Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy

• Status: Recruiting
• Trial end date: 2028-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

A randomized clinical trial to assess the efficiency of acetylsalicylic acid (aspirin) 150 mg/day started before 15 weeks of gestation in the prevention on maternal and fœtal complications in pregnant women with chronic hypertension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Intercommunal Creteil
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Pregnant patient between 10 and 14 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 an another interventional 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,