Hormone Therapy for Premature Ovarian Insufficiency (POI): Randomised Trial and Long-Term Evaluation

When menopause occurs in women under the age of 40 it is called Premature Ovarian Insufficiency (POI). Those with POI can experience unpleasant menopausal symptoms, and in the long-term can be at higher risk of bone thinning, fractures, heart disease and memory problems compared with women who experience menopause at a later, more typical age. Treatments can involve hormone replacement therapy (HRT) and the combined contraceptive pill (COC) - both have advantages and disadvantages, and this research is to determine which is best for relief of symptoms and for long-term risks using questionnaires and bone density measurements, as well as blood samples. 

If you are over 18 and under 40 and have a diagnosis of POI, you could be eligible for this trial. 

Reduction of Surgical Site Infection using several Novel Interventions

When undergoing surgery, there is a risk of developing a surgical site infection (SSI). ROSSINI2 is investigating whether different in-theatre interventions reduce the rate of SSIs in abdominal surgery (excluding c-sections). If you choose to take part, you will be randomly allocated an intervention, or you may be in the control group in which you will undergo your operation in the normal way with no trial intervention used. 

If you are interested, please contact the research team at research@lwh.nhs.uk or via phone at 0151 702 4496, where they will provide information about the trial prior to surgery. You can also discuss this with your surgeon.

Sugammadex for preventIoN oF pOst-operative pulmoNary complIcAtions (SINFONIA)

This study is looking into how best to look after patients who are having surgery and undergoing general anaesthetic. As part of general anaesthetic you are given a drug to relax your muscles, and at the end of surgery you are given a drug to reverse the effects of the muscle relaxant.

This trial is comparing two different drug treatments, both of which are commonly used to reverse muscle relaxants. These are sugammadex of neostigmine with co-administration of glycopyrrolate. The study aims to show if one drug is better than the other, particularly in reducing the risk of breathing problems and pneumonia. 

If you are interested in taking part or learning more information about the study, please call 0151 702 4346 or email research@lwh.nhs.uk.

Proactive against reactive therapy for the prevention of lichen sclerosus exacerbation and progression of disease – a pragmatic, parallel group randomised controlled trial with embedded economic evaluation and process evaluation

The aim of the study is to assess whether in people 5 years and older with controlled vulval Lichen Sclerosis, if proactive therapy is better than reactive therapy in reducing the number of flares. If you take part in the study you will be randomised to either reactive treatment (using prescribed steroid creams when you have a flare) or proactive treatment (using prescribed steroid creams continuously) to see which one is better in the short and long term. 

If you are interested in taking part, please contact the research nurses on 0151 702 4496, or research@lwh.nhs.uk

HYPATIA - A prospective randomised controlled trial of Hydroxychloroquine to improve Pregnancy Outcome in women with Antiphospholipid Antibodies

If you have antiphospholipid antibodies or antiphospholipid syndrome and you are currently planning for pregnancy, you may be eligible for the HYPATIA study. We are looking to answer the question as to whether hydroxychloroquine may help improve pregnancies in women with antiphospholipid antibodies. 

If you are interested in taking part, please contact the research team at research@lwh.nhs.uk, or call 0151 702 4496.

Evaluating a new patient-reported outcome questionnaire to assess the outcomes of prolapse, incontinence and mesh complication surgery as part of the APPRAISE Study

If you have undergone pelvic floor surgery for either pelvic organ prolapse, urinary incontinence and/or mesh complications, you may be eligible to take part in the APPRAISE study, a questionnaire study aiming to explore your experiences of pelvic floor surgery and the impact this has had on your quality of life and the symptoms you have experienced.

This aims to create a final version of a questionnaire that could then be used to improve the care of people undergoing pelvic floor surgery in the future, and inform and support healthcare professionals and policy makers. 

If you would like to take part, please contact the research team at research@lwh.nhs.uk, or call us on 0151 702 4496.

