Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy
Recruiting · NCT04356326 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Intercommunal Creteil
View the official record on ClinicalTrials.gov →Interventions studied
Aspirin 150 mgPlacebo
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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,
Where it is running
20 locations listed.
- 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
- CHU Lyon - Lyon, France
- Hôpital St Joseph - Marseille, France
- CHRU Nancy - Nancy, France
- CHU Nantes - Nantes, France
- CHU Cochin- Port Royal, AP-HP - Paris, France
- CHU Robert Débré, AP-HP - Paris, France
- CHU Tenon - Paris, France
- Hôpital Trousseau, AP-HP - Paris, France
- CH Poissy - Poissy, France
- CHU St Etienne - Saint-Etienne, France
- CHU Toulouse - Toulouse, France
- CHU Tours - Tours, France