NCT04356326 Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy
| NCT ID | NCT04356326 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Centre Hospitalier Intercommunal Creteil |
| Condition | Chronic Hypertension Complicating Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2021-02-15 |
| Primary Completion | 2026-02 |
Trial Parameters
Eligibility Fast-Check
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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 thrombo