Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Spontaneous preterm birth (SPTB) <34 weeks
研究概览
简要总结
Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.
The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with a short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on the use of cervical pessary in pregnancy or guidelines for management have been assessed.
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
- None
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
- •18-50 years of age
- •Singleton pregnancy (limits the participants to female gender)
- •Short cervical length (less than or equal to 25 mm) on second trimester transvaginal ultrasound at 18-23 6/7 weeks gestation
排除标准
- •Multiple gestation
- •Prior spontaneous preterm birth 16-36 6/7 weeks
- •Ruptured membranes
- •Lethal fetal structural anomaly
- •Fetal chromosomal abnormality
- •Cerclage in place (or planned placement)
- •Vaginal bleeding
- •Suspicion of chorioamnionitis
- •Ballooning of membranes outside the cervix into the vagina or CL = 0 mm on transvaginal ultrasound
- •Painful regular uterine contractions
- •Placenta previa
研究组 & 干预措施
Cervical Pessary
The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)
干预措施: Cervical pessary (Device)
No intervention
No pessary No pessary will be used. Subjects will receive standard obstetrical management
结局指标
主要结局
Spontaneous preterm birth (SPTB) <34 weeks
时间窗: Less than 34 weeks gestation
Spontaneous preterm delivery less than 34 weeks of gestation
次要结局
- preterm premature rupture of membranes(Less than 34 weeks gestation)
- Latency(time of delivery)
- SPTB <37w(Less than 37 weeks gestation)
- SPTB <32w(Less than 32 weeks gestation)
- SPTB <28w(Less than 32 weeks gestation)
- Gestational age at delivery(Time of delivery)
- Type of delivery(time of delivery)
- Maternal side effects(Time of delivery)
- Birth weight(Time of delivery)
- Neonatal death(Between birth and 28 days of age)
- perinatal death(fetal death after 20 weeks)
- Composite adverse perinatal outcome(Between birth and 28 days of age)
- Chorioamnionitis(Time of delivery)
- Adminssion to neonatal intensive care unit(Between birth and 28 days of age)
研究者
Gabriele Saccone
Medical Doctor
Federico II University