Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity : a Multicenter Randomized Trial
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to determine whether first-trimester screening for preeclampsia based on the FMF algorithm (a combination of maternal clinical, sonographic and biochemical parameters), improves maternal or perinatal health.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Pregnancy between 11 and 14 WG
• Age ≥18 years
• Affiliated to or beneficiary of a health insurance system (including AME)
• Signed informed consent
Locations
Other Locations
France
CHU Angers
RECRUITING
Angers
CHU de Bordeaux
RECRUITING
Bordeaux
Hôpital Femme Mère Enfant
RECRUITING
Bron
Hôpital Antoine Béclère
RECRUITING
Clamart
CHU Estaing
RECRUITING
Clermont-ferrand
Hôpital Intercommunal Créteil
RECRUITING
Créteil
CHU Dijon Bourgogne
RECRUITING
Dijon
CHU Lille
RECRUITING
Lille
Hôpital de la conception et de la Timone
RECRUITING
Marseille
Hôpital Nord
RECRUITING
Marseille
CHRU de Nancy
RECRUITING
Nancy
Hôpital Femme - Maternité
RECRUITING
Nantes
Hôpital Armand Trousseau
RECRUITING
Paris
Hôpital Cochin (site Port-Royal)
RECRUITING
Paris
Hôpital Saint-Joseph
RECRUITING
Paris
CHI de Poissy
RECRUITING
Poissy
Hôpital Sud Rennes
RECRUITING
Rennes
CHU Charles Nicolle
RECRUITING
Rouen
CHU Strasbourg, CMCO Schiltigheim
RECRUITING
Strasbourg
Hôpital de Hautepierre
RECRUITING
Strasbourg
Hôpital Paule de Viguier
RECRUITING
Toulouse
Hôpital Bretonneau
RECRUITING
Tours
Contact Information
Primary
Vassilis TSATSARIS, MD, PhD
vassilis.tsatsaris@aphp.fr
01 58 41 38 71
Backup
Alice CAMARA, MSc
alice.camara@aphp.fr
01 58 41 12 11
Time Frame
Start Date: 2023-03-06
Estimated Completion Date: 2026-03-06
Participants
Target number of participants: 14500
Treatments
Experimental: With first trimester preeclampsia screening
Risk assessment of developing preeclampsia between 11 and 14 WG based on maternal parameters, blood pressure measurement, Doppler measurements of the uterine arteries and maternal PlGF concentration. Patients at high risk of preeclampsia are treated with aspirin.
No_intervention: Without first trimester preeclampsia screening
Usual prenatal care
Related Therapeutic Areas
Sponsors
Collaborators: URC-CIC Paris Descartes Necker Cochin, INSERM, Epopé team
Leads: Assistance Publique - Hôpitaux de Paris