（阿拉伯糖）栓剂预防双胎妊娠早产的开放性随机试验：卫生经济学和可接受性研究（STOPPIT-2）方案。
Open randomised trial of the (Arabin) pessary to prevent preterm birth in twin pregnancy with health economics and acceptability: STOPPIT-2-a study protocol.
机构信息
Tommy's Centre for Maternal and Fetal Health, MRC Centre for Maternal and Fetal Health, University of Edinburgh, Edinburgh, UK.
Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.
出版信息
BMJ Open. 2018 Dec 6;8(12):e026430. doi: 10.1136/bmjopen-2018-026430.
INTRODUCTION
The STOPPIT-2 study aims to determine the clinical utility of the Arabin cervical pessary in preventing preterm birth in women with a twin pregnancy and a short cervix, about which there is current uncertainty. STOPPIT-2 will resolve uncertainty around effectiveness for women with a twin pregnancy and a cervical length of 35 mm or less, define adverse effects, ascertain acceptability and estimate National Health Service costs and savings.
METHODS
STOPPIT-2 is a pragmatic multicentre open-label randomised controlled trial. Consenting women with twin pregnancy will have an transvaginal ultrasound scan of their cervical length performed between 18+0 and 20+6 weeks' gestation by an accredited practitioner: women with a cervical length of ≤35 mm will be eligible for inclusion in the treatment phase of the study. The intervention by the insertion of the Arabin cervical pessary will be compared with standard treatment (no pessary).The primary outcomes are (obstetric) spontaneous onset of labour for the mother leading to delivery before 34 weeks' gestation and (neonatal) a composite of specific adverse outcomes or death occurring up to the end of the first 4 weeks after the estimated date of delivery to either or both babies.We plan to recruit 500 women in the treatment phase of the study. Assuming a treatment effect of 0.6, and background rates of 35% and 18%, respectively, for each of the primary outcomes, our study has 85% power to detect a difference between the intervention and the control groups.
ANALYSIS
Data will be analysed on the intention-to-treat principle.
ETHICS
STOPPIT-2 was approved by the South East Scotland Ethics Committee 02 on 29 August 2014, reference number 14/SS/1031 IRAS ID 159610.
DISSEMINATION
Peer reviewed journals, presentations at national and international scientific meetings.
TRIAL REGISTRATION NUMBER
ISRCTN98835694 and NCT02235181.
简介
STOPPIT-2 研究旨在确定阿拉伯宫颈托在预防双胎妊娠且宫颈较短的女性早产方面的临床应用价值，目前对此存在不确定性。STOPPIT-2 将解决双胎妊娠且宫颈长度为 35mm 或更短时有效性方面的不确定性，确定不良反应，确定可接受性，并估算国民保健服务成本和节约。
方法
STOPPIT-2 是一项实用的多中心开放性随机对照试验。符合条件的双胎妊娠妇女在 18+0 至 20+6 孕周期间将由认可的从业者进行经阴道超声检查宫颈长度：宫颈长度≤35mm 的妇女将有资格纳入研究的治疗阶段。干预措施是插入阿拉伯宫颈托，与标准治疗（无托）进行比较。主要结局为母亲（产科）自发性分娩提前至 34 孕周前，以及（新生儿）特定不良结局或死亡的复合结局，发生在两个婴儿预计出生日期后的第 1 至第 4 周结束之前。我们计划在研究的治疗阶段招募 500 名妇女。假设治疗效果为 0.6，且主要结局的背景发生率分别为 35%和 18%，我们的研究有 85%的效能检测干预组和对照组之间的差异。
分析
将根据意向治疗原则进行数据分析。
伦理
STOPPIT-2 于 2014 年 8 月 29 日由东南苏格兰伦理委员会 02 批准，编号为 14/SS/1031，IRAS ID 159610。
传播
同行评议期刊，在国家和国际科学会议上的演讲。
试验注册编号
ISRCTN98835694 和 NCT02235181。
Zotero 插件