Clinical trial Recruiting at 22 sites Interventional Ages 18 and up Women only

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 typeInterventional
Ages18 Years and up
SexWomen only
Enrollment14500 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations22 sites (Angers and 21 other locations)
StatusRecruiting
StartedMarch 6, 2023
Main results expectedAugust 2026
Study endsFebruary 2027
Registry record updatedMarch 27, 2026
Trial IDNCT05521776 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.