Antenatal Allopurinol in Intrauterine Growth Restriction

Study Overview
=================
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.

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

Conditions
-----------------
Fetal Growth Retardation

Intervention / Treatment
-----------------
* Drug: Allopurinol


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Allopurinol|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| free radical production / oxidative stress |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| foetal parameters (Doppler, cardiotocography) |  |  | 
| postponement of birth |  |  | 
| morbidity (including long term neurodevelopmental outcome) |  |  | 
| mortality |  |  | 
| pharmacokinetices |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allopurinol, Fetal Growth Retardation, Oxidative Stress, Placental Insufficiency