title: EVERREST prospective study: a 6-year prospective study to define the clinical and biological characteristics of pregnancies affected by severe early onset fetal growth restriction.
abstract: Fetal growth restriction (FGR) is a serious obstetric condition for which there is currently no treatment. The EVERREST Prospective Study has been designed to characterise the natural history of pregnancies affected by severe early onset FGR and establish a well phenotyped bio-bank. The findings will provide up-to-date information for clinicians and patients and inform the design and conduct of the EVERREST Clinical Trial: a phase I/IIa trial to assess the safety and efficacy of maternal vascular endothelial growth factor (VEGF) gene therapy in severe early onset FGR. Data and samples from the EVERREST Prospective Study will be used to identify ultrasound and/or biochemical markers of prognosis in pregnancies with an estimated fetal weight (EFW) <3rd centile between 20+0 and 26+6 weeks of gestation.
  
  
  
  This is a 6 year European multicentre prospective cohort study, recruiting women with a singleton pregnancy where the EFW is <3rd centile for gestational age and <600 g at 20+0 to 26+6 weeks of gestation. Detailed data are collected on: maternal history; antenatal, peripartum, and postnatal maternal complications; health economic impact; psychological impact; neonatal condition, progress and complications; and infant growth and neurodevelopment to 2 years of corrected age in surviving infants. Standardised longitudinal ultrasound measurements are performed, including: fetal biometry; uterine artery, umbilical artery, middle cerebral artery, and ductus venosus Doppler velocimetry; and uterine artery and umbilical vein volume blood flow. Samples of maternal blood and urine, amniotic fluid (if amniocentesis performed), placenta, umbilical cord blood, and placental bed (if caesarean delivery performed) are collected for bio-banking. An initial analysis of maternal blood samples at enrolment is planned to identify biochemical markers that are predictors for fetal or neonatal death.
  
  
  
  The findings of the EVERREST Prospective Study will support the development of a novel therapy for severe early onset FGR by describing in detail the natural history of the disease and by identifying women whose pregnancies have the poorest outcomes, in whom a therapy might be most advantageous. The findings will also enable better counselling of couples with affected pregnancies, and provide a valuable resource for future research into the causes of FGR.
  
  
  
  NCT02097667 registered 31stOctober 2013.
authors.affiliation: Institute for Women's Health, University College London, London, UK. rebecca.spencer@ucl.ac.uk.|Institute for Women's Health, University College London and NIHR University College London Hospitals Biomedical Research Centre, London, UK. rebecca.spencer@ucl.ac.uk.
authors.forename: Rebecca
authors.identifier: 0000-0002-3019-0322
authors.initials: R
authors.lastname: Spencer
authors.affiliation: Department of Statistical Science, University College London, London, UK.
authors.forename: Gareth
authors.initials: G
authors.lastname: Ambler
authors.affiliation: Department of Clinical Sciences Lund, Obstetrics and Gynecology, Skane University Hospital, Lund University, Lund, Sweden.
authors.forename: Jana
authors.initials: J
authors.lastname: Brodszki
authors.affiliation: Obstetrics and Fetal Medicine Unit, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Anke
authors.initials: A
authors.lastname: Diemert
authors.affiliation: BCNatal, Hospital Clinic and Hospital Sant Joan de Deu, University of Barcelona, CIBERER and IDIBAPS, Barcelona, Spain.
authors.forename: Francesc
authors.initials: F
authors.lastname: Figueras
authors.affiliation: BCNatal, Hospital Clinic and Hospital Sant Joan de Deu, University of Barcelona, CIBERER and IDIBAPS, Barcelona, Spain.
authors.forename: Eduard
authors.initials: E
authors.lastname: Gratacós
authors.affiliation: Department of Clinical Sciences Lund, Obstetrics and Gynecology, Skane University Hospital, Lund University, Lund, Sweden.
authors.forename: Stefan R
authors.initials: SR
authors.lastname: Hansson
authors.affiliation: Obstetrics and Fetal Medicine Unit, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Kurt
authors.initials: K
authors.lastname: Hecher
authors.affiliation: Neonatal Medicine, University College London Hospitals, London, UK.
authors.forename: Angela
authors.initials: A
authors.lastname: Huertas-Ceballos
authors.affiliation: Institute for Women's Health, University College London and NIHR University College London Hospitals Biomedical Research Centre, London, UK.
authors.forename: Neil
authors.initials: N
authors.lastname: Marlow
authors.affiliation: Department of Clinical Sciences Lund, Obstetrics and Gynecology, Skane University Hospital, Lund University, Lund, Sweden.
authors.forename: Karel
authors.initials: K
authors.lastname: Marsál
authors.affiliation: Department of Clinical Sciences Lund, Obstetrics and Gynecology, Skane University Hospital, Lund University, Lund, Sweden.
authors.forename: Eva
authors.initials: E
authors.lastname: Morsing
authors.affiliation: Institute for Women's Health, University College London and NIHR University College London Hospitals Biomedical Research Centre, London, UK.
authors.forename: Donald
authors.initials: D
authors.lastname: Peebles
authors.affiliation: Magnus Life Science, London, UK.
authors.forename: Carlo
authors.initials: C
authors.lastname: Rossi
authors.affiliation: Paediatric and Developmental Pathology, Great Ormond Street Hospital, London, UK.
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Sebire
authors.affiliation: Institute for Women's Health, University College London, London, UK.
authors.forename: John F
authors.initials: JF
authors.lastname: Timms
authors.affiliation: Institute for Women's Health, University College London and NIHR University College London Hospitals Biomedical Research Centre, London, UK.
authors.forename: Anna L
authors.initials: AL
authors.lastname: David
mesh_terms: D001783:Blood Flow Velocity; D002986:Clinical Trials as Topic; D015331:Cohort Studies; D005060:Europe; D005260:Female; D005317:Fetal Growth Retardation / Q000000981:diagnostic imaging* / Q000453:epidemiology / Q000503:physiopathology / Q000628:therapy; D005333:Fetus / Q000098:blood supply / Q000000981:diagnostic imaging*; D015316:Genetic Therapy; D006801:Humans; D020768:Middle Cerebral Artery / Q000000981:diagnostic imaging*; D065886:Neurodevelopmental Disorders / Q000453:epidemiology; D011247:Pregnancy; D011248:Pregnancy Complications / Q000453:epidemiology; D011262:Pregnancy Trimester, Second; D011446:Prospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D016216:Ultrasonography, Prenatal; D014469:Umbilical Arteries / Q000000981:diagnostic imaging*; D055988:Uterine Artery / Q000000981:diagnostic imaging*; D042461:Vascular Endothelial Growth Factor A
chemical_list: D042461:Vascular Endothelial Growth Factor A
keywords: Angiogenic; Doppler ultrasound; Fetal growth restriction; Outcome; Placental insufficiency; Prediction; Prospective cohort; Ultrasound biometry; Uteroplacental