About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
---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,
Trial design
Parallel
Treatments tested in this trial
Aspirin 150 mg
DrugTreatment 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.
Placebo
DrugTreatment 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.
Treatment groups
Trial outcomes
Primary outcomes
Composite morbidity-mortality criterion including preeclampsia, intra-uterine growth retardation <10th percentile, placental abruption, Preterm birth < 37 weeks of gestation, Perinatal death, Maternal death
A composite morbidity-mortality criterion that includes the occurrence during pregnancy or postpartum of at least one of the following events: preeclampsia, IUGR \<10th percentile, placental abruption, Preterm birth \< 37 weeks of gestation, Perinatal death (death from 22 weeks of gestation until 28 days after birth), Maternal death
Secondary outcomes
IUGR (< 10th percentile of birth weight)
Rate of IUGR (\< 10th percentile of birth weight)
Placental abruption
Rate of placental abruption
Preterm birth < 37 weeks of gestation
Rate of severe preterm delivery (\< 37 weeks of gestation)
Maternal death
Rate of severe maternal death
Sponsors and contacts
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