NCT00306462终止不适用
Randomized Double-Blinded Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor Between 24 to 32 6/7 Weeks' Gestation
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation
研究概览
简要总结
Primary Hypothesis:
Acute tocolysis (48 hours) using oral nifedipine is more effective than intravenous magnesium sulfate in prolonging pregnancy in women with preterm labor with intact membranes between 24 and 32 6/7 weeks' gestation.
详细描述
Primary Objective:
To compare the efficacy of oral nifedipine versus IV magnesium sulfate on the rate of preterm delivery at <37 weeks in women with preterm labor between 24 and 32 6/7 weeks gestation.
Secondary Objective:
- To compare maternal side effects between the two tocolytic agents
- To compare neonatal morbidities between the two study groups.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women in preterm labor between 24 to 32 6/7 weeks' gestation with intact membranes with an age range of 15 to 50 years old.
排除标准
- •Cervical dilatation of ≥ 6 cm
- •Maternal contraindication to tocolysis
- •Known fetal anomalies
- •Suspected chorioamnionitis
- •Nonreassuring fetal heart tracing
- •Vaginal bleeding due to placenta previa or abruptio placenta
- •Preterm premature rupture of membranes
- •Prolapsed membranes
- •Human immunodeficiency virus positive
- •Multiple gestation
- •Patients on procardia within 24 hours of po intake
- •Magnesium sulfate tocolysis prior to randomization
- •Patient refusal
研究组 & 干预措施
1
Active Comparator
Intravenous magnesium sulfate or placebo
干预措施: Magnesium sulfate (Drug)
2
Active Comparator
Oral nifedipine or placebo
干预措施: Oral Nifedipine or placebo (Drug)
结局指标
主要结局
Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation
时间窗: 4 years
次要结局
- Maternal complications associated with each drugs. Neonatal morbidities associated with prematurity(4 years and 9 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Nifedipine Versus Magnesium Sulfate for Late Preterm TocolysisThreatened Preterm LaborNCT05343806Assiut University264
已完成
不适用
Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized TrialObstetric Labor, PrematureNCT00185900Stanford University192
已完成
4 期
Magnesium Sulphate Injection in Treatment of Myofascial Trigger PointsTrigger Point Pain, MyofascialNCT04742140Fayoum University180
已完成
不适用
the effect of Mg sulfate and Nifedipine effect on umbilical cord blood PHCord PH in preterm neonates.Labour and delivery complicated by biochemical evidence of fetal stressIRCT201103025955N1Vice Chncellor For Research Hamedan University Of Medical Siences60
已完成
2 期
Effect of magnesium sulfate and nifedipine in preterm laborIRCT20201017049052N1Ahvaz University of Medical Sciences100