Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity (RANSPRE) (NCT05521776) | Clinical Trial Compass
RecruitingNot Applicable
Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity (RANSPRE)
France14,500 participantsStarted 2023-03-06
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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