Prevention of Maternal and Perinatal Complications by Enoxaparin in Women With Previous Severe Preeclampsia
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
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)
.