Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy (NCT04356326) | Clinical Trial Compass
RecruitingPhase 3
Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy
France500 participantsStarted 2021-02-15
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Composite morbidity-mortality criterion including preeclampsia, intra-uterine growth retardation <10th percentile, placental abruption, Preterm birth < 37 weeks of gestation, Perinatal death, Maternal death