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临床试验/NCT00789919
NCT00789919已完成不适用

Mild Preeclampsia Near Term: Deliver or Deliberate?

University of Mississippi Medical Center2 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2002年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
185
试验地点
2
主要终点
Progression to severe preeclampsia in the control group necessitating delivery of the infant.

研究概览

简要总结

Preeclampsia with new-onset hypertension and proteinuria is a pregnancy-specific disease that affects 5-7% of gestations usually after the 20th week. Most cases are mild, but severe cases exhibit multiple abnormalities in blood and maternal organ systems. Severe forms of preeclampsia/eclampsia are a major contributor to maternal death in the world. Delivery stops disease progression and recovery can begin. Patients with mild preeclampsia between 34-38 weeks' gestation usually are hospitalized for evaluation and close monitoring of signs, symptoms, and certain laboratory studies as reflectors of disease status. As inpatients mothers are monitored frequently for evidence of maternal or fetal compromise until 38 weeks gestation when delivery is accomplished. If a patient with mild preeclampsia labors after 34 weeks, no attempt is made to stop labor and delivery is undertaken. It remains unclear when during the third trimester that delivery should be accomplished for maximal maternal safety and minimal fetal risk. In this research project, we will identify patients who are at least 34 weeks pregnant with mild preeclampsia. After informed consent to participate in the trial, we will randomize participants to either be delivered immediately or treated with observation and maternal-fetal surveillance in hospital as described previously with delivery at 38 weeks. There will be 110 participants enrolled in each arm of the study for a total of 220 patients who will be managed in the Wiser Hospital. We intend to analyze a number of maternal and fetal outcomes including cost comparisons for the care of both mother and fetus in the two groups of randomized patients. The findings should impact care of the pregnant patient with mild preeclampsia in the third trimester with regard to how early and how late in gestation that delivery should be accomplished for optimal maternal and perinatal benefit.

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
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Mild Preeclampsia equal to or greater than 34 weeks' and less that 38 weeks' gestation singleton gestation no maternal or fetal contraindications to conservative management

排除标准

  • Non-gestational diabetes Chronic hypertension Severe preeclampsia Non-reassuring fetal assessment intrauterine growth restriction fetal anomalies multiple gestation premature preterm rupture of membranes placenta previa unexplained vaginal bleeding antihypertensive use current gestation poor dating criteria contraindication to conservative management active labor at admission

结局指标

主要结局

Progression to severe preeclampsia in the control group necessitating delivery of the infant.

时间窗: End of study

次要结局

  • Maternal morbidity(End of study)
  • Fetal morbidity and mortality(End of study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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