Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Hospitalier Intercommunal Creteil

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Aspirin 150 mg

    Drug

    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.

  • Placebo

    Drug

    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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Aspirin 150 mgExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

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

Time frame
9 months

Secondary outcomes

1

IUGR (< 10th percentile of birth weight)

Rate of IUGR (\< 10th percentile of birth weight)

Time frame
9 months
2

Placental abruption

Rate of placental abruption

Time frame
9 months
3

Preterm birth < 37 weeks of gestation

Rate of severe preterm delivery (\< 37 weeks of gestation)

Time frame
9 months
4

Maternal death

Rate of severe maternal death

Time frame
9 months

Other outcomes

Sponsors and contacts

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