Evaluation Of Pessaries In Twin Pregnancies With A Short Cervix (25 mm) Between 20-28 WG
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Demonstrate the profit of 10 days in the pessary group compared to control.
研究概览
简要总结
Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea
详细描述
Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea To show that the use of pessary makes it possible to lengthen the duration of the pregnancy of at least 10 days in patients with a twin pregnancy and a uterine collar length < = 25 mm measured by echography between 20 and 28 SA compared to the group controls.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years (legal majority in France)
- •Inclusion pessary positioning before 28 WG
- •Twin pregnancies, mono or dichorionic, diamniotic
- •Transvaginal cervical length ( 25mm between 20 et 28 WG
- •Intact membranes
- •No signs of infection (negative urine culture, CRP <10mg/l , blood white cell count <15000/ml)
- •Patient accepting follow-up
- •Covered by health insurance for France
排除标准
- •No more cervix
- •Chorioamnionitis
- •Abnormal CTG
- •Placenta praevia
- •Singleton or multiple >2
- •Monochorionic monoamniotic twin pregnancy
- •Preeclampsia or other PIH
- •Uncontrolled diabetes
- •Other maternal of fetal pathology responsible for preterm deliveries
- •Patient included in other therapeutic trials
- •Patient without legal freedom to consent
- •Homeless or no fixed address
结局指标
主要结局
Demonstrate the profit of 10 days in the pessary group compared to control.
时间窗: at least 10 days
Demonstrate the profit of 10 days in the pessary group compared to control
次要结局
- To evaluate and compare the frequency of the childbirth < 34 SA(before 34 weeks)
- Deliveries (<34WG)(34 weeks)
- Evaluate the rate of side effects of pessaries(during the pessaries)
- Neonatal outcome(before 28 weeks)