{"title":"胎儿镜激光凝血治疗双胎输血综合征预防早产的阿拉伯颈托:一项多中心随机对照试验。","authors":"","doi":"10.1016/j.ajog.2023.11.1245","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Miscarriage and preterm birth are leading causes of loss and disability in monochorionic twins after laser treatment of twin-twin transfusion syndrome.</p></div><div><h3>Objective</h3><p>This study aimed to investigate the use of cervical pessary to reduce preterm birth before 32 weeks of gestation in monochorionic diamniotic twin pregnancies after fetal surgery for twin-twin transfusion syndrome.</p></div><div><h3>Study Design</h3><p>In this open-label multicenter randomized trial, pregnant women carrying monochorionic diamniotic twins requiring fetoscopic laser coagulation for twin-twin transfusion syndrome were randomly assigned in a 1:1 ratio to pessary placement or conservative management. The primary outcome was birth before 32 weeks of gestation. The secondary outcomes were birth before 28, 30, 34, or 37 weeks of gestation; preterm premature rupture of membranes; fetal and neonatal survival; and a composite of maternal and neonatal complications. The estimated sample size was 364 patients, with 182 cases in each arm of the study. The analysis was performed according to the intention-to-treat principle. Moreover, 2 interim analyses were planned.</p></div><div><h3>Results</h3><p>The trial was stopped prematurely after the first planned interim analysis for futility. Overall, 137 women were included in the analysis, 67 in the pessary group and 70 in the conservative management group. Preterm birth before 32 weeks of gestation occurred in 27 of 67 women (40.3%) in the pessary group and in 25 of 70 women (35.7%) in the conservative management group (adjusted odds ratio, 1.19; 95% confidence interval, 0.58–2.47; <em>P</em>=.63). No differences between groups were observed in the rate of deliveries before 28, 30, 34, and 37 weeks of gestation. Overall survival to delivery was 91.2% (125/137) for at least 1 twin, and 70.8% (97/137) for both twins, with no difference between groups. Neonatal survival at 30 days was 76.5% (208/272). There was no difference between the groups in maternal or neonatal morbidity.</p></div><div><h3>Conclusion</h3><p>In monochorionic diamniotic twin pregnancies requiring fetal therapy for twin-twin transfusion syndrome, routine use of cervical pessary did not reduce the rate of preterm birth before 32 weeks of gestation.</p></div>","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":null,"pages":null},"PeriodicalIF":8.7000,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002937823020598/pdfft?md5=9c62f1086200c21784475e0eac6fcaf2&pid=1-s2.0-S0002937823020598-main.pdf","citationCount":"0","resultStr":"{\"title\":\"The Arabin cervical pessary for the prevention of preterm birth in twin-to-twin transfusion syndrome treated by fetoscopic laser coagulation: a multicenter randomized controlled trial\",\"authors\":\"\",\"doi\":\"10.1016/j.ajog.2023.11.1245\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Miscarriage and preterm birth are leading causes of loss and disability in monochorionic twins after laser treatment of twin-twin transfusion syndrome.</p></div><div><h3>Objective</h3><p>This study aimed to investigate the use of cervical pessary to reduce preterm birth before 32 weeks of gestation in monochorionic diamniotic twin pregnancies after fetal surgery for twin-twin transfusion syndrome.</p></div><div><h3>Study Design</h3><p>In this open-label multicenter randomized trial, pregnant women carrying monochorionic diamniotic twins requiring fetoscopic laser coagulation for twin-twin transfusion syndrome were randomly assigned in a 1:1 ratio to pessary placement or conservative management. The primary outcome was birth before 32 weeks of gestation. The secondary outcomes were birth before 28, 30, 34, or 37 weeks of gestation; preterm premature rupture of membranes; fetal and neonatal survival; and a composite of maternal and neonatal complications. The estimated sample size was 364 patients, with 182 cases in each arm of the study. The analysis was performed according to the intention-to-treat principle. Moreover, 2 interim analyses were planned.</p></div><div><h3>Results</h3><p>The trial was stopped prematurely after the first planned interim analysis for futility. Overall, 137 women were included in the analysis, 67 in the pessary group and 70 in the conservative management group. Preterm birth before 32 weeks of gestation occurred in 27 of 67 women (40.3%) in the pessary group and in 25 of 70 women (35.7%) in the conservative management group (adjusted odds ratio, 1.19; 95% confidence interval, 0.58–2.47; <em>P</em>=.63). No differences between groups were observed in the rate of deliveries before 28, 30, 34, and 37 weeks of gestation. Overall survival to delivery was 91.2% (125/137) for at least 1 twin, and 70.8% (97/137) for both twins, with no difference between groups. Neonatal survival at 30 days was 76.5% (208/272). There was no difference between the groups in maternal or neonatal morbidity.