Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.
Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.
Am J Obstet Gynecol MFM. 2021 Mar;3(2):100307. doi: 10.1016/j.ajogmf.2021.100307. Epub 2021 Jan 7.
Cervical pessary has been proven to be effective in reducing the rate of preterm birth in asymptomatic women with singleton gestations and short cervical length in the midtrimester of pregnancy; however, the efficacy of this device in women with arrested preterm labor is still a subject of debate.
This study aimed to test the hypothesis that the use of a cervical pessary in women with singleton pregnancy and arrested preterm labor would reduce the risk of preterm birth at <37 weeks of gestation.
This study is a parallel group, nonblinded, randomized trial. Participants included in the study were women with a diagnosis of arrested preterm labor between 24 0/7 and 33 6/7 weeks of gestations. The participants were randomized to either the cervical pessary group or no pessary group in a 1:1 ratio. The primary endpoint was preterm birth at <37 weeks of gestation. A sample size of 120 participants was determined, but the trial was concluded before the completion of enrollment.
A total of 61 women with singleton pregnancies and arrested preterm labor at 24 0/7 to 33 6/7 weeks of gestation were enrolled in the trial. Of the 61 women, 32 were randomized to the cervical pessary group and 29 to the control group. Preterm birth at <37 weeks of gestation occurred in 14 women (43.8%) in the pessary group and 6 women (20.7%) in the control group (relative risk, 2.98; 95% confidence interval, 0.96-9.30).
In this underpowered trial, among women with singleton pregnancies and arrested preterm labor, compared with no pessary use, the use of a cervical pessary does not result in a lower rate of preterm birth at <37 weeks of gestation.
宫颈托已被证明可有效降低中期妊娠无症状单胎妊娠且宫颈短的女性早产率；然而，该装置在早产停止的女性中的疗效仍存在争议。
本研究旨在检验宫颈托用于单胎妊娠且早产停止的女性是否可降低<37 孕周早产的风险的假设。
本研究为平行组、非盲、随机试验。研究纳入的参与者为妊娠 24 0/7 至 33 6/7 周诊断为早产停止的女性。参与者以 1:1 的比例随机分配至宫颈托组或无托组。主要结局为<37 孕周的早产。确定了 120 名参与者的样本量，但在完成入组前试验即已结束。
共有 61 名妊娠 24 0/7 至 33 6/7 周的单胎妊娠且早产停止的女性参与了本试验。61 名女性中，32 名随机分配至宫颈托组，29 名分配至对照组。宫颈托组 14 名女性（43.8%）和对照组 6 名女性（20.7%）发生<37 孕周的早产（相对风险，2.98；95%置信区间，0.96-9.30）。
在本研究中，与未使用托相比，在单胎妊娠且早产停止的女性中，宫颈托的使用并未降低<37 孕周的早产率。但因本试验效力不足，上述结论尚需进一步研究证实。
