Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05521776

Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity (RANSPRE)

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-27

14500

Participants Needed

22

Research Sites

204 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

I

INSERM, Epopé team

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity (RANSPRE)

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnancy between 11 and 14 weeks of gestation
  • Age 18 years or older
  • Affiliated to or beneficiary of a health insurance system (including AME)
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Gestational age less than 11 weeks or more than 14 weeks
  • Known ectopic pregnancy
  • Known non-ongoing pregnancy
  • Known multiple pregnancy
  • History of preeclampsia in a previous pregnancy
  • Pregnancies with major fetal abnormality identified at first-trimester ultrasound before randomization
  • Absence of health insurance
  • Contraindication to aspirin (bleeding disorders, active peptic ulceration, hypersensitivity to aspirin, NSAID-exacerbated respiratory disease, severe liver or heart dysfunction)
  • Women regularly taking low-dose aspirin started before pregnancy (except for assisted reproduction indication)
  • Age less than 18 years
  • Poor understanding of the French language

AI-Screening

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Trial Site Locations

Total: 22 locations

1

CHU Angers

Angers, France

Actively Recruiting

2

CHU de Bordeaux

Bordeaux, France

Actively Recruiting

3

Hôpital Femme Mère Enfant

Bron, France

Actively Recruiting

4

Hôpital Antoine Béclère

Clamart, France

Actively Recruiting

5

CHU Estaing

Clermont-Ferrand, France

Actively Recruiting

6

Hôpital Intercommunal Créteil

Créteil, France

Actively Recruiting

7

CHU Dijon Bourgogne

Dijon, France

Actively Recruiting

8

CHU Lille

Lille, France

Actively Recruiting

9

Hôpital de la conception et de la Timone

Marseille, France

Actively Recruiting

10

Hôpital Nord

Marseille, France

Actively Recruiting

11

CHRU de Nancy

Nancy, France

Actively Recruiting

12

Hôpital Femme - Maternité

Nantes, France

Actively Recruiting

13

Hôpital Armand Trousseau

Paris, France

Actively Recruiting

14

Hôpital Cochin (site Port-Royal)

Paris, France

Actively Recruiting

15

Hôpital Saint-Joseph

Paris, France

Actively Recruiting

16

CHI de Poissy

Poissy, France

Actively Recruiting

17

Hôpital Sud Rennes

Rennes, France

Actively Recruiting

18

CHU Charles Nicolle

Rouen, France

Actively Recruiting

19

CHU Strasbourg, CMCO Schiltigheim

Strasbourg, France

Actively Recruiting

20

Hôpital de Hautepierre

Strasbourg, France

Actively Recruiting

21

Hôpital Paule de Viguier

Toulouse, France

Actively Recruiting

22

Hôpital Bretonneau

Tours, France

Actively Recruiting

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Research Team

V

Vassilis TSATSARIS, MD, PhD

CONTACT

V

Valérie PLENCE, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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