Cervical Cerclage for Preventing Spontaneous Preterm Birth in Twin Pregnancies With Transvaginal Ultrasound Cervical Length ≤ 15mm: a Study Protocol for a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Preterm delivery less than 34 weeks
研究概览
简要总结
This is a multicenter randomized study designed to determine if ultrasound indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women with twin gestations and cervical length ≤15mm, diagnosed by transvaginal ultrasound between 16 to 23 6/7 weeks of gestation.
详细描述
Twin pregnancies have 59% incidence of preterm delivery (before 37 weeks of gestation), with increased perinatal mortality and neonatal morbidity. No therapy has proven effective in preventing preterm birth in twins. The transvaginal cervical length (TVCL) performed before 24 weeks have been determined to be the best tool to identified women with twin pregnancy at risk of preterm birth (PTB). When short TVCL is identified before 24 weeks, the risk of preterm birth is 60%-70% for TVCL ≤25mm and 80%-90% for TVCL ≤15mm. There are a small number of case reports of cervical cerclage in twin pregnancies with cervical length ≤15mm that suggest decreased preterm birth by 80%. The investigators' objective is to determine if ultrasound indicated cerclage in reduces the incidence of spontaneous preterm birth <34 weeks and improve perinatal outcome in asymptomatic women with twin gestations and cervical length ≤15mm between 16 to 23 6/7 weeks of gestation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women more than 18 years of age (limits the participants to female gender)
- •Diamniotic twin pregnancy
- •Asymptomatic
- •Transvaginal cervical length ≤ 15 mm between 16-23 6/7 weeks gestation
排除标准
- •Singleton or higher order than twins multiple gestation
- •Transvaginal cervical length >15mm
- •Cervical dilation with visible amniotic membranes
- •Amniotic membranes prolapsed into the vagina
- •Fetal reduction after 14 weeks form higher order
- •Monoamniotic twins
- •Twin-twin transfusion syndrome
- •Ruptured membranes
- •Major fetal structural anomaly
- •Fetal chromosomal abnormality
- •Cerclage already in place for other indication
- •Active vaginal bleeding
- •Clinical chorioamnionitis
- •Placenta previa
- •Painful regular uterine contractions
结局指标
主要结局
Preterm delivery less than 34 weeks
时间窗: at delivery
Incidence of preterm birth less than 34 weeks (any indication)
次要结局
- Interval between diagnosis and delivery(at delivery)
- Neonatal death(Between birth and 28 days of age)
- Spontaneous preterm birth rates(at delivery)
- Preterm delivery less than <32 weeks, <28 weeks, or <24 weeks(at delivery)
- Mean gestational age at delivery(at delivery)
- Premature rupture of membranes(at delivery)
- Chorioamnionitis(at delivery)
- Composite adverse neonatal outcome(Incidence between birth and 28 days of age)
- Maternal death(Between birth and 6 weeks postpartum)
- Birth weight at birth(at delivery)
- Gestational age at spontaneous rupture of membranes(at delivery)