Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy, a Multicenter Prospective Randomized Double-blind Placebo-controlled Trial.

CHASAP

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.

2021-02-15

2026-02-01

2030-02-01

Recruiting

Early phase I

500

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,

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective multicentric randomized double-blind superiority trial, placebo-controlled, on two parallel arms', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': "The treatment will be administered double blind. Pouches or tablets and caskets will be indistinguishable, prepared in advance and made available to pharmacies in participating hospitals by the sponsor. The treatment boxes are given as the monthly visits to the patient, a reassignment box will be required on the server at each visit to obtain a new cabinet number. The cabinet number (detachable label) used at each visit will be reported in the patient's file.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}

2023-09-26