OBJECTIVE: 

To evaluate the use of cervical dilators concurrently with misoprostol to shorten labor in second-trimester medical termination of pregnancy.

METHODS: 

This multicenter randomized controlled trial compared the efficacy of cervical dilators inserted concurrently with misoprostol with that of misoprostol, alone, to shorten labor for women undergoing termination of pregnancy between 15 0/7 and 27 6/7 weeks of gestation. The primary outcome was the proportion of women with a duration of labor exceeding 12 hours. Secondary outcomes included median duration of labor, time to amniotomy, side effects, complications, NPRS (Numeric Pain Rating Scale) score, and women's distress as measured by the IES-R (Impact of Event Scale-Revised). These outcomes also were studied separately in the nulliparous subgroup. To demonstrate a reduction of 50% of the proportion of women with a duration of labor exceeding 12 hours in the dilator group, with a power of 80% and a 2-sided 0.05 significance level, a sample of 268 women (134 in each group) was required.

RESULTS: 

Between December 2017 and September 2019, this study enrolled and analyzed 347 women: 174 in the dilator group and 173 in the control group, including 87 and 93 nulliparous patients, respectively. Sociodemographic and obstetric characteristics were similar between groups. The proportion of women with labor exceeding 12 hours was not different between groups (49/174 [28.2%] in the dilator group vs 53/173 [30.6%] in the control group [P=.61] for the whole population, and 37/87 [42.5%] vs 42/93 [45.2%] [P=.72], respectively, among nulliparous patients). Median duration of labor was 8.5 hours in the dilator group compared with 9.2 hours in the control group (P=.65) for the whole population, and 10.5 hours compared with 11.8 hours, respectively, among nulliparous patients (P=.33). Median time to amniotomy was 3.6 hours in the dilator group compared with 5.0 hours in the control group (P=.08) for the whole population, and 3.5 hours compared with 6.7 hours, respectively, among nulliparous patients (P=.003). Side effects, complications, NPRS score, and IES-R score were similar between groups.

CONCLUSION: 

Cervical dilators inserted concurrently with misoprostol did not reduce the proportion of women whose labor exceeded 12 hours compared with misoprostol alone.

CLINICAL TRIAL REGISTRATION: 

ClinicalTrials.gov, NCT03194230.

中文翻译：

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宫颈扩张器与米索前列醇同时使用以缩短妊娠中期终止妊娠的产程：一项随机对照试验

 客观的：

评价在妊娠中期药物终止妊娠中同时使用宫颈扩张器和米索前列醇来缩短产程。

 方法：

这项多中心随机对照试验比较了与米索前列醇同时插入的宫颈扩张器与单独使用米索前列醇的效果，以缩短妊娠 15 0/7 至 27 6/7 周期间终止妊娠的妇女的产程。主要结果是分娩持续时间超过 12 小时的女性比例。次要结局包括中位产程持续时间、羊膜切开时间、副作用、并发症、NPRS（数字疼痛评定量表）评分以及通过 IES-R（修订后的事件影响量表）测量的女性痛苦程度。这些结果也在未产亚组中单独进行了研究。为了证明扩张器组产程超过 12 小时的女性比例减少了 50%，功效为 80%，双侧 0.05 显着性水平，样本为 268 名女性（每组 134 名） ）是必需的。

 结果：

2017年12月至2019年9月期间，这项研究招募并分析了347名女性：扩张器组174名，对照组173名，分别包括87名和93名未产妇。各组之间的社会人口统计学和产科特征相似。分娩时间超过 12 小时的妇女比例在各组之间没有差异（扩张器组为 49/174 [28.2%]，对照组为 53/173 [30.6%] [ P =.61]）未生育患者中分别为 37/87 [42.5%] vs 42/93 [45.2%] [ P =.72]）。整个人群中，扩张器组的中位产程持续时间为 8.5 小时，而对照组为 9.2 小时 ( P =.65)；未产妇的中位产程持续时间为 10.5 小时和 11.8 小时 ( P =.33)。整个人群中，扩张器组至羊膜切开术的中位时间为 3.6 小时，而对照组为 5.0 小时 ( P = 0.08)；未产妇患者中位羊膜穿刺术的中位时间为 3.5 小时和 6.7 小时 ( P = 0.003)。各组之间的副作用、并发症、NPRS 评分和 IES-R 评分相似。

 结论：

与单独使用米索前列醇相比，与米索前列醇同时置入宫颈扩张器并没有降低产程超过 12 小时的女性比例。

临床试验注册：

临床试验.gov ，NCT03194230。