Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity (RANSPRE)
Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity : a Multicenter Randomized Trial
Assistance Publique - Hôpitaux de Paris
14,500 participants
Mar 6, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Pregnancy between 11 and 14 WG
- Age ≥18 years
- Affiliated to or beneficiary of a health insurance system (including AME)
- Signed informed consent
Exclusion Criteria11
- Gestational age \<11 WG and \>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 before pregnancy (except ART indication)
- Age \<18 years
- Poor understanding of the French language
Interventions
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.
Locations(22)
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NCT05521776