Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Low-molecular-weight Heparin in Constituted Vascular Intrauterine Growth Restriction. Randomized Multicenter Trial
Brief Summary:
Constituted vascular intrauterine growth restriction (CVIG) is correlated to an abnormal placenta development, with an alteration of the maternal-fetal circulation, coagulation troubles, and apparition of placental infarcts. CVIG represents the third cause of perinatal mortality in France, and is associated to an important morbidity. For birth-weights < 10th percentile of the gestational age, the neonatal death risk is doubled, compared to abnormal weights. 35% of CVIG are linked to vascular causes and are integrated in the placental vascular diseases.
To answer this objective, researchers propose a multicentric clinical trial, randomized, open, in two parallel groups, comparing the enoxaparin subcutaneous administration at preventive doses associated to the usual care (group 1) versus the usual care only (group 2). The inclusion of 81 patients per group is scheduled, meaning 162 patients in total. Participation for each patient starts at the first consultation until 1 month after delivery. Inclusion time is 22 months. Total duration is 26 months.