本文由小咖机器人翻译整理

期刊来源：BMJ

原文链接：https://doi.org/10.1136/bmj-2023-077033

摘要内容如下：

客观

比较宫颈栓和阴道黄体酮在预防单胎妊娠妇女围产期不良结局和早产方面的有效性，这些单胎妊娠妇女在妊娠小于34周时无自发性早产，且宫颈短至35 mm或更短。

设计

开放标签，多中心，随机，对照试验。

设置

荷兰20家医院和5家产科超声诊所。

参与者

符合条件的妇女为健康的单胎妊娠，且在妊娠18至22周之间无症状的短宫颈（35mm或更短）。排除标准为既往自然早产小于34周、原位环扎术、产妇年龄小于18岁、主要先天性畸形、既往参与本试验、阴道失血、宫缩、宫颈长度小于2 mm或宫颈扩张3 cm或以上。样本量设定为628名参与者。

干预措施

除常规产科护理外，在胎膜破裂、感染迹象或早产的情况下，按1:1随机分配至阿拉宾宫颈栓或阴道黄体酮，每日200 mg，直至妊娠36周或更早。

主要结果指标

主要结局是复合不良围产期结局。次要转归是小于28、32、34和37周的（自发性）早产率。计划对25 mm或更短的宫颈长度进行预先确定的亚组分析。

结果

从2014年7月1日至2022年3月31日，635名参与者被随机分配到子宫托（n=315）或黄体酮（n=320）组。612例纳入意向治疗分析。303名使用子宫托的参与者中有19名（6%）发生复合不良围产期结局，而黄体酮组309名参与者中有17名（6%）发生复合不良围产期结局（粗相对风险1.1（95%置信区间（CI）0.60至2.2））。两组间自发性早产率无显著差异。在宫颈长度等于或小于25mm的亚组中，子宫托给药组孕周小于28周的自发性早产发生率高于黄体酮给药组（10/62（16%）v3/69（4%），相对危险度3.7（95%CI 1.1-12.9）），子宫托给药组的不良围产期结局发生率似乎更高（15/62（24%）V8/69（12%），相对风险2.1（0.95至4.6））。

结论

在妊娠小于34周且无自发性早产的单胎妊娠妇女中，中期妊娠宫颈长度小于或等于35 mm时，子宫托并不比阴道孕酮更好。在宫颈长度小于或等于25 mm的亚组中，子宫托似乎在预防不良结局方面效果较差。总体而言，对于单胎妊娠、宫颈较短且既往无妊娠小于34周的自发性早产的妇女，与阴道黄体酮相比，宫颈栓在预防早产和连续不良结局方面的优越性无法得到证实。

试用注册

国际临床试验注册平台（ICTRP，EUCTR2013-002884-24-NL）。

英文原文如下：

Abstracts

OBJECTIVE  To compare the effectiveness of cervical pessary and vaginal progesterone in the prevention of adverse perinatal outcomes and preterm birth in pregnant women of singletons with no prior spontaneous preterm birth at less than 34 weeks' gestation and who have a short cervix of 35 mm or less.

DESIGN  Open label, multicentre, randomised, controlled trial.

SETTING  20 hospitals and five obstetric ultrasound practices in the Netherlands.

PARTICIPANTS  Women with a healthy singleton pregnancy and an asymptomatic short cervix of 35 mm or less between 18 and 22 weeks' gestation were eligible. Exclusion criteria were prior spontaneous preterm birth at less than 34 weeks, a cerclage in situ, maternal age of younger than 18 years, major congenital abnormalities, prior participation in this trial, vaginal blood loss, contractions, cervical length of less than 2 mm or cervical dilatation of 3 cm or more. Sample size was set at 628 participants.

INTERVENTIONS  1:1 randomisation to an Arabin cervical pessary or vaginal progesterone 200 mg daily up to 36 weeks' of gestation or earlier in case of ruptured membranes, signs of infection, or preterm labour besides routine obstetric care.

MAIN OUTCOME MEASURES  Primary outcome was a composite adverse perinatal outcome. Secondary outcomes were rates of (spontaneous) preterm birth at less than 28, 32, 34, and 37 weeks. A predefined subgroup analysis was planned for cervical length of 25 mm or less.

RESULTS  From 1 July 2014 to 31 March 2022, 635 participants were randomly assigned to pessary (n=315) or to progesterone (n=320). 612 were included in the intention to treat analysis. The composite adverse perinatal outcome occurred in 19 (6%) of 303 participants with a pessary versus 17 (6%) of 309 in the progesterone group (crude relative risk 1.1 (95% confidence interval (CI) 0.60 to 2.2)). The rates of spontaneous preterm birth were not significantly different between groups. In the subgroup of cervical length of 25 mm or less, spontaneous preterm birth at less than 28 weeks occurred more often after pessary than after progesterone (10/62 (16%) v 3/69 (4%), relative risk 3.7 (95% CI 1.1 to 12.9)) and adverse perinatal outcomes seemed more frequent in the pessary group (15/62 (24%) v 8/69 (12%), relative risk 2.1 (0.95 to 4.6)).

CONCLUSIONS  In women with a singleton pregnancy with no prior spontaneous preterm birth at less than 34 weeks' gestation and with a midtrimester short cervix of 35 mm or less, pessary is not better than vaginal progesterone. In the subgroup of a cervical length of 25 mm or less, a pessary seemed less effective in preventing adverse outcomes. Overall, for women with single baby pregnancies, a short cervix, and no prior spontaneous preterm birth less than 34 weeks' gestation, superiority of a cervical pessary compared with vaginal progesterone to prevent preterm birth and consecutive adverse outcomes could not be proven.

TRIAL REGISTRATION  International Clinical Trial Registry Platform (ICTRP, EUCTR2013-002884-24-NL).

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