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

Abstract

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.

A comparative study of sublingual versus oral misoprostol following oral mifepristone for second trimester termination of pregnancy

“…5 In a similar study conducted by Devendra Kushwaha et al who found the mean±SD induction to evacuation interval in the sublingual group and oral groups were 5.6±4.54 hours and 9.44±5.61 hours respectively. 8 In a similar study by Ngai et al average dose of Misoprostol in Group-A and Group-B was 600 µg and 1200 µg respectively (P < 0.05). 7 The results of present study were comparable to Caliskan E et al who found total dose of Misoprostol was 543±422 µg in the sublingual group, 878±533 µg in the vaginal group and 741±413 µg in the oral group (P < 0.001).…”

“…9 The results of present study were comparable to study done by Devendra Kushwaha et al who found the number of cases aborted with 1 dose of Misoprostol was higher in the sublingual group (86%) as compared to oral group (P=0.004). 8 However, Ngai et al found need of curettage in study and control group was 24.6% and 18.6% respectively. 7 The results were comparable with study done by Tang OS et al who found that 10 (17.2%) and 7 (11.7%) subjects in the sublingual and oral groups respectively required surgical evacuation for incomplete abortion.…”

Sublingual versus vaginal misoprostol for medical termination of pregnancy: a comparative study

“…In the oral group, dose requirement were one (62%), two (10%) three (10%) and four (18%) respectively. 22 In a study done by Hooja N et al, the mean dose required in sublingual was 1564 mcg and in vaginal group was 2044 mcg and this was statistically significant(<0.001). Whereas In our study the mean dose required in sublingual was 1300 and in vaginal was 1253 mcg respectively.…”

Comparison of different regimes of misoprostol for the termination of early pregnancy failure

“…With doses over 400 mcg, diarrhea can occur and some women patients experience a brief increase in temperature with shivering. Both effects are dose dependent and settle rapidly without 17 observed that the side effects, fever, nausea and vomiting more in the SL group, diarrhea and hot flushes more in the oral group. In our study also, fever/chills, vomiting were more in sublingual group.…”