Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes After Assisted Reproductive Technology
Recruiting · NCT05625724 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Toulouse
View the official record on ClinicalTrials.gov →Interventions studied
AspirinPlacebo
What this trial is about
This study seeks to validate the hypothesis that nulliparous pregnant women after Assisted Reproductive Technology (ART) are at high risk of preeclampsia and perinatal complications and represent a subgroup for which aspirin prophylaxis during pregnancy may be effective in the prevention of preterm preeclampsia and other perinatal adverse outcomes.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Nulliparous women aged 18 years or more
- Pregnancy following ART, including in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), oocyte donation or intrauterine insemination with sperm donor
- Singleton pregnancy
- Evolutive pregnancy between 9 and 14 weeks of gestation
- Women affiliated to a French Social Security Insurance or equivalent social protection
- Written informed consent
Exclusion criteria
- Major fetal abnormality
- Regular treatment with aspirin (including antiphospholipid syndrome)
- Aspirin contraindications (allergy, von Willebrand disease, peptic ulceration, hemophilia)
- Women protected by law.
- Women included in another interventional study.
Where it is running
21 locations listed.
- CHU Angers - Angers, France
- CHU Bordeaux - Bordeaux, France
- CHU Clermont-Ferrand - Clermont-Ferrand, France
- CHU Dijon-Bourgogne - Dijon, France
- CHU Lille - Lille, France
- HCL - Groupement Hospitalier Est, Hôpital Femme Mère Enfant - Lyon, France
- AP-HM Hôpital de la Conception - Marseille, France
- AP-HM Hôpital Nord - Marseille, France
- CHU Montpellier - Montpellier, France
- CHRU Nancy - Nancy, France
- CHU Nantes - Nantes, France
- CHU Nîmes - Nîmes, France
- Groupe hospitalier St Joseph - Paris, France
- Hôpital Armand - Trousseau - Paris, France
- Hôpital Cochin - Paris, France
- CHI Poissy Saint Germain en Laye - Poissy, France
- CHU Poitiers - Poitiers, France
- CHU Rennes - Rennes, France
- CHU Saint Etienne, Hôpital Nord - Saint-Etienne, France
- CHU Strasbourg - Strasbourg, France
- CHU Toulouse - Toulouse, France