Katherine Twining Network

Newsletter Spring 2015

Tracy Holtham & Maria DAmico 2015

The Katherine Twining Research

Network, established in 2011
facilitates multidisciplinary research
in reproductive health and childbirth
and the development and delivery of
women's health services.

Inside:
2

Katherine Twining Our Vision

Interviews with Clinical Midwives

Portfolio studies led and

supported by the Network

Clinical Research Network

10 Crown Initiative
11 Elly update
12 Contact details

About the Katherine Twining Network

The Katherine Twining Research Network,
established in 2011 facilitates multidisciplinary
research in reproductive health and childbirth
and the development and delivery of womens
health services.
Our Vision
The Katherine Twining Research Network aims
to bring together doctors, nurses, midwives
and researchers working towards improvement
in Womens Health in East London and
beyond.

to facilitate multi-disciplinary studies in

reproductive health. Our unique expertise
in education and research provides an ideal
environment to promote clinical research and
to nurture the next generation of researchers.

The Network is well positioned to reach out

to one of the most diverse and vibrant
communities. Working with collaborators
around the world, the Network endeavors

Power of the Network

There has been a dramatic increase in the
number of women recruited to trials across
hospitals within the Network since conception.

Interviews with Zahra AhmadianMoghadam and Florence Ojetunde

Zahra has worked as a midwife
and midwifery supervisor since
1988 in Iran, where she gained
her BSc and MSc in midwifery.
She has worked in all aspects of
midwifery both within the delivery
suite and the community. She is
currently working within the antenatal clinic at Royal
London Hospital. Zahra identifies and recruits patients
to the ESTEEM trial in addition to her clinical work.
What has been your experience recruiting patients to
clinical trials?
My experience has been very positive. Often women
will come to their booking appointment having read the
information leaflets provided. Women are often very
keen to participate in research or not at all. In my
experience, those women who are keen and not eligible
to be recruited to ESTEEM, often ask if there are any
other studies that they can participate in.
How did you find the addition of recruiting to trials
within the routine clinical work you undertake?
We have 1 hour and 20 minutes to complete the
booking appointment. This includes completing all
the relevant paper work and making any appropriate
referrals. Explaining about ESTEEM usually takes 10-15
minutes. However occasionally when they attend late it
does add some time pressure. Recruiting is quicker
when the eligible women have received the information
leaflet and have the background information.
Do you feel research is important to your clinical
practice?
I have a background in research and so I feel very
passionate about it. I think that research is important
in improving long term health and participating in
research is very rewarding. Research is also necessary
to develop new guidelines and update our clinical
practice.

Success in research can only be achieved by the direct involvement of

the team providing everyday clinical care and through collaborative work.

What drives you to participate in research?

I believe all clinicians should promote research
as it improves the care we give to women.

Professor Shakila Thangaratinam, Maternal and Perinatal Health, QMUL

It should be everyones responsibility to promote

research actively. In my experience ESTEEM has been
really positively received by the community, which is
very encouraging.

2 Katherine Twining Network

Florence has been working as

a midwife at Newham since
September 2008. She began
her career as a registered nurse
before becoming a midwife.
Florence currently works within
the antenatal clinic, undertaking
the booking visits and identifies women who can be
recruited to the ESTEEM trial.
What has been your experience recruiting patients to
clinical trials?
Recruiting patients to clinical trials has been a fantastic
experience and a real eye opener. Recruiting to trials
can be challenging, as often women need to have the
consent form explained and what happens if they wish
to leave the trial at any point.
How did you find the addition of recruiting to trials
within the routine clinical work you undertake?
It can be difficult to strike the right balance. This is
particularly the case when dealing with high-risk
patients and explaining all the necessary clinical details
to them in addition to providing the details and
consenting them for ESTEEM. However, if women
have received the information leaflets in their booking
appointment invitation letter often the process is
straightforward.
Do you feel research is important to your clinical
practice?
Research is very important to clinical practice. We as
midwives are the first point of contact and therefore it
is our duty to promote research awareness within the
community. The population we serve often are not
aware of measures that can be taken to improve their
health and the health of their baby. It is our duty to
inform them.
What drives you to participate in research?
Including women in clinical trials is a great opportunity
to help them to improve their health. By participating in
research these womens lives and health are improved.
I believe that all research is important in midwifery and
wider afield. It is our job to promote research within
medicine.
Every individual within the NHS should be taking part
in research.
Katherine Twining Network 3

