Intra-uterine Growth Restriction, Pre-eclampsia
Conditions
Keywords
Low Dose Acetylsalicylic Acid, Prevention, Pre-eclampsia, Intra-uterine Growth Restriction, Primiparous Women, Bilateral Uterine Artery Notches, First Quarter
Brief summary
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.
Interventions
DRUGAspirin
Aspirin, 160 mg per day until 34 weeks of gestation
DRUGPlacebo
Placebo, 160 mg per day until 34 weeks of gestation
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Nulliparous (no previous pregnancy ≥ 22 SA) * Singleton pregnancy * Gestational age ≤ 15 +6 weeks * Bilateral uterine artery notch (grade ≥ 2) and/or bilateral uterine artery PI ≥ 1.7 during first trimester ultrasound (CRL between 45 and 84 mm) * Maternal informed consent obtained * Affiliated to social security system
Exclusion criteria
* Women considering voluntary pregnancy termination (≤ 14 weeks) * Pre-existing (maternal) indication for premature delivery before 37 weeks * Fetal condition detected during the first trimester scan (fetal malformation or nuchal translucency ≥ 95th percentile) * Women under anticoagulation * Allergy or hypersensitivity to Kardegic® or one of its constituents * Secondary hemostasis disorder responsible for bleeding or risk of bleeding * Peptic ulcer under evolution * Lupus or antiphospholipid syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preeclampsia (diagnosed per ACOG criteria) and small for gestational age at birth (≤5th percentile on customized growth curves) | women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Small for gestational age at birth (≤5th percentile on customized growth curves) | 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 | women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks |
| Severe pre-eclampsia (ACOG criteria) | women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks |
| Pre-eclampsia (ACOG criteria) | women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks |
| Adverse effects of treatment | 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) | women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks |
Other
| Measure | Time frame |
|---|---|
| Mode of delivery (vaginal or cesarean) | women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks |
| Mode of anesthesia for delivery | women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks |
Countries
France, Martinique
Outcome results
None listed