Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women

Enoxaparine en PREvention Des insuffiSAnces Placentaires Chez Les Femmes eNCEintes

Assessment of the effectiveness of Enoxaparin, at a preventive dose, combined with Aspirin treatment versus Aspirin only treatment in reducing placental insufficiency in pregnant women.

Randomized, prospective, monocentric, open-label comparative study with two parallel groups (Enoxaparin, at a preventive dose, combined with Aspirin versus Aspirin alone), with the main objective being to evaluate the effectiveness of enoxaparin, at a preventive dose, in reducing placental insufficiency during pregnancy in pregnant women.

Inclusion Criteria:

• Age ≥ 18 years and
• Age ≤ 45 years and
• Single and confirmed pregnancy and
• Intrauterine growth restriction (IUGR) history with an estimated fetal weight (ESW) < 3rd percentile and / or
• In utero fetal death (IUFD) history > 12 weeks of amenorrhea (WA) and / or
• Central Retroplacental hematoma (RPH) history < 34 WA and / or
• History of severe preeclampsia < 34 WA and
• Informed consent, written and obtained

Exclusion Criteria:

• Age <18 years or
• Age > 45 years or
• Multiple pregnancy or
• Pregnancy > 7 WA or
• Positive immunological assessment or
• Known history of Thromboembolic diseases, Hemorrhagic diseases, Systemic Lupus Erythematosus (SLE), Heparin-induced thrombocythemia (HIT), Suspicion of thrombophilia (burdened history) or an episode of Deep Vein Thrombosis (DVT) or
• Anticoagulation required or
• Thrombocythaemia < 100,000 plq / µl or
• Weight > 100 kg or
• Osteoporosis or
• Known allergy to the study products or
• Inability to ensure injections' administration or
• Family history of DVT before 40 years of age or