Clinical Trial: Antenatal Allopurinol in Intrauterine Growth Restriction
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Does Antenatal Allopurinol Administration Improve Maternal and Neonatal Outcome in Intrauterine Growth Restriction?
Brief Summary:
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.
Detailed Summary:
Sponsor: UMC Utrecht
Current Primary Outcome: free radical production / oxidative stress
Original Primary Outcome: Same as current
Current Secondary Outcome:
- foetal parameters (Doppler, cardiotocography)
- postponement of birth
- morbidity (including long term neurodevelopmental outcome)
- mortality
- pharmacokinetices
Original Secondary Outcome: Same as current
Information By: UMC Utrecht
Dates:
Date Received: June 29, 2006
Date Started: July 2006
Date Completion: July 2013
Last Updated: April 25, 2008
Last Verified: June 2006
