Effectiveness and safety of a new vaginal misoprostol product specifically labeled for cervical ripening and labor induction.
OBJECTIVE
The purpose of this study was to evaluate the effectiveness and safety of misoprostol in two different formulations: vaginal tablets of 25 microg and one-eighth of a 200-microg oral tablet, also administered intravaginally, for cervical ripening and labor induction of term pregnancies with an indication for that.


METHODS
A single-blind, randomized, controlled clinical trial was carried out in 120 pregnant women who randomly received one of the two formulations. The main dependent variables were mode of delivery, need for additional oxytocin, time between beginning of induction and delivery, perinatal results, complications, and maternal side effects. Student's t, Mann-Whitney, chi2, Fisher's Exact, Wilcoxon and Kolmogorov-Smirnoff tests, as well as survival analysis, were used in the data analysis.


RESULTS
There were no significant differences between the groups in terms of general characteristics, uterine contractility, and fetal well-being during labor, cesarean section rates, perinatal outcomes, or maternal adverse events. The mean time between the beginning of cervical ripening and delivery was 31.3 h in the vaginal tablet group and 30.1 h in the oral tablet group, a difference that was not statistically significant.


CONCLUSIONS
The results showed that the 25-microg vaginal tablets of misoprostol were as effective and safe for cervical ripening and labor induction as the dose-equivalent fraction of 200-microg oral tablets.
Cecatti
José Guilherme
JG
Department of Obstetrics and Gynecology, School of Medical Sciences (FCM), University of Campinas, SP, Brazil. cecatti@unicamp.br
Tedesco
Ricardo Porto
RP
Pires
Helaine Maria Besteti
HM
Calderon
Iracema Matos
IM
Faúndes
Aníbal
A
D000282:Administration, Intravaginal; D000328:Adult; D020070:Cervical Ripening / Q000187:drug effects*; D002584:Cervix Uteri / Q000187:drug effects; D005260:Female; D006801:Humans; D007751:Labor, Induced / Q000379:methods*; D016595:Misoprostol / Q000008:administration & dosage / Q000627:therapeutic use*; D010120:Oxytocics / Q000008:administration & dosage / Q000627:therapeutic use*; D010865:Pilot Projects; D011247:Pregnancy; D011256:Pregnancy Outcome; D016037:Single-Blind Method; D016896:Treatment Outcome
D010120:Oxytocics; D016595:Misoprostol