美国哥伦比亚大学Matthew K. Hoffman团队研究了子宫颈托预防早产的效果。相关论文于2023年7月25日发表在《美国医学会杂志》上。

经阴道超声评估的宫颈短是早产的一个既定风险因素。子宫颈托预防单胎妊娠早产的研究结果与经阴道超声检查宫颈短的证据存在矛盾。

为了确定放置子宫颈托是否能降低宫颈短患者在37周前早产或胎儿死亡的风险，2017年2月到2021年11月5日，研究组在美国的12个中心进行了一项多中心、随机、非盲的试验，比较了子宫颈托与常规护理的效果。研究参与者是单胎妊娠的非流产个体，在妊娠16周0天至23周6天时，经阴道超声宫颈长度不超过20毫米。既往有自发性早产的个体被排除在外。参与者被1:1随机分组，接受由受过训练的临床医生放置的子宫颈托（n = 280）或常规护理（n = 264）。阴道孕酮的使用由治疗临床医生自行决定。主要结局是37周前分娩或胎儿死亡。

共有544名参与者（64%）参加了这项研究，计划样本量为850人（平均年龄29.5岁）。在第三次中期分析之后，由于担心胎儿或新生儿/婴儿死亡以及无效，研究招募被停止。基线特征在随机接受子宫颈托治疗的参与者和随机接受常规护理的参与者之间是平衡的；98.9%接受阴道孕酮治疗。在一项随机分析中，127名参与者（45.5%）随机接受子宫颈托治疗发生主要结局，常规护理组有127名（45.6%），相对风险为1.00。在随机接受子宫颈托治疗的患者中有13.3%，随机接受常规护理的患者中有6.8%发生了胎儿或新生儿/婴儿死亡（相对风险为1.94）。

研究结果表明，单胎妊娠且宫颈长度小于等于20mm的非流产个体使用宫颈托并不能降低早产风险，并且与更高的胎儿或新生儿/婴儿死亡率相关。

附：英文原文

Title: Cervical Pessary for Prevention of Preterm Birth in Individuals With a Short Cervix: The TOPS Randomized Clinical Trial

Author: Matthew K. Hoffman, Rebecca G. Clifton, Joseph R. Biggio, George R. Saade, Lynda G. Ugwu, Monica Longo, Sabine Z. Bousleiman, Kelly Clark, William A. Grobman, Heather A. Frey, Suneet P. Chauhan, Lorraine Dugoff, Tracy A. Manuck, Edward K. Chien, Dwight J. Rouse, Hyagriv N. Simhan, M. Sean Esplin, George A. Macones, National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network, Melissa T. Bickus, Francesca L. Facco, Alan T.N. Tita, Janatha S. Grant, Brian M. Casey, Stacy L. Harris, Lorie M. Harper, Donna M. Dunn, Sherri A. Longo, Melissa A. Hendricks, Kathleen Lata-Arias, Maged M. Costantine, Anna B. C. Bartholomew, Dawn M. Cline, Stephanie L. Harper, Calvin L. Ward, Nicole M. Gardner, Stephanie J. Brindle, Samantha L. Weigand, David S. McKenna, Esther K. Snow, Kathleen A. Fennig, Mounira A. Habli, Donna S. Lambers, Marta C. McClellan, Torri D. Metz, Amber N. Sowles, Michael W. Varner, Kim A. Hill, Valerie S. Morby, Catherine E. Meadows, Donna M. Allard, Erika F. Werner, Janet L. Rousseau, Jane Milano, Christian M. Pettker, Jessica Leventhal, Cynthia Gyamfi-Bannerman, Ronald J. Wapner, Vilmarie M. Carmona, Brandy S. Firman, Ashley Q. Vanneman, Kristy T. Palomares, Imene Beche, Daniel W. Skupski, Rosalyn A. Chan-Akeley, Ashley E. Salazar, Luis D. Pacheco, Leah M. McCoy, Antonio F. Saad, Sangeeta Jain, Chasey I. Omere, Corey C. Clifford, Mollie A. McDonnold, Edward K. Chien, Wendy B. Dalton, LuAnn A. Polito

Issue&Volume: 2023/07/25

Abstract:

Importance  A short cervix as assessed by transvaginal ultrasound is an established risk factor for preterm birth. Study findings for a cervical pessary to prevent preterm delivery in singleton pregnancies with transvaginal ultrasound evidence of a short cervix have been conflicting.

Objective  To determine if cervical pessary placement decreases the risk of preterm birth or fetal death prior to 37 weeks among individuals with a short cervix.

Design, Setting, and Participants  We performed a multicenter, randomized, unmasked trial comparing a cervical pessary vs usual care from February 2017 through November 5, 2021, at 12 centers in the US. Study participants were nonlaboring individuals with a singleton pregnancy and a transvaginal ultrasound cervical length of 20 mm or less at gestations of 16 weeks 0 days through 23 weeks 6 days. Individuals with a prior spontaneous preterm birth were excluded.

Interventions  Participants were randomized 1:1 to receive either a cervical pessary placed by a trained clinician (n=280) or usual care (n=264). Use of vaginal progesterone was at the discretion of treating clinicians.

Main Outcome and Measures  The primary outcome was delivery or fetal death prior to 37 weeks.

Results  A total of 544 participants (64%) of a planned sample size of 850 were enrolled in the study (mean age, 29.5 years [SD, 6 years]). Following the third interim analysis, study recruitment was stopped due to concern for fetal or neonatal/infant death as well as for futility. Baseline characteristics were balanced between participants randomized to pessary and those randomized to usual care; 98.9% received vaginal progesterone. In an as-randomized analysis, the primary outcome occurred in 127 participants (45.5%) randomized to pessary and 127 (45.6%) randomized to usual care (relative risk, 1.00; 95% CI, 0.83-1.20). Fetal or neonatal/infant death occurred in 13.3% of those randomized to receive a pessary and in 6.8% of those randomized to receive usual care (relative risk, 1.94; 95% CI, 1.13-3.32).

Conclusions and Relevance  Cervical pessary in nonlaboring individuals with a singleton gestation and with a cervical length of 20 mm or less did not decrease the risk of preterm birth and was associated with a higher rate of fetal or neonatal/infant mortality.

DOI: 10.1001/jama.2023.10812

Source: https://jamanetwork.com/journals/jama/article-abstract/2807569