EVERREST interview study: Fetal Growth Restriction
Research type
Research Study
Full title
Qualitative semi-structured interviews in four European countries with women/couples who have experienced a pregnancy affected by severe early-onset fetal growth restriction
IRAS ID
140510
Contact name
Anna David
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Research summary
The study aims to evaluate the attitudes, moral values and personal preferences of women/couples who have been affected by severe early-onset Fetal Growth Restriction (FGR) in a pregnancy in the past. FGR is a condition in pregnancy where the fetus fails to grow sufficiently, usually because of decreased blood supply to the uterus and placenta. If severe and early of onset, FGR has a significant risk of stillbirth or the birth of a very low birthweight baby. No effective treatment is currently available. Once severe early-onset FGR is identified in mid pregnancy, women/couples currently face a stark choice between delivering their baby very prematurely in the knowledge that they might die in the neonatal intensive care unit, or allowing the pregnancy to continue with the strong likelihood that the baby will die in the womb. The study also aims to evaluate the attitudes of these women/couples to a proposed EU wide trial investigating whether growth factor gene therapy improves the outcome in severe early-onset FGR. This growth factor gene therapy has the intended benefit of (a) avoiding miscarriage, stillbirth or medical/surgical termination of the pregnancy and (b) to improve babies’ chances of survival and reduce the burden of disease and disability after birth by increasing their growth rate during pregnancy, gestational age at birth and birthweight. It would be administered to pregnant women (rather than the fetus) who are affected by this serious condition. The treatment seeks to promote increased delivery of nutrients to the placenta by increasing uterine blood supply through the dilation and new formation of blood vessels . Research which has been carried out in animals has shown that this treatment may improve fetal growth.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/0030
Date of REC Opinion
7 Feb 2014
REC opinion
Further Information Favourable Opinion