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Principal Investigator – Current Trials
TRUFFLE 2
Optimal Monitoring
The TRUFFLE group aims to address the question of the optimal monitoring and thresholds for delivery in late-onset fetal growth restriction, from 32-36 weeks gestation. To date no intervention other than delivery has been reported to have an impact on late onset fetal growth restriction.
However, increasing the prevalence of even late-preterm birth by intervening in pregnancies thought to be at risk is associated with increased morbidity for the woman (from Caesarean section, induction of labour) and her baby (increased risk of poor condition at birth and the consequences of neonatal admissions), through to even small but significant increases in the risk of special needs at school.
Feasibility Study
A preliminary feasibility study (TRUFFLE 2 Feasibility Study: audit of current practice) is needed to identify suitable neonatal outcomes for a trial on which a trial size calculation can be based. These outcomes would be evaluated in a randomised management trial (TRUFFLE 2 RCT).
Hence the aim of this study is to perform a prospective observational audit of practice and feasibility study (TRUFFLE 2 Feasibility Study) to identify predictors of perinatal outcome in a comprehensive third trimester ultrasound monitoring strategy that will inform the design of a formal trial (TRUFFLE 2 RCT). This feasibility study is the largest of its type, started in 2017 and is likely to complete in early/mid 2018.
Cohesive Partnership
The TRUFFLE 2 group remains a cohesive partnership of leading UK, European and Scandinavian perinatal centres where there are excellent fetal medicine, obstetric and neonatal services. This group now numbers over 30. Its members are committed to und
UNiCoRN
MRC Funded
UNiCoRN is an MRC funded prospective cohort study of pregnant women of white and south Asian descent (n=750), being led by KCL with collaborators at the University of Leicester, due to start recruiting in October 2022.
Different Types of GDM
Despite the one-size-fits-all approach to management and risk assessment, evidence is emerging together with our clinical experience, that GDM is a heterogeneous group of disorders, all leading to hyperglycaemia, which might lead to different outcomes (e.g. different risk of adverse outcomes in pregnancy or after pregnancy) and may benefit from stratified treatments. UNiCoRN aims to unpick different types of GDM, particularly focusing on insulin resistance and insulin secretory dysfunction subtypes and will explore whether these differ by ethnicity.
Cohesive Partnership
We will be collecting information about each pregnancy, diet and exercise, glucose measures (including continuous glucose monitoring), and timed blood samples during a five-point oral glucose tolerance test, and other biological samples such as urine. We aim to work towards tailored treatment of each woman (regardless of ethnicity) according to their subtype of GDM, and hope that this will also facilitate ways to best prevent Type 2 diabetes after pregnancy.
Current Research
Principal Investigator for PReCePT
Metabolic Adaptation
During pregnancy, a woman’s body adapts with changes in blood pressure, heart function and protein production. Abnormal cardiovascular and/or metabolic adaptation to pregnancy may be linked to the development of pregnancy complications such as preeclampsia and/or growth restricted babies.
Once diagnosed with preeclampsia and/or growth restriction in baby, there usually comes a point of clinical decompensation in mum and or baby, prompting urgent delivery of the baby.
PRECEPT study
For the PRECEPT study, we aim to recruit approximately 160 women, 100 of whom will have healthy ongoing pregnancies. The remaining 60 will be categorized based on preeclampsia (PE), fetal growth restriction (FGR) or both and further subdivided into 4 gestation bands.
Metabolic Tests
In the PE and/or FGR groups, we will carry out cardiovascular and metabolic tests at diagnosis, throughout, and after pregnancy. In the healthy ongoing pregnancy group, we will see them to perform the same tests at around 28/32/36 weeks and after pregnancy.
Observational
The study is observational with no intervention. All cardiovascular tests are noninvasive, and women will be required to provide a urine and blood sample for metabolite analysis. Where possible, blood tests will be timed with clinically indicated blood sampling as part of their routine management.
Data
Data from this study will establish a profile of values at different gestation and changes through pregnancy for cardiovascular and metabolite processes. If changes in cardiovascular function are seen prior to or in conjunction with clinical deterioration, it raises the prospect of prompt intervention and potential therapies.
Innocor
The PRECEPT study will be conducted at Queen Charlotte’s & Chelsea Hospital, Imperial Healthcare NHS Trust in close collaboration with the University of Cambridge (who has collaborated on the design of the protocol and loaned ‘Innocor’ – one of the machines used for cardiovascular testing).
Principal Investigator for DESIGN
In the UK the number of babies stillborn has not fallen in the past 20 years. Most babies that die before birth are normal, but many weigh less than expected. A small baby in the womb may reflect suboptimal placental (afterbirth) function. However, some babies are small and are normally grown reflecting the constitution of the parents.
The Growth Assessment Programme (GAP) aims to improve the identification of small babies by considering maternal characteristics such as size and ethnicity when assessing growth. Evidence from only observational studies suggests that GAP is better at identifying babies at risk. However, a key concern is that adjustment for maternal ethnicity, some very small or very large babies might be missed or wrongly identified.
Correct identification of small babies is fundamental as appropriate management and follow-up reduces their risk of a stillbirth. Therefore, a well-designed clinical trial is needed to assess if GAP is better in identifying small babies.
Randomised Trial
This is a cluster randomised trial. Hospitals are randomised, rather than individual women who will receive the care allocated to their hospital avoiding contamination of the intervention. All maternity units in the trial will introduce the GAP programme eventually, but one group will use GAP immediately, while the other group will delay implementation of GAP. The time before the introduction of GAP in the delayed arm means we can compare maternity units using GAP with those continuing with usual care.
End of the Trial
In the end of the trial we will be able to inform the best way to identify small babies. We will also look at stillbirth and other important outcomes. We will also ask women about their experiences of care. Finally, we will estimate the impact of GAP on clinical service provision and health economics.
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