Antenatal Allopurinol in Intrauterine Growth Restriction

April 25, 2008 updated by: UMC Utrecht

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3508 AB
        • Wilhelmina Children's Hospital / UMC Utrecht
        • Principal Investigator:
          • Manon Benders, MD, PhD
        • Sub-Investigator:
          • Helen Torrance, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
free radical production / oxidative stress

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

June 29, 2006

First Submitted That Met QC Criteria

June 29, 2006

First Posted (Estimate)

June 30, 2006

Study Record Updates

Last Update Posted (Estimate)

April 28, 2008

Last Update Submitted That Met QC Criteria

April 25, 2008

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC UMCU 05-207K

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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