Universal Transvaginal Cervical Length Screening Program for Prevention of Preterm Birth in Singletons Without Prior Preterm Birth: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,334
- 试验地点
- 3
- 主要终点
- preterm birth rate
研究概览
简要总结
This is a non-blinded randomized screening trial of asymptomatic singleton pregnancies without prior spontaneous preterm birth who are randomized to either transvaginal ultrasound cervical length screening program (i.e. intervention group) or no screening (i.e. control group). Women are consented and randomized at the time of their routine anatomy scan between 18 0/7 and 23 6/7 weeks. Women randomized in the transvaginal ultrasound cervical length screening will receive a single transvaginal ultrasound cervical length measurement after the anatomy scan. The cervical length will be measured by operators with certification of competence in the technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton gestations
- •No prior SPTB
排除标准
- •Multiple gestations
- •History of SPTB in a prior pregnancy
- •Rupture of membranes at the time of randomization
- •Known major fetal structural (i.e. defined as those that are lethal or require prenatal or postnatal surgery) or chromosomal abnormality
- •Fetal death at the time of randomization
- •Cerclage in situ at the time of randomization
- •Pessary in situ at the time of randomization
- •Vaginal bleeding at the time of randomization
- •Women who are unconscious, severly ill, mentally handicapped, or under the age of 18 years.
结局指标
主要结局
preterm birth rate
时间窗: Less than 37 weeks
either spontaneous or indicated preterm delivery
次要结局
- birth weight(time of delivery)
- preterm birth rate(ess than 24, 28, 32, 30, and 34 weeks gestation)
- admission to neonatal intensive care unit(time of delivery)
- neonatal death(Between birth and 28 days of age)
- Composite of adverse perinatal outcomes(Between birth and 28 days of age)
- perinatal death(Between birth and 28 days of age)
研究者
Gabriele Saccone
Principal Investigator
Federico II University