Portfolio Studies led by the

Katherine Twining Network

Portfolio Studies Supported by

Katherine Twining Network

Completed Portfolio

The Katherine Twining Network continues to

support and actively recruits to the following
portfolio studies.

Medal
MRI to Establish Diagnosis Against Laparoscopy
Number of patients: 250 women
Number of sites: 6 centres
Funder: NIHR HTA
KT Sites: The Royal London (Miss Elizabeth Ball),
Whipps Cross (Mr Funlayo Odejinmi), Newham
(Mr Antonios Antoniou), Homerton (Miss Sandra
Watson), Southend (Mr Winston Justin).
Grant award: 1,325,199.71 NIHR Funding

Prep
Prediction of Risk of complication in early
onset Pre-eclampsia
Number of patients: 936 women
No of sites: 53 centres
Funder: NIHR HTA
KT Sites: The Royal London (Mr Rehan Khan),
Whipps Cross (Mr Manish Gupta), Newham
(Mr Vincent Oon), Southend (Mr Raajkumar
Sundararajah), Queens Romford (Miss Celia
Burrell), North Middlesex (Miss Zeudi Ramsey
Marcelle), West Middlesex (Miss Louise Page),
The Royal Free (Miss Rezan Kadir).
Grant award: 847,249 NIHR Funding

Salvo
Cell salvage during caesarean section
Number of patients: 3050 women
No of sites: 22 centres
Funder: NIHR HTA
KT Sites: The Royal London (Matthew Hogg),
Whipps Cross (Sajith Philip), Romford
(Vinod Patil).
Grant award: 1.8 million NIHR funding

4 Katherine Twining Network

Empire
Antiepileptic Drug Monitoring in Pregnancy
Number of patients: 564 women
No of sites: 51 centres
Funder: NIHR HTA
KT Sites: The Royal London (Dr Rehan Khan),
Whipps Cross (Dr Sujatha Thamban), Newham
(Dr A Shah), Romford (Dr Leye Thompson).
Grant award: 1.8 million NIHR Funding

RAPID: New Methods of Detecting Problems

in pregnancy
Reliable Accurate Prenatal non-Invasive
Diagnosis (RAPID) an integrated project to
refine and implement safer antenatal testing
for single gene disorders.

Esteem
Effect of simple, targeted diet in pregnant women
with metabolic risk factors on pre-eclampsia.
Number of patients: 3640 women
No of sites: 3 centres
Funder: NIHR HTA
KT Sites: The Royal London (Dr Rehan Khan),
Whipps Cross (Dr Manish Gupta), Newham
(Mr Vincent Oon).
Grant award: 498,898 Barts Charity

PAGE: Prenatal Assessment of Genomes

and Exomes project
To establish the reliability of genome and
exome sequencing for screening of fetal
genetic conditions and chromosomal
abnormalities in amniotic fluid and chorionic
villi for use as an efficient rapid single
diagnostic test now, and to apply to free fetal
DNA once extraction techniques are refined.

New Study to Commence

NIPD: Non Invasive Prenatal Diagnosis

of Sickle Cell Disease or Thalassaemia
This study is looking at developing a maternal
blood test, which will give the
haemaglobinopathy status of the fetus.
Currently any woman wishing to know the
Sickle or thalassaemia status of their unborn
baby would need to undergo invasive testing.

PrePro
Probiotics in the prevention of preterm birth
pilot randomised trial (PrePro) is a Barts Charity
funded feasibility trial to determine the biological
effects of probiotics on the vaginal flora and
examine the components that will be essential
to the success of a double-blind, placebocontrolled randomised trial (RCT) on the effects
of oral probiotics administered daily from early
pregnancy on the risk of pre-term birth.

