Centre for Women and Children's Health Research, Harris-Wellbeing Preterm Birth Research Group, University of Liverpool, Liverpool Women's Hospital, Liverpool, UK.
Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, UK.
J Matern Fetal Neonatal Med. 2021 Jan;34(1):49-57. doi: 10.1080/14767058.2019.1588245. Epub 2019 Mar 21.
To assess feasibility for a definitive randomized controlled trial (RCT) comparing three treatments for short cervix in a population at high risk for spontaneous preterm birth (sPTB) over a 1-year period. Three arm, open label feasibility randomized clinical study. Women with singleton pregnancy with risk factors for sPTB (history of sPTB or prelabor premature rupture of membranes (PPROM) <34 weeks or significant cervical surgery), and short cervix on transvaginal ultrasound scan detected between 16 and 24 weeks gestation were randomized to receive either cervical cerclage, vaginal pessary, or vaginal progesterone 200 mg nocte. Pregnancy outcomes and treatment costs were collected from hospital records, NHS Reference costs, and British National Formulary costs. Feasibility targets were defined as (i) at least 55% of eligible women randomized; (ii) maximum 5% failure to adhere to the protocol per arm; (iii) maximum 5% loss to short-term follow-up. Of 417 women screened between October 2015 and 2016, 25 (6%) were eligible for trial inclusion, of whom 18 (72%) agreed to participate at the rate 0.75 participants/site/month. Adherence to protocol was 100% in pessary and cerclage arms and 80% in vaginal progesterone arm (95% CI 24-100%). No participants were lost to follow up. Cost of interventions accounted for 6% (95% CI 2-10%) of overall health care expenditure. A definitive clinical trial comparing treatments for prevention of sPTB in high-risk women with short cervix is feasible but will be challenging due to small numbers of eligible participants.
评估在 1 年内对有自发性早产 (sPTB) 高危因素的人群中，通过三种治疗方法比较短宫颈的一项明确的随机对照试验 (RCT) 的可行性。这是一项三臂、开放性标签可行性随机临床试验。有 sPTB 病史或早发性胎膜早破 (PPROM) <34 周或有明显宫颈手术史的单胎妊娠且有短宫颈的孕妇，在妊娠 16-24 周时经阴道超声检查确诊，将随机分为接受宫颈环扎术、阴道栓剂或阴道用黄体酮 200mg 每晚治疗。妊娠结局和治疗费用均从医院记录、NHS 参考成本和英国国家处方集成本中收集。可行性目标定义为：(i) 至少 55%的合格女性随机分组；(ii) 每个组最多有 5%的患者未遵守方案；(iii) 短期随访的失访率最多有 5%。在 2015 年 10 月至 2016 年期间，共筛查了 417 名女性，其中 25 名（6%）符合试验纳入标准，18 名（72%）患者同意参加，每个研究点每月入组 0.75 名患者。阴道栓剂和环扎术组的依从性为 100%，阴道用黄体酮组为 80%（95%CI 24-100%）。没有患者失访。干预措施的成本占总医疗支出的 6%（95%CI 2-10%）。在有短宫颈的高危孕妇中，比较治疗方法预防 sPTB 的一项明确的临床试验是可行的，但由于合格参与者人数较少，因此具有挑战性。
