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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| LEO Pharma | INDUSTRY |
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The purpose of the study is to investigate if treatment with an anticoagulant drug increases birth weight in pregnancies complicated by fetal growth restriction.
Clinical purpose:
1. To examine whether treatment with low molecular weight heparin in pregnant women with Intrauterine Growth Restriction (IUGR)increases the birth weight of the child. Our hypothesis is that an increased birth weight leads to reduced morbidity and mortality among these children.
Laboratory purposes:
Design: The study is a prospective randomised study where pregnant women with suspected severe IUGR are randomised either to treatment with Innohep® or no treatment. Half of the women receive Innohep® and half of the women do not receive treatment.
Endpoints The primary endpoint is the difference in birth weight in children born of women receiving Innohep® during pregnancy and children born of women who have not received Innohep® during pregnancy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Innohep | Active Comparator | Tinzaparin 4500 I.U. sub cutaneous once daily until gestational week 37 |
|
| no treatment | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Innohep (Tinzaparin) | Drug | Dose: 4,500 IU daily in half of the study populationrandomised to treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| birth weight | We compare birth weight in children born of women from the 2 study arms | Birth weight registered at birth |
| Measure | Description | Time Frame |
|---|---|---|
| maternal morbidity | Comorbidity registered up to one year after birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Mette Hvas, PhD, professor | Department of Clinical Biochemistry, Aarhus University Hospital, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consultant phD professor Anne-Mette Hvas | Aarhus | Central Jutland | 8200 | Denmark | ||
| Department of Obstetrics |
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| D001724 | Birth Weight |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000078222 | Tinzaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| tinzaparin | Drug | Dose 4,500 IE daily |
|
|
| Herning |
| 7400 |
| Denmark |
| Department of Obstetrics | Randers | Denmark |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002241 |
| Carbohydrates |