The UNITY Trial - A randomised controlled trial evaluating the clinical and cost effectiveness of IVF versus IUI for Unexplained Infertility

We want to compare whether it is better for couples with unexplained infertility to undergo 1 cycle of IVF (in-vitro fertilisation) treatment or 3 cycles of IUI (intrauterine insemination) treatment. We will then compare both the success and costs of these treatments. 

Regardless of which treatment group you are allocated to, you will receive the usual follow-up care from your fertility team. 

If you are interested in learning more and taking part in the study, please contact the research team at research@lwh.nhs.uk, or on 0151 702 4496.

Preventing Ovarian Cancer Through Early Excision of Tubes and Late Ovarian Removal

PROTECTOR is an observational  research study for women who are at an increased risk of developing ovarian cancer. Some women may carry a fault/alteration in their BRCA1 or BRCA2 gene making them high risk. Whilst, others may be at an increased risk due to a strong family history of cancer or a fault in another ovarian cancer causing gene like RAD51C, RAD51D or BRIP1. This study aims to assess the impact on women of a new two-step option to prevent ovarian cancer. This involves initially just having your tubes (fallopian tubes) removed to prevent ovarian cancer. This is followed by removing your ovaries in a separate operation at a later date of your choosing. The study assesses women’s views and the impact of this approach to prevent ovarian cancer on sexual function, hormone levels, quality of life and overall satisfaction. Outcomes from this new approach are compared to the traditional approach of removal of both tubes and ovaries at the same operation. We also compared this to the well-being of women who do not have an operation.

ChemoINTEL Assay Algorithm: Development Study Synopsis: Advanced Stage Epithelial Ovarian Cancer

A company called Pierian Biosciences Limited aims to develop a method called a prediction algorithm that uses the results from a test on tumour tissue which will give an accurate prediction of the cancer's sensitivity to chemotherapy treatment, or in other words which chemotherapy would be most effective at treating the cancer. This study is aimed toward those with suspected or confirmed ovarian cancer. 

If you are interested in taking part in the study or would like more information, please call 0151 702 4496 or email research@lwh.nhs.uk.

ENDO-CARE: Can Supported Weight Loss Reduce Womb Cancer Surgery Complications?

This study is trying to see if for people carrying excess weight, losing even a few pounds reduces complications from surgery for womb cancer and help people recover faster. This involves being chosen at random to either receive standard care or supported weight loss, where a specialist will provide nutritious soups and shakes to assist with weight loss and provide support over the phone. 

If you are interested in taking part or would like to learn more about the study, please call 0151 702 4496 or contact the research team at research@lwh.nhs.uk.

Collection and storage of tissue from gynaecological surgery (hysterectomy)

The Research Tissue Bank collects and stores tissue taken at surgery for research. By doing this the research tissue bank is able to build up a valuable collection that will be used by research groups investigating complications of the female reproductive system. It is hoped that the resulting knowledge will help other women in the future.

TTTS Registry - Multiple Pregnancy Registry

The purpose of this registry is to address the gaps in knowledge in order to inform us what is the best treatment to offer in multiple pregnancies that develop complications, and what is the best way to monitor for the development of these complications. This should ultimately improve the care we provide to these women and babies. Furthermore, the registry will help us to ensure that all units caring for women with multiple pregnancies in the UK are providing consistent, evidence-based care. The registry will also provide a platform to allow long-term follow-up of these children at a national level.

C-STICH2: Emergency Cervical Cerclage to Prevent Miscarriage and Preterm Birth: a Randomised Controlled Trial

A cervical cerclage is the placement of a stitch to keep the neck of the womb closed. A stitch can be placed in a planned way because of a risk of preterm birth based on a woman’s pregnancy history or because the neck of the womb is shorter than normal on an ultrasound scan but still closed. Sometimes the neck of the womb can start to open and expose the bag of water around the baby. If this happens between 16 and 28 weeks of pregnancy, an emergency stitch is sometimes inserted to try to delay delivery. Prolonging the pregnancy so that the baby can be born when they are bigger and stronger may give them a better chance of surviving and suffering from fewer complications of prematurity. However, doctors do not know if an emergency cerclage works. There is some evidence it may prolong pregnancy but it is possible that it will also speed up delivery by causing infection or damage to the neck of the mother’s womb

This study will ask women who have an open neck of the womb with the bag of waters around the baby coming through, to have either an emergency stitch or no emergency stitch. Which treatment they will receive will be decided by a process that randomly allocates a woman to one group or the other.

