2 Katherine Twining Network

Zahra has worked as a midwifeand midwifery supervisor since1988 in Iran, where she gainedher BSc and MSc in midwifery.

She has worked in all aspects ofmidwifery both within the deliverysuite and the community. She is

currently working within the antenatal clinic at RoyalLondon Hospital. Zahra identifies and recruits patientsto the ESTEEM trial in addition to her clinical work.

What has been your experience recruiting patients toclinical trials?My experience has been very positive. Often women will come to their booking appointment having read theinformation leaflets provided. Women are often verykeen to participate in research or not at all. In myexperience, those women who are keen and not eligibleto be recruited to ESTEEM, often ask if there are anyother studies that they can participate in.

How did you find the addition of recruiting to trialswithin the routine clinical work you undertake?We have 1 hour and 20 minutes to complete thebooking appointment. This includes completing all the relevant paper work and making any appropriatereferrals. Explaining about ESTEEM usually takes 10-15minutes. However occasionally when they attend late itdoes add some time pressure. Recruiting is quickerwhen the eligible women have received the informationleaflet and have the background information.

Do you feel research is important to your clinicalpractice?I have a background in research and so I feel verypassionate about it. I think that research is important in improving long term health and participating inresearch is very rewarding. Research is also necessaryto develop new guidelines and update our clinicalpractice.

What drives you to participate in research? I believe all clinicians should promote research as it improves the care we give to women.

It should be everyones responsibility to promoteresearch actively. In my experience ESTEEM has beenreally positively received by the community, which isvery encouraging.

Interviews with Zahra Ahmadian-Moghadam and Florence Ojetunde

Katherine Twining Network 3

Our VisionThe Katherine Twining Research Network aimsto bring together doctors, nurses, midwivesand researchers working towards improvementin Womens Health in East London andbeyond.

The Network is well positioned to reach out to one of the most diverse and vibrantcommunities. Working with collaboratorsaround the world, the Network endeavors

to facilitate multi-disciplinary studies inreproductive health. Our unique expertise in education and research provides an idealenvironment to promote clinical research andto nurture the next generation of researchers.

Power of the NetworkThere has been a dramatic increase in thenumber of women recruited to trials acrosshospitals within the Network since conception.

About the Katherine Twining Network

Florence has been working as a midwife at Newham sinceSeptember 2008. She began her career as a registered nursebefore becoming a midwife.

Florence currently works withinthe antenatal clinic, undertaking

the booking visits and identifies women who can berecruited to the ESTEEM trial.

What has been your experience recruiting patients toclinical trials?Recruiting patients to clinical trials has been a fantasticexperience and a real eye opener. Recruiting to trialscan be challenging, as often women need to have theconsent form explained and what happens if they wishto 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 isparticularly the case when dealing with high-riskpatients and explaining all the necessary clinical detailsto them in addition to providing the details andconsenting them for ESTEEM. However, if women have received the information leaflets in their bookingappointment invitation letter often the process isstraightforward.

Do you feel research is important to your clinicalpractice?Research is very important to clinical practice. We asmidwives are the first point of contact and therefore it is our duty to promote research awareness within thecommunity. The population we serve often are notaware of measures that can be taken to improve theirhealth and the health of their baby. It is our duty toinform them.

What drives you to participate in research? Including women in clinical trials is a great opportunityto help them to improve their health. By participating inresearch these womens lives and health are improved.I believe that all research is important in midwifery andwider afield. It is our job to promote research withinmedicine.

Every individual within the NHS should be taking part in research.

The Katherine Twining Research Network,established in 2011 facilitates multidisciplinaryresearch in reproductive health and childbirth and the development and delivery of womenshealth services.

Success in research can only be achieved by the direct involvement ofthe team providing everyday clinical care and through collaborative work.

