EudraCT Number: 2013-005398-32
Project ID number: LWH 0980/ UoL 000984
Patient Information Sheet (Mother)
Version: 4.1 September 2014
Date: 11/09/2014
STRIDER: Sildenafil therapy for early-onset intrauterine fetal growth
restriction (IUGR)
Your doctor will have talked to you about your baby and the signs that he or she is not growing as well as
expected. You may feel concerned by this news but we want to reassure you that your healthcare team will
ensure that you and your baby get the care you need throughout the rest of your pregnancy.
As a result of your baby’s diagnosis of severe intrauterine fetal growth restriction (IUGR), we are asking you
to think about taking part in a research study called STRIDER (sildenafil therapy for early-onset intrauterine
fetal growth restriction). Before you decide whether or not to take part, it is important that we tell you why
the research is being done and what it will involve. Please read and, if you want to, discuss the following
information with other people. We realise that this is a difficult time for you, and that you have lots to think
about. One of our team will go through the information with you and answer any questions you have.
The decision to join or not join the study is entirely yours – be reassured that the care provided for you,
your baby and your family will not be affected by your decision. The only differences will be that you will be
asked to take some medication that this study is looking at, and some extra blood tests and blood pressure
monitoring will be done. These are described below.
Why the study is being carried out
Babies with IUGR start growing normally in the womb (uterus), but then their growth slows down. As you
have already been informed your baby’s growth has been severely reduced(severe IUGR), which can have
a number of possible complications, which include the need to deliver the baby early, and health problems
during childhood. In some cases the baby can be too small to survive. This may occur before birth (stillbirth)
or shortly after birth.
STRIDER Patient Information Sheet
Version: 4.1
11/09/2014
EudraCT Number: 2013-005398-32
Project ID number: LWH 0980/ UoL 000984
At the moment, once we know a baby has IUGR, we carefully monitor him or her with ultrasound and heart
rate tracings (using cardiotocography or CTG). Together with you as the parents, we plan the baby’s
delivery for a time when the benefits of being born outweigh the risks of a longer pregnancy.
The aim of this study is to see whether giving pregnant women a medication called sildenafil (better known
as Viagra) improves the flow of blood to the placenta. As the placenta supplies blood and nutrients to the
developing baby, we believe that improving the blood flow might help overcome some of the problems
causing poor growth. We want to see whether this means we can delay delivering the baby so he or she has
more time in the womb, which is usually the best place for the baby to develop.
For this study, we are asking pregnant women whose babies have been found to have severe IUGR before
30 weeks of pregnancy to take part. Some of the women in the study will be given sildenafil and some will
be given a tablet containing no active medication, called a placebo. We will then compare what happens in
each group of women to get a true picture of the effect of the sildenafil. The rest of the care that women
and their babies get will be the same, so the only difference will be whether or not the woman has taken
sildenafil.
Currently available evidence
Studies in animals have shown that sildenafil can increase the blood flow through the blood vessels of the
womb and placenta. Several studies in small numbers of pregnant women have suggested that this could
help with the baby’s’ growth. However, at this stage it is not possible to say for certain whether sildenafil
treatment will allow us to delay birth and improve health of babies’ long term.
Taking part
It is up to you to decide whether or not to take part. If you do decide to take part, keep this information
sheet as you may want to read it again. You will also need to sign a consent form. You will be able to stop
taking part in the study at any time, and you don’t need to give a reason. If you do not feel able to take part
it won’t in any way affect the care you or your family receives.
If you take part
If you agree to take part in the STRIDER study , you will be given medication to take (by mouth) three times
a day, from the time you start the study until you reach 32 weeks of pregnancy or the baby is born. You
won’t know whether you are taking sildenafil or the placebo, and neither will your doctor or pharmacist.
STRIDER Patient Information Sheet
Version: 4.1
11/09/2014
EudraCT Number: 2013-005398-32
Project ID number: LWH 0980/ UoL 000984
In addition to your regular ultrasound scans you will have extra blood tests and more detailed monitoring
of your blood pressure. This will be carried out by your hospital doctors or research midwives. Detailed
blood pressure monitoring will involve placing a Velcro cuff on your arm. In some hospitals as part of the
study extra monitoring of your heart will be carried out. If you are asked to take part, this heart monitoring
is a painless, non-invasive procedure where 4 stickers are placed on the skin of your chest to record the
signal from your heart – very similar to routine ECG heart monitoring done in GP practices.
