Prevention of Maternal and Perinatal Complications by Enoxaparin in Women With Previous Severe Preeclampsia

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: Female

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) .

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Acetylsalicylic acid lysinate; Aspirin; Enoxaparin

Criteria

Inclusion Criteria:

• Patient ≥ 18 years

• Patient with a previous severe preeclampsia that occurred at less than 34 weeks' gestation

• Patient between 7 and 13 weeks +6 days at first prenatal visit

• Singleton pregnancy

• Affiliation to social security

• Informed consent given after receiving information on the study.

Exclusion Criteria:

• Patient under law protection

• Inability to sign written consent

• Inability to follow the protocol because of a psychiatric disease

• History of deep venous thromboembolism during previous pregnancy

• Need of low molecular weight heparin during pregnancy

• Previous arterial thrombosis

• Patient having a cardiac valvular prosthesis that necessitates anticoagulation during pregnancy

• Renal failure (creatinine clearance < 30 ml/min, or serum creatinine > 180 µmol/L

• Previous hemorrhagic disease

• A disease that might bleed (gastric ulcer)

• Antiphospholipid antibody syndrome

• Allergy to Aspirin

• Allergy to heparins

• Thrombocytopenia related to heparin use

• Thrombocytopenia <100,000 /µL at first prenatal visit

• Antecedent of osteoporosis

• Inability to do subcutaneous injection of heparin

• Weight > 100 kg

• Patient included in another interventional trial

• Patient positive for anti-phospholipids antibodies

• Patient positive for HIV or HCV or HBS