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Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy

RecruitingPhase 3

Sponsor: Centre Hospitalier Intercommunal Creteil

Conditions: Chronic Hypertension Complicating Pregnancy, Pre-Eclampsia, Intrauterine Growth Restriction, Aspirin, Perinatal Death

Interventions: Aspirin 150 mg, Placebo

Countries: France

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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,

Locations (20)

Bordeaux, France
Caen, France
Clamart, France
Colombes, France
Créteil, France
Dijon, France
Le Kremlin-Bicêtre, France
Lille, France
Lyon, France
Marseille, France
Nancy, France
Nantes, France
Paris, France
Paris, France
Paris, France
Paris, France
Poissy, France
Saint-Etienne, France
Toulouse, France
Tours, France