RECRUITINGPhase 3INTERVENTIONAL
Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes After Assisted Reproductive Technology
Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes in Nulliparous Women After Assisted Reproductive Technology. APPART
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Aspirin
Experimental drug administrated orally
DRUG
Placebo
Treatment for the control group
Locations (20)
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