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Antenatal Allopurinol in Intrauterine Growth Restriction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00346463
Recruitment Status : Unknown
Verified June 2006 by UMC Utrecht.
Recruitment status was:  Not yet recruiting
First Posted : June 30, 2006
Last Update Posted : April 28, 2008
Information provided by:
UMC Utrecht

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2006
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. free radical production / oxidative stress

Secondary Outcome Measures :
  1. foetal parameters (Doppler, cardiotocography)
  2. postponement of birth
  3. morbidity (including long term neurodevelopmental outcome)
  4. mortality
  5. pharmacokinetices

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00346463

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Contact: Manon Benders, MD, PhD 0031 30 2504545
Contact: Frank van Bel, Prof MD, PhD 0031 30 2504545

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Wilhelmina Children's Hospital / UMC Utrecht
Utrecht, Netherlands, 3508 AB
Principal Investigator: Manon Benders, MD, PhD         
Sub-Investigator: Helen Torrance, MD         
Sponsors and Collaborators
UMC Utrecht
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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
Layout table for additonal information Identifier: NCT00346463    
Other Study ID Numbers: METC UMCU 05-207K
First Posted: June 30, 2006    Key Record Dates
Last Update Posted: April 28, 2008
Last Verified: June 2006
Keywords provided by UMC Utrecht:
Fetal Growth Retardation
Oxidative Stress
Placental Insufficiency
Additional relevant MeSH terms:
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Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Protective Agents
Physiological Effects of Drugs