Antenatal Allopurinol in Intrauterine Growth Restriction
Does Antenatal Allopurinol Administration Improve Maternal and Neonatal Outcome in Intrauterine Growth Restriction?
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2006
CompletedFirst Posted
Study publicly available on registry
June 30, 2006
CompletedStudy Start
First participant enrolled
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedApril 28, 2008
June 1, 2006
June 29, 2006
April 25, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
free radical production / oxidative stress
Secondary Outcomes (5)
foetal parameters (Doppler, cardiotocography)
postponement of birth
morbidity (including long term neurodevelopmental outcome)
mortality
pharmacokinetices
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
Study Sites (1)
Wilhelmina Children's Hospital / UMC Utrecht
Utrecht, Utrecht, 3508 AB, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Frank van Bel, Prof MD, PhD
Wilhelmina Children's Hospital / UMC Utrecht
- PRINCIPAL INVESTIGATOR
Manon Benders, MD, PhD
Wilhelmina Children's Hospital, UMC Utrecht
- PRINCIPAL INVESTIGATOR
Helen Torrance, MD
Wilhelmina Children's Hospital / UMC Utrecht
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 29, 2006
First Posted
June 30, 2006
Study Start
July 1, 2006
Study Completion
July 1, 2013
Last Updated
April 28, 2008
Record last verified: 2006-06