FEMME: A randomised trial of treating Fibroids

with either Embolisation or Myomectomy, to
Measure the Effect on quality of life, among
women wishing to avoid hysterectomy.
Study to assess the benefits of either
myomectomy or uterine artery embolisation
on the quality of life of women with
symptomatic fibroids.
TABLET: Thyriod AntiBodies
and LEvoThyroxine Trial
To assess the efficacy and mechanism of
thyroxine treatment on pregnancy and neonatal
outcomes in women with thyroid antibodies.
It is a randomised, placebo-controlled,
double-blind, multi-centre trial.
DAPPA: Diagnostic Accuracy in Pre-eclampsia
using Proteinuria Assessment
To evaluate the accuracy of spot proteinuria
in comparison to twenty four hour proteinuria
in women with suspected pre-eclampsia.
HABSELECT: Hyaluronic Acid Binding
Sperm Selection
To determine the efficacy of hyaluronanselected IntraCytoplasmic Sperm Injection
(PICSI) versus PVP ICSI.

Target No. of participants: 366

Number of sites: 4 centres
Duration: 18 months

Katherine Twining Network 5

Portfolio Studies Supported by

Katherine Twining Network
ASPRE
Combined multi-marker screening and
randomised patient treatment with aspirin for
evidence-based pre-eclampsia prevention.
To examine if the prophylactic use of low-dose
aspirin from the first trimester of pregnancy in
women at increased risk for PET can reduce
the incidence and severity of the disease.
StAmP
A proof of principle, double-blind, randomised,
placebo-controlled, multi centre trial of
pravaStatin to ameliorate early onset preeclampsia.
To establish whether pravastatin causes a
significant reduction of circulating antiangiogenic factors in women with early-onset
pre-eclampsia.
EMR200061-005: Phase III Pergoveris in ART
To demonstrate superiority of Pergoveris
versus GONAL-f in POR (poor ovarian
response) patients defined according to the
criteria set forth by the ESHRE (European
Society of Human Reproduction and
Embryology).

6 Katherine Twining Network

CCRN 955 Uterine Fibroids

A prospective muliticentre, non-interventional
study of women treated with Esmya as preoperative treatment of moderate to severe
symptoms of uterine fibroids..
35/39 Trial: Induction of labour versus
expectant management for women over 35 yrs
The primary aim of this randomised controlled
trial is to test the null hypothesis that a policy
of induction of labour at 39 weeks gestation for
women over the age of 35 years reduces
caesarean section rates.
Investigating the prevalence of thyroid
antibodies
A prospective observational study investigating
the prevalence of thyroid antibodies in women
of reproductive age.
SAFE
The objectives and work of SAFEthe Special
Non-invasive Advances in Fetal and Neonatal
Evaluation network, a European Union
Framework VI network of excellence is
described. We demonstrate how this network
facilitates the implementation of non-invasive
prenatal diagnosis (NIPD) for single gene
disorders, fetal rhesus typing, aneuploidy
and pregnancy complications.

South Asian Womens Access

to Pregnancy Services
To investigate uptake of antenatal care and
other pregnancy related services by South
Asian women living in the East London borough
of Newham (UK), Oslo (Norway) and South
Asia.
NIPT for Aneuploidy Evaluation Study
The goal of this study is to evaluate various
aspects of delivering NIPT for aneuploidy
within the NHS. The evaluation will look at
factors such as uptake of Down's syndrome
screening and NIPT, affect on numbers of
invasive tests and other laboratory issues.
Life Study
This pioneering study that will track the growth,
development, health, wellbeing and social
circumstances of over 80,000 UK babies as
they grow up. It will create a powerful resource
that will transform our ability to shape research
and policies aimed at giving children in the UK
the best possible start in life.
The Mens Safer Sex (MenSS) Trial
A protocol for a pilot randomised controlled trial
of an interactive digital intervention to increase
condom use in men.