The research team will try to complete these tests during your stay in hospital or during your regular
hospital appointments, if you are monitored from home. Appointments may take a little longer than
normal to complete.
We will collect your placenta after the baby is born to study in the laboratory; the placenta is no longer
required by the baby and is normally disposed of after birth. If you want to keep the placenta, we will not
collect it. We may also take some blood from the part of your baby’s cord still attached to the placenta but
only after the cord has been cut, so we will not take any blood samples directly from your baby.
The STRIDER study is a UK based research study, but is also part of a larger international study of sildenafil.
Whilst the UK study is large enough to answer the question of whether sildenafil is beneficial in treating
babies with IUGR, by combining the data from this study with the other international studies we will be
able to get a much clearer picture of its effectiveness. We will share anonymous data from your pregnancy
with our international colleagues to achieve this.
At present we haven’t got funding for long term follow-up of mothers and babies who have taken part in
this study to confirm that they remain healthy. Our aim is to organize this in future and we would,
therefore, wish to stay in touch with you and baby after birth. This would allow us to ask you for a separate
permission to participate in any such follow-up study.
Confidentiality
We will follow the guidelines for studies such as STRIDER to make sure what we are doing is legal and
ethical (that is, morally right). All the information we collect about you and your pregnancy will be handled
in confidence.. All samples and data will be stored securely. If any results provide information that means
the care of you or your baby should change, we will inform your medical doctor.
STRIDER Patient Information Sheet
Version: 4.1
11/09/2014
EudraCT Number: 2013-005398-32
Project ID number: LWH 0980/ UoL 000984
A copy of your completed consent form will be sent to the Liverpool Clinical Trials Unit to allow them to
check you have agreed to the trial. This will be kept in a secure location away from all the study data.
Data collected during the study may be transferred for the purpose of collection analysis/registration
within or outside the European Economic Area. Any information you give us will only be used by the
international STRIDER research team.
We will take all reasonable steps to protect your privacy and any confidential information (such as your
name & address) will be removed before being shared.
After the study and the combined data analysis any further use of the data by researchers will be
conducted only after ethical approval has been given.
Involvement of the General Practitioner/Family Doctor (GP)
With your consent, your GP will be informed of your involvement in the trial. Any other medical
practitioners who treat you e.g. should you be admitted to hospital for any reason, will also be informed.
Possible benefits
We hope that the results of the study overall will show us whether sildenafil helps pregnancies affected by
severe IUGR. If our results show it does, we will be able to use this knowledge to improve the care for
affected women and their babies. It is possible that sildenafil may not work in the way we intended. This is
also very important so we can focus our future efforts on other possible treatments, but they will be tested
in the same way we are testing sildenafil. We will make sure your doctor is informed of any progress in
developing new treatments that could be available to you in future pregnancies.
Possible disadvantages and risks
Blood sampling will be carried out by someone who is skilled in taking blood. You may have some bruising
at the site of blood collection, but this will go after a few days.
The studies of sildenafil in animals, large numbers of non-pregnant adults and small numbers of pregnant
women and unborn babies have not shown harmful effects. Like all medicines, it is not possible to say that
sildenafil is 100% safe, but based on what is known it is unlikely that the use of sildenafil in pregnancy will
harm you or your baby.
STRIDER Patient Information Sheet
Version: 4.1
11/09/2014
EudraCT Number: 2013-005398-32
Project ID number: LWH 0980/ UoL 000984
We know that people receiving sildenafil can have some short lasting side effects like headache, flushing,
blurred vision and indigestion. Sildenafil can cross the placenta and babies may be at risk of side effects. At
present we do not know whether these side effects are relevant to a fetus or how they compare to any
discomfort experienced by a baby with IUGR. Sildenafil has been used in pregnant women and premature
babies previously but none of these side effects have been reported in babies. The long-term
consequences, positive or negative, of exposure to sildenafil before birth are not known. This is why we
plan to follow the babies after they are born.
