Screening for preeclampsia in early pregnancy
Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity : a Multicenter Randomized Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 14500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 22 sites (Angers and 21 other locations) |
| Trial ID | NCT05521776 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have shown success with similar screening approaches, indicating a promising avenue for early detection and prevention of preeclampsia.
Eligibility criteria
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 this trial is running
Angers and 21 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.