Pre-term Cord Clamping Trial

Immediate cord clamping versus deferred cord
clamping for preterm birth before 32 weeks
gestation: a pilot randomised trial.
CCRN 2850 Multifollicular Development
A phase III, randomized, controlled, singleblind, multicentre, parallel arm trial to assess
the efficacy and safety of Pergoveris
(follitropin alfa and lutropin alfa) and GONALf (follitropin alfa) for multifollicular
development as part of an assisted
reproductive technology treatment cycle
in poor ovarian responders.
Start at the beginning
This is a pilot randomised control trial to assess
the feasibility and efficacy of a web-based
education tool in improving nutritional and
lifestyle behaviours in women planning a
pregnancy.
The Immunological basis of preterm delivery
The immunological basis for increased Preterm
Delivery in HIV-1 infected pregnant women and
the influence of different classes of
antiretroviral therapy.

Katherine Twining Network 7

Katherine Twining Network Studies: Year 2014/2015

Clinical Research Network

A list of studies by site that are currently conducting research

Title of Study
CCRN 955 Uterine Fibroids
EMPiRE AntiEpileptic drug Monitoring in PREgnancy
PREP Prediction of Risks in Early Onset Pre-eclampsia
Induction of labour versus expectant management for women over 35 yrs
ESTEEM Effect of simple, targeted diet in pregnant women with metabolic
risk factors on pre-eclampsia
Investigating the prevalence of thyroid antibodies
SALVO Cell salvage during caesarean section
SAFE Special non-invasive Advances in Foetal and neonatal Evaluation
DAPPA Diagnostic Accuracy in Pre-eclampsia using Proteinuria Assessment
TABLET Thyriod AntiBodies and LEvoThyroxine Trial

528
97
44
34
26
1

Research Delivery Manager:

Investigating the prevalence of thyroid antibodies

HABSelect Hyaluronic Acid Binding Sperm Selection
TABLET Thyriod AntiBodies and LEvoThyroxine Trial

310
196
20

Divisional Clinical Lead:

Dr William vant Hoff (Great Ormond Street)

Deputy Research Delivery Manager:

Heidi Chandler

Portfolio Officer for Reproductive Health & Childbirth:

Alison Anstead

Administrative Assistant:

Syvella Kirwan

Local Speciality Lead:

Dr Simona Cicero

Barts

Whipps Cross

Newham

Queens

Induction of labour versus expectant management for women over 35 yrs

EMPiRE AntiEpileptic drug Monitoring in PREgnancy
ESTEEM Effect of simple, targeted diet in pregnant women with metabolic
risk factors on pre-eclampsia.
Investigating the prevalence of thyroid antibodies
DAPPA Diagnostic Accuracy in Pre-eclampsia using Proteinuria Assessment
SALVO Cell salvage during caesarean section
TABLET Thyriod AntiBodies and LEvoThyroxine Trial
South Asian Womens Access to Pregnancy Services
EMPiRE AntiEpileptic drug Monitoring in PREgnancy
PREP Prediction of Risks in Early Onset Pre-eclampsia
ESTEEM Effect of simple, targeted diet in pregnant women with metabolic
risk factors on pre-eclampsia
Investigating the prevalence of thyroid antibodies
TABLET Thyriod AntiBodies and LEvoThyroxine Trial

Participants

The NIHR Clinical Research Network: North Thames

www.crn.nihr.ac.uk/north-thames

Site
Royal London

35
3
3
3

7
1
169
121
20
19
9
9
1
1
216
74
4

NIPT for Aneuploidy Evaluation Study

EMPiRE AntiEpileptic drug Monitoring in PREgnancy
PREP Prediction of Risks in Early Onset Pre-eclampsia
FEMME A randomised trial of treating Fibroids with either Embolisation or Myomectomy,
to Measure the Effect on quality of life, among women wishing to avoid hysterectomy
Life Study This is a pilot randomised control trial to assess the feasibility and efficacy
of a web-based education tool in improving nutritional and lifestyle behaviours in women
planning a pregnancy
SALVO Cell salvage during caesarean section
SAFE Special non-invasive Advances in Foetal and neonatal Evaluation

