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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allopurinol | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| free radical production / oxidative stress |
| Measure | Description | Time Frame |
|---|---|---|
| foetal parameters (Doppler, cardiotocography) | ||
| postponement of birth | ||
| morbidity (including long term neurodevelopmental outcome) |
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Inclusion Criteria:
Mothers with a gestational age (GA) of 30 to 36 weeks with:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manon Benders, MD, PhD | Contact | 0031 30 2504545 | m.benders@umcutrecht.nl | |
| Frank van Bel, Prof MD, PhD | Contact | 0031 30 2504545 | f.vanbel@umcutrecht.nl |
| Name | Affiliation | Role |
|---|---|---|
| Frank van Bel, Prof MD, PhD | Wilhelmina Children's Hospital / UMC Utrecht | Study Director |
| Manon Benders, MD, PhD | Wilhelmina Children's Hospital, UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilhelmina Children's Hospital / UMC Utrecht | Utrecht | Utrecht | 3508 AB | Netherlands |
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| D010927 | Placental Insufficiency |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| mortality |
| pharmacokinetices |
| Helen Torrance, MD |
| Wilhelmina Children's Hospital / UMC Utrecht |
| Principal Investigator |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010922 | Placenta Diseases |