Carboprost vs Oxytocin as the First Line Treatment of Primary Postpartum Haemorrhage. A phase IV, double-blind, double-dummy, randomised controlled trial.

Excessive bleeding after childbirth (also known as postpartum haemorrhage or PPH) is a common problem which affects 1 in 20 women.

COPE is a research study to compare two drugs currently used to treat PPH, to decide which is better. The two drugs are carboprost and oxytocin.

Perinatal and 2 year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 Randomised Trial

Currently, doctors don’t have good information to help them decide about the best time to deliver a baby between 32 and 36 weeks of pregnancy. At the moment many different approaches are being used. This study aims to find answers about the safest time to deliver the baby.

Pregnancy Antihypertensive Drugs - Which Agent is Best?

This study aims to find out which blood pressure medication is best at treating high blood pressure in pregnancy, as untreated high blood pressure can cause serious complications for the mother and the baby. We want to find out which of the two most commonly used medicines to treat this (labetalol and nifedipine) is the best at treating high blood pressure without having troublesome side effects. 

Intervention or Expectant Management for Early Onset Selective Foetal Growth Restriction in Monochorionic Twin Pregnancy

This study aims to investigate the feasibility of a study comparing which is the best way to manage monochorionic twin pregnancies complicated by selective foetal growth restriction, comparing active intervention with expectant management. 

Children Growing Up in Liverpool - Longitudinal Birth Cohort and CityLab Linked Data

C-GULL is an exciting new research study focused on improving the health and wellbeing of children and their families in the Liverpool City Region. The C-GULL study will collect information, including samples and data, from 10,000 children and their families, starting in pregnancy and continuing throughout life, linking data from different sources and using it to track the health and development of a person throughout their life, in order to better understand the factors that can improve the lives and health outcomes of children and their families in the Liverpool City Region. 

All pregnant people aged 16 years and older who are pregnant with their first child and have chosen for their care to be at Liverpool Women's NHS Foundation Trust are eligible to take part in this study. Their partners (if applicable) will also be asked if they would like to take part. 

Planning mode of birth in routine antenatal care: development of a decision aid (Plan-A)

This study aims to develop a decision aid to support pregnant women to choose between planning vaginal or caesarean birth during routine antenatal care. Childbirth often involves unexpected, sometimes unwanted, medical input, while some women wish they had received assistance to give birth but were not offered it. Both issues can lead to health problems. Decision aids are tools that provide a framework for balanced consideration of care options to support choice and reduce regret. No decision aid exists for routine planning of how to give birth. 

If you or your partner are currently pregnant, or if you have given birth within the past 10 years, we would like to hear what information you feel is important to consider when planning how to give birth, your individual experiences of planning the birth, and how care can be improved to ensure that an informed decision can be made. 

If you are interested in taking part, please contact plana@abdn.ac.uk, or call 01224438425 between 9-5 Mon-Fri. 

Calcium Supplementation for Prevention of Pre-eclampsia in High Risk Women: CaPE Trial

Pre-eclampsia affects one in 30 pregnancies in the UK, and usually presents with high blood pressure and protein in the urine. Complications of pre-eclampsia can make women very unwell and the baby may also have reduced growth, be born too early or even die. Currently, aspirin is used to reduce the risk of pre-eclampsia but it only has modest benefits. Calcium may be beneficial for preventing pre-eclampsia but most previous studies have been conducted in populations with low dietary calcium intake, so findings have not been viewed as applicable to a population with adequate calcium intake, such as in the UK. 

 CaPE is a randomised, blinded, placebo controlled multicentre trial to assess the clinical and cost-effectiveness of oral calcium supplementation of 2 grams per day taken from 12 to 22 weeks’ gestation until delivery plus usual care (including aspirin) compared with usual care alone in reducing the risk of pre-eclampsia and its complications in women at high risk of developing pre-eclampsia.

