Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity (RANSPRE)
Recruiting now · Not applicable
Conditions studied: Preeclampsia (PE)
In brief
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.
Key facts
- Study ID
- NCT05521776
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 14500
- Starts
- 2023-03-06
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Pregnancy between 11 and 14 WG
- Age ≥18 years
- Affiliated to or beneficiary of a health insurance system (including AME)
- Signed informed consent
You may not qualify if…
- 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
- CHU Angers — Angers, France (enrolling)
- CHU de Bordeaux — Bordeaux, France (enrolling)
- Hôpital Femme Mère Enfant — Bron, France (enrolling)
- Hôpital Antoine Béclère — Clamart, France (enrolling)
- CHU Estaing — Clermont-Ferrand, France (enrolling)
- Hôpital Intercommunal Créteil — Créteil, France (enrolling)
- CHU Dijon Bourgogne — Dijon, France (enrolling)
- CHU Lille — Lille, France (enrolling)
- Hôpital de la conception et de la Timone — Marseille, France (enrolling)
- Hôpital Nord — Marseille, France (enrolling)
- CHRU de Nancy — Nancy, France (enrolling)
- Hôpital Femme - Maternité — Nantes, France (enrolling)
- Hôpital Armand Trousseau — Paris, France (enrolling)
- Hôpital Cochin (site Port-Royal) — Paris, France (enrolling)
- Hôpital Saint-Joseph — Paris, France (enrolling)
- CHI de Poissy — Poissy, France (enrolling)
- Hôpital Sud Rennes — Rennes, France (enrolling)
- CHU Charles Nicolle — Rouen, France (enrolling)
- CHU Strasbourg, CMCO Schiltigheim — Strasbourg, France (enrolling)
- Hôpital de Hautepierre — Strasbourg, France (enrolling)
- Hôpital Paule de Viguier — Toulouse, France (enrolling)
- Hôpital Bretonneau — Tours, France (enrolling)
Full record on ClinicalTrials.gov
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