The objective of this study is to test the efficacy of low-dose aspirin (160 mg/day), given bedtime and started early during pregnancy (≤ 15 +6 weeks of gestation) in nulliparous pregnant women selected as "high-risk" by the presence of a bilateral uterine artery notch and/or bilateral uterine artery PI ≥ 1.7 during the first trimester ultrasound scan (11-13+6 weeks), to prevent the occurrence of pre-eclampsia or small for gestational age at birth.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,106
Aspirin, 160 mg per day until 34 weeks of gestation
Placebo, 160 mg per day until 34 weeks of gestation
Service de Gynécologie-Obstétrique, Groupe Hospitalier Pellegrin, CHRU de Bordeaux
Bordeaux, France
Service de Gynécologie-Obstétrique, HFME, Hospices Civils de Lyon
Bron, France
Service de gynécologie-obstétrique, Polyclinique du PARC
Caen, France
Service de Gynécologie-Obstétrique, Hôpital d'Estaing, CHU de Clermont-Ferrand
Clermont-Ferrand, France
Service de gynécologie-obstétrique, Hôpital Couple Enfant, CHRU de Grenoble
Grenoble, France
Cabinet Mosaïque Santé
La Chaussée-Saint-Victor, France
Service de gynécologie-obstétrique, CHR Le Mans
Le Mans, France
Service de Gyénécologie-Obstétrique, Hôpital Jeanne de Flandre, CHRU de Lille
Lille, France
Service de Gynécologie-Obstétrique, Hôpital Arnaud de Villeneuve, CHRU de Montpellier
Montpellier, France
Service de gynécologie-obstétrique, Hôpital Mère-Enfant, CHRU de Nantes
Nantes, France
...and 7 more locations
Preeclampsia (diagnosed per ACOG criteria) and small for gestational age at birth (≤5th percentile on customized growth curves)
Time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Small for gestational age at birth (≤5th percentile on customized growth curves)
Time frame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
Pre-eclampsia (ACOG criteria) requiring delivery before 34 weeks
Time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Severe pre-eclampsia (ACOG criteria)
Time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Perinatal death (22 weeks of gestation to 7 days postnatal)
Time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Pre-eclampsia (ACOG criteria)
Time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Adverse effects of treatment
Time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
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