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Antenatal Allopurinol in Intrauterine Growth Restriction

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00346463
Enrollment
50
Registered
2006-06-30
Start date
2006-07-31
Completion date
2013-07-31
Last updated
2008-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Growth Retardation

Keywords

Allopurinol, Fetal Growth Retardation, Oxidative Stress, Placental Insufficiency

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.

Interventions

DRUGAllopurinol

Sponsors

UMC Utrecht
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
free radical production / oxidative stress

Secondary

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

Countries

Netherlands

Contacts

Primary ContactManon Benders, MD, PhD
m.benders@umcutrecht.nl0031 30 2504545
Backup ContactFrank van Bel, Prof MD, PhD
f.vanbel@umcutrecht.nl0031 30 2504545

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026