Oral Nifedipine Versus Intravenous Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa: Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- The duration of prolongation of gestation
研究概览
简要总结
Antepartum hemorrhage is defined as bleeding from or within the female genital tract, occurring from 28+0 weeks of pregnancy and till delivery of the fetus. it occurs in 3-5% of pregnancies and is an important cause of perinatal and maternal morbidity and mortality worldwide
详细描述
There are many tocolytic agents may have a role in conservative management of placenta previa such as magnesium sulfate, calcium channel blockers and β-sympathormimetics. In 2004 Sharma suggests that ritodrine hydrochloride in patients with symptomatic placenta previa tends to prolong the pregnancy and result in an increase in birth weight of the babies without causing any adverse effect on the mother and fetus
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Estimated gestational age : between 28 weeks and 37 week's gestation
- •Confirmed Placenta previa; either major or minor degrees.
- •Placenta previa with preterm uterine contractions
排除标准
- •Severe attack of bleeding requiring an immediate intervention.
- •Fetal heart rates instability or non-reassuring tracing
- •Intrauterine fetal death or major fetal anomalies.
- •If associated with abruptio placentae
- •Patients with known bleeding disorders or on anticoagulant therapy
- •Patients with severe medical disorders as myasthenia gravis documented magnesium toxicity.
研究组 & 干预措施
Nifidipne
received oral nifedipine 10 mg every 20 minutes for three doses, followed by 10 mg orally every 6 hours
干预措施: Nifedipine (Drug)
Magnisum sulphate
Patients in the MgSO4 group received intravenous 6 g bolus MgSO4 20% followed by a 2 g/h infusion
干预措施: Magnesium Sulfate (Drug)
结局指标
主要结局
The duration of prolongation of gestation
时间窗: 1 month
measured from the time of enrollment to the time of delivery
次要结局
未报告次要终点
研究者
ramy nasser
Principal investigator
Assiut University