Antenatal Allopurinol in Intrauterine Growth Restriction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by UMC Utrecht.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00346463
First received: June 29, 2006
Last updated: April 25, 2008
Last verified: June 2006
  Purpose

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 Intervention
Fetal Growth Retardation
Drug: Allopurinol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Does Antenatal Allopurinol Administration Improve Maternal and Neonatal Outcome in Intrauterine Growth Restriction?

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

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

Estimated Enrollment: 50
Study Start Date: July 2006
Estimated Study Completion Date: July 2013
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346463

Contacts
Contact: Manon Benders, MD, PhD 0031 30 2504545 m.benders@umcutrecht.nl
Contact: Frank van Bel, Prof MD, PhD 0031 30 2504545 f.vanbel@umcutrecht.nl

Locations
Netherlands
Wilhelmina Children's Hospital / UMC Utrecht Not yet recruiting
Utrecht, Netherlands, 3508 AB
Principal Investigator: Manon Benders, MD, PhD         
Sub-Investigator: Helen Torrance, MD         
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00346463     History of Changes
Other Study ID Numbers: METC UMCU 05-207K
Study First Received: June 29, 2006
Last Updated: April 25, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Allopurinol
Fetal Growth Retardation
Oxidative Stress
Placental Insufficiency

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Growth Disorders
Pathologic Processes
Pregnancy Complications
Allopurinol
Antimetabolites
Antioxidants
Antirheumatic Agents
Enzyme Inhibitors
Free Radical Scavengers
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014