PURPOSE: to compare the effectiveness and safety of sublingual misoprostol (25 µg) versus vaginal misoprostol (25 µg) (Prostokos®) for labor induction with gestational age > 37 weeks and unripe cervices. METHODS: a randomized controlled clinical trial was performed at the Maternidade Monteiro de Morais (CISAM-UPE), in Recife - PE, Brazil, from October 2003 to February 2004. One hundred and twenty-three women with gestational age > 37 weeks, Bishop score <8, not in labor and with medical indication for interruption of pregnancy were included in this study. The women received randomly 25 µg sublingual misoprostol or 25 µg vaginal misoprostol every 6 h, not exceeding eight doses. In order to evaluate the differences between the groups, means, standard deviations, Student's t-test, c² trend and Mann-Whitney test were used. The statistical significance was considered to be 5%. RESULTS: there were no significant differences between the number of women with vaginal delivery in the sublingual group as compared with the vaginal group (65.5 vs 75.8%, p<0.22), or in the interval of time between the induction onset and delivery (24 h and 42 min vs 20 h and 37 min respectively, p=0.11). The two groups, sublingual and vaginal, also did not differ as to the hyperstimulation syndrome (1.7 vs 3.2%, p=0.95), meconium incidence (5.2 vs 4.8%, p=0.74), Apgar score <7 at 5 min (3.4 vs 4.8%, p=0.98) and other adverse effects. CONCLUSION: twenty-five micrograms of sublingual misoprostol every six h presented the same effectiveness and safety as an equal vaginally administered dose of this substance. Sublingual misoprostol seems to be acceptable and is another option to be considered for labor induction.
Labor induction; Misoprostol; Normal pregnancy; Cesarean section
