Fetal Growth RetardationNCT00346463
Antenatal Allopurinol in Intrauterine Growth Restriction
A study testing Allopurinol in people with Fetal Growth Retardation, run by UMC Utrecht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fetal Growth Retardation
- What is being tested?
- Allopurinol
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2006to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wilhelmina Children's Hospital / UMC Utrecht
Utrecht, Utrecht, 3508 AB
Manon Benders, MD, PhD
Helen Torrance, MD
About this study
Official title: 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.
- Conditions
- Fetal Growth Retardation
- Being tested
- Allopurinol
- Keywords
- Allopurinol, Fetal Growth Retardation, Oxidative Stress, Placental Insufficiency
- Medical subject headings
- Fetal Growth Retardation, Placental Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
free radical production / oxidative stress
Secondary outcomes (5)
foetal parameters (Doppler, cardiotocography)
postponement of birth
morbidity (including long term neurodevelopmental outcome)
mortality
pharmacokinetices
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2006 (estimated)
- Study startJul 2006
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Investigators
- Frank van Bel, Prof MD, PhD, Study director, Wilhelmina Children's Hospital / UMC UtrechtManon Benders, MD, PhD, Principal investigator, Wilhelmina Children's Hospital, UMC UtrechtHelen Torrance, MD, Principal investigator, Wilhelmina Children's Hospital / UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346463
- Sponsor's protocol ID
- METC UMCU 05-207K
- Status last verified
- Jun 2006
- First submitted
- 29 Jun 2006
- Last updated
- 28 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Antenatal Allopurinol Administration Improve Maternal and Neonatal Outcome in Intrauterine Growth Restriction?
- ClinicalTrials.gov ID
- NCT00346463
- Acronym / sponsor ID
- METC UMCU 05-207K
- Conditions
- Fetal Growth Retardation
- Keywords
- Allopurinol, Fetal Growth Retardation, Oxidative Stress, Placental Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- Jul 2013 (estimated)
- First posted
- 30 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Foetal growth retardation (growth <10th percentile) and
- Abnormal Doppler flow in the umbilical cord (umbilical artery pulsatility index (PI)>95th percentile)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allopurinol | Drug | – |
Primary outcome
free radical production / oxidative stress
5 secondary outcomes
foetal parameters (Doppler, cardiotocography)
postponement of birth
morbidity (including long term neurodevelopmental outcome)
mortality
pharmacokinetices
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank van Bel, Prof MD, PhD study director
Wilhelmina Children's Hospital / UMC Utrecht
Manon Benders, MD, PhD principal investigator
Wilhelmina Children's Hospital, UMC Utrecht
Helen Torrance, MD principal investigator
Wilhelmina Children's Hospital / UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allopurinol in people with Fetal Growth Retardation, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manon Benders, MD, PhD (0031 30 2504545, m.benders@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
free radical production / oxidative stress. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2008.