Physical Examination-Indicated Pessary
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Neonatal survival
研究概览
简要总结
Cervical insufficiency, previously referred to as cervical incompetence, has classically been defined as painless dilation of the cervix in the absence of contractions or bleeding in the second trimester resulting in recurrent pregnancy losses. Painless mid-trimester cervical dilation is an uncommon finding in the general population occurring in less than 1% of pregnancies. Cerclage for the prevention pregnancy loss in cases with both prior preterm births and/or second trimester losses, as well as second trimester cervical dilatation in the index pregnancy, was first reported in the 1950's. Cerclage placement in this setting has been variably referred to as "physical exam-indicated cerclage", "rescue cerclage", and "emergency cerclage". To date, the benefits of cerclage for this indication are not entirely clear.
A recent meta-analysis showed that physical exam-indicated cerclage is associated with a reduction in perinatal mortality and prolongation of pregnancy when compared to no such cerclage.
Recently, several RCTs have shown that cervical pessary could decrease the incidence of PTB in several populations.
Thus, the aim of our trial as noninferiority trial is to evaluate the efficacy of pessary compared to cervical cerclage in prevention of PTB in women in the setting of mid-trimester cervical dilation
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancies
- •Cervical dilation between 1 to 5 cm and/or visible membranes by pelvic exam or speculum exam between at 16-23 6/7 weeks gestation
排除标准
- •Pessary or cerclage already in situ
- •active vaginal bleeding
- •Placenta previa/accreta
- •Multiple gestations
- •Amniotic membranes prolapsed beyond external os into the vagina, unable to visualize cervical tissue
- •Ruptured amniotic membranes at the time of diagnosis of dilated cervix
- •Cervical dilation more than 5 cm
- •Labor (progressing cervical dilation) or painful regular uterine contractions
研究组 & 干预措施
Cervical pessary
Arabin Pessary
干预措施: Arabin Pessary (Device)
Cervical cerclage
McDonald Cerclage
干预措施: Cervical cerclage (Device)
结局指标
主要结局
Neonatal survival
时间窗: From delivery to 28 days
次要结局
- Birth weight(time of delivery)
- gestational age at delivery(time of delivery)
- Preterm birth(time of delivery)
- Latency(time of delivery)
研究者
Gabriele Saccone
MD
Federico II University