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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Inclusion Criteria : - Pregnancy between 11 and 14 WG - Age ≥18 years - Affiliated to or beneficiary of a health insurance system (including AME) - Signed willing to sign a consent form 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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 (20)

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