Skip to main content
OpenTrials
Completed

NCT Number: NCT01729468

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pre-eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Intra-uterine Growth Restriction Pregnancy Complications Urogenital Diseases

Age range

18 month and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Service de Gynécologie-Obstétrique, Groupe Hospitalier Pellegrin, CHRU de Bordeaux, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

Aspirin, 160 mg per day until 34 weeks of gestation

Placebo

Drug

Placebo, 160 mg per day until 34 weeks of gestation

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Other outcomes

  1. Mode of delivery (vaginal or cesarean)

    Time frame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks

  2. Mode of anesthesia for delivery

    Time frame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: PERASTUN

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2012
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.