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

Regional University Hospital Center (CHRU)

Status and phase

Completed

Phase 4

Conditions

Pre-eclampsia

Intra-uterine Growth Restriction

Treatments

Drug: Placebo

Drug: Aspirin

Study type

Interventional

Funder types

Other

Identifiers

NCT01729468

A120316-72 (Other Identifier)

2012-R8 (Other Identifier)

912140 (Other Identifier)

2011-003536-30 (EudraCT Number)

PHRN08-FP/PERASTUN

Details and patient eligibility

About

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.

Enrollment

1,106 patients

Sex

Female

Ages

18+ months old

Volunteers

No Healthy Volunteers

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