ABSTRACT
A prospective, randomized, controlled clinical trial was conducted to evaluate the
safety and efficacy of a single, 0.5-mg dose of prostaglandin E2 gel in a shelf-stable triacetin base administered intracervically in patients with
an unfavorable cervix (Bishop score ≤ 4) 12 hours prior to oxytocin-induction of labor.
Forty-eight evaluable patients were enrolled, 25 in the PGE2 group and 23 in the control group. PGE2 gel treatment resulted in a significant improvement in the mean Bishop score compared
to control (3.14 versus 0.70, P < .00005). Sixty-four percent of the patients treated with PGE2 had regular uterine contractions during the 12-hour preinduction period beginning
2.18 ± 2.0 hours after gel insertion, compared to 9% in the control group, P = .0001. Moreover, 12% (3/25) of the patients receiving PGE2 progressed into active labor and delivered during the preinduction period. The duration
of oxytocin infusion required for the induction or augmentation of labor was significantly
shorter for patients who received intracervical PGE2 gel compared to the control group (13.1 ± 8.1 versus 19.0 ± 8.7, P < .05). However, there was no significant difference in the incidence of cesarean
section between the two study groups (40 and 22% in the PGE2 and control groups, respectively). No episodes of uterine hypertonus or hyperstimulation
or gastrointestinal side effects occurred as a result of PGE2 gel treatment. The authors conclude that a single intracervical 0.5-mg dose of PGE2 in a stable triacetin base for patients with Bishop scores ≤ 4 was a safe and effective
cervical priming agent that significantly decreased the required duration of oxytocin
infusion for labor induction; however, PGE2 gel priming did not decrease the incidence of cesarean birth.