Premature Labour Screening by Cervical Ultrasound for Asymptomatic Pregnant Women in the PACA Region. Various Treatment Strategies : 1. Progesterone 200mg (Vaginal Way) 2. Pessary 3. Vaginal Stitching 4. Rest
试验速览
- 阶段
- 不适用
- 入组人数
- 3,500
- 试验地点
- 1
- 主要终点
- delivery rate before 37 weeks
研究概览
简要总结
State of the question and research objective: International trials have shown that ultrasound measurement of the cervix identifies a population at high risk of preterm delivery. In case of short neck several types of treatments can be recommended: progesterone, the establishment of a strapping or pessary. These three treatments reduce the risk of preterm delivery. There is no French study.
The objective of this study is to reduce prematurity in the PACA region Monaco-Corsica by introducing a routine ultrasound screening strategy asymptomatic short necks.
Population concerned: All patients with active singleton pregnancy between 16 and 26 SA SA are eligible to ultrasound of the cervix.
- Primary endpoint: delivery rate before 37 weeks.
- Criteria secondary judgments rate of deliveries before 37 weeks, neonatal mortality morbidity.
Expected result: a prematurity of 50%
详细描述
State of the question and research objective: International trials have shown that ultrasound measurement of the cervix identifies a population at high risk of preterm delivery. In case of short neck several types of treatments can be recommended: progesterone, the establishment of a strapping or pessary. These three treatments reduce the risk of preterm delivery. There is no French study.
The objective of this study is to reduce prematurity in the PACA region Monaco-Corsica by introducing a routine ultrasound screening strategy asymptomatic short necks.
Expected result: a prematurity of 50%
Population concerned: All patients with active singleton pregnancy between 16 and 26 SA SA are eligible to ultrasound of the cervix.
Method of observation and deduction investigation: Study before / after comparing two periods: period A (2013) and Period B (2015).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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,
- •pregnancy with single fetus,
- •gestational age between 16SA and 26SA,
- •asymptomatic patients, that is to say, without sign of preterm labor layout
排除标准
- •Maternal Pathology (Pre Eclampsia, non-insulin dependent diabetes, insulin dependent gestational diabetes or unbalanced)
- •uterine malformation
- •fetal malformation or fetal chromosomal abnormality
- •premature Work in Progress (cervix dilated to more than 2 cm or regular uterine contractions and felt)
- •Signs of chorioamnionitis
- •Allergy to progesterone
- •Taking progesterone in the month preceding the inclusion
结局指标
主要结局
delivery rate before 37 weeks
时间窗: 21 weeks maximum
次要结局
- neonatal mortality(about 30 weeks)
- length of stay in intensive care(about 30 weeks)
- rate of newborns admitted to intensive care in the first month of life(about 30 weeks)