</p></div><div><h3>Conclusion</h3><p>In monochorionic diamniotic twin pregnancies requiring fetal therapy for twin-twin transfusion syndrome, routine use of cervical pessary did not reduce the rate of preterm birth before 32 weeks of gestation.</p></div>\",\"PeriodicalId\":7574,\"journal\":{\"name\":\"American journal of obstetrics and gynecology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":8.7000,\"publicationDate\":\"2024-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S0002937823020598/pdfft?md5=9c62f1086200c21784475e0eac6fcaf2&pid=1-s2.0-S0002937823020598-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"American journal of obstetrics and gynecology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0002937823020598\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"American journal of obstetrics and gynecology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0002937823020598","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景:流产和早产是双胎输血综合征激光治疗后单绒毛膜双胞胎损失和残疾的主要原因。目的:探讨双胎输血综合征胎儿手术后单绒毛膜双羊膜双胎妊娠使用宫颈托减少32周前早产的效果。研究设计:在这个开放标签的多中心随机试验中,携带单绒毛膜双羊膜双胞胎的孕妇需要胎儿镜激光凝固治疗双胎输血综合征,按1:1的比例随机分配到子宫内膜放置或保守治疗。主要结局为32周前分娩。次要结局是28,30,34或37周前出生,胎膜早破,胎儿和新生儿生存,以及孕产妇和新生儿并发症的综合。估计样本量为364例患者,每组研究182例。根据意向治疗原则进行分析。计划进行两次中期分析。结果:在第一次计划的中期分析无效后,试验过早停止。137名女性参与了分析,其中67名在子宫内膜组,70名在保守管理组。子宫托组32周前早产发生率为27/67(40.3%),保守管理组为25/70 (35.7%)(aOR, 1.19;95%ci, 0.58-2.47, p = 0.63)。28周、30周、34周、37周前产程组间差异无统计学意义。至少一个双胞胎的总生存率为91.2%(125/137),两个双胞胎的总生存率为70.8%(97/137),组间无差异。30天新生儿存活率为76.5%(208/272)。在产妇或新生儿发病率组之间没有差异。结论:单绒毛膜双羊膜双胎妊娠因双胎输血综合征需要胎儿治疗,常规使用宫颈托不能降低32周前早产的发生率。
The Arabin cervical pessary for the prevention of preterm birth in twin-to-twin transfusion syndrome treated by fetoscopic laser coagulation: a multicenter randomized controlled trial
Background
Miscarriage and preterm birth are leading causes of loss and disability in monochorionic twins after laser treatment of twin-twin transfusion syndrome.
Objective
This study aimed to investigate the use of cervical pessary to reduce preterm birth before 32 weeks of gestation in monochorionic diamniotic twin pregnancies after fetal surgery for twin-twin transfusion syndrome.
Study Design
In this open-label multicenter randomized trial, pregnant women carrying monochorionic diamniotic twins requiring fetoscopic laser coagulation for twin-twin transfusion syndrome were randomly assigned in a 1:1 ratio to pessary placement or conservative management. The primary outcome was birth before 32 weeks of gestation. The secondary outcomes were birth before 28, 30, 34, or 37 weeks of gestation; preterm premature rupture of membranes; fetal and neonatal survival; and a composite of maternal and neonatal complications. The estimated sample size was 364 patients, with 182 cases in each arm of the study. The analysis was performed according to the intention-to-treat principle. Moreover, 2 interim analyses were planned.
Results
The trial was stopped prematurely after the first planned interim analysis for futility. Overall, 137 women were included in the analysis, 67 in the pessary group and 70 in the conservative management group. Preterm birth before 32 weeks of gestation occurred in 27 of 67 women (40.3%) in the pessary group and in 25 of 70 women (35.7%) in the conservative management group (adjusted odds ratio, 1.19; 95% confidence interval, 0.58–2.47; P=.63). No differences between groups were observed in the rate of deliveries before 28, 30, 34, and 37 weeks of gestation. Overall survival to delivery was 91.2% (125/137) for at least 1 twin, and 70.8% (97/137) for both twins, with no difference between groups. Neonatal survival at 30 days was 76.5% (208/272). There was no difference between the groups in maternal or neonatal morbidity.
Conclusion
In monochorionic diamniotic twin pregnancies requiring fetal therapy for twin-twin transfusion syndrome, routine use of cervical pessary did not reduce the rate of preterm birth before 32 weeks of gestation.
期刊介绍:
The American Journal of Obstetrics and Gynecology, known as "The Gray Journal," covers the entire spectrum of Obstetrics and Gynecology. It aims to publish original research (clinical and translational), reviews, opinions, video clips, podcasts, and interviews that contribute to understanding health and disease and have the potential to impact the practice of women's healthcare.
Focus Areas:
Diagnosis, Treatment, Prediction, and Prevention: The journal focuses on research related to the diagnosis, treatment, prediction, and prevention of obstetrical and gynecological disorders.
Biology of Reproduction: AJOG publishes work on the biology of reproduction, including studies on reproductive physiology and mechanisms of obstetrical and gynecological diseases.
Content Types:
Original Research: Clinical and translational research articles.
Reviews: Comprehensive reviews providing insights into various aspects of obstetrics and gynecology.
Opinions: Perspectives and opinions on important topics in the field.
Multimedia Content: Video clips, podcasts, and interviews.
Peer Review Process:
All submissions undergo a rigorous peer review process to ensure quality and relevance to the field of obstetrics and gynecology.