Efficacy and Safety of MgSO4 as Tocolytics Compared to Ritodrine in Preterm Labor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Efficacy of MgSO4 as tocolytics : increased interval of uterine contraction, decreased maternal painful sensation, stopping the cervical change
研究概览
简要总结
Ritodrine is the conventional and the only approved tocolytics in Korea(by KFDA), although it was withdrawn from the US market more than 10 years ago. As already known well, ritodrine has many side effects such as tachycardia, hyperglycemia, pulmonary edema and so on. When such complications of ritodrine appears, clinicians consider of using MgSO4 as substitute, but its use is off-the-label yet in Korea. Facing this discrepancy, the investigators want to compare the efficacy and safety of MgSO4 with ritodrine and prove that MgSO4 is not inferior to ritodrine as tocolytics. For the singleton and twin pregnancies between 24+0weeks and 34 completed weeks whose uterine contraction is more than 4 during 20 minutes period with their cervical ripening is more than 25%, the investigators randomise them in Ritodrine group or MgSO4 group. Then, the investigators will check the change of their interval of uterine contraction, degree of pain and the appearance of any side effects or treatment failure sign.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age of 24+0 to 34+6weeks
- •singleton and twin pregnancies
- •preterm labor with more than 4 times of uterine contraction for 20 minutes or more than 8 times for 1 hour on external tocography
- •cervical dilatation of 0 to 3cm and cervical ripening more than 25%, or cervical length in sonography below 2cm
排除标准
- •triplet etc
- •preterm premature rupture of membrane
- •cervical dilatation more than 3cm
- •history of cerclage operation during this pregnancy
- •placenta previa
- •severe hypertensive diseases in pregnancy
- •history of administration of any tocolytics 12 hours before enrollment
- •fever more than 38.0'c
研究组 & 干预措施
MgSO4 arm
who were randomised to have MgSO4 as tocolytics
干预措施: MgSO4 (Drug)
YTP(ritodrine) arm
who randomly assigned to have Yutopar(ritodrine) as tocolytics
干预措施: YTP(Ritodrine) (Drug)
结局指标
主要结局
Efficacy of MgSO4 as tocolytics : increased interval of uterine contraction, decreased maternal painful sensation, stopping the cervical change
时间窗: 48 hours later
次要结局
未报告次要终点