We will stop the trial medication at 32 weeks and babies will not be given trial medication after birth. We
do not know the effect of stopping sildenafil that has been given to a fetus, but we will monitor all
pregnancies that continue beyond 32 weeks and examine carefully any babies born before 32 weeks.
Talk to a member of our team if you have any concerns. The STRIDER trial has been designed to have robust
and continuous independent review of safety during and after treatment to monitor for any unexpected
side-effects.
If you or your baby is harmed by taking part in this research project, there are no special compensation
arrangements. If you are harmed and this is due to someone’s negligence, then you may have grounds for
a legal action for compensation against the NHS Trust where you are being treated, but you may have to
pay for your legal costs. The normal National Health Service complaints mechanisms will be available to you
(if appropriate).
In the event of a defective product then you may have grounds for a legal action for compensation against
the manufacturer, but you may have to pay for your own legal costs.
Leaving the study
You are free to withdraw at any time, without giving a reason; just inform a member of our team of your
decision, this will not affect your care. If you do choose to leave the study, we will not use the results from
your blood tests or monitoring in the study and we will destroy all your samples that were collected for the
study. No further information on how your pregnancy progressed will be collected for the study.
What will happen to any samples I give?
Placenta &/or blood samples will be collected specifically for this study. The samples will be coded and no
personal data (name or address) will be stored with the sample. The tests on the blood will be carried out
STRIDER Patient Information Sheet
Version: 4.1
11/09/2014
EudraCT Number: 2013-005398-32
Project ID number: LWH 0980/ UoL 000984
in laboratories in the UK and abroad. As a result, your samples will be transferred out of the UK. All samples
will be initially processed and stored in the hospital where you’re being cared for, in accordance with the
Human Tissue Act. We will also ask whether you would be willing to donate (or ‘gift’) the samples taken for
this study to be used for other ethically approved research studies into pregnancy problems. Blood and
placental tissue may be used in a number of research projects and/or for research related to the
development of pharmaceutical products, diagnostics or medical aids by other scientists and research
organisations within and outside the European Economic Area, in universities, the NHS or commercial
companies involved in medical research worldwide which may also involve discussions with regulatory
authorities
The results of this study
The results from this project will be published as research papers in respected medical journals. No data
will be published that will allow women or their babies to be identified. We will also provide the results on
the STRIDER website (www.stridertrial.co.uk) which you will be able to access if you wish further
information.
Further information and support
The patient information sheet is not available in web format, please use the contact details below to
request a patient information sheet.
Please contact Mr Lawrence Impey on 01865 851165 or the Research Midwives on 01865 572258 to discuss
any questions or worries about the study, or if you have any complaints. If your concerns are not resolved,
please contact the Patient Advice Liaison Service (PALS) on 01865 741166 or contact The Research &
Development Dept. Research Governance Office on 01865 572224.
The STRIDER study is funded by a National Institute of Health Research ‘Efficacy and Mechanism Evaluation’
grant. This research is being organised by the Department of Women’s and Children’s Health at the
University of Liverpool. It is being led by:

Professor Zarko Alfirevic, who is Professor in Fetal& Maternal Medicine at University of
Liverpool/Liverpool Women's Hospital

Dr Andrew Sharp, who is Clinical Lecturer at the University of Liverpool/Liverpool Women’s
Hospital
STRIDER Patient Information Sheet
Version: 4.1
11/09/2014
EudraCT Number: 2013-005398-32
Project ID number: LWH 0980/ UoL 000984
Who has reviewed the study?
All research involving people is looked at by an independent group of people, called a Research Ethics
Committee, to protect the interests of the people taking part. This study has been reviewed and given
favourable opinion by NRES Committee North East – Newcastle and North Tyneside 2. REC No: should be
inserted here.
Thank you for taking the time to read and consider this information sheet. Should you decide to take part in
the study, you will be given a copy of the information sheet and a signed consent form to keep.
STRIDER Patient Information Sheet
Version: 4.1
11/09/2014