trial

A randomized clinical trial comparing the short-term side effects of sublingual and buccal routes of misoprostol administration for medical abortions up to 63 days’ gestation

“…However, the symptom was a subjective experience, and our study was not powered to compare this difference. A recent study comparing 400 mcg buccal and 400 mcg sublingual misoprostol in an open-label study found that the combined incidence of fever or chills was 18% in the buccal group and 25% in the sublingual group, with the difference almost reaching statistical significance with p value of .05 [13]. This effect may be explained by the higher misoprostol plasma concentrations after sublingual administration when compared with buccal administration in the pharmacokinetic study [7].…”

“…They probably had complete abortion, although they were not included in the category of complete abortion as we did not know whether they had subsequent surgical evacuation or not according to our definition in the protocol. The complete abortion rates in the study by Raghaven et al [13] were over 95% in both the sublingual and the buccal groups, although a lower dose of 400 mcg of misoprostol was used. However, only 37 and 38 subjects in the two groups had a gestational age between 50 and 63 days, respectively, in that study.…”

“…There is a need for a direct comparison of these two routes of administration before any definitive conclusions can be drawn. There is only one randomized clinical trial which directly compared the side effect profiles between 400 mcg sublingual and 400 mcg buccal misoprostol, although the patients were not blinded to their intervention [13]. The purpose of the present double-blind study is to compare the incidence of side effects of buccal and sublingual misoprostol when combined with mifepristone.…”

Mifepristone With Buccal Misoprostol for Medical Abortion

“…All studies used a regimen with 200 mg mifepristone and 800 micrograms misoprostol buccally 13,[17][18][19][20] except for one study that used 200 mg mifepristone and 400 micrograms misoprostol buccally. 21 Clinical outcomes for one study, which included women who were treated but were actually not pregnant, were recalculated to include only women who were pregnant. 13 An additional 14 studies (n532,099) examined clinical outcomes when women were instructed to use buccal misoprostol between 24 and 48 hours after mifepristone (Table 3).…”

“…Overall, the side-effect profile of both regimens is comparable, and regimens with buccal misoprostol have been shown to be well tolerated and acceptable to participants. 18,19,21,24 Despite the presence of data supporting buccal misoprostol in medical abortion, there are still gaps in the literature, specifically with use 24 hours after mifepristone. Based on the available literature, the overall efficacy of regimens with a 24-hour interval There is also a paucity of data on the actual time interval at which women actually administer misoprostol when instructed to use buccal misoprostol in a 24-to 48-hour window after mifepristone.…”