Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity (RANSPRE)

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Severe perinatal morbidity — From birth up to 7 days of life
  The primary outcome will be severe perinatal morbidity defined by a composite criterion including at least one of the following: * perinatal mortality (stillbirth ≥ 20 WG or with birth weight \> 500 g or neonatal death within 7 days of life) or prematurity \< 34 WG or birth weight \< 3° percentile. * prematurity \< 34 WG: birth before ≥ 34 WG * birth weight \< 3° percentile

Trial sites (22)

More Assistance Publique - Hôpitaux de Paris trials in France