Endocervical prostaglandin E2 gel for preinduction cervical ripening. Clinical trial results

Randomized, clinical trial results of a standardized, stable prostaglandin E2 (PGE2) preparation (0.5-mg PGE2 in a 2.5-mL gel base) applied endocervically as a single dose 12 hours prior to oxytocin induction were studied. The trials, conducted in the United States and Canada, included 538 women; 277 treated with PGE2 gel and 261 controls, with initial Bishop scores of < or = 4. Compared to controls, PGE2 recipients had significant improvement in cervical Bishop scores (P < .01) and a high rate of labor (47.4% vs. 9.6%, P < .001) during the 12-hour ripening period. In reporting centers, delivery during this same interval occurred without use of oxytocin in PGE2 patients (25.4%) vs. controls (4.9%). PGE2 reduced induction to delivery intervals and the duration of oxytocin administration. Although the composite cesarean section rates were lower in PGE2 recipients than in controls (28.5% vs. 32.9%), this difference did not achieve statistical significance. Maternal and fetal outcome and the incidence of complications were similar in the two groups. These studies confirm the safety and efficacy of this standardized PGE2 preparation as a means of cervical ripening in parturients with highly unfavorable cervixes.