Recruiting
Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity (RANSPRE)
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.
ClinicalTrials.gov IDNCT05521776
PhaseNA
Enrollment14500
SponsorAssistance Publique - Hôpitaux de Paris
Age18 Years and older
SexFEMALE
Conditions studied
Preeclampsia (PE)
About this study
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.
Interventions
- Procedure: First-trimester preeclampsia screening (FMF triple test) — An algorithm assessing the risk of developing preeclampsia combining maternal parameters, blood pressure measurement, Doppler measurements of the uterine arteries and maternal PlGF concentrations. For women in the screening group, a Doppler study of the uterine arteries and a blood test to quantify PlGF concentrations will be performed within 2 days of randomization, allowing the risk to be calculated according to the screening test. For women with a positive screening test (i.e. predicted risk\> 1/100), a treatment with aspirin will be prescribed at 160 mg/day, started as soon as possible and before 15 WG, and taken up to 36 WG, in the absence of contraindications. For women with negative screening, usual pregnancy monitoring without aspirin will be offered.
Primary outcomes
- Severe perinatal morbidity (From birth up to 7 days of life)
Eligibility information
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
Study locations
- CHU Angers, Angers, France
- CHU de Bordeaux, Bordeaux, France
- Hôpital Femme Mère Enfant, Bron, France
- Hôpital Antoine Béclère, Clamart, France
- CHU Estaing, Clermont-Ferrand, France
- Hôpital Intercommunal Créteil, Créteil, France
- CHU Dijon Bourgogne, Dijon, France
- CHU Lille, Lille, France
- Hôpital de la conception et de la Timone, Marseille, France
- Hôpital Nord, Marseille, France
Showing 10 of 22 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-14.