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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023597-39 | EudraCT Number |
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| Name | Class |
|---|---|
| Hospital Vall d'Hebron | OTHER |
| Hospital Sant Joan de Deu | OTHER |
| Hospital de Cruces | OTHER |
| Parc Sanitari Sant Joan de Déu |
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This is a Multicenter, randomized, open-label, parallel groups study to test the hypothesis that prophylactic low molecular weight heparin (LMWH) (enoxaparin) initiated before 14 weeks of gestation could improve maternal and perinatal outcome in women at high risk for developing placental-mediated pregnancy complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enoxaparin | Experimental | Subcutaneous administration of one dose daily of enoxaparin |
|
| expectant management | No Intervention | Usual management |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug | 40 mg (4000 IU) women <80 kg at the time of randomization or 60 mg (6000 IU) women> 80 kg at the time of randomization One dose daily. Subcutaneous administration. Treatment periods: the same day of the Initiation visit (from 9 to 13.6 weeks of gestation) until 36 weeks gestation. |
| Measure | Description | Time Frame |
|---|---|---|
| Development of any of these complications of placental insufficiency | Development of any of these complications of placental insufficiency: preeclampsia, intrauterine growth restriction, abruption placentae, and/or intrauterine fetal demise | from date of randomization until the date of delivery (assessed up to 30 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational age at birth | Gestational age at birth | from date of randomization until the date of delivery (assessed up to 30 weeks) |
| Days of hospitalization during pregnancy | Days of hospitalization during pregnancy |
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Inclusion Criteria:
Pregnant women ≥18 years
Gestational age < 14 weeks at randomisation
One or more of the following complications in a previous pregnancy:
Uterine arteries Pulsatility Index (mPI) Doppler ≥95th percentile at 11-14 weeks of gestation.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LluÃs Cabero, MD PhD | Hospital Vall d'Hebron | Study Chair |
| Elisa Llurba, MD | Hospital Vall d'Hebron | Principal Investigator |
| Maria Dolores Gómez, MD | Hospital Sant Joan de Deu | Principal Investigator |
| Txantón MartÃnez-Astorquiza, MD | Hospital de Cruces | Principal Investigator |
| Raul De Diego, M.D. | Parc Sanitari Sant Joan de Deu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Vall d'Hebron | Barcelona | Barcelona | 08035 | Spain | ||
| Hospital Sant Joan de Deu |
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| ID | Term |
|---|---|
| D010927 | Placental Insufficiency |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D010922 | Placenta Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| OTHER |
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|
| from randomization to the time of delivery (30 weeks) |
| Days of maternal hospitalization in the postpartum period | Days of maternal hospitalization in the postpartum period | from delivery until discharge (an expected average of one week) |
| Neonatal Data | weight, height, head circumference, Apgar score 1-5 min, arterial pH, venous base excess (BE) of umbilical cord gases, and complications | after the delivery (an expected average of one month) |
| Esplugues de Llobregat |
| Barcelona |
| 08950 |
| Spain |
| Parc sanitari Sant Joan de Deu | Sant Boi de Llobregat | Barcelona | 08830 | Spain |
| Hospital de Cruces | Barakaldo | Vizcaya | 48903 | Spain |
| D046110 | Hypertension, Pregnancy-Induced |
| D002241 |
| Carbohydrates |