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.
Pregnancy between 11 and 14 WG
Age ≥18 years
Affiliated to or beneficiary of a health insurance system (including AME)
Signed informed consent
Gestational age <11 WG or >14 WG
Known ectopic pregnancy
Known non-ongoing pregnancy
Known multiple pregnancy
Parallel
First-trimester preeclampsia screening (FMF triple test)
Procedure/SurgeryAn 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.
Severe perinatal morbidity
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
Incidence of preeclampsia
PE defined as gestational hypertension (GH: systolic BP ≥140 and/or diastolic BP ≥90 mm Hg) and proteinuria ≥ 0.30g/day (or PCr ratio ≥30 mg/mmol, or two at least ++ on dipstick analysis if no 24-hour collection is available), at or after 20 WG and up to discharge from hospital after delivery. PE also defined according to the 2018 ISSHP in the absence of proteinuria in case of GH with maternal organ dysfunction: • creatinine ≥90 µmol/L • transaminases \>40 IU/L • eclampsia, altered mental status, blindness, stroke, severe headache unresponsive to medication, and persistent visual scotomata) • platelet count \<150000/μL, DIVC, hemolysis • Fetal weight \<3° centile, abnormal umbilical artery Doppler (PI\>90° centile), or stillbirth - Early-onset PE \<34 WG, late-onset PE ≥34 WG-Superimposed pre-eclampsia when a woman with chronic hypertension develops proteinuria (in the absence of preexisting proteinuria) or any of the maternal organ dysfunction consistent with preeclampsia, after 20 W.
Incidence of components of moderate and severe maternal morbidity
Assessed during pregnancy and up to discharge from hospital after delivery (max 30 days) * Severe maternal morbidity (EPIMOMS composite criterion) * Postpartum hemorrhage (\>500 mL), severe postpartum hemorrhage (\>1000 mL), in the 24 hours of delivery as assessed by clinicians in charge of delivery * Gestational hypertension * Cesarean delivery * Abruptio placenta * Maternal ICU admission * Maternal death * HELLP Syndrome
Incidence of components of moderate and severe perinatal morbidity
* Perinatal death (stillbirth or neonatal death within 7 days of life) * Transfer to NICU * Miscarriage defined by fetal loss before 20 weeks of gestation * Stillbirth defined by intra uterine or perpartum fetal death at or after 20 WG * Perinatal death (stillbirth defined by intra uterine or perpartum fetal death at or after 20 WG or neonatal death within 7 days of life) * Gestational age at delivery * Prematurity \< 37 WG, \<32 WG, \< 28WG * At delivery, Apgar score \<7 at 5 min, umbilical cord pH \<7.00 and Base excess \>-12 * Birth weight, birth weight percentile for gestational age \< 32 WG, birth weight \< 3° percentile for gestational age, birth weight \< 10° percentile for gestational according to the EPOPE charts * Transfer to NICU from delivery and up to discharge from hospital (max 30 days) * Small vulnerable newborn (SVN): among live newborns, all neonates with preterm birth \< 37 WG or birth weight \< 2500g or birth weight \< 10e sex adjusted WHO standards (SGA).
Impact of first-trimester PE screening on potential adverse events
\- Overmedicalization and iatrogenesis: total number of ultrasound exams during pregnancy, total number of prenatal visits (planned, emergency), total number of hospitalizations during pregnancy and number of days, antihypertensive treatment, heparin treatment
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
INSERM, Epopé team
Collaborator
URC-CIC Paris Descartes Necker Cochin
Collaborator
