OBJECTIVE: Our objective was to compare the sublingual administration and the vaginal administration of misoprostol for cervical priming before first-trimester surgical abortion. DESIGN: We used an open, multicenter, randomized trial. LOCATIONS: We conducted the study in four clinics (in Valencia, Castelló, Murcia and Murcia Capital) in Spain. PARTICIPANTS: A total of 1424 healthy pregnant women with amenorrhea of <or=84 days who voluntarily decided to terminate their pregnancy participated in the study. METHODS: Women were randomly assigned to receive a single dose of 400 microg of misoprostol either sublingually or vaginally 1-3 h before aspiration. OUTCOME MEASURES: The outcome measures assessed were cervical dilation before surgery and surgical time needed for aspiration. The incidence of side effects, such as nausea, vomiting, diarrhea, fever/chills and paresthesia, was evaluated. RESULTS: The mean cervical dilation achieved was 6.8+/-0.8 and 6.7+/-0.9 mm for the sublingual and vaginal groups, respectively. The mean surgical time was 7.0+/-2.8 and 7.4+/-2.5 min for the sublingual and vaginal groups, respectively. Nausea, vomiting and diarrhea were more frequent in the sublingual group. CONCLUSIONS: Both regimens had equal efficacy; however, the sublingual route caused more side effects.
RCT Entities:
OBJECTIVE: Our objective was to compare the sublingual administration and the vaginal administration of misoprostol for cervical priming before first-trimester surgical abortion. DESIGN: We used an open, multicenter, randomized trial. LOCATIONS: We conducted the study in four clinics (in Valencia, Castelló, Murcia and Murcia Capital) in Spain. PARTICIPANTS: A total of 1424 healthy pregnant women with amenorrhea of <or=84 days who voluntarily decided to terminate their pregnancy participated in the study. METHODS:Women were randomly assigned to receive a single dose of 400 microg of misoprostol either sublingually or vaginally 1-3 h before aspiration. OUTCOME MEASURES: The outcome measures assessed were cervical dilation before surgery and surgical time needed for aspiration. The incidence of side effects, such as nausea, vomiting, diarrhea, fever/chills and paresthesia, was evaluated. RESULTS: The mean cervical dilation achieved was 6.8+/-0.8 and 6.7+/-0.9 mm for the sublingual and vaginal groups, respectively. The mean surgical time was 7.0+/-2.8 and 7.4+/-2.5 min for the sublingual and vaginal groups, respectively. Nausea, vomiting and diarrhea were more frequent in the sublingual group. CONCLUSIONS: Both regimens had equal efficacy; however, the sublingual route caused more side effects.