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

NCT01729468 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1106

Last updated 2025-12-22

No results posted yet for this study

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

DRUG

Aspirin

Aspirin, 160 mg per day until 34 weeks of gestation

DRUG

Placebo

Placebo, 160 mg per day until 34 weeks of gestation

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Franck PERROTIN, MD-PhD · University Hospital, Tours

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-27
Primary Completion
2016-10-25
Completion
2016-10-25

Countries

  • France
  • Martinique

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01729468 on ClinicalTrials.gov