NCT04356326 Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 500 participants in total. It began in 2021-02-15 with a primary completion date of 2029-02-28.

Brief Summary

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.

Eligibility Criteria

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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