Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women

• Status: Completed
• Trial end date: 2018-07-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Les Laboratoires des Médicaments Stériles
• Treatments: Aspirin; Enoxaparin

Criteria

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