EVERREST: Developing a therapy for Fetal Growth Restriction
Research type
Research Study
Full title
EVERREST: A 6 year prospective study to define the clinical and biological characteristics of pregnancies affected by severe early onset Fetal Growth Restriction
IRAS ID
129705
Contact name
Anna David
Contact email
Sponsor organisation
University College London
Research summary
Fetal Growth Restriction (FGR) is a major obstetric problem, affecting 1.46 million fetuses worldwide/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 combination of FGR and prematurity is associated with a significant risk of neonatal mortality and short and long-term complications. Even modest increases in birthweight (e.g from 500 to 600g) and gestation at delivery (e.g from 26 to 27 weeks) are associated with significantly better outcomes but there are currently no treatments.
The EVERREST Clinical Trial, funded by the EC, aims to develop a treatment which will increase fetal growth in severe early onset FGR. It will use gene therapy injected into the uterine arteries of the mother to increase the levels of vascular endothelial growth factor (VEGF) and so increase uterine artery blood flow and fetal growth.
The EVERREST prospective study (this application) aims to form a clinical database and biobank of pregnancies affected by severe early onset FGR to improve understanding of the condition and serve as a comparison to assess the safety and efficacy of this intervention.
The prospective study will take place across four European centers who will later take part in the EVERREST Clinical Trial. Women with singleton fetuses with early onset FGR will be approached to take part in the study. Participating women will provide blood samples, details of their clinical condition, samples of umbilical cord blood, placenta and myometrial and placental bed biopsies at the time of Caesarean section (if needed). Data on short and long-term outcomes of the babies will be collected. All data will be entered onto a central database for eventual use as a comparator for treated women on the EVERREST Clinical Trial, for which separate ethical approval will be sought.
REC name
London - Stanmore Research Ethics Committee
REC reference
13/LO/1254
Date of REC Opinion
17 Sep 2013
REC opinion
Favourable Opinion