经阴道使用 Pessary 预防单胎早产（PoPPS）：随机对照试验。
Prevention of preterm birth with pessary in singletons (PoPPS): randomized controlled trial.
机构信息
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA, USA.
出版信息
Ultrasound Obstet Gynecol. 2018 May;51(5):573-579. doi: 10.1002/uog.18908. Epub 2018 Apr 10.
OBJECTIVE
To determine if pessary use prevents preterm birth (PTB) in women with singleton pregnancy, with short cervical length (CL) measured on transvaginal sonography (TVS) and without prior spontaneous PTB (sPTB).
METHODS
This was an open-label multicenter randomized trial of asymptomatic women presenting at 18 + 0 to 23 + 6 weeks' gestation with a singleton pregnancy, CL ≤ 25 mm on TVS and no prior sPTB. sPTB included those with spontaneous onset of labor and those with rupture of membranes prior to labor. Subjects were randomized to receive either a Bioteque cup pessary or no pessary. Pessaries were inserted by trained maternal-fetal medicine staff. Vaginal progesterone was recommended to women with CL ≤ 20 mm. The primary outcome was PTB < 37 weeks. A sample size of 121 women in each group (n = 242) was needed to detect a reduction in the primary outcome from 30% in the no-pessary group to 15% in the pessary group. The trial was stopped early before complete enrollment.
RESULTS
Between 17 March 2014 and 29 July 2016, 17 383 women underwent CL measurement on TVS. Of these, 422 (2.4%) had CL ≤ 25 mm and 391 (92.7%) met the full eligibility criteria, of which 122 (31.2%) agreed to randomization. Sixty-one (50%) women were randomized to the pessary group and 61 (50%) to the no-pessary group. Baseline characteristics were similar between the groups. There were no significant differences between the pessary and no-pessary groups in the rate of PTB < 37 weeks (43% vs 40%; relative risk 1.09; 95% CI, 0.71-1.68) or in secondary outcomes, such as rate of PTB < 34 weeks, rate of PTB < 28 weeks, gestational age at delivery, birth weight and rate of composite adverse neonatal outcome.
CONCLUSIONS
Cervical pessary use was not associated with prevention of PTB in women with a singleton pregnancy, short CL on TVS and no prior sPTB in this small, underpowered randomized controlled trial. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.
目的
确定在无先前自发性早产（sPTB）病史且经阴道超声（TVS）测量宫颈长度（CL）短于 25mm 的单胎妊娠女性中，使用宫颈托是否能预防早产（PTB）。
方法
这是一项在 18+0 至 23+6 孕周之间无症状、单胎妊娠、CL 经 TVS 测量为 ≤25mm 且无先前 sPTB 病史的女性中进行的开放性、多中心、随机临床试验。sPTB 包括自发临产和临产前行胎膜破裂。受试者被随机分配至使用 Bioteque 杯状宫颈托或不使用宫颈托。由受过培训的母胎医学工作人员插入宫颈托。对于 CL ≤20mm 的女性，建议使用阴道孕酮。主要结局为 <37 孕周的 PTB。每组 121 名女性（n=242）的样本量可检出无宫颈托组的主要结局（30%）降低至宫颈托组的 15%。在完成全部入组之前，试验提前终止。
结果
2014 年 3 月 17 日至 2016 年 7 月 29 日期间，有 17383 名女性接受了 TVS 下 CL 测量。其中，422 名（2.4%）CL≤25mm，391 名（92.7%）符合全部纳入标准，其中 122 名（31.2%）同意随机分组。61 名（50%）女性被随机分配至宫颈托组，61 名（50%）女性被分配至无宫颈托组。两组间基线特征相似。宫颈托组与无宫颈托组在 <37 孕周的 PTB 发生率（43% vs 40%；相对风险 1.09；95%CI，0.71-1.68）或次要结局发生率（如 <34 孕周的 PTB 发生率、<28 孕周的 PTB 发生率、分娩时的孕龄、出生体重和复合不良新生儿结局发生率）方面均无显著差异。
结论
在这项小型、效力不足的随机对照试验中，对于无先前 sPTB 病史且经 TVS 测量 CL 短于 25mm 的单胎妊娠女性，使用宫颈托与预防 PTB 无关。版权所有 © 2017 ISUOG。由 John Wiley & Sons Ltd 出版。
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