Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes in Nulliparous Women After Assisted Reproductive Technology. APPART
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
CHU Angers
RECRUITING
Angers
CHU Bordeaux
RECRUITING
Bordeaux
CHU Clermont-Ferrand
RECRUITING
Clermont-ferrand
CHU Dijon-Bourgogne
RECRUITING
Dijon
CHU Lille
RECRUITING
Lille
HCL - Groupement Hospitalier Est, Hôpital Femme Mère Enfant
RECRUITING
Lyon
AP-HM Hôpital de la Conception
RECRUITING
Marseille
AP-HM Hôpital Nord
RECRUITING
Marseille
CHU Montpellier
RECRUITING
Montpellier
CHRU Nancy
RECRUITING
Nancy
CHU Nantes
RECRUITING
Nantes
CHU Nîmes
RECRUITING
Nîmes
Groupe hospitalier St Joseph
RECRUITING
Paris
Hôpital Armand - Trousseau
NOT_YET_RECRUITING
Paris
Hôpital Cochin
RECRUITING
Paris
CHI Poissy Saint Germain en Laye
RECRUITING
Poissy
CHU Poitiers
NOT_YET_RECRUITING
Poitiers
CHU Rennes
RECRUITING
Rennes
CHU Saint Etienne, Hôpital Nord
RECRUITING
Saint-etienne
CHU Strasbourg
RECRUITING
Strasbourg
CHU Toulouse
RECRUITING
Toulouse
Contact Information
Primary
Paul GUERBY, MD
guerby.p@chu-toulouse.fr
5 67 77 12 33
Backup
Delphine DUCHANOIS, Midwife
duchanois.d@chu-toulouse.fr
5 67 77 12 33
Time Frame
Start Date:2023-08-02
Estimated Completion Date:2026-05
Participants
Target number of participants:1164
Treatments
Experimental: Aspirin
Low-dose Aspirin: 150mg, daily, oral route, at bedtime, initiated between 9 and 14 weeks of gestation, until 35 (+6) weeks of gestation, or in the event of earlier delivery, until the onset of labor.
Placebo_comparator: Control
Matching placebo administrated daily, oral route, at bedtime, initiated between 9 and 14 weeks of gestation, until 35 (+6) weeks of gestation, or in the event of earlier delivery, until the onset of labor.