Pessary in Prevention of Preterm Birth for Women With Twin Pregnancies and Short Cervical Length
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 242
- 试验地点
- 2
- 主要终点
- Spontaneous Preterm delivery <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. Multiple gestations are at increased risk of SPTB. A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB, in both singletons and twins.
The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of the cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on use of the 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
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
outcomes assessor and data analyst
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
- •Twin pregnancy (limits the participants to female gender)
- •Short cervical length (less than or equal to 30 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation
排除标准
- •Singleton or higher order than twins multiple gestation
- •Monoamniotic twins
- •Twin twin transfusion syndrome
- •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
- •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 36th 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 delivery <34 weeks
时间窗: Less than 34 weeks gestation
次要结局
- Spontaneous rupture of membranes(Less than 34 weeks gestation)
- Type of delivery (if cesarean or operativa vaginal or spontaneous vaginal delivery)(Time of delivery)
- Composite perinatal outcome(Between birth and 28 days of age)
- Birth weight(Time of delivery)
- Neonatal death(Between birth and 28 days of age)
- Maternal side effects(Maternal side effects)
- Gestational age(Time of delivery)
- Spontaneous preterm birth rates <37, <28 and <24 weeks(Less than 24, 28, 34 and 37 weeks gestation)
研究者
Gabriele Saccone
Medical Doctor
Federico II University