A Novel Protocol for Postpartum Magnesium Sulfate in Severe Preeclampsia When the Woman Received Less That 8 Hours Before Delivery. Six Versus Twenty-four Hours Postpartum
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 3
- 主要终点
- Seizure (Eclampsia)
研究概览
简要总结
There are huge doubts as to how long to keep postpartum magnesium sulfate. Studies demonstrating the usefulness for 24, 12 or 6 hours are of little evidence and do not take into account the use of magnesium sulphate before delivery. Termination of pregnancy is the best option to prevent eclampsia and magnesium sulphate has proven effective, but do not know the minimum effective dose.The investigators believe that if the patient has received less than 8 continuous hours of magnesium sulphate before delivery, maintain magnesium sulfate for 6 hours is as effective as keeping it for 24 hours.
详细描述
The definitive treatment known for pre-eclampsia is the interruption of pregnancy. While the definitive treatment is the pregnancy interruption, management includes other measures that have proven effective, including the administration of antihypertensive drugs for severe hypertension and that the use of anticonvulsant such as the magnesium sulfate.
There are multiple studies that prove the effectiveness of magnesium sulfate to prevent eclampsia in patients with severe / serious disorder. Unfortunately these studies used the drug before birth and continue after birth. Therefore the investigators can not conclude whether the administration just before pregnancy is sufficient to prevent seizure. That is, if the cure or definitive treatment of pre-eclampsia is the interruption, did not seem necessary to justify the administration of anticonvulsant drugs after birth. Obvious post delivery management sulfate arises from the large number of postpartum eclampsia reported in many studies. It is unknown if the administration of magnesium sulfate for a minimum period not yet determined before birth and delivery requires even keep the drug after discontinuation.
For all these reasons the investigators propose the following: A randomized trial where all those patients who received magnesium sulfate for less that 8 hours before birth will be randomized to two groups of study: 1- Continue magnesium sulfate for 24 hours and 2-Continue magnesium sulfate for 6 hours postpartum.
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
- 14 Years 至 44 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Severe hypertensive disorder receiving magnesium sulfate prophylaxis for less than 8 hours at birth.
排除标准
- •Complications such as: HELLP syndrome, renal failure, eclampsia, retinal detachment, cerebral edema, pulmonary edema, hypertensive encephalopathy.
研究组 & 干预措施
Six Hours Postpartum
The woman received magnesium sulfate for 6 hours after delivery as prophylaxis to eclampsia.
干预措施: Magnesium Sulfate (Drug)
Twenty-four hours Postpartum
The woman received magnesium sulfate for 24 hours after delivery as prophylaxis to eclampsia.
干预措施: Magnesium Sulfate (Drug)
结局指标
主要结局
Seizure (Eclampsia)
时间窗: 72 hours postpartum
Seizure during the first 72 hours post delivery
次要结局
- Diuresis postpartum(72 hours postpartum)
- Persistent symptomatology(24 hours postpartum)
研究者
Paulino Vigil-De Gracia
Co-Investigator
Complejo Hospitalario Dr. Arnulfo Arias Madrid
