Ectopic Pregnancy DIagnosis sTudy:

Developing metabolomics profile analysis in biofluids to detect an ectopic pregnancy in symptomatic women in early pregnancy

Approximately 1 in 3 of all women who are pregnant, will visit the gynaecological emergency department in early pregnancy because of bleeding and/or abdominal pain. One woman in thirty with these symptoms will have, a pregnancy that grows outside of the womb (an ectopic pregnancy).

An ectopic pregnancy can be in the fallopian tube, ovaries or anywhere in the pelvis. Even with all modern technologies, it is still difficult to diagnose an ectopic pregnancy, with more than half not diagnosed when women first seek medical help. Because of this, we need to improve the way we diagnose an ectopic pregnancy by developing better tests in order to reduce the health risks and stress to women. We are looking for 625 women who are in the beginning of their pregnancy (less than 10 weeks from their last period) and visit the Liverpool Women’s Hospital emergency department because of bleeding and/or abdominal pain. We are trying to develop an easy and quick test that can accurately identify women with ectopic pregnancies

A double-blind, randomised, placebo-controlled multi centre study to investigate safety and efficacy of elinzanetant for the treatment of vasomotor symptoms in women who are not suitable for hormonal therapy

If you are a woman between 18 to 70, have breast cancer or are at high risk of having breast cancer, and are currently suffering from hot flushes due to taking hormonal therapy for breast cancer, you may be eligible to take part in OASIS-4, where doctors are testing an investigational medication to see if it reduces hot flushes caused by hormonal therapies for breast cancer like tamoxifen and aromatase inhibitors.

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. 

A multi-centre randomised controlled trial to determine the effectiveness of laparoscopic removal of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women

Around 50% of women with chronic pelvic pain will have a condition called endometriosis which can only be diagnosed by laparoscopy (a keyhole operation). If superficial peritoneal endometriosis (found on the surface of the lining of the pelvis) is found at laparoscopy, it is usually surgically 'cut out' or 'burned off'. However, many women do not get complete pain relief after the endometriosis has been removed, and some have complications from the surgery. Many will need repeat operations for their endometriosis, and a recent study reported that 90% of those who have surgery had a recurrence of pain within 2 years. 

We want to determine whether removing superficial peritoneal endometriosis improves painful symptoms and quality of life, which surgical approach may be best, or whether surgery is of no benefit, worsens symptoms or may even cause harm. 

Any woman who is having a diagnostic laparoscopy for suspected endometriosis is eligible to take part.

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.

Investigation of the Role of Sperm Quality in Fertility Diagnosis, Fertility Treatment and Miscarriage

The purpose of this study is to examine how the quality of your sperm affects your fertility diagnosis or fertility treatment success. Most research to date has focused on the woman and very little is known about the impact that sperm have on fertilisation, embryo quality, pregnancy or miscarriage.

Letrozole Or Clomifene for Ovulation Induction: Letrozole or Clomifene, with or without metformin, for ovulation induction in women with polycystic ovary syndrome: a 2x2 factorial design randomised trial (The LOCI Trial)

In order for you to conceive naturally, an egg will need to be released from your ovary. For women with PCOS, this does not always happen, and therefore we need to give medicines to help your body release an egg. There are two drugs we can give to help you release an egg; one called ‘clomifene’ and another called ‘letrozole’. There is another drug called ‘metformin’ that we can also give you at the same time as these other drugs, but we are not sure if this carries any additional benefit. Overall, we are not sure which drugs are best for ovulation induction and a successful pregnancy outcome. The purpose of this study is to test which drugs are best.

Assessment of Conventional Dosing in Women undergoing ART with Follitropin Delta Treatment (ADAPT-1)

This study is investigating which medication used to stimulate follicle growth in the human ovary for assisted reproductive technologies (ART) treatments such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) may lead to the better ovarian response, which may lead to a successful pregnancy.

Those who choose to take part will be randomised to REKOVELLE or GONAL F, which are both used as part of standard care. Those who are eligible to take part will receive a cycle of IVF without charge.

