Ewert Karine, Powers Barbara, Robertson Steve, Alfirevic Zarko
Controlled Therapeutics (Scotland) Ltd, East Kilbride, United Kingdom.
Obstet Gynecol. 2006 Nov;108(5):1130-7. doi: 10.1097/01.AOG.0000239100.16166.5a.
To assess the ability of a controlled-release misoprostol vaginal insert to induce labor using dose reservoirs of 25, 50, 100, and 200 microg.
This double-blind, dose ranging, randomized study was carried out in parous women requiring induction of labor at term. Each woman was randomly assigned to receive a single misoprostol vaginal insert that could remain in place for up to 24 hours and was removed for onset of active labor, an adverse event, or having reached 24 hours in situ. The primary outcome measure was time from insertion of the misoprostol vaginal insert to vaginal delivery of the neonate.
A total of 124 women participated in the study. The median time to vaginal delivery was 27.5, 19.1, 13.1, and 10.6 hours for the 25-, 50-, 100-, and 200-microg doses, respectively. The percentage of women who delivered vaginally within 12 hours was 9%, 14%, 47%, and 53% (P<.001 using the 25-microg group as the comparator) and within 24 hours was 42%, 79%, 81%, and 70% (P=.003). Uterine hyperstimulation syndrome occurred in one woman who received the 25-mug, two women who received the 100-microg, and three women who received the 200-microg dose reservoirs.
Misoprostol vaginal inserts effectively induced labor in pregnant parous women at term.
I.
评估使用25、50、100和200微克剂量储存器的控释米索前列醇阴道栓剂引产的能力。
这项双盲、剂量范围、随机研究在足月需要引产的经产妇中进行。每位女性被随机分配接受单个米索前列醇阴道栓剂，该栓剂可在原位保留长达24小时，并在出现活跃宫缩、发生不良事件或达到24小时时取出。主要结局指标是从插入米索前列醇阴道栓剂到新生儿经阴道分娩的时间。
共有124名女性参与了该研究。25微克、50微克、100微克和200微克剂量组阴道分娩的中位时间分别为27.5小时、19.1小时、13.1小时和10.6小时。12小时内经阴道分娩的女性比例分别为9%、14%、47%和53%（以25微克组作为对照，P<.001），24小时内经阴道分娩的女性比例分别为42%、79%、81%和70%（P=.003）。接受25微克剂量储存器的1名女性、接受100微克剂量储存器的2名女性和接受200微克剂量储存器的3名女性发生了子宫过度刺激综合征。
米索前列醇阴道栓剂可有效诱导足月妊娠经产妇分娩。
I级。
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