Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy

Launched by CENTRE HOSPITALIER INTERCOMMUNAL CRETEIL · Apr 21, 2020

Keywords

ClinConnect Summary

This clinical trial, titled "Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy," is studying whether taking a daily dose of aspirin (150 mg) can help prevent complications for pregnant women who have chronic hypertension. Chronic hypertension means having high blood pressure before pregnancy or being diagnosed with it early in pregnancy. The study aims to see if aspirin can reduce risks for both the mother and the baby, including serious conditions like pre-eclampsia, which affects blood pressure during pregnancy, and issues with the baby's growth.

To participate, women must be pregnant and between 10 and 19 weeks along, have chronic hypertension, and be in a singleton pregnancy (meaning just one baby). They must also agree to participate by signing a consent form. However, this study excludes women with certain health conditions, such as those needing blood-thinning medications or with severe kidney or liver problems. If eligible, participants can expect regular check-ups and monitoring throughout the trial to assess the effects of aspirin on their health and pregnancy outcomes. This research is currently recruiting new participants, and it's important to discuss with a healthcare provider if you think you might qualify.

Gender

FEMALE

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,