1/2 A randomized controlled trial of pravastatin to prevent preeclampsia in high-risk women

1/2 普伐他汀预防高危女性先兆子痫的随机对照试验

基本信息

  • 批准号:
    10705607
  • 负责人:
  • 金额:
    --
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2019
  • 资助国家:
    美国
  • 起止时间:
    2019-08-01 至 2024-07-31
  • 项目状态:
    已结题

项目摘要

ABSTRACT Preeclampsia complicates approximately 3% to 5% of pregnancies and remains a major cause of maternal and neonatal morbidity and mortality. Women who have experienced preeclampsia in one pregnancy are at high risk for preeclampsia in subsequent pregnancies with the magnitude of the risk depending on the severity and gestational age at delivery in the index pregnancy. Preeclampsia shares pathogenic similarities with adult cardiovascular diseases as well as many risk factors. Endothelial dysfunction and inflammation are fundamental for the initiation and progression of both. Prevention of preeclampsia using various supplements and medications have had limited success. In contrast, there is strong evidence that 3-hydroxy-3- methylglutaryl-coenzyme A reductase inhibitors (statins) are beneficial in primary and secondary prevention of cardiovascular mortality and other cardiovascular events. Biological plausibility, animal data, and pilot clinical trials support a similar role for pravastatin, a hydrophilic statin with a favorable safety profile, in preventing preeclampsia prevention. In addition, the current evidence from animal studies and human pregnancy exposure cohorts do not support previous teratogenicity claims of pravastatin. Therefore, we propose a multicenter, double-blind, placebo-controlled randomized clinical trial to determine whether prophylactic treatment with pravastatin administered early in pregnancy reduces preeclampsia in high-risk women. A total of 1,760 pregnant women at high risk for preeclampsia (due to history of preeclampsia in a prior pregnancy that required delivery before 360/7 weeks) will be randomized between 100/7 and 166/7 weeks to pravastatin 10 mg or similar-appearing placebo, daily at bedtime until delivery. Women and their neonates will be followed throughout pregnancy and up to 6 weeks post partum to address the primary aim: evaluate whether treatment with pravastatin reduces the recurrence rate of preeclampsia; as well as the following secondary aims: (1) evaluate whether pravastatin improves maternal and neonatal outcomes; (2) assess the maternal and fetal/ neonatal safety profile of pravastatin during pregnancy; and (3) determine whether pravastatin administration in pregnancy reverses the angiogenic imbalance associated with preeclampsia by reducing the concentrations of the anti-angiogenic factors soluble Fms-like tyrosine kinase-1 (sFlt-1) and soluble endoglin (sEng), and increasing that of placental growth factor PlGF (angiogenic).
摘要

项目成果

期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

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Maged Costantine其他文献

Maged Costantine的其他文献

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{{ truncateString('Maged Costantine', 18)}}的其他基金

Developing Extracellular Vesicle Based MPRINT Translational Resource Platform for Monitoring Therapeutics Response During Pregnancy
开发基于细胞外囊泡的 MPRINT 转化资源平台,用于监测妊娠期间的治疗反应
  • 批准号:
    10747545
  • 财政年份:
    2023
  • 资助金额:
    --
  • 项目类别:
1/2 A randomized controlled trial of pravastatin to prevent preeclampsia in high-risk women
1/2 普伐他汀预防高危女性先兆子痫的随机对照试验
  • 批准号:
    10087196
  • 财政年份:
    2019
  • 资助金额:
    --
  • 项目类别:
1/2 A randomized controlled trial of pravastatin to prevent preeclampsia in high-risk women
1/2 普伐他汀预防高危女性先兆子痫的随机对照试验
  • 批准号:
    10162643
  • 财政年份:
    2019
  • 资助金额:
    --
  • 项目类别:
1/2 A randomized controlled trial of pravastatin to prevent preeclampsia in high-risk women
1/2 普伐他汀预防高危女性先兆子痫的随机对照试验
  • 批准号:
    10455106
  • 财政年份:
    2019
  • 资助金额:
    --
  • 项目类别:
NICHD Maternal Fetal Medicine Units Network
NICHD 母胎医学单位网络
  • 批准号:
    9891074
  • 财政年份:
    1992
  • 资助金额:
    --
  • 项目类别:
NICHD maternal fetal medicine units network
NICHD母胎医学单位网
  • 批准号:
    10681772
  • 财政年份:
    1992
  • 资助金额:
    --
  • 项目类别:
NICHD maternal fetal medicine units network
NICHD母胎医学单位网
  • 批准号:
    10379413
  • 财政年份:
    1992
  • 资助金额:
    --
  • 项目类别:
NICHD maternal fetal medicine units network
NICHD母胎医学单位网
  • 批准号:
    10254471
  • 财政年份:
    1992
  • 资助金额:
    --
  • 项目类别:
Comprehensive evaluation of the safety and utility of pravastatin in prevention of preeclampsia in high-risk pregnant women
普伐他汀预防高危孕妇子痫前期的安全性和有效性综合评价
  • 批准号:
    9119186
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
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