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