RecruitingPhase 3NCT04356326

Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy

Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy, a Multicenter Prospective Randomized Double-blind Placebo-controlled Trial.


Sponsor

Centre Hospitalier Intercommunal Creteil

Enrollment

500 participants

Start Date

Feb 15, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • 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 Criteria20

  • 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,

Interventions

DRUGAspirin 150 mg

Treatment assigned by randomization will be prescribed immediately and continued throughout pregnancy up to 35 weeks + 6 days for both groups. The active or placebo will be dispensed by the centre's pharmacy. Treatment will be taken in the evening. A daily log is given to patients and must be completed every day.

DRUGPlacebo

Treatment assigned by randomization will be prescribed immediately and continued throughout pregnancy up to 35 weeks + 6 days for both groups. The active or placebo will be dispensed by the centre's pharmacy. Treatment will be taken in the evening. A daily log is given to patients and must be completed every day.


Locations(20)

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

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NCT04356326


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