Professor Shakila Thangaratinam, Maternal and Perinatal Health, QMUL

Katherine Twining Network 54 Katherine Twining Network

Completed Portfolio

MedalMRI to Establish Diagnosis Against LaparoscopyNumber of patients: 250 womenNumber of sites: 6 centres Funder: NIHR HTAKT Sites: The Royal London (Miss Elizabeth Ball),Whipps Cross (Mr Funlayo Odejinmi), Newham(Mr Antonios Antoniou), Homerton (Miss SandraWatson), Southend (Mr Winston Justin).Grant award: 1,325,199.71 NIHR Funding

PrepPrediction of Risk of complication in early onset Pre-eclampsiaNumber of patients: 936 womenNo of sites: 53 centres Funder: NIHR HTAKT Sites: The Royal London (Mr Rehan Khan),Whipps Cross (Mr Manish Gupta), Newham (Mr Vincent Oon), Southend (Mr RaajkumarSundararajah), Queens Romford (Miss CeliaBurrell), North Middlesex (Miss Zeudi RamseyMarcelle), West Middlesex (Miss Louise Page),The Royal Free (Miss Rezan Kadir).Grant award: 847,249 NIHR Funding

SalvoCell salvage during caesarean sectionNumber of patients: 3050 womenNo of sites: 22 centres Funder: NIHR HTAKT Sites: The Royal London (Matthew Hogg),Whipps Cross (Sajith Philip), Romford (Vinod Patil).Grant award: 1.8 million NIHR funding

EmpireAntiepileptic Drug Monitoring in PregnancyNumber of patients: 564 womenNo of sites: 51 centresFunder: NIHR HTAKT 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

EsteemEffect of simple, targeted diet in pregnant womenwith metabolic risk factors on pre-eclampsia.Number of patients: 3640 womenNo of sites: 3 centresFunder: 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

New Study to Commence

PreProProbiotics in the prevention of preterm birth pilot randomised trial (PrePro) is a Barts Charityfunded feasibility trial to determine the biologicaleffects of probiotics on the vaginal flora andexamine the components that will be essential to the success of a double-blind, placebo-controlled randomised trial (RCT) on the effectsof oral probiotics administered daily from earlypregnancy on the risk of pre-term birth.

Target No. of participants: 366Number of sites: 4 centresDuration: 18 months

Portfolio Studies led by the Katherine Twining Network

The Katherine Twining Network continues tosupport and actively recruits to the followingportfolio studies.

RAPID: New Methods of Detecting Problems in pregnancyReliable Accurate Prenatal non-InvasiveDiagnosis (RAPID) an integrated project torefine and implement safer antenatal testing for single gene disorders.

PAGE: Prenatal Assessment of Genomes and Exomes projectTo establish the reliability of genome andexome sequencing for screening of fetalgenetic conditions and chromosomalabnormalities in amniotic fluid and chorionicvilli for use as an efficient rapid singlediagnostic test now, and to apply to free fetalDNA once extraction techniques are refined.

NIPD: Non Invasive Prenatal Diagnosis of Sickle Cell Disease or ThalassaemiaThis study is looking at developing a maternalblood test, which will give thehaemaglobinopathy status of the fetus.Currently any woman wishing to know theSickle or thalassaemia status of their unbornbaby would need to undergo invasive testing.

FEMME: A randomised trial of treating Fibroidswith either Embolisation or Myomectomy, toMeasure the Effect on quality of life, amongwomen wishing to avoid hysterectomy.Study to assess the benefits of eithermyomectomy or uterine artery embolisation on the quality of life of women withsymptomatic fibroids.

TABLET: Thyriod AntiBodies and LEvoThyroxine TrialTo assess the efficacy and mechanism ofthyroxine treatment on pregnancy and neonataloutcomes in women with thyroid antibodies. It is a randomised, placebo-controlled, double-blind, multi-centre trial.

DAPPA: Diagnostic Accuracy in Pre-eclampsiausing Proteinuria AssessmentTo evaluate the accuracy of spot proteinuria in comparison to twenty four hour proteinuriain women with suspected pre-eclampsia.

HABSELECT: Hyaluronic Acid Binding Sperm SelectionTo determine the efficacy of hyaluronan-selected IntraCytoplasmic Sperm Injection(PICSI) versus PVP ICSI.

Portfolio Studies Supported byKatherine Twining Network

Katherine Twining Network 76 Katherine Twining Network

ASPRECombined multi-marker screening andrandomised patient treatment with aspirin forevidence-based pre-eclampsia prevention.

To examine if the prophylactic use of low-doseaspirin from the first trimester of pregnancy inwomen at increased risk for PET can reducethe incidence and severity of the disease.

StAmPA proof of principle, double-blind, randomised,placebo-controlled, multi centre trial ofpravaStatin to ameliorate early onset pre-eclampsia.

