Study on the Prediction and Prevention of Twin Premature Birth
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Neonatal prognosis
研究概览
简要总结
Research Objectives:
- Establish a prediction and scoring system for twin premature birth.
- To investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth.
- To investigate the effect of stress cervical ligation in preventing premature delivery of twins.
- The optimal dose of atosiban for the treatment of twin premature birth.
- The influence of delivery mode on twin premature infants under 32 weeks.
详细描述
Research Objectives:
- Establish a prediction and scoring system for twin premature birth.
- To investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth.
- To investigate the effect of stress cervical ligation in preventing premature delivery of twins.
- The optimal dose of atosiban for the treatment of twin premature birth.
- The influence of delivery mode on twin premature infants under 32 weeks. It has now entered the second phase: clinical data collection
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
- Double (Participant, Care Provider)
盲法说明
The participants and the treating physicians were not informed of the grouping
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •twins with cervical length ≤ 25 mm by vaginal ultrasound at 14-32 weeks no contractions, abdominal pain and vaginal bleeding No complicated twin complications occurred during pregnancy
排除标准
- •Patients undergoing selective cervical ligation before 14 weeks of gestation history of liver problems or cholestasis during pregnancy Abnormal liver enzymes Abnormal renal function Local allergy to trace natural progesterone Recurrent vaginal bleeding Recurrent vaginal infection Ultrasound diagnosis of fetal abnormality Intrauterine treatment for fetal abnormalities
研究组 & 干预措施
progesterone 200mg
Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 200mg
干预措施: Progesterone (Drug)
progesterone 400mg
Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 400mg
干预措施: Progesterone (Drug)
progesterone 600mg
Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 600mg
干预措施: Progesterone (Drug)
结局指标
主要结局
Neonatal prognosis
时间窗: one week
Preterm birth rate (\<37 weeks of gestation), early preterm birth rate (\<32 weeks of gestation), need to receive anti-tocolytic treatment; Rates of premature rupture of membranes (\<37 weeks), neonatal perinatal mortality and morbidity.
次要结局
- Gestational age and prolongation of gestational age at delivery(one year)
研究者
Caixia Liu
Shengjing hospital
Shengjing Hospital