The EVERREST Prospective Study

The EVERREST project is developing a potential treatment for fetal growth restriction, using maternal growth factor therapy.

This medicine has improved fetal growth in animals. It is not available for humans yet but we hope to begin testing the medicine in 2 years’ time. To make sure that this medicine is safe and effective we need to collect information from pregnancies where it is not given, to allow a comparison to be made. We will also collect samples, which will be tested for chemicals, proteins and genes which are linked to how babies grow. This will help us understand more about why severe early onset FGR happens. It may help us develop tests we can use in the future to predict who will be affected and what complications their babies are likely to have.

What Does the EVERREST Prospective Study Involve?

We are collecting detailed information about women and their babies during and after pregnancies complicated by severe early onset FGR. This includes neonatal outcome in the Neonatal Intensive Care Unit and long-term. It is part of our usual care to monitor these pregnancies with regular ultrasound scans and follow up babies who are discharged to see how they grow and develop. This means most of this information will be collected at routine appointments.

We are also collecting a biobank of samples, which will be used to help us understand more about severe early onset FGR.

We will take samples of the women’s blood when they join the study and before delivery of their babies. We will collect samples of the placenta, cord and cord blood at delivery. If the baby is delivered by Caesarean, samples will also be collected from the womb.

Who Can be Included in the EVERREST Prospective Study?

Inclusion Criteria:

Live singleton fetus
20+0 to 26+6 weeks
Estimated fetal weight < 3rd centile and less than 600g
Written informed consent

Exclusion Criteria:

Multiple pregnancy
Maternal age <18
Known abnormal karyotype or fetal structural abnormality at enrolment
Indication for immediate delivery
Maternal HIV or hepatitis B or C
Premature preterm rupture of membranes before enrolment
Women who lack the capacity to give informed consent or who medical or psychiatric condition means they cannot participate.

If you are not sure whether a woman is eligible for the study, or have any other questions, please contact us

EVERREST study protocol

Spencer R, Ambler G, Brodszki J, Diemert A, Figueras F, Gratacos E, Hansson SR, Hecher K, Huertas-Ceballos A, Marlow N, Marsal K, Morsing E, Peebles DM, Rossi C, Sebire NJ, Timms JF, David AL. 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 2017;17(1):43.

ClinicalTrials.gov ID: NCT02097667