Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity (RANSPRE)
Recruiting · NCT05521776 · Interventional (participants receive a specific treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
First-trimester preeclampsia screening (FMF triple test)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Pregnancy between 11 and 14 WG
- Age ≥18 years
- Affiliated to or beneficiary of a health insurance system (including AME)
- Signed informed consent
Exclusion criteria
- Gestational age \<11 WG or \>14 WG
- Known ectopic pregnancy
- Known non-ongoing pregnancy
- Known multiple pregnancy
- History of PE in a previous pregnancy
- Pregnancies complicated by major fetal abnormality identified at the first-trimester ultrasound if performed before randomization
- Absence of health insurance
- Contra-indication to aspirin (bleeding disorders such as von Willebrand's disease, active peptic ulceration, hypersensitivity to aspirin, active peptic ulceration, NSAID-exacerbated respiratory disease, severe liver or heart dysfunction)
- Women taking low-dose aspirin regularly and started before pregnancy (except ART indication)
- Age \<18 years
- Poor understanding of the French language
Where it is running
22 locations listed.
- CHU Angers - Angers, France
- CHU de Bordeaux - Bordeaux, France
- Hôpital Femme Mère Enfant - Bron, France
- Hôpital Antoine Béclère - Clamart, France
- CHU Estaing - Clermont-Ferrand, France
- Hôpital Intercommunal Créteil - Créteil, France
- CHU Dijon Bourgogne - Dijon, France
- CHU Lille - Lille, France
- Hôpital de la conception et de la Timone - Marseille, France
- Hôpital Nord - Marseille, France
- CHRU de Nancy - Nancy, France
- Hôpital Femme - Maternité - Nantes, France
- Hôpital Armand Trousseau - Paris, France
- Hôpital Cochin (site Port-Royal) - Paris, France
- Hôpital Saint-Joseph - Paris, France
- CHI de Poissy - Poissy, France
- Hôpital Sud Rennes - Rennes, France
- CHU Charles Nicolle - Rouen, France
- CHU Strasbourg, CMCO Schiltigheim - Strasbourg, France
- Hôpital de Hautepierre - Strasbourg, France
- Hôpital Paule de Viguier - Toulouse, France
- Hôpital Bretonneau - Tours, France