Chua S, Arulkumaran S, Yap C, Selamat N, Ratnam S S
Department of Obstetrics and Gynaecology, National University Hospital, Singapore.
Obstet Gynecol. 1995 Oct;86(4 Pt 1):550-4. doi: 10.1016/0029-7844(95)00214-c.
To determine whether the use of a prostaglandin (PG) E2 3-mg pessary followed by a delay of 12 hours before stimulation of labor with oxytocin improves obstetric outcome compared with the use of a placebo pessary.
One hundred fifty-five nulliparas at term with poor cervical scores (modified Bishop score below 6 of 10) and premature rupture of membranes (PROM) were recruited for this double-blind, placebo-controlled randomized trial. On admission to the study, either a PGE2 pessary or an identical-appearing placebo pessary was inserted into the posterior fornix. If labor did not start in the next 12 hours or if symptoms and signs of infection were evident, labor was induced with oxytocin infusion. Assignment was unblinded at the end of the study, and details of the labor and maternal and neonatal outcome in women who received a PG pessary were compared with those who received a placebo pessary.
Women receiving a PG pessary were significantly less likely to require stimulation of labor at the end of 12 hours than were those given a placebo pessary (37 versus 58%, P = .002). The mean time between admission to study and delivery was significantly shorter in the PG group compared with the placebo group (15 versus 19 hours, P = .01). The rate of cesarean delivery was not statistically different in the two groups (13.9% with PG versus 15.8% with placebo).
In nulliparas with poor cervical scores who present with PROM at term and no evidence of infection or obstetric complications, use of a PGE2 pessary resulted in more women establishing labor earlier, with a resultant reduction in the admission-to-delivery interval, compared with the use of a placebo pessary. The cesarean delivery rates in the two groups were similar, and there were no significant differences in neonatal outcome.
确定与使用安慰剂阴道栓剂相比，使用3毫克前列腺素（PG）E2阴道栓剂并在使用缩宫素引产之前延迟12小时是否能改善产科结局。
招募了155名单胎足月、宫颈评分低（改良Bishop评分低于10分中的6分）且胎膜早破（PROM）的初产妇进行这项双盲、安慰剂对照的随机试验。在研究入组时，将PGE2阴道栓剂或外观相同的安慰剂阴道栓剂插入后穹窿。如果在接下来的12小时内未开始分娩，或者出现感染的症状和体征，则通过静脉输注缩宫素引产。在研究结束时解除盲法，将接受PG阴道栓剂的女性的分娩情况以及母婴结局细节与接受安慰剂阴道栓剂的女性进行比较。
与接受安慰剂阴道栓剂的女性相比，接受PG阴道栓剂的女性在12小时结束时需要引产的可能性显著降低（37%对58%，P = 0.002）。与安慰剂组相比，PG组从研究入组到分娩的平均时间显著缩短（15小时对19小时，P = 0.01）。两组剖宫产率无统计学差异（PG组为13.9%，安慰剂组为15.8%）。
对于足月胎膜早破、宫颈评分低且无感染或产科并发症证据的初产妇，与使用安慰剂阴道栓剂相比，使用PGE2阴道栓剂可使更多女性更早开始分娩，从而缩短入院至分娩的间隔时间。两组剖宫产率相似，新生儿结局无显著差异。
