Fetal Middle Cerebral Artery Doppler in Preterm Births Receiving Magnesium Sulfate for Neuroprotection
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- changes in fetal middle cerebral artery Doppler indices
研究概览
简要总结
Two groups of women with preterm labor will be included. One will receive magnesium sulfate for neuroprotection and the other will receive placebo. Fetal middle cerebral artery Doppler indices will be measured before and after intake of either magnesium sulfate or placebo to find if any significant changes occur in fetal cerebral blood flow.
详细描述
The study will include women with preterm labor with gestational age less than 32 weeks. women will be randomized to receive either magnesium sulfate (loading dose 6 g over 20 minutes followed by maintenance dose of 1 g/hour for 24 hours), or placebo in the form of sodium chloride solution 0.9% over 24 hours. Fetal middle cerebral artery Doppler indices [Peak systolic velocity (PSV), Pulsatility index (PI), and resistance index (RI)] will be recorded before and after treatment in both groups. Results of Doppler indices will be compared between both groups and before and after intake of magnesium sulfate to find out if middle cerebral artery Doppler of the fetus can explain the mechanism behind the use of magnesium sulfate for fetal neuroprotection in preterm births.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women with preterm labor
- •gestational age less than 32 weeks
- •singleton pregnancy
排除标准
- •contraindication or hypersensitivity to magnesium
- •preeclampsia
- •multiple pregnancy
- •intake of magnesium sulfate in this pregnancy before
研究组 & 干预措施
magnesium sulfate
this group will receive magnesium sulfate loading dose 6 g in 500 cc of ringer solution over 20 minutes then maintenance dose of 1 g/ hour for 24 hours.
干预措施: Magnesium Sulfate (Drug)
placebo group
this group will receive sodium chloride 0.9% solution for 24 hours.
干预措施: 0.9% sodium chloride solution (Other)
结局指标
主要结局
changes in fetal middle cerebral artery Doppler indices
时间窗: 3 months
次要结局
- maternal adverse effects of magnesium sulfate(3 months)
研究者
Ghada Abdel Fattah
assistant professor of Obstetrics and Gynecology
Cairo University