Magnesium Sulphate for Fetal Neuroprotection in Full Term Deliveries
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Apgar score
研究概览
简要总结
Pregnant women diagnosed to have intrapartum fetal distress (Non reassuring or pathological changes according to NICE guidelines 2017) in any of the groups will receive the allocated treatment at least 20 minute before the procedure (emergency CS).
measures to reduce the effect of hypoxia will be applied to all participate through:
- The position of the mother will be changed to left lateral position (allow increased blood supply).
- I.V. fluid bolus (to avoid maternal dehydration).
- Oxytocin or cervical ripening agent will be discontinued.
- Fetal heart rate monitoring with cardiotocography will be attempted.
- If umbilical cord prolapse is noted, elevate the presenting fetal part until preparing for emergency operative delivery.
- After birth, Apgar score will be used to identify distress newborns that need resuscitation.
The study comprised 200 pregnant women. They were divided into two groups each are 100:
- Group A: pregnant women diagnosed to have intrapartum fetal distress who will receive MgSO4.
- Group B: pregnant women diagnosed to have intrapartum fetal distress who will receive placebo
详细描述
Pregnant women diagnosed to have intrapartum fetal distress (Non reassuring or pathological changes according to NICE guidelines 2017) in any of the groups will receive the allocated treatment at least 20 minute before the procedure (emergency CS).
measures to reduce the effect of hypoxia will be applied to all participate through:
- The position of the mother will be changed to left lateral position (allow increased blood supply).
- I.V. fluid bolus (to avoid maternal dehydration).
- Oxytocin or cervical ripening agent will be discontinued.
- Fetal heart rate monitoring with cardiotocography will be attempted.
- If umbilical cord prolapse is noted, elevate the presenting fetal part until preparing for emergency operative delivery.
- After birth, Apgar score will be used to identify distress newborns that need resuscitation.
The study comprised 200 pregnant women. They were divided into two groups each are 100:
- Group A: pregnant women diagnosed to have intrapartum fetal distress who will receive MgSO4.
- Group B: pregnant women diagnosed to have intrapartum fetal distress who will receive placebo
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women at least 37 week of gestation.
- •Not more than 35 years old.
- •Fetal distress (perinatal asphyxia) diagnosed by CTG changes (Non reassuring or pathological changes according to NICE guidelines 2017).
- •Clinical chorioamnionitis.
- •Prolonged rupture of membranes
排除标准
- •Medical disorders such as chronic hypertension, preeclampsia, eclampsia, DM, pulmonary hypertension, hepatic coma with risk of renal failure, and any renal, cardiac or pulmonary disease.
- •Consanguinity.
- •Preterm labor.
- •Fetal malpresentation.
- •Contraindications to the use of Magnesium Sulphate.
- •Any indication for magnesium Sulphate therapy (seizure prophylaxis or tocolysis).
- •Myasthenia gravis.
- •Congenital fetal anomalies.
- •Fetal growth restriction (birth weight < 10th Percentile for gestational age).
- •Advanced cervical dilation (8cm).
研究组 & 干预措施
MgSO4 group
will receive a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose
干预措施: MgSo4 (Drug)
placebo group
will receive an equal volume of isotonic 0.9% saline over 15-20 minutes
干预措施: Isotonic saline (Drug)
结局指标
主要结局
Apgar score
时间窗: 1 minute after delivery
Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration between 0 and 10
次要结局
未报告次要终点
研究者
Ahmed M Maged, MD
professor
Cairo University