Spring 2015
WOMEN’S HEALTH RESEARCH NEWSLETTER
The Women's Health Research Team at UCLH are mainly funded by the North Thames Local Clinical Research
Network (LCRN) to work on a variety of National Institute for Health Research (NIHR) portfolio studies. We are
launching our Research Newsletter to keep the wider team up to date with past, present and future studies which
will be circulated quarterly. We’d like all eligible women to be offered the chance to take part in research.
Who is in the research team?
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Gina Buquis, Research nurse (NNU – 07921182597)
Rebecca Daley, Research Midwife & Co-ordinator (FMU ext. 76164 / GOSH 02078298653)
Samantha Edwards, Research Genetic Counsellor & Co-ordinator (FMU ext. 76164 / GOSH)
Sarah Eklodios, Research Nurse (EPU)
Frida Forya, Research Nurse (EPU / FMU ext. 76164)
Paula Lavandeira Fernandez, Research Midwife (FMU ext. 76164)
Chiara Messina, Research Midwife (Delivery Suite bleep 1202)
Jade Okell, Research nurse (NNU - 07969 348069)
Kerry Oxenford, Research Midwife (FMU ext. 76164)
What studies are running?
PHOENIX: Pre-eclampsia in Hospital - Early Induction or Expectant
Management
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: Women with pre-eclampsia between 34+0 and 36+6 weeks will be randomised to immediate delivery
(within 48 hours) or expectant management with delivery at 37 weeks (or earlier if indicated).
Please help by contacting Chiara, Paula or Kerry on 07903 949876 or ex 76164 if you are caring for a woman
with pre-eclampsia at 34+0 - 36+6.
OBS2: Obstetric Bleeding Study 2
Aim: To determine whether the early treatment of post-partum haemorrhage (PPH) with
Fibrinogen can reduce bleeding and the number of units required to be transfused.
Recruitment: Women can be recruited once the estimated blood loss after childbirth has
reached 1000mls.
Please help us by giving the information leaflet to women in your care during pregnancy or labour. The leaflet
can be found at each midwife station in every department. To find more, bleep Chiara on 1220.
RAPID: New Methods of Detecting Problems in Pregnancy
Aim: To develop earlier and safer ways of detecting genetic problems in pregnancy using
DNA from the baby found in the mother’s blood, such as Non-Invasive Prenatal Testing
(NIPT) for Down’s syndrome.
Recruitment: Any woman or couple attending the FMU for a CVS or amniocentesis is
approached to provide blood samples for the biobank, which allows comparison of these
new tests with those in current use. UCLH have recruited over 4000 women to RAPID.
PAGE: Prenatal Assessment of Genomes and Exomes
Aim: To improve the prenatal diagnosis of genetic causes of fetal structural abnormalities by evaluating the role of
more detailed analysis of fetal DNA (exome and genome sequencing)
Recruitment: Women undergoing CVS or amniocentesis will be approached to provide any excess sample from their
invasive test, both parents are asked to provide a blood sample to aid in the analysis and interpretation of the
sequencing results. Parents will be advised that no results will be available in the course of the pregnancy. However,
any results that might have clinical implications will be fed back via standard genetic pathways when available.
Amniotic Fluid, Placental and Fetal Stem Cells:
Aim: To find out whether we can grow stem cells from amniotic fluid, placental tissue and fetal fluid in the laboratory
to repair damaged tissues such as muscle and bone.
Recruitment: Women attending FMU for a CVS or amniocentesis are asked to provide any excess sample.
Does vascular endothelial growth factor gene therapy safely improve outcome in
severe early-onset fetal growth restriction (FGR)?
Aim: To collect a detailed database of information about what happens to mothers and babies affected by severe earlyonset 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.
Recruitment: Women with severe early onset FGR will be approached to provide samples of blood, placental tissue and
cord blood, and if the baby is delivered by Caesarean section, a small piece of tissue from the wall of the womb.
STRIDER: Sildenafil therapy for early-onset intrauterine fetal growth restriction (IUGR):
Aim: To see whether giving pregnant women sildenafil (Viagra) improves blood flow to the placenta. We believe that
improving the blood flow 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.
Recruitment: Women with severe IUGR before 30 weeks are randomised to take sildenafil or placebo. As a blind study,
the patient does not know if they are taking sildenafil or a placebo.
CLIMB:
Aim: To determine the relationship between cervical length, inflammation, infection, bacterial colonisation, and the
maternal and fetal inflammatory response that results in preterm birth. This study will help us identify women at risk of
preterm birth and to target interventions at women most likely to benefit and to reassure the remainder of women.
C-STICH: Cerclage suture type for insufficient cervix and its effect on health outcomes
Aim: To examine the effect of using monofilament suture material compared with braided suture
material on pregnancy loss rate in women with an insufficient cervix requiring cervical cerclage.
Recruitment: Women with an insufficient cervix requiring cervical cerclage will be randomised.
ASTEROID (phase 2 study)
Aim: To assess the effects and safety of vilaprisan medication in women with uterine fibroids compared to placebo.
Recruitment: Non-pregnant women with fibroids and heavy menstrual bleeding will be randomised. As a blind study,
patient does not know if they are taking vilaprisan or a placebo.
Prevention of Retinopathy of Prematurity (ROP)
Aim: To compare the severity of Retinopathy of Prematurity (ROP) in premature infants given Mecasermin Rinfabate
(rhIGF-1/rhIGFBP-3) medication versus standard neonatal care with no administration of study drug.
Recruitment: Participants will be recruited prior to delivery and will be randomised in the first 24hrs of birth.
PDP: Preterm Development Project
Aims: 1) How do brain structure and connections in preterm babies differ from those of
full term babies at the same age? 2) Do measures of brain structure, growth and
developmental function relate to developmental attainment at 2 years and at school age?
Recruitment: Participants will have a MRI scan of the head at around 32 weeks and at full term. They will also be
followed up at the Neuro-development clinic from 3 months old up to 2 years old.
If you want to know more
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Protocols and participant information sheets are available on the EGAMaternity shared drive in the
“research protocols” folder.
Visit www.uclh.nhs.uk/researchgateway
Or just ask one of us as we’d love for everyone to get involved.
What next?
The next issue of the research newsletter will be circulated in August. We would love your
input! If you have something you would like to include or if you have a burning question
relating to research or one of the studies we’ve introduced above please don’t hesitate to
let us know.
We look forward to hearing from you!
Samantha.Edwards5@nhs.net or Paula.Lavandeira-Fernandez@nhs.net