To establish whether pravastatin causes asignificant reduction of circulating anti-angiogenic factors in women with early-onsetpre-eclampsia.

EMR200061-005: Phase III Pergoveris in ARTTo demonstrate superiority of Pergoverisversus GONAL-f in POR (poor ovarianresponse) patients defined according to thecriteria set forth by the ESHRE (EuropeanSociety of Human Reproduction andEmbryology).

CCRN 955 Uterine FibroidsA prospective muliticentre, non-interventionalstudy of women treated with Esmya as pre-operative treatment of moderate to severesymptoms of uterine fibroids..

35/39 Trial: Induction of labour versusexpectant management for women over 35 yrsThe primary aim of this randomised controlledtrial is to test the null hypothesis that a policy of induction of labour at 39 weeks gestation forwomen over the age of 35 years reducescaesarean section rates.

Investigating the prevalence of thyroidantibodiesA prospective observational study investigatingthe prevalence of thyroid antibodies in womenof reproductive age.

SAFEThe objectives and work of SAFEthe SpecialNon-invasive Advances in Fetal and NeonatalEvaluation network, a European UnionFramework VI network of excellence isdescribed. We demonstrate how this networkfacilitates the implementation of non-invasiveprenatal diagnosis (NIPD) for single genedisorders, fetal rhesus typing, aneuploidy and pregnancy complications.

South Asian Womens Access to Pregnancy ServicesTo investigate uptake of antenatal care andother pregnancy related services by SouthAsian women living in the East London boroughof Newham (UK), Oslo (Norway) and SouthAsia.

NIPT for Aneuploidy Evaluation StudyThe goal of this study is to evaluate variousaspects of delivering NIPT for aneuploidywithin the NHS. The evaluation will look atfactors such as uptake of Down's syndromescreening and NIPT, affect on numbers ofinvasive tests and other laboratory issues.

Life StudyThis pioneering study that will track the growth,development, health, wellbeing and socialcircumstances of over 80,000 UK babies asthey grow up. It will create a powerful resourcethat will transform our ability to shape researchand policies aimed at giving children in the UKthe best possible start in life.

The Mens Safer Sex (MenSS) TrialA protocol for a pilot randomised controlled trialof an interactive digital intervention to increasecondom use in men.

Pre-term Cord Clamping TrialImmediate cord clamping versus deferred cordclamping for preterm birth before 32 weeksgestation: a pilot randomised trial.

CCRN 2850 Multifollicular DevelopmentA phase III, randomized, controlled, single-blind, multicentre, parallel arm trial to assessthe efficacy and safety of Pergoveris(follitropin alfa and lutropin alfa) and GONAL-f (follitropin alfa) for multifolliculardevelopment as part of an assistedreproductive technology treatment cycle in poor ovarian responders.

Start at the beginningThis is a pilot randomised control trial to assessthe feasibility and efficacy of a web-basededucation tool in improving nutritional andlifestyle behaviours in women planning apregnancy.

The Immunological basis of preterm deliveryThe immunological basis for increased PretermDelivery in HIV-1 infected pregnant women andthe influence of different classes ofantiretroviral therapy.

Portfolio Studies Supported byKatherine Twining Network


A list of studies by site that are currently conducting research

Katherine Twining Network Studies: Year 2014/2015

Site Title of Study Participants

Royal London CCRN 955 Uterine Fibroids 35EMPiRE AntiEpileptic drug Monitoring in PREgnancy 3PREP Prediction of Risks in Early Onset Pre-eclampsia 3Induction of labour versus expectant management for women over 35 yrs 3ESTEEM Effect of simple, targeted diet in pregnant women with metabolic risk factors on pre-eclampsia 528Investigating the prevalence of thyroid antibodies 97SALVO Cell salvage during caesarean section 44SAFE Special non-invasive Advances in Foetal and neonatal Evaluation 34DAPPA Diagnostic Accuracy in Pre-eclampsia using Proteinuria Assessment 26TABLET Thyriod AntiBodies and LEvoThyroxine Trial 1

Barts Investigating the prevalence of thyroid antibodies 310HABSelect Hyaluronic Acid Binding Sperm Selection 196TABLET Thyriod AntiBodies and LEvoThyroxine Trial 20

