Informations générales (source: ClinicalTrials.gov)
Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy, a Multicenter Prospective Randomized Double-blind Placebo-controlled Trial. (CHASAP)
Interventional
Phase 3
Centre Hospitalier Intercommunal Creteil (Voir sur ClinicalTrials)
février 2021
février 2030
29 juin 2024
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.
Etablissements
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
---|---|---|---|---|---|
AP-HP - Hôpital Armand Trousseau-La Roche Guyon | Pierre DELORME | Contact (sur clinicalTrials) | |||
AP-HP - Hôpital Cochin | Vassilis TSATSARIS | Contact (sur clinicalTrials) | |||
AP-HP - Hôpital Louis Mourier | Jeanne SIBIUDE | Contact (sur clinicalTrials) | |||
AP-HP - Hôpital Tenon | Anne-Gaël CORDIER | Contact (sur clinicalTrials) | |||
CHI DE CRETEIL | Edouard LECARPENTIER, Ph | Contact (sur clinicalTrials) | |||
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
CH Poissy - Poissy - France | Paul BERVEILLER | Contact (sur clinicalTrials) | |||
CHRU Lille - Lille - France | Louise GHESQUIERE | Contact (sur clinicalTrials) | |||
CHRU Nancy - Nancy - France | Contact (sur clinicalTrials) | ||||
CHU Antoine Béclère, AP-HP - Clamart - France | Alexandra BENACHI | Contact (sur clinicalTrials) | |||
CHU Bicêtre, AP-HP - Le Kremlin-Bicêtre - France | Claire SZMULEWICZ | Contact (sur clinicalTrials) | |||
CHU Bordeaux - Bordeaux - France | Loïc SENTILHES | Contact (sur clinicalTrials) | |||
CHU Caen - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
CHU Dijon - Dijon - France | Emmanuel SIMON | Contact (sur clinicalTrials) | |||
CHU Lyon - Lyon - France | Jérôme MASSARDIER | Contact (sur clinicalTrials) | |||
CHU Nantes - Nantes - France | Norbert WINER | Contact (sur clinicalTrials) | |||
CHU Robert Débré, AP-HP - Paris - France | Diane KORB | Contact (sur clinicalTrials) | |||
CHU St Etienne - Saint-Étienne - France | Tiphaine BARJAT | Contact (sur clinicalTrials) | |||
CHU Toulouse - Toulouse - France | Paul GUERBY | Contact (sur clinicalTrials) | |||
CHU Tours - Tours - France | Contact (sur clinicalTrials) | ||||
Hôpital St Joseph - Marseille - France | Contact (sur clinicalTrials) |
Critères
Femme
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
- 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
- ---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,