Antenatal Allopurinol in Intrauterine Growth Restriction
Primary Purpose
Fetal Growth Retardation
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Allopurinol
Sponsored by
About this trial
This is an interventional treatment trial for Fetal Growth Retardation focused on measuring Allopurinol, Fetal Growth Retardation, Oxidative Stress, Placental Insufficiency
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
Sites / Locations
- Wilhelmina Children's Hospital / UMC Utrecht
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00346463
Brief Title
Antenatal Allopurinol in Intrauterine Growth Restriction
Official Title
Does Antenatal Allopurinol Administration Improve Maternal and Neonatal Outcome in Intrauterine Growth Restriction?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
UMC Utrecht
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Growth Retardation
Keywords
Allopurinol, Fetal Growth Retardation, Oxidative Stress, Placental Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Primary Outcome Measure Information:
Title
free radical production / oxidative stress
Secondary Outcome Measure Information:
Title
foetal parameters (Doppler, cardiotocography)
Title
postponement of birth
Title
morbidity (including long term neurodevelopmental outcome)
Title
mortality
Title
pharmacokinetices
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manon Benders, MD, PhD
Phone
0031 30 2504545
Email
m.benders@umcutrecht.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Frank van Bel, Prof MD, PhD
Phone
0031 30 2504545
Email
f.vanbel@umcutrecht.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank van Bel, Prof MD, PhD
Organizational Affiliation
Wilhelmina Children's Hospital / UMC Utrecht
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Manon Benders, MD, PhD
Organizational Affiliation
Wilhelmina Children's Hospital, UMC Utrecht
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helen Torrance, MD
Organizational Affiliation
Wilhelmina Children's Hospital / UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilhelmina Children's Hospital / UMC Utrecht
City
Utrecht
ZIP/Postal Code
3508 AB
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manon Benders, MD, PhD
First Name & Middle Initial & Last Name & Degree
Helen Torrance, MD
12. IPD Sharing Statement
Learn more about this trial
Antenatal Allopurinol in Intrauterine Growth Restriction
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