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Report for Clinical Trial NCT00986765
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Preeclampsia (PE) complicates 2-8% of pregnancies. It is associated with an increased risk of
adverse maternal (death, eclampsia, abruptio placenta, HELLP syndrome) and perinatal
(perinatal death, growth restriction, prematurity) outcomes. The only definite treatment of
PE remains pregnancy termination. Therefore, prevention of PE remains an important challenge.
Low dose aspirin may be used in the prevention of PE, particularly in women who had a severe
preeclampsia before 34 weeks. Its efficiency, however, is very weak. Recently, it has been
suggested that low molecular weight heparin might be useful in the prevention of PE.
The aim of this study is to analyze the usefulness of the enoxaparin 4000 UI/day in the
prevention of a composite maternal or perinatal morbidity (occurrence of one of the following
events: maternal death, PE, fetal growth retardation, abruptio placenta, perinatal death) in
women who previously had a severe preeclampsia at less than 34 weeks' gestation. To answer
this question, the investigators propose to conduct a multicenter prospective randomized
trial that will compare two groups in parallel: a group where women will have an association
of enoxaparin 4000 U/day and aspirin 100 mg/day and another group where women would have only
aspirin 100 mg/day. The number of patients needed is 255 (amendment n°2-approved 06/12/2011)
.
Name: Lovenox® (enoxaparin)
Description: Injectable solution 4000 UI
Type: Drug
Group Labels: 1 Lovenox® , 4000 UI/day (+ Aspegic®)
Name: Aspegic ® (Aspirin)
Description: 100 mg/day
Type: Drug
Group Labels: 1 Aspegic ®, 100 mg/day
Primary Outcomes
Measure: The primary outcome is a composite morbidity that may occur : maternal death, or perinatal death, or preeclampsia, or abruptio placenta, or fetal growth restriction. Time: from randomization until one month after the delivery
Secondary Outcomes
Measure: Recurrence of preeclampsia alone Time: from randomization until one month after the delivery
Measure: Recurrence of severe preeclampsia Time: from randomization until one month after the delivery
Measure: Fetal growth restriction alone Time: from randomization until one month after the delivery
Measure: Severe fetal growth restriction (< 5th percentile) Time: from randomization until one month after the delivery
Measure: Perinatal death alone Time: from randomization until one month after the delivery
Measure: Neonatal death Time: from randomization until one month after the delivery
Measure: Abruption alone Time: from randomization until one month after the delivery
Measure: Maternal death Time: from randomization until one month after the delivery
Measure: Fetal loss (10-21 weeks) Time: from randomization until one month after the delivery
Measure: Fetal death Time: from 15 weeks to delivery
Measure: Recurrence of preeclampsia controlled for thrombophilia analysis (polymorphism of factor V Leiden, prothrombin G20210A gene polymorphism) Time: from randomization until one month after the delivery
Measure: Recurrence of preeclampsia controlled for angiogenic factors (free VEGF and PlGF, sFlt1, sEng) Time: from randomization until one month after the delivery
Measure: Neonatal morbidity (NICU transfer, length of hospitalization, mechanical ventilation > 24 hours, respiratory distress syndrome, necrotizing enterocolitis, periventricular leucomalacia, bronchopulmonary dysplasia, intraventricular hemorrhage grade III-IV) Time: from randomization until one month after the delivery
Measure: Enoxaparin toxicity: hemorrhage, skin reaction, thrombocytopenia (<100000/µL) related to heparin Time: from randomization until one month after the delivery
Measure: Bone fracture Time: from randomization until one month after the delivery
Purpose: Prevention
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 G20210A
Recurrence of preeclampsia controlled for thrombophilia analysis (polymorphism of factor V Leiden, prothrombin G20210A gene polymorphism). --- G20210A ---