Acceptability and safety profile of oral and sublingual misoprostol for uterine evacuation following early fetal demise

BACKGROUND: It has been established that sublingual (SL) route of misoprostol has a great potential to be developed for medical abortion, but there is dearth of evidence to reveal satisfaction rate and safety profile among patients of oral and SL routes. Thus, this study was conducted to provide an insight into the acceptability and safety profile of the same. MATERIALS AND METHODS: A randomized controlled trial was carried out by giving 200 mg mifepristone orally, followed by administration of 600 μg misoprostol orally to 50 women and sublingually to 50 women. The primary endpoints of study were measurements of acceptability and safety profile parameters (average blood loss, nausea, vomiting, diarrhea, hot flushes, fever) of both the groups. The secondary endpoints of the study were number of doses required for complete abortion, success rate and the induction to evacuation interval in both the groups. RESULTS: SL route of administration was more acceptable than the oral route (P = 0.009). Average blood loss was higher in the oral group than in the SL group (P = 0.001). Amongst the side effects, 34% in the SL group and 52% in the oral group had nausea (P = 0.264), 22% in the SL group and 44% in the oral group had vomiting (P = 0.031), 48% in the SL group and 86% in the oral group had diarrhea (P < 0.05), hot flushes were presented by 24% in the SL group and 50% in the oral group (P < 0.05), fever was presented by 20% in the SL group and 44% in the oral group (P < 0.05), and the number of cases aborted with only one dose was higher (86%) in the SL group as compared to 63% in the oral group (P = 0.004). The evacuation (success) rates were 92% in the SL group and 84% in the oral group (P = 0.218) and the mean ± SD induction to evacuation intervals in the SL and oral groups were 5.6 ± 4.54 hours and 9.44 ± 5.61 hours, respectively (P = 0.0002). CONCLUSION: The SL route had fewer undesirable effects, was more satisfactory, required less number of doses and was more acceptable to the patient compared to the oral route.