Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term (MEXPRE-Latin)
Expectant Management of Severe Preeclampsia at 28 to 33 Week's Gestation:a Randomized Controlled Trial
How best to manage preeclampsia remote from term is controversial because of conflicting maternal and neonatal risks. Gestational age is the most important determinant of neonatal outcome. There are two basic approaches when delivery is not clear indicated by assessment of maternal and fetal well-being. The interventionist care when the delivery is planned within 48 hours and the expectant care which refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery.
The purpose of this study is to evaluate maternal and perinatal outcomes with expectant vs interventionist or aggressive management of severe preeclampsia at 28 to 33 weeks of gestation.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ciudad Guatemala、危地马拉
- Hospital de Gineco-Obstetricia del seguro social
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Gauyas、厄瓜多尔
- Hospital Terodoro Maldonado, del IESS
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Quito、厄瓜多尔
- Hospital Carlos Andrade Marin
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Toluca、墨西哥
- Hospital de Ginecologia del Instituto Materno Infantil
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Maracaibo、委内瑞拉
- Hospital Nuestra Señora de Chiquinquira
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Panamá、巴拿马
- Complejo Hospitalario Caja de Seguro Social
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Panamá、巴拿马
- Hospital Santo Tomas
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Lima、秘鲁
- Hospital Nacional Madre Niño, Lima Perú
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Pregnancy with severe preeclampsia and 28 to 33 weeks of gestation
Exclusion Criteria:
- Uncontrollable blood pressure or persistent severe hypertension (160/110 mmHg)
- Persistent symptoms of preeclampsia
- Maternal complications (HELLP syndrome, acute renal insufficiency, cerebral edema, eclampsia, pulmonary edema)
- Fetal death, restriction of fetal grown
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：Expectant management
Expectant management: refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery.
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有源比较器：Interventionist management
Interventionist management: in which blood pressure is stabilized, corticosteroids are given for acceleration of fetal maturity and delivery is planned within 48-72 hours.
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Termination of pregnancy (delivery)after completed corticosteroids
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Perinatal death
大体时间：After begining the randomization until 4 weeks after delivery.
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Number of perinatal in each group (interventionist or expectant management)
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After begining the randomization until 4 weeks after delivery.
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Perinatal complications and maternal complications
大体时间：Maternal and perinatal complication after begining the randomization until 4 weeks after delivery.
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Maternal and perinatal complication after begining the randomization until 4 weeks after delivery.
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合作者和调查者
调查人员
- 首席研究员：Paulino Vigil-De Gracia, MD、Complejo Hospitalario
- 学习椅：Jack Ludmir, MD、Pennsylvania Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.