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RECRUITING
NCT05521776
NA

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Official title: Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity : a Multicenter Randomized Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

14500

Start Date

2023-03-06

Completion Date

2027-02

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

PROCEDURE

First-trimester preeclampsia screening (FMF triple test)

An algorithm assessing the risk of developing preeclampsia combining maternal parameters, blood pressure measurement, Doppler measurements of the uterine arteries and maternal PlGF concentrations. For women in the screening group, a Doppler study of the uterine arteries and a blood test to quantify PlGF concentrations will be performed within 2 days of randomization, allowing the risk to be calculated according to the screening test. For women with a positive screening test (i.e. predicted risk\> 1/100), a treatment with aspirin will be prescribed at 160 mg/day, started as soon as possible and before 15 WG, and taken up to 36 WG, in the absence of contraindications. For women with negative screening, usual pregnancy monitoring without aspirin will be offered.

Locations (22)

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