NCT01729468

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,106 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: Female
• Age: 18 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Pre-eclampsia
• Intra-uterine Growth Restriction

Interventions

Type	Name	Description
DRUG	Aspirin	Aspirin, 160 mg per day until 34 weeks of gestation
DRUG	Placebo	Placebo, 160 mg per day until 34 weeks of gestation

Timeline

• Start date: 2012-06-27
• Primary completion: 2016-10-25
• Completion: 2016-10-25
• First posted: 2012-11-20
• Last updated: 2025-12-22

Locations

17 sites across 2 countries: France, Martinique