6332
6
6

The Mens Safer Sex (MenSS) Trial: a website to increase condom use
Pre-term Cord Clamping Trial
CCRN 2850 Multifollicular development
HABSelect Hyaluronic Acid Binding Sperm Selection
Start at the beginning
SAFE Special non-invasive Advances in Foetal and neonatal Evaluation
The immunological basis of preterm delivery
ASPRE Combined Multi-Marker Screening and Randomised Patient Treatment
with Aspirin for Evidence-based Pre-eclampsia Prevention

82
16
5
112
55
14
7

North Middlesex EMPiRE AntiEpileptic drug Monitoring in PREgnancy

SAFE Special non-invasive Advances in Foetal and neonatal Evaluation
ASPRE Combined Multi-Marker Screening and Randomised Patient Treatment
with Aspirin for Evidence-based Pre-eclampsia Prevention

2
31

Homerton

183
11
7

Royal Free

FEMME A randomised trial of treating Fibroids with either Embolisation or Myomectomy,

to Measure the Effect on quality of life, among women wishing to avoid hysterectomy

Southend

PREP Prediction of Risks in Early Onset Pre-eclampsia

8 Katherine Twining Network

CRN: North Thames is hosted by Barts Health NHS Trust covers the geography of North Central
London, Essex and Hertfordshire (a population of 5.7m; 10% of the NHS) and over 10% of the NIHR
portfolio is lead from CRN. Trusts within the Katherine Twining Network are therefore covered by
CRN: North Thames and the research which takes place is looked after by the team in Division 3.
Dawn Beaumont-Jewell

Currently within the Katherine Twining Network, there are 11 studies open and recruiting. In the
14/15 financial year, uploaded recruitment data to date is showing that the Katherine Twining
Network has recruited 8,825 participants. As the total number of recruits to the Reproductive
Health and Child Birth specialty for the whole of North Thames is about 14, 824 participants,
this represents a contribution of almost 60% well done!
We thank you for all your hard work and hope that this support continues!

Katherine Twining India

The KT Twining between India and UK aims
to promote shared learning on maternal and
neonatal health issues both in East London
and India. This collaborative research will be
mutually beneficial to both countries. It aims
to increase the awareness about public health
issues and maternal death rates. It will also
enable us to share and show how obstetrics
and midwifery practice works in both countries,
particularly in hospitals, co-located units, and
standalone birth centres in rural India. The first
exchange is anticipated in November 2015 in
Hyderabad at the Fernandez Hospital and rural
setting. A multidisciplinary team will be
conducting the first session of Train the
Trainer training.

Katherine Twining Network 9

Elly Update
The unwarranted variation in reporting of trial outcomes can result in difficulties
in synthesising evidence to generate recommendations for clinical practice which
ultimately is detrimental to the health of women and their babies. The Core Outcomes
in Womens health (CROWN) initiative is an international initiative, led by journal editors,
to address this problem by harmonising outcome reporting in womens health research.
Aims of the Core Outcomes in Womens Health
(CROWN) Initiative
Form a consortium among all womens health
journals to promote core outcome sets in all
areas of our specialty.
Encourage researchers to develop core
outcome sets using robust consensus
methodology involving multiple stakeholders,
including patients.
Strongly encourage the reporting of results
for core outcome sets.
Organise robust peer-review and effective
dissemination of manuscripts describing
core outcome sets.
Facilitate embedding of core outcome sets
in research practice, working closely with
researchers, reviewers, funders, and
guideline makers.
Although checklists exist for the reporting of
clinical trials, core outcome sets (COS) differ
because they are a disease-specific agreed set
of outcomes that are established as a reporting
standard minimum for all relevant clinical trials.
For example, COS for medical treatment of
menorrhagia might include, number of days
taken off work, haemoglobin level and use of
sanitary protection but a COS for trials
assessing the effectiveness of cervical sutures
for preventing late miscarriage and preterm
birth would be likely to include gestational age
at delivery and rates of chorioamnionitis.