If you are interested in taking part, please contact the Research Midwives on 0151 702 4355, or at research.midwives@lwh.nhs.uk

Whole Genome Sequencing (WGS) to identify the genetic determinants of Spontaneous Pre-Term Birth: A nationwide multicentre cohort study

If you have had a spontaneous preterm birth (if your baby was unexpectedly born early), you may be eligible for the PRESTIGE study. This study involves taking one small blood sample and pregnancy information to investigate if there are specific genetic factors related to preterm birth.

If you are interested in taking part in the study, please contact the research team at research.midwives@lwh.nhs.uk, or on 0151 702 4355

The Generation Study

This study aims to try to find genetic conditions early in affected babies, and to learn more about genes and health. To do this, we will ask to take a blood sample at birth from cord blood or a heel prick from the newborn baby. This sample will be analysed for many genetic conditions (around 200 conditions), and you will be informed if any condition is found. This test is in addition to the newborn blood spot screening currently offered on the NHS. 

Multicentre open label, pragmatic randomised controlled trial of early surfactant therapy versus expectant management in late preterm and early term infants with respiratory distress

To investigate whether, in later preterm and early term infants with respiratory distress, the early use of surfactant, versus expectant management, results in shorter duration of hospital stay and fewer babies who fail to respond to treatment.

neoGASTRIC: Avoiding Routine Gastric Residual Volume Measurement in Neonatal Critical Care, a Multi-centre Randomised Controlled Trial

About one in seven babies born in the UK each year need specialist neonatal care in a hospital because they are born too early, are born very small or have a medical condition. Ensuring these babies have enough nutrition is a key part of their care. Premature babies are fed milk every few hours through a soft plastic tube into their stomach, called a gastric tube. As their stomachs and digestive systems are not yet ready for lots of milk, the amount given each feed is increased slowly. Some doctors and nurses regularly check how much milk is left in a baby's stomach, called 'routinely measuring gastric residual volumes'. They check because they believe it will help them know how the baby is coping with the milk feeds and they also think it may help to identify a severe disease called necrotising enterocolitis. However, others think measuring gastric volumes may be bad for babies and that it is inaccurate, uncomfortable for the baby and may actually be harmful. We want to answer the question: Is routinely measuring gastric residual volumes good or bad for babies?

This is an opt-out research trial, designed to be as simple as possible for families - you will be presented with an information sheet if eligible, and if you would like to discuss this further with the research team please call 0151 702 4084.

DOLFIN - Developmental Outcomes of Long Term Feed Supplementation in Neonates

This study is designed to test whether adding a daily nutrient supplement (food substance) to the normal milk and weaning foods of babies born with Hypoxic Ischaemic Encephalopathy (where the brain did not receive enough oxygen around time of birth) or babies born premature (born less than 28 weeks of gestation) can help improve their neurological development in later childhood (such as how they think, play and interact with others). The supplement contains substances that occur naturally in a healthy diet (and are often used as food supplements). Babies will be randomly allocated to receive supplement or a substance that looks the same (placebo).Supplement will be given twice a day mixed with a baby's normal milk or weaning foods until the baby is one year of age. Parents will be supported by hospital staff. Parents will also be asked to complete questionnaires at NNU discharge, 6, 12, 18, and 24 months about family circumstances, quality of life and their child's neurological development.

A small study has been carried out in the UK and the results were promising, but we need to find out more. We are aiming to include about 1,010 babies in order to be confident of finding out whether the supplement improves babies neurological development, or not. If the study tells us the supplement is effective, it might be given to babies as part of usual NHS care in the future.

If you would like to learn more about this study, please contact the neonatal research team on 0151 702 4084.

