Pessary as Adjunctive Therapy to Cerclage for the Prevention of Preterm Birth
试验速览
- 阶段
- 3 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
Cervical cerclage was devised in the 1950's for women with prior early preterm births (PTB) who developed a dilated cervix detected by manual exam in the second trimester. In contemporary practice, there are three possible indications for cerclage. History-indicated cerclage (HIC) is defined as a cerclage placed usually between 12-15 weeks based solely on poor prior obstetrical history, e.g. multiple second trimester losses due to painless dilatation. Ultrasound-indicated cerclage (UIC) is defined as a cerclage placed usually between 16-23 weeks for transvaginal ultrasound (TVU) cervical length (CL) < 25mm in a woman with a prior spontaneous PTB. Physical-exam indicated is defined as a cerclage placed usually between 16-23 weeks because of cervical dilatation of 1 or more centimeters detected on physical (manual) examination.
Randomized trials and meta-analysis of these have shown that UIC is associated with significant reduction in PTB and improved neonatal outcome, whereas evidence of efficacy for history-indicated cerclage and physical exam-indicated cerclage is limited. In the United States, the national data shows that the rate of cerclage has decreased in the last few years. The indications of placement of cerclage have recently changed, and so it is important to evaluate how many women are getting this procedure. With the recent completion of clinical trials, it is plausible that obstetricians and perinatologists may have become more selective in terms of the best candidates for cerclage.
The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB as adjuctive therapy in women with UIC
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 gestations
- •Women with prior preterm birth and with short cervical length (TVU CL <25 mm) who underwent UIC
排除标准
- •multiple gestation
- •Ruptured membranes
- •Lethal fetal structural anomaly
- •Fetal chromosomal abnormality
- •Vaginal bleeding
- •Suspicion of chorioamnionitis
- •Ballooning of membranes outside the cervix into the vagina
- •Painful regular uterine contractions
- •Placenta previa
结局指标
主要结局
Preterm delivery
时间窗: Less than 34 weeks gestation
次要结局
- Birth weight(Time of delivery)
- Spontaneous rupture of membranes(Less than 34 weeks gestation)
- Neonatal death(Between birth and 28 days of age)
- Spontaneous preterm birth rates(Less than 24, 28, 34 and 37 weeks gestation)
- Chorioamnionitis(Time of delivery)
- Preterm delivery(Less than 24, 28 and 37 weeks)
- significant adverse maternal effects(Time of delivery)
- Intolerance to pessary(prior to delivery)
- Type of delivery: rate of cesaran delivery, vaginal delivery and operative vaginal delivery(Time of delivery)
- Gestational age at delivery(Time of delivery)
- Composite adverse neonatal outcome(Between birth and 28 days of age)
- Admission to neonatal intensive care unit(Between birth and 28 days of age)
研究者
Gabriele Saccone
Medical Doctor
Federico II University