NCT05521776 Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity (RANSPRE)
| NCT ID | NCT05521776 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Preeclampsia (PE) |
| Study Type | INTERVENTIONAL |
| Enrollment | 14,500 participants |
| Start Date | 2023-03-06 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 14,500 participants in total. It began in 2023-03-06 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Catherine DENEUX, MD, PhD
STUDY DIRECTOR
Institut National de la Santé Et de la Recherche Médicale, France
Frequently Asked Questions
Who can join the NCT05521776 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preeclampsia (PE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05521776 currently recruiting?
Yes, NCT05521776 is actively recruiting participants. Contact the research team at vassilis.tsatsaris@aphp.fr for enrollment information.
Where is the NCT05521776 trial being conducted?
This trial is being conducted at Angers, France, Bordeaux, France, Bron, France, Clamart, France and 11 additional locations.
Who is sponsoring the NCT05521776 clinical trial?
NCT05521776 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Catherine DENEUX, MD, PhD at Institut National de la Santé Et de la Recherche Médicale, France. The trial plans to enroll 14,500 participants.