WithHolding Enteral Feeds Around Blood Transfusion (WHEAT International Trial)

The WHEAT International trial will compare two different approaches, feeding babies or not feeding babies during blood transfusions, to work out which one is better. Both approaches are standard practice in the UK but we don’t know how best to feed babies during blood transfusions – some hospitals and doctors stop feeds while others don’t. This is important because babies that are born early often need blood transfusions because they become anaemic (they do not have enough red blood cells, which can cause weakness or breathlessness). We know babies need blood transfusions, but we do not know how best to look after them during the transfusion.

Can the diagnostic accuracy of newborn eye screening for congenital cataract be improved with digital imaging? The Digital Imaging versus Ophthalmoscopy (DIvO) study.

Cataract (cloudiness of the lens) is the major cause of avoidable child blindness in the world and affects 1 in 3000 UK infants. Cataracts are present in both eyes in more than half of the babies affected. All UK babies are examined (screened) for cataract twice within the first 8 weeks of life. This study aims to test if screening using a new hand-held digital imaging device (Neocam) is more accurate than the ophthalmoscope for newborn eye screening.

You may be approached for DiVO after giving birth, before or after your newborn's first cataract screening. For more information please contact the research midwives at 0151 702 4355, or research.midwives@lwh.nhs.uk

A Phase 2b, Multicenter, Randomized, Open-label, Two‑Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity. 

Babies born prematurely often have problems with their lungs and breathing immediately after birth and after they go home from hospital. This study is investigating if a drug called mecasermin rinfabate (OHB-607) can decrease the risk of breathing problems and lung disease, in particular bronchopulmonary dysplasia (BPD). 

If you are interested in learning more or taking part in the study, please contact the research team at research@lwh.nhs.uk or on 0151 702 4084

Epidemiological Study Of Familial Breast Cancer

We are trying to find out more about the causes of breast, ovarian and prostate cancer in people with a family history of the disease. A small number of people have an increased risk of these cancers as a result of inheriting a mutation in specific genes, but we do not know what other genetic or lifestyle factors may be important. This study is trying to identify these other risk factors. This is a long-term study, which has and will continue to contribute to scientific papers.

Phenotyping Of Rare Genetic Overgrowth Disorders

We would like to increase our understanding of the clinical and genetic features of rare genetic overgrowth disorders. At present we do not fully understand the genetic causes of these conditions and the medical problems that are associated with each condition. Studying the clinical features (the ‘phenotype’) of individuals with overgrowth disorders will increase our knowledge of these conditions.

Improving our understanding of these disorders will enable health care professionals to provide more accurate information and the best possible care to individuals with overgrowth conditions. Identifying the genetic causes may also help with developing treatments in the future.

The Identification and Characterisation of Inherited Predispositions to Colorectal Tumours (CORGI) 2

Malignant bowel tumours, such as cancers, are rather common and benign bowel tumours, such as polyps are very common. Inherited factors (genes) may increase or decrease a person’s risk of bowel tumours. We are studying patients and families with a history of bowel tumours in order to identify genes that could affect the risk of developing this condition and find out why they have this effect. We are also studying patients and families who have developed tumours, such as cancers of the uterus (womb), that are potentially related to bowel cancer.

The purpose of this study is to identify and characterise new hereditary factors that may lead to the development of bowel tumours. In turn, this will increase our understanding of why bowel tumours develop

Flagship Study Exploring Needs, Technical Aspects and Quality Assurance of RNA Analysis as a Means to Interpret Sequence Variants of Unknown Significance

The aim of this study is to identify new gene faults and to understand which gene faults found during gene sequencing are disease causing. This will be done by looking to see if a gene fault affects splicing of the gene or of other genes. Finding which do will help make genetic testing possible for the disorder. This knowledge may eventually help in the management and treatment of these or other illnesses. Our research can also help understand how these genes normally work in the human body and brain.

EDEN - Prospective Study of Autism Emergence From Infancy in Neurofibromatosis Type 1

Many children with NF1 can have difficulties such as Autism Spectrum Disorder (ASD) and Attention deficit Hyperactive Disorder (ADHD). But we don’t understand how these conditions develop, what the early indicators of these difficulties might be or why some children with Nf1 are protected from these difficulties. We hope that this research study will help us develop new tests that may in the long-term, help us with earlier diagnosis and developing new treatments for children with NF1.

