EVERREST - Developing a Therapy for Fetal Growth Restriction. A 6 Year Prospective Study to Define the Clinical and Biological Characteristic of Pregnancies Affected by Severe Early Onset Fetal Growth Restriction.

Fetal Growth Restriction (FGR) is a major obstetric problem, affecting 1.46 million fetuses worldwide each year and contributing to 50% of stillbirths. Severe early onset FGR affects 1 in 500 pregnancies, leading to stillbirth or the need for delivery before 28 weeks gestation. The EVERREST prospective study plans to clinically and biochemically characterise a cohort of pregnancies affected by severe early onset FGR across the four European centres. A database will be created containing information about antenatal investigations, maternal complications, fetal outcome and neonatal progress. This will be linked to a biobank containing samples of maternal blood, umbilical cord, umbilical cord blood, placenta, placental bed and myometrium.

There are three aims to this study:

1. To provide data from pregnancies affected by severe early onset FGR with which to compare outcomes from a group of pregnancies that will undergo treatment using maternal Ad.VEGF gene therapy.
2. To provide important information about the likely prognosis for babies born after affected pregnancies in the short and long term. These are data which are currently lacking.
3. To provide samples that will be used to investigate the biological mechanisms that underlie the condition, which subsequently may be used to provide biomarkers of outcome.

The design of the project has involved consultation with leading European fetal medicine specialists, neonatologists, pathologists and biomedical scientists who form part of the EVERREST consortium. The multicenter nature of the project raises issues of confidentiality and data protection but also allows for a larger data set from which to draw more meaningful conclusions. Furthermore it means that the findings are applicable not just in the United Kingdom but also in Europe. It also provides a larger group of patients from which to recruit to the EVERREST trial. The project has also been given approval by the National Institute for Health Research, funded Fetal Medicine Clinical Study Group at the Royal College of Obstetrician and Gynecologists, of which the PI is a member. Other leading Fetal Medicine centres across the United Kingdom will be involved in recruiting to the prospective study so that a wider picture of severe FGR and samples from affected pregnancies are available in the UK.

Recruitment Women referred to the Fetal Medicine Unit for suspected severe early onset Fetal Growth Restriction will be given a Participant Information Sheet (PIS) to read. If the diagnosis of severe early onset FGR is made women will be asked if they are interested in taking part in the study. Interested eligible women will meet with a member of the research team who will read through the PIS with them and answer any questions they have. If the woman would like more time to decide they can meet with a member of the research team at a subsequent hospital appointment.