Whipps Cross Induction of labour versus expectant management for women over 35 yrs 7EMPiRE AntiEpileptic drug Monitoring in PREgnancy 1ESTEEM Effect of simple, targeted diet in pregnant women with metabolic risk factors on pre-eclampsia. 169Investigating the prevalence of thyroid antibodies 121DAPPA Diagnostic Accuracy in Pre-eclampsia using Proteinuria Assessment 20SALVO Cell salvage during caesarean section 19TABLET Thyriod AntiBodies and LEvoThyroxine Trial 9

Newham South Asian Womens Access to Pregnancy Services 9EMPiRE AntiEpileptic drug Monitoring in PREgnancy 1PREP Prediction of Risks in Early Onset Pre-eclampsia 1ESTEEM Effect of simple, targeted diet in pregnant women with metabolic risk factors on pre-eclampsia 216Investigating the prevalence of thyroid antibodies 74TABLET Thyriod AntiBodies and LEvoThyroxine Trial 4

Queens NIPT for Aneuploidy Evaluation Study 6332EMPiRE AntiEpileptic drug Monitoring in PREgnancy 6PREP Prediction of Risks in Early Onset Pre-eclampsia 6FEMME 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 4Life 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 183SALVO Cell salvage during caesarean section 11SAFE Special non-invasive Advances in Foetal and neonatal Evaluation 7

Homerton The Mens Safer Sex (MenSS) Trial: a website to increase condom use 82Pre-term Cord Clamping Trial 16CCRN 2850 Multifollicular development 5HABSelect Hyaluronic Acid Binding Sperm Selection 112Start at the beginning 55SAFE Special non-invasive Advances in Foetal and neonatal Evaluation 14The immunological basis of preterm delivery 7ASPRE Combined Multi-Marker Screening and Randomised Patient Treatment with Aspirin for Evidence-based Pre-eclampsia Prevention 0

North Middlesex EMPiRE AntiEpileptic drug Monitoring in PREgnancy 2SAFE Special non-invasive Advances in Foetal and neonatal Evaluation 31ASPRE Combined Multi-Marker Screening and Randomised Patient Treatment with Aspirin for Evidence-based Pre-eclampsia Prevention 0

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 0

Southend PREP Prediction of Risks in Early Onset Pre-eclampsia 1

Research Delivery Manager: Dawn Beaumont-Jewell

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

Clinical Research NetworkThe NIHR Clinical Research Network: North Thameswww.crn.nihr.ac.uk/north-thames

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

Currently within the Katherine Twining Network, there are 11 studies open and recruiting. In the14/15 financial year, uploaded recruitment data to date is showing that the Katherine TwiningNetwork has recruited 8,825 participants. As the total number of recruits to the ReproductiveHealth 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 IndiaThe KT Twining between India and UK aims to promote shared learning on maternal andneonatal health issues both in East London and India. This collaborative research will bemutually beneficial to both countries. It aims to increase the awareness about public healthissues and maternal death rates. It will alsoenable us to share and show how obstetrics and midwifery practice works in both countries,particularly in hospitals, co-located units, andstandalone birth centres in rural India. The firstexchange is anticipated in November 2015 inHyderabad at the Fernandez Hospital and ruralsetting. A multidisciplinary team will beconducting the first session of Train the Trainer training.


Since the launch of ELLY in March 2014 wehave been working hard and planning for theupcoming year, which will bring with it someexciting projects.

Preparations for the MOMS (emergencyobstetrics skills) course in Bangalore andSyhlet provinces are underway. These will runin collaboration with Chelsea and WestminstersBorne charity with the aim of improving themanagement of obstetric emergencies in theseareas. We also now have a research fellowworking with ELLY. Dr Soha Sobhy has apassion for global maternal health and iscurrently undertaking evidence synthesis workon maternal morbidity looking at its prediction,prevention and management. This in in thehope that this can affect change and improveoutcomes globally.