SCOTTY Study - Whole Genome Sequencing Study of Young Colon Cancer Patients and Their Parents

Our aim in this study is to conduct detailed genetic analysis of blood and tissue removed from tumours from individuals who have developed bowel cancer at a young age and also blood samples from each of their parents. These samples will be analysed using a technique called “NextGeneration Sequencing” (NGS).  NGS is a scientific technique that gives us a “read-out” of all the genetic information that is stored in our DNA within each of our cells within the body. It is this information that makes every person unique.  We aim to identify changes in patients DNA (mutations) that may not be present in parents. We aim to collect this information to help us identify mutations that are causing bowel cancer.  This will in the long term help us to develop new treatments and predict who will be susceptible to cancer and so be able to prevent disease progression.

Genetics of endocrine tumours

This study aims to identify genes (part of our cells which carry inherited information) and proteins, which play a part in the development of endocrine tumours.

Over 900,000 new cases of prostate cancer are diagnosed worldwide every year. Studies have indicated that men who carry certain gene mutations are more susceptible to prostate cancer than men without a mutation. It has also been suggested that mutations may in some cases cause more aggressive prostate cancer.

The aim of this study is to follow up a group of men who have prostate cancer and who are known to have a mutation in a prostate cancer predisposition gene. The information we collect will be used to determine whether there are differences in the aggressiveness of the disease. Ultimately the aim of this research is to help improve our understanding and enable us to give better treatment advice to men receiving a diagnosis of prostate cancer.

Molecular Pathology of Human Genetic Disease is a well established study that aims to recruit participants with suspected or known genetic disorders to study genetic aetiology, natural history and predictors of outcome.

HumGenDis It is not restricted to any particular phenotype or condition but currently the major topics of interest are:
• Inherited Renal Cell Carcinoma (RCC)
• Inherited Phaeochromocytoma/Paraganglioma (PPGL)
• Multiple Primary Tumours
• Methylation alterations in congenital imprinting disorders (e.g. Beckwith-Wiedemann syndrome, Silver-Russell syndrome) and chromatin disorders
• Wild type Gastrointestinal Stromal Tumour

Precision-HBOC: Stratifying Risk for Early Detection in Hereditary Breast and Ovarian Cancer

Women with disease-causing gene changes (faults/mutations) in BRCA1, BRCA2, PALB2, CHEK2 and ATM are at an increased risk of developing certain types of cancer - specifically breast (all genes) and epithelial ovarian cancer (BRCA1, BRCA2, PALB2 only). At present, the risk estimates given by most health practitioners to women are broad (e.g. 35-85% lifetime risk of breast cancer for BRCA1 and BRCA2) and are not personalised. This can make it difficult for women to make informed decisions regarding risk management options available to them. By combining information about genetic, lifestyle and hormonal risk factors, we can produce a narrower, more personalised risk estimate (e.g. 44% lifetime risk of breast cancer). In this study we aim to test whether offering personalised risk estimates to women undergoing predictive testing in genetics centres in the UK and USA better supports women’s mental health and choices about their clinical care, relative to standard care. In addition, we will explore the experiences of both staff and women taking part in the study to understand whether personalised risk estimates are acceptable, feasible and cost-effective for use in clinical care.

If you are interested in taking part, please contact the research team at research@lwh.nhs.uk, or call the genetics research team on 07971515805.

Genetic Rare Disease Observation Cohort (Musketeers Study)

2000 children per year are born in the UK with a rare genetic syndrome. These children have complex medical problems and require more hospital appointments and attendances than other children. As each syndrome affects a small number of children research into individual syndromes is limited - so often doctors don't know how to monitor these children and what investigations and treatments they need. This has meant that parents have formed syndrome-specific social media support groups to gather and share information. 

This study aims to see if gaps in information can be filled in by working together with parents and social media groups to use information they are already gathering. 

If you have a child with a rare genetic syndrome and would like to take part, please speak to the genetics department or contact research@lwh.nhs.uk.