RecruitingNot ApplicableNCT05521776

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

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

14,500 participants

Start Date

Mar 6, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether first-trimester screening for preeclampsia (a dangerous blood pressure condition during pregnancy) — and starting low-dose aspirin for those at high risk — reduces serious complications for mothers and babies in France. You may be eligible if: you are at least 18 years old; you are between 11 and 14 weeks pregnant; you have health insurance; and you have signed the consent form. You may NOT be eligible if: you are outside the 11–14 week window; you have a known miscarriage, ectopic pregnancy, twin pregnancy, or major fetal abnormality; you have had preeclampsia in a previous pregnancy; you have a condition that makes aspirin unsafe (like bleeding disorders, stomach ulcers, or aspirin allergy); or you are already taking regular low-dose aspirin for other reasons. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREFirst-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

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NCT05521776


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