CompletedPhase 3

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

France257 participantsStarted 2009-06

Plain-language 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) .

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary outcome is a composite morbidity that may occur : maternal death, or perinatal death, or preeclampsia, or abruptio placenta, or fetal growth restriction.

Timeframe: from randomization until one month after the delivery

Trial details

NCT IDNCT00986765

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-11

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