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Report for Clinical Trial NCT00986765

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Low Molecular Weight Heparin, Enoxaparin, to Prevent Adverse Maternal and Perinatal Outcomes in Women With Previous Severe Preeclampsia at Less Than 34 Weeks' Gestation. A Prospective Randomized Trial

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) .

NCT00986765 Preeclampsia
MeSH: Pre-Eclampsia
HPO: Preeclampsia Toxemia of pregnancy

2 Interventions

Name: Lovenox® (enoxaparin)

Description: Injectable solution 4000 UI

Type: Drug

Lovenox® , 4000 UI/day (+ Aspegic®)

Name: Aspegic ® (Aspirin)

Description: 100 mg/day

Type: Drug

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 ---



HPO Nodes


HPO:
Preeclampsia
Genes 18
F5 HELLPAR SLC25A20 CORIN PPARG CFI NOS3 DHPS HBA1 CFH STOX1 CYP11B1 LBR CD46 EP300 HBA2 ADGRG6 CYP11B2
Toxemia of pregnancy
Genes 21
PPARG LMNA F5 NR3C2 HELLPAR SLC25A20 CORIN PPARG CFI NOS3 DHPS HBA1 CFH STOX1 CYP11B1 LBR CD46 EP300 HBA2 ADGRG6 CYP11B2