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临床试验/NCT00346463
NCT00346463Unknown不适用

Does Antenatal Allopurinol Administration Improve Maternal and Neonatal Outcome in Intrauterine Growth Restriction?

UMC Utrecht2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年7月最近更新:
适应症
相关药物

试验速览

阶段
不适用
发起方
UMC Utrecht
入组人数
50
试验地点
2
主要终点
free radical production / oxidative stress

研究概览

简要总结

Growth retardation in utero may be caused by uteroplacental vascular insufficiency. When Doppler ultrasound studies of the umbilical artery are abnormal pathological intrauterine growth restriction (IUGR) can be diagnosed. IUGR fetuses have a higher mortality and morbidity, both perinatally and on the longer term. This is probably due to chronic malnourishment and hypoxia due to placental insufficiency. This placental dysfunction causes generation of harmful free oxygen radicals in the fetus. The IUGR fetus has a diminished antioxidative capacity which means these free radicals cannot be buffered sufficiently. This leads to fetal oxidative stress.

Previous studies have shown that allopurinol can inhibit the cascades that lead to generation of free radicals. High dosed allopurinol also scavenges radicals and binds free iron without adverse effects on the fetus or mother.

As IUGR is associated with placental insufficiency and excessive production of free radicals we hypothesize that antenatal allopurinol administration could lead to a decrease in oxidative stress in the mother and fetus and subsequent improvement of the maternal and/or neonatal outcome.

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
Double

入排标准

性别
All
接受健康志愿者

入选标准

  • Mothers with a gestational age (GA) of 30 to 36 weeks with:
  • Foetal growth retardation (growth <10th percentile) and
  • Abnormal Doppler flow in the umbilical cord (umbilical artery pulsatility index (PI)>95th percentile)

排除标准

  • Congenital, chromosomal or syndromal abnormalities
  • Positive screening for intrauterine viral infections
  • Mothers with gout and high uric acid
  • creatinine > 100 umol/l
  • ASAT > 80 U/l, ALAT > 80 U/l
  • Uric acid > 0,50 mmol/l

结局指标

主要结局

free radical production / oxidative stress

次要结局

  • foetal parameters (Doppler, cardiotocography)
  • postponement of birth
  • morbidity (including long term neurodevelopmental outcome)
  • mortality
  • pharmacokinetices

研究者

发起方
UMC Utrecht
申办方类型
Other

研究点 (2)

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