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Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy

RecruitingPhase 3Ages 18 Years - anyFemaleCentre Hospitalier Intercommunal Creteil
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In plain words

What the trial is, and whether it could suit you

A randomized clinical trial to assess the efficiency of acetylsalicylic acid (aspirin) 150 mg/day started before 20 weeks of gestation in the prevention on maternal and fœtal complications in pregnant women with chronic hypertension.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Pregnant patient between 10 and 19 weeks of gestation + 6 days * Chronic hypertension, whether treated or not, know before pregnancy or diagnosed before randomization * Singleton pregnancy * Signed the written informed consent * Affiliation to social security Exclusion Criteria: * ---Medical history requiring anticoagulation (antiphospholipid syndrome, deep vein thromboembolic disease, pulmonary embolism, atherothrombosis, patient with mechanical heart valves), * Patient receiving aspirin for another indication outside pregnancy, * Patient with significant proteinuria (\> 300mg/24 hours or a proteinuria/creatininuria ratio ≥ 30mg/mmol), * Active bleeding, * History of severe PE with delivery \< 34 weeks of gestation, * Hypersensitivity to salicylates such as aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs), * Platelet count lower than 100,000 cells/microliter (dosage less than 6 months old), * Hemostasis disorders, including hemophilia (with thrombocytopenia) * Any constitutional or acquired hemorrhagic disease, (including digestive hemorrhages, history of hemorrhagic stroke and thrombocytopenia * Human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus positive serum, * Patient included in another interventional study which could interfere with the results of the study, * Age \<18 years old, * Women under the protection of justice, * Patients with psychiatric follow-up, poor understanding of French or cognitive problems, * Duodenal ulcer, * Severe renal impairment, * Severe hepatic insufficiency, * Severe cardiac impairment, * Gout, * Patients with known glucose-6-phosphate dehydrogenase deficiency,
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What it tests

  • Aspirin 150 mg
  • Placebo
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Where

20 sites
CHU Bordeaux
Bordeaux, France
CHU Caen
Caen, France
CHU Antoine Béclère, AP-HP
Clamart, France
Hôpital Louis Mourier, AP-HP
Colombes, France
Centre Hospitalier Intercommunal de Créteil
Créteil, France
CHU Dijon
Dijon, France
CHU Bicêtre, AP-HP
Le Kremlin-Bicêtre, France
CHRU Lille
Lille, France

…and 12 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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