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Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity: a Multicenter Randomized Trial
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-27
14500
Participants Needed
22
Research Sites
26 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
Researchers are evaluating whether screening for preeclampsia in the first trimester of pregnancy using the FMF algorithm improves health outcomes for mothers and their babies. Preeclampsia affects 2% of pregnancies and can cause serious complications. This study aims to provide strong evidence on the benefits, risks, and costs of early screening combined with aspirin treatment for those identified at risk. The study compares two groups of pregnant women between 11 and 14 weeks gestation. One group receives the FMF triple test, which includes maternal factors, blood pressure, uterine artery Doppler, and blood markers (PlGF). Women at high risk are prescribed aspirin daily from early pregnancy until 36 weeks. The other group receives usual prenatal care without preeclampsia screening. Screening and treatment are integrated into routine first-trimester care. Participants will complete questionnaires about satisfaction and anxiety during pregnancy and after delivery. Researchers will monitor severe perinatal morbidity, including stillbirth, early birth before 34 weeks, and very low birth weight. They will also assess preeclampsia rates, maternal health complications, aspirin side effects, healthcare use, and costs. The study will track participants until about 30 days after delivery to evaluate the impact of screening on health and well-being.
CONDITIONS
Brief Title
Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity (RANSPRE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnancy between 11 and 14 weeks of gestation
- Age 18 years or older
- Affiliated with or beneficiary of a health insurance system
- Signed informed consent to participate
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
- Major fetal abnormality detected at first-trimester ultrasound before randomization
- Absence of health insurance
- Contraindication to aspirin such as bleeding disorders, active peptic ulceration, aspirin allergy, NSAID-exacerbated respiratory disease, severe liver or heart dysfunction
- Regular use of low-dose aspirin started before pregnancy (except for assisted reproductive technology indication)
- Age under 18 years
- Poor understanding of the French language
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at first-trimester ultrasound between 11 and 14 weeks of gestation
Duration - From screening visit up to delivery
Participants are monitored during pregnancy with routine prenatal care including assessments of maternal and fetal health. For those in the screening group, a Doppler study and blood test are performed to assess preeclampsia risk and guide aspirin treatment if indicated.
Routine prenatal visits including first-trimester ultrasound and additional assessments as part of routine care
Duration - From 20 weeks gestation up to 30 days after delivery
Participants complete self-administered questionnaires assessing satisfaction and anxiety at 20 weeks gestation and within 30 days postpartum.
2 questionnaire assessments (at 20 weeks and postpartum)
Trial Site Locations
Total: 22 locations
1
CHU Angers
Angers, France
Actively Recruiting
2
CHU de Bordeaux
Bordeaux, France
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3
Hôpital Femme Mère Enfant
Bron, France
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4
Hôpital Antoine Béclère
Clamart, France
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5
CHU Estaing
Clermont-Ferrand, France
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6
Hôpital Intercommunal Créteil
Créteil, France
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7
CHU Dijon Bourgogne
Dijon, France
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8
CHU Lille
Lille, France
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9
Hôpital de la conception et de la Timone
Marseille, France
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10
Hôpital Nord
Marseille, France
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11
CHRU de Nancy
Nancy, France
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12
Hôpital Femme - Maternité
Nantes, France
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13
Hôpital Armand Trousseau
Paris, France
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14
Hôpital Cochin (site Port-Royal)
Paris, France
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15
Hôpital Saint-Joseph
Paris, France
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16
CHI de Poissy
Poissy, France
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17
Hôpital Sud Rennes
Rennes, France
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18
CHU Charles Nicolle
Rouen, France
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19
CHU Strasbourg, CMCO Schiltigheim
Strasbourg, France
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20
Hôpital de Hautepierre
Strasbourg, France
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21
Hôpital Paule de Viguier
Toulouse, France
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22
Hôpital Bretonneau
Tours, France
Actively Recruiting
Research Team
V
Vassilis TSATSARIS, MD, PhD
V
Valérie PLENCE, MSc
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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