Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers

• Status: Completed
• Trial end date: 2016-10-25
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Tours
• Treatments: Aspirin

Criteria

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