NCT01380158撤回不适用
Preventing Preterm Birth With a Pessary
Medstar Health Research Institute6 个研究点 分布在 1 个国家开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 6
- 主要终点
- delivery prior to 37 weeks of gestation
研究概览
简要总结
The primary objective of this study, is to determine the effect of a Cup pessary, a device that is currently readily available in the USA and similar in design to the Arabin pessary, on the incidence of delivery prior to 37 weeks in women with a history of prior spontaneous birth (before 37 weeks) and incidentally found to have a cervix less than 25 mm in length prior to 23 weeks.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancies in patients with a history of spontaneous preterm birth (previous delivery between 17 0/7 weeks and 36 6/7 weeks).
- •Women ages 18 to 45 years of age
排除标准
- •Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), fetal death, or fetal growth restriction diagnosed before randomization.
- •Presence of prophylactic cervical cerclage
- •Significant maternal-fetal complications (treated chronic hypertension, insulin dependant diabetes mellitus, red cell isoimmunization)
- •Painful regular uterine contractions, or ruptured membranes
- •Visual cervical dilation of 2cm or greater and visible membranes.
- •Patients with a pregnancy dated by an ultrasound after 20 weeks gestation.
结局指标
主要结局
delivery prior to 37 weeks of gestation
时间窗: within the first 30 days after delivery of the neonate
Gestational age at birth will be recorded
次要结局
- Major adverse neonatal outcomes(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Rate of birth less than seven days from randomization(within the first 30 days after delivery of the neonate)
- Perinatal death(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Low birth weight(within the first 30 days after delivery of the neonate)
- Need for neonatal special care(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Previable birth (<24 weeks)(within the first 30 days after delivery of the neonate)
- Incidence of complications due to pessary(Every 4 weeks while pregnant with pessary in situ)
研究者
研究点 (6)
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