米索前列醇阴道栓剂与阴道分娩时间：一项随机对照试验。
Misoprostol vaginal insert and time to vaginal delivery: a randomized controlled trial.
机构信息
University of California, Irvine, Orange, California; Long Beach Memorial Medical Center, Long Beach, California; Temple University School of Medicine, Philadelphia, Pennsylvania; Drexel University College of Medicine, Philadelphia, Pennsylvania; Watching Over Mothers & Babies Foundation, Tucson, Arizona; and Ferring Pharmaceuticals, Copenhagen, Denmark.
出版信息
Obstet Gynecol. 2013 Aug;122(2 Pt 1):201-209. doi: 10.1097/AOG.0b013e31829a2dd6.
OBJECTIVE
To compare the efficacy and safety of a 200-microgram misoprostol vaginal insert with a 10-mg dinoprostone vaginal insert for reducing the time to vaginal delivery.
METHODS
In a phase III, double-blind, multicenter study, women being induced with a modified Bishop score of 4 or less were randomly assigned to receive either a 200-microgram misoprostol vaginal insert or a 10-mg dinoprostone vaginal insert. Coprimary end points were time to vaginal delivery and rate of cesarean delivery. Secondary end points included time to any delivery mode, time to onset of active labor, and oxytocin use.
RESULTS
A total of 1,358 women were randomized to receive the 200-microgram misoprostol vaginal insert (n=678) or dinoprostone vaginal insert (n=680). Women receiving the misoprostol vaginal insert had a significantly shorter median time to vaginal delivery compared with patients receiving the dinoprostone vaginal insert (21.5 hours compared with 32.8 hours, P<.001). Cesarean delivery occurred in 26.0% and 27.1% of women receiving the misoprostol vaginal insert and dinoprostone vaginal insert, respectively. A significant reduction in time to any delivery (18.3 hours compared with 27.3 hours), time to onset of active labor (12.1 hours compared with 18.6 hours), and proportion of women requiring predelivery oxytocin (48.1% compared with 74.1%) was observed with the misoprostol vaginal insert compared with dinoprostone vaginal insert (P<.001 for each). Uterine tachysystole requiring intervention occurred in 13.3% and 4.0% of participants receiving the misoprostol vaginal insert and dinoprostone vaginal insert, respectively (P<.001).
CONCLUSION
Use of a 200-microgram misoprostol vaginal inset significantly reduced times to vaginal delivery and active labor with reduced need for oxytocin compared with the dinoprostone vaginal insert. Cesarean delivery rates were similar with both treatments. Tachysystole was more common in women receiving the 200-microgram misoprostol vaginal insert.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, www.clinicaltrials.gov, NCT01127581.
LEVEL OF EVIDENCE
I.
目的
比较 200 微克米索前列醇阴道栓剂与 10 毫克地诺前列酮阴道栓剂用于减少阴道分娩时间的疗效和安全性。
方法
在一项 III 期、双盲、多中心研究中，将改良 Bishop 评分为 4 分或更低的引产妇女随机分配至接受 200 微克米索前列醇阴道栓剂或 10 毫克地诺前列酮阴道栓剂治疗。主要终点为阴道分娩时间和剖宫产率。次要终点包括任何分娩方式的时间、活跃分娩的时间和催产素的使用。
结果
共 1358 名妇女被随机分配至接受 200 微克米索前列醇阴道栓剂（n=678）或地诺前列酮阴道栓剂（n=680）。与接受地诺前列酮阴道栓剂的患者相比，接受米索前列醇阴道栓剂的患者中位阴道分娩时间明显缩短（21.5 小时比 32.8 小时，P<.001）。米索前列醇阴道栓剂组和地诺前列酮阴道栓剂组分别有 26.0%和 27.1%的妇女行剖宫产术。与地诺前列酮阴道栓剂相比，米索前列醇阴道栓剂显著缩短了任何分娩方式的时间（18.3 小时比 27.3 小时）、活跃分娩的时间（12.1 小时比 18.6 小时）和需要产前催产素的妇女比例（48.1%比 74.1%）（P<.001）。米索前列醇阴道栓剂组和地诺前列酮阴道栓剂组分别有 13.3%和 4.0%的参与者发生需要干预的子宫收缩过速（P<.001）。
结论
与地诺前列酮阴道栓剂相比，使用 200 微克米索前列醇阴道栓剂可显著缩短阴道分娩和活跃分娩时间，减少催产素的需求。两种治疗方法的剖宫产率相似。米索前列醇阴道栓剂组的宫缩过速更为常见。
临床试验注册
ClinicalTrials.gov，www.clinicaltrials.gov，NCT01127581。
证据水平
I。
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