A double-blind study 4 compared the efficacy and safety of pretreatment with mifepristone followed by treatment with misoprostol with the efficacy and safety of misoprostol use alone for the management of early pregnancy loss. 300 women were randomly assigned to receive pretreatment with 200 mg of oral mifepristone followed by 800 μg of vaginal misoprostol (mifepristone-pretreatment group), or 800 μg of vaginal misoprostol alone (misoprostol-alone group). Women in whom the gestational sac was not expelled (after 1 to 4 days) were offered expectant management, a second dose of misoprostol, or uterine aspiration. Complete expulsion after one dose of misoprostol occurred in 124/148 women (83.8%; 95% CI 76.8 to 89.3) in the mifepristone-pretreatment group and in 100/149 women (67.1%; 95% CI 59.0 to 74.6) in the misoprostol-alone group (RR 1.25; 95% CI 1.09 to 1.43). Uterine aspiration was performed less frequently in the mifepristone-pretreatment group than in the misoprostol-alone group (8.8% vs. 23.5%; RR 0.37; 95% CI, 0.21 to 0.68). Bleeding that resulted in blood transfusion occurred in 2.0% of the women in the mifepristone-pretreatment group and in 0.7% of the women in the misoprostol-alone group (P=0.31); pelvic infection was diagnosed in 1.3% of the women in each group.
A Cochrane review [Abstract] 1 included 43 trials involving a total of 4966 women. Vaginal misoprostol hastened miscarriage (complete or incomplete) when compared with placebo: e.g. complete miscarriage less than 24 hours (RR 4.23, 95% CI 3.01 to 5.94; 5 trials, n=305), with no significant increase in nausea or diarrhoea. Lower-dose regimens of vaginal misoprostol tend to be less effective in producing miscarriage with similar incidence of nausea. Oral misoprostol was less effective than vaginal misoprostol in producing complete miscarriage, sublingual misoprostol had equivalent efficacy to vaginal misoprostol but was associated with more frequent diarrhoea. Vaginal misoprostol may be less effective in accomplishing a complete miscarriage compared to surgical management (average RR 0.40, 95% CI 0.32 to 0.50; 6 trials, n=943, I² = 46%) and may be associated with more nausea (1 trial ). Mifepristone did not appear to further hasten miscarriage when added to a misoprostol regimen (RR 1.18, 95% CI 0.95 to 1.47; 3 trials, n=447).
In another Cochrane review [Abstract] 2 about termination of pregnancy in the second or third trimester for women with a fetal anomaly or fetal death vaginal misoprostol was as effective as traditional agents (e.g. gemeprost, prostaglandin E2 and prostaglandin F2alpha),in ensuring vaginal birth within 24 hours, with a similar induction to birth interval. Vaginal misoprostol was associated with a reduction in the occurrence of maternal gastrointestinal side effects such as nausea, vomiting and diarrhoea when compared with other prostaglandin preparations. While the different treatments involving various prostaglandin preparations appear comparable for the reported outcomes, the information available regarding rare maternal complications, such as uterine rupture, was limited. Vaginal misoprostol was more effective in ensuring vaginal birth within 24 hours with fewer side effects than oral misoprostol.
An another Cochrane review [Abstract] 3 included 24 trials involving a total of 5 577 women with gestational age less than 13 weeks. There was no difference in complete miscarriage when comparing misoprostol treatment (all vaginally administered) with expectant care (average RR 1.23, 95% CI 0.72 to 2.10; 2 studies, n=150; very low-quality evidence), or in the need for surgical evacuation (average RR 0.62, 95% CI 0.17 to 2.26; 2 studies, n=308; low-quality evidence). 16 studies addressed the comparison of misoprostol (7 oral, 6 vaginal, 2 sub-lingual, one vaginal + oral) with surgical evacuation. There was a slightly lower incidence of complete miscarriage with misoprostol (average RR 0.96, 95% CI 0.94 to 0.98; 15 studies, n=3862; very low-quality evidence) but with success rate high for both methods. Overall, there were fewer surgical evacuations with misoprostol (average RR 0.05, 95% CI 0.02 to 0.11; 13 studies, n=3070) but more unplanned procedures (average RR 5.03, 95% CI 2.71 to 9.35; 11 studies, n=2690 women). There were few data on ‘deaths or serious complications'. Five trials compared different routes of administration and/or doses of misoprostol. There was no clear evidence of one regimen being superior to another.
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