Effect of preinduction cervical softening with dinoprostone gel on outcome of oxytocin-induced labor.

Five hundred fourteen pregnant women at or near term with medically indicated inductions and unfavorable cervical induction features (Bishop score 0-4) were enrolled in an open-label randomized multicenter clinical trial to study the effect of endocervical administration of 0.5 mg of dinoprostone cervical gel as a preinduction cervical ripening agent. Patients in the treatment group (n = 265) received dinoprostone cervical gel 12 hours prior to oxytocin induction; patients in the control group (n = 249) were observed during this period. Thirteen patients in each group were excluded from efficacy evaluations. All patients were included in safety analysis. A mean Bishop score increase of 2.9 points was achieved in the treatment group, as compared with 0.6 point in the control group (P < 0.001). During the observation period, spontaneous labor occurred in a significantly greater percentage of patients in the treatment group (27%) than in the control group (2%). The percentage of patients who achieved labor either during the observation period or during the initial induction attempt was significantly larger in the dinoprostone cervical gel group (71.8%) than in the control group (54.2%). In addition, there was a statistically significant (P < 0.001) difference in median induction-to-vaginal delivery time for the treatment group (10.6 hr) and the control group (13.0 hr). Side effects were reported for 42% and 35% of patients in the treatment and control groups, respectively, with fetal heart rate abnormalities reported for approximately 27% of patients in each group.(ABSTRACT TRUNCATED AT 250 WORDS)