Locally the work continues with regular skillstraining for our midwives and doctors. This yearwe aim to concentrate on local projects in EastLondon. With the intention of seeking excitingprojects involving womens health in EastLondon we will be hosting a Dragons Den typeevent. So put your thinking caps on and watchthis space for the event date. Our fundraisingwork is ongoing and we couldnt achieveanything without your support. Overall we haveraised 24,778.21 for ELLY and we lookforward to raising much more this year. Lookout for this and other fundraising events.

www.ellyappeal.org.uk

Elly Update

The unwarranted variation in reporting of trial outcomes can result in difficulties in synthesising evidence to generate recommendations for clinical practice whichultimately 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 healthjournals to promote core outcome sets in allareas of our specialty.

Encourage researchers to develop coreoutcome sets using robust consensusmethodology involving multiple stakeholders,including patients.

Strongly encourage the reporting of results for core outcome sets.

Organise robust peer-review and effectivedissemination of manuscripts describing core outcome sets.

Facilitate embedding of core outcome sets in research practice, working closely withresearchers, reviewers, funders, andguideline makers.

Although checklists exist for the reporting ofclinical trials, core outcome sets (COS) differbecause they are a disease-specific agreed setof outcomes that are established as a reportingstandard minimum for all relevant clinical trials.For example, COS for medical treatment ofmenorrhagia might include, number of daystaken off work, haemoglobin level and use ofsanitary protection but a COS for trialsassessing the effectiveness of cervical suturesfor preventing late miscarriage and pretermbirth would be likely to include gestational ageat delivery and rates of chorioamnionitis.

Core outcomes from the Katherine TwiningNetworkThe Womens Health Research Unit at QueenMary University is actively involved in thedevelopment of core outcome sets forobstetrics and gynaecology. Professor KhalidKhan along with the CROWN initiative andGOnet (Global Obstetrics Network) havedeveloped a COS for pre-term birth. There are a number of COS under development,including the management of epilepsy duringpregnancy, treatments for endometriosis andfor the management of heavy menstrualbleeding. We hope to secure funding soonwhich will allow us to develop COS for thesurgical management of gynaecologicalcancers and pre-malignant conditions.

Ultimately, we hope to become an internationalcentre for the development of core outcomesfor womens health and to be able to offersupport to other researchers and clinicianshoping to improve study reporting bydeveloping COS.

How can trainees get involved?Trainees working in the Katherine Twiningnetwork hospitals may be asked to identifypatients to take part in core outcomeworkshops and might be asked to participate in Delphi surveys. COS are going to becomeincreasingly important in future research workand it is important that trainees understandhow they will be used. For more informationabout COS and CROWN please visit theCROWN website www.crown-initiative.org


Dr Julie Dodds Role of a SeniorClinical Trials ManagerIn conjunction with the UnitDirectors, I am responsible forshaping and executing thestrategic direction of the Unit. I

oversee the operational procedures within theunit and make the day to day unit managementdecisions. My day varies from linemanagement of Unit staff, reviewing trialdocumentation, participating in trialmanagement meetings to ensure the smoothrunning of the projects, submission of fundingapplications, setting-up new trials, managingthe trial budgets and liaising with internal andexternal bodies. I work closely with BartsHealth Trust (namely the research staffrecruiting to trials) and our Joint Research andManagement Office at QMUL (who deal withbudgets, contracts and sponsorship).

I have also conducted a systematic review forthe Unit and I am involved in writing academicpapers for publication and reports to ourfunders. I thoroughly enjoy the challenges thatmy job brings. I am excited about the newprojects we have coming on board and thepotential we have to positively impact the livesof mothers and babies. The team are allworking towards a common vision, whichmakes the Unit an inspiring place to work


Katherine Twining Network Team:

Katherine Twining NetworkWomens Health Research UnitCentre for Primary Care and Public HealthBlizard InstituteBarts and The London Schoolof Medicine and DentistryYvonne Carter Building58 Turner StreetLondon E1 2ABTel:+44 (0)20 7882 2525Fax:+44 (0)20 7882 6047email: [email protected]

Professor Khalid KhanWomen's Health and Clinical Epidemiology

Professor Shakila ThangaratinamMaternal and Perinatal Health

Dr Julie DoddsSenior Clinical Trials Manager

Tracy HolthamAdministrator

Mr Richard HowardChair KT Network Annual Meeting 2015Consultant Obstetrician and Gynaecologist

katherine twining network - newsletter spring 2015

Documents

clinical research andto

katherine twining networkzahra

thenumber of women

eligible women

experience esteem

network endeavors

health services

clinical midwives