If you are interested in the study, please contact the research team at research@lwh.nhs.uk or via phone on 0151 702 4496.

Study to Investigate Intra-Uterine Temperature and Intra-Uterine Oxygen Levels in Females with Normal Menstrual Cycles

Many couples suffering from subfertility cannot be provided with a diagnosis, and current treatments aimed at improving embryo implantation are not guided by information about the environment of the woman's uterus (intra-uterine environment). 

This study will investigate the dissolved oxygen levels and temperature inside the uterus of women with no reproductive problems by inserting a small device similar to a copper coil IUD to measure this environment and determine what the optimal levels are, in order to provide better fertility treatment to women in the future. 

If you would like to know more about this study, please contact the research team at research@lwh.nhs.uk, or via the phone on 0151 702 4346. 

Refining Ovarian Cancer Test Accuracy Scores:

A test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer

We know that lots of women have symptoms such as bloating and tummy discomfort. It is also very common to have cysts (balloon like swellings) on women’s ovaries picked up by ultrasound. In addition, some women have higher levels of a blood test called CA125; this blood test is abnormal in lots of conditions - women with periods, fibroids, appendicitis etc. A very small number of women with ovarian cysts or abnormal CA125 will go on to be diagnosed with ovarian cancer.

The purpose of this study is to identify better tests for women with ovarian cysts or abnormal blood tests so we can pick up ovarian cancer earlier. This will also reduce unnecessary tests, hospital visits and distress in women who don’t have cancer.

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.

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.

Placental Growth Factor Led Management of the Small for Gestational Age Foetus: A Feasibility Study

The PLANES study is a randomised controlled trial investigating the feasibility of using biomarker led care for pregnant women who are carrying a small for gestational age (SGA) foetus. Women with a SGA foetus who wish to take part will have additional blood tests to track the health of a smaller foetus, and provide a care plan to safely keep the foetus inside the womb for longer, prolonging pregnancy and potentially improving the health of the baby.

Women with a SGA foetus and a normal biomarker ratio will have a repeat ultrasound and repeated blood test to retest the biomarker ratio every 2 weeks up until delivery. Your care pathway will be dictated by your blood test results and adjusted accordingly. This will be discussed with you by your medical team.

Rotation of the foetal head at full cervical dilatation

At the end of labour, a 'back to back' or 'malposition' of the baby can result in more difficult birth, higher chance of tears, and need for a caesarean section. In this situation the doctors will help turn the baby so their head is in the best position for birth.

We are investigating how best to get babies into a good position for a vaginal birth, using either: manual rotation (by hand) or rotation with instrument (forceps or suction cup).

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. 

Is the Vaginal Microbiome and Metabolome Associated with Spontaneous Preterm Birth (sPTB) in multiple pregnancies?

In this study, we want to explore what microscopic organisms (bacteria, yeasts and viruses) in the vagina during pregnancy may be related to premature birth of twins, to potentially recognise specific organisms that may link with with preterm birth. The study will also collect a measurement of how 'stiff' the neck of the womb (cervix) is along with blood samples to investigate if this will also help predict preterm birth.

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. 

Fluids Exclusively Enteral from Day 1

In this study we want to find out whether babies born 8-10 weeks early will do better if we feed them fully with milk from the first day. We want to know whether this will help babies go home sooner (reduce the number of days they need to stay in hospital). We will also check if this helps reduce infection risks, affects the risk of NEC, and helps mothers breast feed and be more involved in caring for their baby.

Neonatal Antimicrobial Resistance and Outcome

Infections are an important cause of deaths in babies during their first weeks of life. Infection is typically non-specific in presentation. This means clinicians must start antibiotics early and “guess” which antibiotics to use. We know from our surveillance network that in 10-20% of cases the antibiotics chosen will not be the correct ones. A small study showed that when this mismatch occurred the babies had a high mortality. We wish to collect information on neonatal infections, identify the pathogens associated with deaths and determine if gaps in optimal antibiotic treatment are related or lead to poor outcomes.

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.

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