Randomised Controlled trial with Pravastatin versus placebo for Prevention of preeclampsia (STATIN trial) (Q3138701): Difference between revisions
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Étude contrôlée randomisée avec Pravastatine versus placebo pour la prévention de la prééclampsie (essaiSTATIN) | |||
Revision as of 09:39, 2 December 2021
Project Q3138701 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | Randomised Controlled trial with Pravastatin versus placebo for Prevention of preeclampsia (STATIN trial) |
Project Q3138701 in Spain |
Statements
81,600.0 Euro
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102,000.0 Euro
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80.0 percent
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1 January 2018
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31 March 2021
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FUNDACION PARA LA FORMACION E INVESTIGACION SANITARIAS DE LA REGION DE MURCIA (FFIS)
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37°59'32.57"N, 1°7'49.94"W
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30030
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OBJECTIVE: To examine if the prophylactic use of vaginal Utrogestan from the first-trimester of pregnancy in women with twin pregnancy can reduce the incidence of spontaneous delivery before 34 weeks. METHODS: Phase III two-arm double-blinded randomised controlled trial to examine the effect of prophylactic pravastatin from 35-37 weeks' gestation in women at increased risk for term-PE on the incidence and severity of the disease PRIMARY OUTCOME: delivery with preeclampsia SECUNDARY OUTCOME: determine the effect of pravastatin On adverse outcome of pregnancy at any gestation and at = 37 week´s gestationOn the incidence of stillbirth or neonatal death. On neonatal morbidity On neonatal therapy On the incidence of low birth weight below the 3rd, 5th and 10th centile On sFLT and PLGF value 1 and 3 weeks after the onset of treatment Pravastatin safety assessment during pregnancy (Spanish)
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OBJECTIVE: To examine if the prophylactic use of vaginal Utrogestan from the first-trimester of pregnancy in women with twin pregnancy can reduce the incidence of spontaneous delivery before 34 weeks. METHODS: Phase III two-arm double-blinded randomised controlled trial to examine the effect of prophylactic pravastatin from 35-37 weeks’ gestation in women at increased risk for term-PE on the incidence and severity of the disease PRIMARY OUTCOME: delivery with preeclampsia Secundary OUTCOME: determine the effect of pravastatin On adverse outcome of pregnancy at any gestation and at = 37 week’s gestationOn the incidence of Stillbirth or neonatal death. On neonatal morbidity On neonatal therapy On the incidence of low birth weight below the 3 rd, 5th and 10th centile On sFlt and PlGF value 1 and 3 weeks after the onset of treatment Pravastatin safety assessment during pregnancy (English)
12 October 2021
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Murcia
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Identifiers
PI17_01350
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