Antenatal Allopurinol in Intrauterine Growth Restriction

Fetal Growth Retardation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00346463
• Other study ID #: METC UMCU 05-207K
• Status: Not yet recruiting
• Phase: N/A
• First received: June 29, 2006
• Last updated: April 25, 2008
• Start date: July 2006
• Est. completion date: July 2013

Study information

• Verified date: June 2006
• Source: UMC Utrecht
• Contact: Manon Benders, MD, PhD
• Phone: 0031 30 2504545
• Email: m.benders[@]umcutrecht.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Growth Retardation

Intervention

Drug:
• Allopurinol

Locations

Country	Name	City	State
Netherlands	Wilhelmina Children's Hospital / UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	free radical production / oxidative stress
Secondary	foetal parameters (Doppler, cardiotocography)
Secondary	postponement of birth
Secondary	morbidity (including long term neurodevelopmental outcome)
Secondary	mortality
Secondary	pharmacokinetices