Women’s Health Research Newsletter
Winter 2016
Obstetric Studies
update
Good Clinical Practice
(GCP) training

PI: Anna David
PI: Seni Subair
Aim: To collect a detailed database
of information about what happens
to mothers and babies affected by
severe early-onset FGR. This will
help us understand more about why
severe early onset FGR happens
and may help us to develop tests we
can use in the future to predict who
will be affected and what
complications babies are likely to
have.
Aim: To determine whether delivery
in women with pre-eclampsia
between 34+0 and 36+6 weeks
reduces complications compared
with the expectant management.
Recruitment: Forty women have
been recruited at UCLH.
Help us: If you are caring for a
woman on labour ward with an
EVERREST sticker on their notes,
please alert the research team as
we need to take cord and placental
samples at delivery.
For more information: Visit
http://everrest-fp7.eu/
Recruitment: Seven women have
been recruited at UCLH
Help us: The target recruitment has
just been increased to two women a
month. With help from clinical staff
to identify potential participants this
should be achievable. So please
continue to alert one of the research
midwives if you are caring for a
woman with preeclampsia.
For more information: Visit
https://www.npeu.ox.ac.uk/phoenix
STOPPIT2
PI: George Attilakos
STRIDER
PI: Anna David
Aim: To see whether giving
pregnant women sildenafil (Viagra)
improves blood flow to the placenta,
which might help overcome some of
the problems causing poor growth,
potentially delaying delivery so the
baby has more time in the womb,
which is usually the best place for
the baby to develop. Women with
severe IUGR before 30 weeks are
randomised to take sildenafil or
placebo.
Recruitment: One woman has been
recruited at UCLH.
Help us: If you are caring for a
woman on labour ward recruited to
STRIDER, please alert the research
team as we need to take cord and
placental samples at delivery.
Aim: To determine whether an
Arabin cervical pessary prevents
preterm birth in women with a twin
pregnancy.
Recruitment: Fifteen women have
been recruited at UCLH (12 to the
screening phase and 3 to the
randomisation phase).
Pessary information for clinical
staff:
 Heavy discharge is normal with
the pessary and is not a reason
for removal.
 A speculum can be performed
with the pessary in situ.
 The research team will arrange
for the pessary to be removed at
35 – 36 weeks gestation.
 If admitted with SROM or
contracting a doctor should
remove the pessary.
For more information: Visit
https://w3.abdn.ac.uk/hsru/STOPPIT
2/
Everyone involved in the conduct of
clinical research must have training
to ensure they are best prepared to
carry out their duties. This is laid
down in the Research Governance
Framework for Health and Social
Care 2005, covering all research in
the NHS in Englan, and in law for
those people working on clinical
trials.
To recruit to research studies you
must complete the online GCP
training course every two years. We
are encouraging all doctors to
complete this training so you can
assist the research midwives and
nurses recruiting to studies that
require a doctor to countersign the
consent form.
When you have completed the
online training or if you have a
current certificate please bring it,
along with your CV, to the research
midwives based in Fetal Medicine.
We can then update the site files
and get your signature on the study
delegation logs. This will help to
ensure that we are able to recruit all
eligible women to our studies.
GCP training is free and open to
anyone to complete. To get access
to the online training please see the
link below:
http://www.crn.nihr.ac.uk/learningdevelopment/good-clinical-practice/
New Studies Opening

Gynaecology Studies update
PRISM
C-STICH
PI: Anna David
PI: Davor Jurkovic
Aim: To examine the effect of using a monofilament
suture material compared with a braided suture material
on pregnancy loss rate and neonatal mortality up to one
month post-delivery in women presenting with
insufficient cervix and treated with cervical cerclage.
Aim: To determine whether progesterone is effective to
prevent miscarriage in women who present with
bleeding in early pregnancy.
Recruitment: We aim to recruit 30 women over the next
19 months in the preterm birth clinic.
For more information: Visit
http://www.birmingham.ac.uk/research/activity/mds/trials
/bctu/trials/womens/C-Stich/about.aspx
PI: Anna David
Aim: To make fetal surgery a safe and accessible
option to clinics and surgeons around the world,
allowing more babies to benefit from improved longterm outcomes.
Recruitment: We aim to recruit 400 women having
fetal MRI over the next 5 years.
For more information: Visit
http://www.gift-surg.ac.uk/
Progesterone is currently used sporadically in
threatened miscarriages, by clinicians, but its efficacy is
not known due to the lack of robust evidence to support
its use.
We are recruiting women who are between 4 and 12
weeks pregnant who present with bleeding, and have an
intrauterine gestation sac on ultrasound. These women
are then randomised to progesterone vaginal pessaries
or placebo, which they will take daily until 16 weeks
gestation
Recruitment: We are recruiting women who are
between 4 and 12 weeks pregnant who present with
bleeding, and have an intrauterine gestation sac on
ultrasound. These women are then randomised to
progesterone vaginal pessaries or placebo, which they
will take daily until 16 weeks gestation
So far, we have randomised 84 women and our aim is to
recruit a total of 250 women.
Help us: If you are caring for a women taking part in
PRISM please ensure they are taking their medication
and if there are any problems please inform the research
team.
For more information: Visit
http://www.medscinet.net/prism/
The Baby Biome Study
PI: Pat O’Brien
Aim: The Baby Biome Study aims to find out how
microbes, the immune system and clinical factors during
pregnancy, birth, and throughout childhood work
together to influence health in later life. To do this we’re
collecting samples from mothers and their babies at
birth (stool and vaginal swabs from mums, stool from
babies, and cord blood). Using these samples, together
with clinical information and record linkage, we will be
able to find out whether, for example, antibiotics or
mode of delivery might affect colonisation of the gut,
how microbes and/or infection at birth might affect the
immune system, and determine whether a child goes on
to develop allergies like asthma and eczema, or
autoimmune diseases, amongst other outcomes.
Recruitment: We are planning to start recruitment for
this study in mid-March.
For more information: Visit
https://twitter.com/babybiomestudy
PRE-EMPT
PI: Dimitri Mavrelos
Aim: This study is for a large randomised controlled
clinical trial in which women undergoing surgery for
endometriosis will be randomly allocated to take long
acting progesterones, either as three monthly injections
or as a contraceptive coil versus the combined oral
contraceptive pill.
This trial will provide information on which treatment is
the most effective in terms of symptom relief.
Recruitment:
Our recruitment target is 20 and we have currently
recruited 14 women to this trial.
For more information: Visit
http://www.birmingham.ac.uk/research/activity/mds/trials
/bctu/trials/womens/pre-empt/index.aspx
The Women’s Health Research Team
If you would like more information about any of our studies or would like your research featured in the winter
newsletter please contact us:
Obstetric studies: ext. 76164 or 07903 949 876
All studies: UCLH.researchmidwives@nhs.net
Gynaecology studies: ext. 71302