Use of a Cervical Cap as an Aid in Uncertain Rupture of Membranes in the Second Trimester
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Changes in amniotic fluid index and single vertical pocket before and after placement of the cervical cap/
研究概览
简要总结
Early preterm premature rupture of membranes (PPROM) complicates 0.7% of pregnancies. When PPROM occurs before the 24th week,the risk of fetal and neonatal death is 70%. There is also a high risk of neonatal and maternal morbidity. When the diagnosis of PPROM is uncertain by physical examination, additional tests are needed. These tests have false positive and false negative rates. The gold standard for diagnosing PPROM is amniocentesis and dye test. This procedure has a risk of infection and abortion.Our hypothesis is that by using a cervical cap for 6 hours and repeated ultrasound exams we can diagnose or rule out PPROM in cases which are uncertain. Our study group will be pregnant women gestational age 14-23, suspected of having PPROM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Gestational age 14-23
- •Single fetus
- •Suspected rupture of membranes
- •Oligohydramnios
排除标准
- •Vaginal bleeding
- •Suspected chorioamnionitis
结局指标
主要结局
Changes in amniotic fluid index and single vertical pocket before and after placement of the cervical cap/
时间窗: the parameters will be measured before placement, 6 hours after placement, 1 hour after displacement
次要结局
- chorioamnionitis and abortion(one week from the start of the study)
研究者
david danon
Doctor
Rabin Medical Center