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

BMC Pregnancy and Childbirth

Study Protocol

Eduard Gratacós¹  Francesc Figueras¹  Karel Marsál²  Jana Brodszki²  Stefan R. Hansson²  Eva Morsing²  Gareth Ambler³  Neil Marlow⁴  Anna L. David⁴  Donald Peebles⁴  John F. Timms⁵  Rebecca Spencer⁶  Carlo Rossi⁷  Angela Huertas-Ceballos⁸  Kurt Hecher⁹  Anke Diemert⁹  Neil J. Sebire^1,10 

[1] BCNatal, Hospital Clinic and Hospital Sant Joan de Deu, University of Barcelona, CIBERER and IDIBAPS, Barcelona, Spain;Department of Clinical Sciences Lund, Obstetrics and Gynecology, Skane University Hospital, Lund University, Lund, Sweden;Department of Statistical Science, University College London, London, UK;Institute for Women’s Health, University College London and NIHR University College London Hospitals Biomedical Research Centre, London, UK;Institute for Women’s Health, University College London, London, UK;Institute for Women’s Health, University College London, London, UK;Institute for Women’s Health, University College London and NIHR University College London Hospitals Biomedical Research Centre, London, UK;Magnus Life Science, London, UK;Neonatal Medicine, University College London Hospitals, London, UK;Obstetrics and Fetal Medicine Unit, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany;Paediatric and Developmental Pathology, Great Ormond Street Hospital, London, UK;

关键词: Fetal growth restriction;    Prospective cohort;    Ultrasound biometry;    Doppler ultrasound;    Angiogenic;    Prediction;    Outcome;    Uteroplacental;    Placental insufficiency;   

DOI  :  10.1186/s12884-017-1226-7

 received in 2016-07-06, accepted in 2017-01-14,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundFetal 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.MethodsThis 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.DiscussionThe 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.Trial registrationNCT02097667 registered 31st October 2013.

【 授权许可】

CC BY   
© The Author(s). 2017