Antenatal Allopurinol During Fetal Hypoxia
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ClinicalTrials.gov Identifier: NCT00189007 |
Recruitment Status
: Unknown
Verified March 2012 by dr. M.J.N.L. Benders, UMC Utrecht.
Recruitment status was: Active, not recruiting
First Posted
: September 16, 2005
Last Update Posted
: March 29, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fetal Hypoxia Reperfusion Injury | Drug: Allopurinol sodium Drug: Mannitol | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 222 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Does Antenatal Allopurinol Administration Reduce Post-hypoxic-ischemic Reperfusion Damage During Fetal Hypoxia in the Newborn? |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | December 2011 |
Estimated Study Completion Date : | December 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: Allopurinol
500 mg allopurinol/ 50 mL water for injection intravenously
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Drug: Allopurinol sodium
Allopurinol sodium 500 mg / 50 mL, intravenously, single dose
Other Name: Acepurin
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Placebo Comparator: Placebo
500 mg mannitol/50 mL water for injection intravenously
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Drug: Mannitol
Mannitol 500 mg/50 mL water for injection, intravenously, single dose
|
- Free radical production and markers of neuronal damage [ Time Frame: Up to 24 hours postpartum ]
- Developmental outcome [ Time Frame: Up to 5 years of age ]
- Mortality [ Time Frame: Up to 28 days postpartum ]
- Severe composite morbidity [ Time Frame: Up to 28 days postpartum ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Gestational age of 36 weeks or more
- Non-reassuring CTG, significant events on the STAN-monitor AND/OR FBS < 7.20
Exclusion Criteria:
- Chromosomal abnormalities

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 ClinicalTrials.gov identifier (NCT number): NCT00189007
Netherlands | |
AMC | |
Amsterdam, Netherlands | |
VUmc | |
Amsterdam, Netherlands | |
Gelre hospitals | |
Apeldoorn, Netherlands | |
Jeroen Bosch Hospital | |
Den Bosch, Netherlands | |
Groene Hart Hospital | |
Gouda, Netherlands | |
UMCG | |
Groningen, Netherlands | |
LUMC | |
Leiden, Netherlands | |
Maastricht University Medical Center | |
Maastricht, Netherlands | |
Wilhelmina Children's Hospital/UMC Utrecht | |
Utrecht, Netherlands, 3508AB | |
Diakonessenhuis | |
Utrecht, Netherlands | |
Maxima Medical Center | |
Veldhoven, Netherlands |
Study Director: | Frank van Bel, Prof MD PhD | Wilhelmina Children's Hospital/UMC Utrecht | |
Principal Investigator: | Manon JN Benders, MD, PhD | UMC Utrecht | |
Principal Investigator: | Jan B Derks, MD, PhD | UMC Utrecht | |
Principal Investigator: | Joepe J Kaandorp, MD | UMC Utrecht | |
Principal Investigator: | Gerard H Visser, MD, PhD | UMC Utrecht | |
Principal Investigator: | Ben WJ Mol, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | |
Principal Investigator: | Carin MA Rademaker, PhD | Clinical Pharmacy, UMCU |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | dr. M.J.N.L. Benders, MD, PhD, UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT00189007 History of Changes |
Other Study ID Numbers: |
ZonMw 170991001 ALLO-trial ( Other Identifier: Dutch Consortium for Studies in Obstetrics and Gynaecology ) 2006-005796-18 ( EudraCT Number ) 170991001 ( Other Grant/Funding Number: ZonMw ) NTR-1383 ( Registry Identifier: Dutch Trial Register ) NL26516.000.09 ( Other Identifier: The Central Committee on Research Involving Human Subjects (CCMO) ) |
First Posted: | September 16, 2005 Key Record Dates |
Last Update Posted: | March 29, 2012 |
Last Verified: | March 2012 |
Keywords provided by dr. M.J.N.L. Benders, UMC Utrecht:
allopurinol neuroprotection reperfusion injury fetal hypoxia post hypoxic-ischemic reperfusion damage |
Additional relevant MeSH terms:
Hypoxia Reperfusion Injury Fetal Hypoxia Signs and Symptoms, Respiratory Signs and Symptoms Vascular Diseases Cardiovascular Diseases Postoperative Complications Pathologic Processes Fetal Diseases Pregnancy Complications Allopurinol Mannitol |
Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Gout Suppressants Antirheumatic Agents Free Radical Scavengers Antioxidants Protective Agents Physiological Effects of Drugs Diuretics, Osmotic Diuretics Natriuretic Agents |