Verify the Safety and Effectiveness of the Cerclage Pessary in the Prevention and Treatment of High-risk Preterm Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Child's birth and survival（rate）
研究概览
简要总结
Verify the safety and effectiveness of the cerclage pessary in the prevention and treatment of high-risk preterm pregnancy.
详细描述
Prospective Open-label Multicentre Randomized Controlled Trial. high-risk preterm pregnancy is that there are at least one history of spontaneous preterm birth and/or late abortion before 34+0 weeks, for high-risk pregnant women that meet the inclusion criteria, the early treatment with cerclage pessary at 12-18weeks compare with routine treatment. The patients will be informed of the intended therapeutic effect and possible side effects. If they agree and after obtaining their informed consent, they will be randomized to test group (cerclage pessary group) and control group (Utrogestan group).
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with a pregnancy and a history of at least one spontaneous preterm birth before 34+0 weeks and/or a history of late abortion
- •12+0 -18+0 weeks of gestation
- •Minimal age of 18 years
- •Informed consent signature
排除标准
- •The previous preterm delivery is iatrogenic proterm labor
- •Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
- •The pregnant woman with severe cervical erosion, cervical polyp, hemorrhage and the doctors think she could not use cerclage pessary
- •The pregnant woman with uterine cervicitis
- •The pregnant woman that has been confirmed premature birth
- •Cerclage prior to randomisation
- •Cerclage prior to randomisation
- •Placenta previa totalis
- •Active vaginal bleeding at the moment of randomization
- •Spontaneous rupture of membranes at the time of randomization
- •Silicone allergy
- •Painful regular uterine contractions
- •The pregnant woman have the indication of operation cervical cerclage
- •Current participation in other RCT
研究组 & 干预措施
pessary
the test group is pessary.The pregnant woman is assigned to the pessary group and after having excluded a vaginal infection the pessary will be inserted directly.
干预措施: pessary (Device)
Progesterone
the control group is progesterone. Pregnant women in the control group were treated by 200 mg QN, it is used for 34 gestational weeks.
干预措施: Progesterone (Drug)
结局指标
主要结局
Child's birth and survival（rate）
时间窗: 34+0 weeks
Child's birth and survival
次要结局
- Rupture of membranes before 32 weeks for mother（rate）(before 37+0 weeks)
- Time to birth of Offspring（gestational weeks）(before 37+0 weeks)
- Birth weight of Offspring(g)(before 37+0 weeks)
- Fetal or neonatal death （rate）(before 37+0 weeks)
- Neonatal morbidity （rate）(before 37+0 weeks)
- Harm from intervention（Case Report Form）(before 37+0 weeks)
- Maternal death（rate）(before 37+0 weeks)
- Significant maternal adverse events (rate)(before 37+0 weeks)
- Physical or psychological intolerance to pessary for mother(number of cases)(before 37+0 weeks)
- inflammation 3rd stage of chorioamnionitis（rate）(before 37+0 weeks)
- Hospitalisation for threatened preterm labour before 32 weeks（Case Report Form）(before 37+0 weeks)