Using aspirin to prevent complications in pregnant women with chronic hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of acetylsalicylic acid (aspirin) at a dosage of 150 mg per day, administered before 20 weeks of gestation, in preventing maternal and fetal complications in pregnant women suffering from chronic hypertension. Chronic hypertension can lead to severe complications such as preeclampsia, intrauterine growth restriction, and even perinatal death. The study aims to provide evidence for the use of low-dose aspirin as a preventive measure, addressing a significant gap in treatment options for this high-risk population. Participants will be randomly assigned to receive either aspirin or a placebo to assess the outcomes.

Why it matters

Who can join: the full rules

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's running

• CHU Bordeaux
  Bordeaux, France Recruiting
• CHU Antoine Béclère, AP-HP
  Clamart, France Recruiting
• Hôpital Louis Mourier, AP-HP
  Colombes, France Recruiting
• Centre Hospitalier Intercommunal de Créteil
  Créteil, France Recruiting
• CHU Dijon
  Dijon, France Recruiting
• CHU Bicêtre, AP-HP
  Le Kremlin-Bicêtre, France Recruiting

Study contacts

• Study coordinator: Edouard LE CARPENTIER
• Email: Edouard.Lecarpentier@chicreteil.fr
• Phone: 01 45 17 50 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.