Prevention of Preterm Birth With a Pessary in Triplet
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Preterm delivery
研究概览
简要总结
The incidence of multiple gestations has increased over the past years, mostly because of increased use of assisted reproductive technologies. Triplet pregnancies are at increased risk of preterm birth (PTB), which is the primary reason for their increased morbidity and mortality compared to singletons. Multiple gestations, including triplets, account for about 3% of all pregnancies in the US but constitute at least 10% of cases of PTB, over 30% of very low birth weight infants, and nearly 20% of infant mortality.
A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of PTB, including in multiple gestations. In singletons with a prior PTB and a short CL <25mm before 24weeks, cerclage is associated with significant decreases in PTB and perinatal morbidity and mortality in the meta-analysis of randomized trials (RCTs). On the contrary, the effect of cerclage in multiple gesttations has been insufficiently studied, with meta-analysis data showing a possible harm from cerclage compared to controls.
The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB in unselected triplet gestations.
We planned to assess outcomes in subgroup analysis of women with short cervical length (TVU CL <30 mm)
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 (Outcomes Assessor)
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
- •Triplet pregnancy (limits the participants to female gender)
- •Gestational age at randomization between 20(0) and 22(6)
排除标准
- •Singleton, twin or higher order than triplets multiple gestation
- •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
Routine care (watch and wait)
Cervical Pessary
Cervical pessary is a medical device used to treat an incompetent (or insufficient) cervix (cervix starts to shorten and open too early). Early in the pregnancy a round silicone pessary is placed at the opening to the cervix to close it, and then remove late in the pregnancy when the risk of a preterm birth has passed.
Cervical pessary has been tried as a simple, non-invasive alternative that might replace the above invasive cervical stitch operation to prevent preterm birth.
干预措施: Cervical Pessary (Device)
结局指标
主要结局
Preterm delivery
时间窗: Less than 34 weeks gestation
次要结局
- Preterm delivery(Less than 24, 28 and 37 weeks)
- Birth weight(Time of delivery)
- Neonatal death(Between birth and 28 days of age)
- Chorioamnionitis(Time of delivery)
- pontaneous preterm birth rates(Less than 24, 28, 34 and 37 weeks gestation)
- Type of delivery: rate of cesaran delivery, vaginal delivery and operative vaginal delivery(Time of delivery)
- Significant adverse maternal effects(Time of delivery)
- Admission to neonatal intensive care unit(Between birth and 28 days of age)
- Gestational age at delivery(Time of delivery)
- Spontaneous rupture of membranes(Less than 34 weeks gestation)
- Composite adverse neonatal outcome(Between birth and 28 days of age)
- Intolerance to pessary(Prior to delivery)
研究者
Gabriele Saccone
Medical Doctor
Federico II University