Status:
COMPLETED
Prevention of Maternal and Perinatal Complications by Enoxaparin in Women With Previous Severe Preeclampsia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Preeclampsia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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, gro...
Detailed Description
1. Purpose of the study: To determine whether low molecular weight heparin (LMWH) enoxaparin decreases the rate of maternal and perinatal composite morbidity in women who previously had a severe preec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT00986765
Start Date
June 1 2009
End Date
November 1 2015
Last Update
January 20 2016
Active Locations (1)
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1
Centre Hospitalier Intercommunal de Créteil
Créteil, France