DIVISION OF CARDIOVASCULAR MEDICINE
University of Oxford
Cardiovascular Clinical Research Facility
Level 1 Oxford Heart Centre, John Radcliffe Hospital, Oxford OX3 9DU
ANTENATAL Invitation Letter- Control
Effect of Prematurity and hypertensive disorders of
pregnancy on Offspring Cardiovascular Health (EPOCH)
Dear Parent
The University of Oxford Division of Cardiovascular Medicine and Departments of
Obstetrics and Paediatrics are doing a joint research project to understand the potential
long term effects of complications during pregnancy such as raised blood pressure and
premature birth on the health of infants. You and your baby are eligible to participate in this
study because you have NOT experienced high blood pressure or preeclampsia (high
blood pressure and protein in the urine) during this, or any other pregnancy and will deliver
your baby at term. We would like to offer you with some brief information about this study
to see if you might be interested in participating.
What is the EPOCH Study? The purpose of the EPOCH study is to find out whether
babies born to a mother who had complications during pregnancy, in particular raised blood
pressure and premature delivery have differences in how their heart and blood vessels look
and work immediately before and after they are born. You are being asked to participate
as a control – that is a patient who did not have these problems, so that we can establish
what happens to hearts and blood vessels in babies following a normal pregnancy.
Why is this being studied? Previous research suggests that children have slightly higher
blood pressure if their mothers had preeclampsia or they were born prematurely It is
possible that these babies have changes in the way their heart and blood vessels function
after birth and we want to investigate if this is the case. We are specifically looking at
changes in the first few days before and after birth because this is known to be a time of
rapid changes and development in the blood vessels of infants. We also want to find out
whether this process is different in infants after one of these complications. This knowledge
could help to develop ways to help prevent heart disease later in life in these children.
Do we have to participate? It is completely up to you whether or not you and your baby
want to participate.
What will happen if we do participate? Participating in our study involves having an extra
ultrasound scan of your baby’s heart before it is born (Visit 0) and then taking
measurements at birth (Visit 1) and when your baby is 3 months old (Visit 2).
Visit 1 will happen in the first few days after your baby is born whilst you are still in hospital.
For you it involves a blood test and a questionnaire asking questions about your
pregnancy and some lifestyle factors
Subject:
Short Title:
Principal Investigator:
AN Invitation Letter - Control
EPOCH
Version/Date:
1.0, Jan 2014
Ethics Ref:
11/SC/0006
Paul Leeson.
Page:
1 of 2
For your baby it involves taking special scans of the heart, blood vessels and arm,
taking blood pressure readings and measuring of their size and weight. An additional
blood sample will be taken at the same time (and by the same person) as blood
samples being taken as requested by your baby’s doctor – if your baby does not
need a blood test as part of their medical care they will NOT receive one as part of
this study.
We will also review you and your baby’s medical notes for detailed information about
the pregnancy, delivery and medical treatment your baby has received since birth.
Visit 2 will be when your baby is 3 months old, and involves exactly the same tests for you
and your baby – except that there will be NO further blood tests for your baby. All of the
scans on your baby’s heart and blood vessels are safe and non-invasive and have been
performed before on infants the same age as your baby.
Are there any benefits for me and my baby? There is no direct benefit for you or your
baby as individuals taking part in this study. We hope that this information may one day
help to identify babies who are at high risk of developing heart disease later in life and
subsequently develop ways to prevent or reduce the risk of heart disease in these infants.
What happens now? If you are interested in learning more about the study let one of the
medical team looking after you know and we will organise for you to meet one of the
researchers and receive some more detailed information on this study and what it would
involve for you and your baby.
Thank you for taking the time to read this.
Yours Sincerely
Professor Paul Leeson
Honorary Consultant Cardiologist,
Department of Cardiovascular Medicine
Clinical Cardiovascular Research Facility
University of Oxford
Dr Brenda Kelly
Consultant Obstetrician
Department of Obstetrics and
Gynaecology
John Radcliffe Hospital
Dr Kenny McCormick
Consultant Neonatologist
Department of Paediatrics
John Radcliffe Hospital
Subject:
Short Title:
Principal Investigator:
AN Invitation Letter - Control
EPOCH
Version/Date:
1.0, Jan 2014
Ethics Ref:
11/SC/0006
Paul Leeson.
Page:
2 of 2