Prospective Validation of First-Trimester Screening for Preterm Preeclampsia in Nulliparous Women (PREDICTION Study)

Author:

Guerby Paul12,Audibert Francois3ORCID,Johnson Jo-Ann4,Okun Nanette5ORCID,Giguère Yves16,Forest Jean-Claude16,Chaillet Nils1ORCID,Mâsse Benoit7,Wright David78,Ghesquiere Louise19,Bujold Emmanuel110ORCID

Affiliation:

1. Reproduction, Mother and Child Health Unit, CHU De Québec-Université Laval Research Center (P.G., Y.G., J.-C.F., N.C., L.G., E.B.), Université Laval, Canada.

2. Department of Gynecology and Obstetrics, Infinity CNRS, Inserm UMR 1291, CHU Toulouse, France (P.G.).

3. Department of Obstetrics and Gynecology, CHU Ste-Justine Research Center, Université de Montréal, Canada (F.A.).

4. Department of Obstetrics and Gynaecology, University of Calgary, AB, Canada (J.-A.J.).

5. Department of Obstetrics and Gynaecology, University of Toronto, ON, Canada (N.O.).

6. Department of Molecular Biology, Medical Biochemistry and Pathology (Y.G., J.-C.F.), Université Laval, Canada.

7. École de Santé Publique de l’Université de Montréal, QC, Canada (B.M.).

8. Institute of Health Research, University of Exeter, United Kingdom (D.W.).

9. Department of Obstetrics, Université de Lille, CHU de Lille, France (L.G.).

10. Department of Gynecology, Obstetrics and Reproduction (E.B.), Université Laval, Canada.

Abstract

BACKGROUND: Fetal Medicine Foundation (FMF) studies suggest that preterm preeclampsia can be predicted in the first trimester by combining biophysical, biochemical, and ultrasound markers and prevented using aspirin. We aimed to evaluate the FMF preterm preeclampsia screening test in nulliparous women. METHODS: We conducted a prospective multicenter cohort study of nulliparous women recruited at 11 to 14 weeks. Maternal characteristics, mean arterial blood pressure, PAPP-A (pregnancy-associated plasma protein A), PlGF (placental growth factor) in maternal blood, and uterine artery pulsatility index were collected at recruitment. The risk of preterm preeclampsia was calculated by a third party blinded to pregnancy outcomes. Receiver operating characteristic curves were used to estimate the detection rate (sensitivity) and the false-positive rate (1-specificity) for preterm (<37 weeks) and for early-onset (<34 weeks) preeclampsia according to the FMF screening test and according to the American College of Obstetricians and Gynecologists criteria. RESULTS: We recruited 7554 participants including 7325 (97%) who remained eligible after 20 weeks of which 65 (0.9%) developed preterm preeclampsia, and 22 (0.3%) developed early-onset preeclampsia. Using the FMF algorithm (cutoff of ≥1 in 110 for preterm preeclampsia), the detection rate was 63.1% for preterm preeclampsia and 77.3% for early-onset preeclampsia at a false-positive rate of 15.8%. Using the American College of Obstetricians and Gynecologists criteria, the equivalent detection rates would have been 61.5% and 59.1%, respectively, for a false-positive rate of 34.3%. CONCLUSIONS: The first-trimester FMF preeclampsia screening test predicts two-thirds of preterm preeclampsia and three-quarters of early-onset preeclampsia in nulliparous women, with a false-positive rate of ≈16%. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02189148.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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