Screening for preeclampsia in early pregnancy
Official title: Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity : a Multicenter Randomized Trial
Run by Assistance Publique - Hôpitaux de Paris · NCT05521776 · Data updated 2026-11-12
This study is testing a new way to screen pregnant women in their first trimester for preeclampsia to see if it can help identify those at risk and improve their health with early treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 14500 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 22 sites (Angers and 21 other locations) |
| Status | Recruiting |
| Started | March 6, 2023 |
| Main results expected | August 2026 |
| Study ends | February 2027 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT05521776 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women aged 18 and older, between 11 and 14 weeks of gestation, who are affiliated with a health insurance system.
✕Probably not a fit
Patients who have a history of preeclampsia in a previous pregnancy or those with contraindications to aspirin will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of first-trimester screening for preeclampsia using the FMF algorithm, which combines maternal clinical, sonographic, and biochemical parameters. By identifying women at risk for preeclampsia early in their pregnancy, the study seeks to improve maternal and perinatal health outcomes through targeted interventions. The screening will help determine the appropriate use of low-dose aspirin, which has been shown to significantly reduce the incidence of preeclampsia and its associated complications. The study will include pregnant women between 11 and 14 weeks of gestation who meet specific eligibility criteria.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rates of preeclampsia and improve health outcomes for mothers and their babies.
How similar studies have gone: Previous studies have shown success with similar screening approaches, indicating a promising avenue for early detection and prevention of preeclampsia.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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CHU Angers
Angers, France Recruiting -
CHU de Bordeaux
Bordeaux, France Recruiting -
Hôpital Femme Mère Enfant
Bron, France Recruiting -
Hôpital Antoine Béclère
Clamart, France Recruiting -
CHU Estaing
Clermont-Ferrand, France Recruiting -
Hôpital Intercommunal Créteil
Créteil, France Recruiting
Show 16 more locations
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CHU Dijon Bourgogne
Dijon, France Recruiting -
CHU Lille
Lille, France Recruiting -
Hôpital de la conception et de la Timone
Marseille, France Recruiting -
Hôpital Nord
Marseille, France Recruiting -
CHRU de Nancy
Nancy, France Recruiting -
Hôpital Femme - Maternité
Nantes, France Recruiting -
Hôpital Armand Trousseau
Paris, France Recruiting -
Hôpital Cochin (site Port-Royal)
Paris, France Recruiting -
Hôpital Saint-Joseph
Paris, France Recruiting -
CHI de Poissy
Poissy, France Recruiting -
Hôpital Sud Rennes
Rennes, France Recruiting -
CHU Charles Nicolle
Rouen, France Recruiting -
CHU Strasbourg, CMCO Schiltigheim
Strasbourg, France Recruiting -
Hôpital de Hautepierre
Strasbourg, France Recruiting -
Hôpital Paule de Viguier
Toulouse, France Recruiting -
Hôpital Bretonneau
Tours, France Recruiting
Study contacts
- Study coordinator: Vassilis TSATSARIS, MD, PhD
- Email: vassilis.tsatsaris@aphp.fr
- Phone: 01 58 41 38 71
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Preeclampsia and normal pregnancy: retinal microcirculation using OCTA
This study tests retinal blood flow in pregnant people with preeclampsia compared to healthy pregnant people using OCTA imaging.
-
Maternal insulin and fat metabolism in pregnancies at risk for preeclampsia and gestational diabetes
This project will try to see if insulin resistance and how the body burns fats early in pregnancy predict later preeclampsia or gestational diabetes in people at higher risk.
-
Origins, features, and effects of preeclampsia on mother and baby
This project will follow pregnant women diagnosed with preeclampsia through late pregnancy, delivery, and early postpartum to collect clinical data and biological samples to see how preeclampsia affects mothers and their babies.
-
National first-trimester screening program to prevent preeclampsia in Denmark
This program will try a new first-trimester screening for pregnant women with a single pregnancy in Denmark to find those at high risk of preeclampsia and offer early prevention such as low-dose aspirin.
-
Blood protein markers and heart changes in pregnant women with preeclampsia
This study tests whether blood proteins can reveal early heart changes in pregnant women with preeclampsia and uses heart ultrasound to see how the heart changes during pregnancy.
-
Heart risk check for young women 3–6 years after pregnancy with or without placental complications.
This project will test an app-based algorithm to see if it can identify cardiovascular risk in women 3–6 years after giving birth, including those who had preeclampsia or low-birth-weight infants.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.