Antenatal Allopurinol in Intrauterine Growth Restriction

Sponsor

UMC Utrecht (Other)

Overall Status

Unknown status

CT.gov ID

NCT00346463

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fetal Growth Retardation	Drug: Allopurinol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2006

Anticipated Study Completion Date :

Jul 1, 2013

Outcome Measures

Primary Outcome Measures

free radical production / oxidative stress []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wilhelmina Children's Hospital / UMC Utrecht	Utrecht		Netherlands	3508 AB

Sponsors and Collaborators

UMC Utrecht

Investigators

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