10 Katherine Twining Network

Core outcomes from the Katherine Twining

Network
The Womens Health Research Unit at Queen
Mary University is actively involved in the
development of core outcome sets for
obstetrics and gynaecology. Professor Khalid
Khan along with the CROWN initiative and
GOnet (Global Obstetrics Network) have
developed a COS for pre-term birth. There
are a number of COS under development,
including the management of epilepsy during
pregnancy, treatments for endometriosis and
for the management of heavy menstrual
bleeding. We hope to secure funding soon
which will allow us to develop COS for the
surgical management of gynaecological
cancers and pre-malignant conditions.
Ultimately, we hope to become an international
centre for the development of core outcomes
for womens health and to be able to offer
support to other researchers and clinicians
hoping to improve study reporting by
developing COS.
How can trainees get involved?
Trainees working in the Katherine Twining
network hospitals may be asked to identify
patients to take part in core outcome
workshops and might be asked to participate
in Delphi surveys. COS are going to become
increasingly important in future research work
and it is important that trainees understand
how they will be used. For more information
about COS and CROWN please visit the
CROWN website www.crown-initiative.org

Since the launch of ELLY in March 2014 we

have been working hard and planning for the
upcoming year, which will bring with it some
exciting projects.
Preparations for the MOMS (emergency
obstetrics skills) course in Bangalore and
Syhlet provinces are underway. These will run
in collaboration with Chelsea and Westminsters
Borne charity with the aim of improving the
management of obstetric emergencies in these
areas. We also now have a research fellow
working with ELLY. Dr Soha Sobhy has a
passion for global maternal health and is
currently undertaking evidence synthesis work
on maternal morbidity looking at its prediction,
prevention and management. This in in the
hope that this can affect change and improve
outcomes globally.
Locally the work continues with regular skills
training for our midwives and doctors. This year
we aim to concentrate on local projects in East
London. With the intention of seeking exciting
projects involving womens health in East
London we will be hosting a Dragons Den type
event. So put your thinking caps on and watch
this space for the event date. Our fundraising
work is ongoing and we couldnt achieve
anything without your support. Overall we have
raised 24,778.21 for ELLY and we look
forward to raising much more this year. Look
out for this and other fundraising events.

www.ellyappeal.org.uk

Dr Julie Dodds Role of a Senior

Clinical Trials Manager
In conjunction with the Unit
Directors, I am responsible for
shaping and executing the
strategic direction of the Unit. I
oversee the operational procedures within the
unit and make the day to day unit management
decisions. My day varies from line
management of Unit staff, reviewing trial
documentation, participating in trial
management meetings to ensure the smooth
running of the projects, submission of funding
applications, setting-up new trials, managing
the trial budgets and liaising with internal and
external bodies. I work closely with Barts
Health Trust (namely the research staff
recruiting to trials) and our Joint Research and
Management Office at QMUL (who deal with
budgets, contracts and sponsorship).
I have also conducted a systematic review for
the Unit and I am involved in writing academic
papers for publication and reports to our
funders. I thoroughly enjoy the challenges that
my job brings. I am excited about the new
projects we have coming on board and the
potential we have to positively impact the lives
of mothers and babies. The team are all
working towards a common vision, which
makes the Unit an inspiring place to work
Katherine Twining Network 11

Katherine Twining Network Team:

Professor Khalid Khan
Women's Health and Clinical Epidemiology
Professor Shakila Thangaratinam
Maternal and Perinatal Health
Dr Julie Dodds
Senior Clinical Trials Manager
Tracy Holtham
Administrator
Mr Richard Howard
Chair KT Network Annual Meeting 2015
Consultant Obstetrician and Gynaecologist

Katherine Twining Network

Womens Health Research Unit
Centre for Primary Care and Public Health
Blizard Institute
Barts and The London Schoolof Medicine and Dentistry
Yvonne Carter Building
58 Turner Street
London E1 2AB
Tel:+44 (0)20 7882 2525
Fax:+44 (0)20 7882 6047
email: ktnetwork@qmul.ac.uk