Clinical studies
Our current clinical studies, finding ways through research to improve reproductive health.
About the CASSAVA study
This research is looking at of babies and women who are in premature labour and for whom it is not known which way is the best for them to give birth: whether it is better (safer) by caesarean section (CS) or better (safer) to try and have a vaginal delivery. The first part of this research is to find out where doctors and women feel that more research on this topic is needed.
The “more research” is likely to be a randomised trial, where women who are willing to take part are allocated either to a CS or to a vaginal delivery “at random” (normally by a computer programme). We can then look at the benefits and any complications in those who have a CS and compare them with those who tried to have a vaginal delivery. Individual women and clinicians in the future can then use this information to decide which is best for them. The “at random” part is important to prevent bias, but it might reduce women’s (and clinician’s) willingness to take part in the research. Therefore, the second part of this research is to find out whether women and clinicians would be willing to take part.
COMMIT
A new global initiative set up to develop a core outcome set for future male fertility trials. Infertility affects about one in six couples, with male factor infertility causing around a third of overall cases. Core Outcome Measures for Infertility Trials (COMMIT) will be made up of clinicians, researchers and men with infertility from 25 different countries.
This multinational group will reach a global consensus to decide which outcomes should be reported and how these should be defined. These outcomes - or the ‘core outcome set’ - will be used in all future male fertility trials. This will create consistent results and a reduction of research waste. Most importantly, researchers from all over the world will be able to collect and use a set of global results and will in turn develop an increased understanding of successful treatments.
The key aim is to improve and streamline research into male infertility to enable healthcare professionals and researchers to provide better care and support for men with infertility. As well as clinicians and researchers, men with fertility problems are being encouraged to contribute, to ensure there is patient involvement and input.
DexFEM
This study builds on previous research which has provided compelling evidence that deficient activity of glucocorticoids in the endometrium is a cause of increased menstrual bleeding. This study aims to demonstrate that a glucocorticoid (dexamethasone), already in common use for other conditions, (eg to treat medical conditions such as asthma and rheumatoid arthritis in early pregnancy), will reverse the endometrial glucocorticoid deficiency and as a result reduce menstrual blood loss.
The study is in two stages, a 12 month workup stage and a 3 year, response adaptive, dose-finding randomised controlled trial. The first stage involves two workup clinical studies to gather preliminary safety and efficacy data from first-in-Heavy Menstrual Bleeding use of oral dexamethasone. They will also provide methodological data for a series of simulation studies to determine a robust adaptive trial design specification.
NIHR global health research group on preterm birth and stillbirth at the University of Edinburgh (the DIPLOMATIC collaboration)
The DIPLOMATIC Group vision is to reduce mortality of children under 5 years within 3 years, by reducing preterm birth and stillbirth and to optimise outcomes for babies born preterm. Focusing on low income countries (LIC) Malawi and Zambia, we will share existing knowledge on evidence based practices (EBP) used in high income countries (HIC) and use new trial designs to test in LIC the effectiveness of a collection of the best practices, and to evaluate how they are best implemented. A range of projects and research takes place across the University within maternal health, including those looking at the links between body mass index during pregnancy, short term morbidity and health service costs, the impact of development aid on maternal health outcomes and the biological effects of stress in utero.
PAPAGENO: A pragmatic approach to the prevention of gestational diabetes and pre-eclampsia in obese pregnant women in resource poor settings
A feasibility study of a randomised clinical trial of metformin (compared with matched placebo) for the prevention of diabetes and hypertensive disorders in pregnant women. This study will help to determine whether routine administration of metformin could prevent gestational diabetes and pregnancy hypertensive disorders in Malawi and Zambia. Gestational diabetes and pregnancy hypertensive disorders both cause significant maternal and neonatal deaths and long term problems, indeed pregnancy hypertensive disorders account for 17.3% of maternal deaths in low income countries, and are the second commonest cause of maternal death after haemorrhage (severe loss of blood).
PIPIN: A Feasibility Study investigating Pravastatin for the Prevention of Preterm Birth in Women
Preterm birth contributes to around 11% of all births worldwide and is the major cause of infant morbidity and mortality.
Whilst in the UK survival of babies born preterm has improved, the proportion of survivors without long term developmental problems has not, and current treatments are ineffective at preventing this. This study aims to see whether women in preterm labour would be willing to be randomised to take a tablet (pravastatin) or placebo. Preterm labour is known to be due to both inflammation within the womb and contractions. Pravastatin in an anti-inflammatory agent which has been used safely in pregnancy, and which appears in in animal studies to reduce preterm labour associated events.
We hope if women are willing to accept this trial and participate, this will help us develop a larger clinical study to find a new treatment for preterm labour.
PIPIN is currently recruiting women in preterm labour. If you would like more information, please contact Eleanor.whitaker@nhs.net
PRE-EMPT
PRE-EMPT Trial is a multicentre randomised controlled trial to compare long-acting reversible contraception (LARC) versus combined oral contraceptive pill (COCP) in women where endometriosis has been confirmed at laparoscopy. Endometriosis affects 6-10% of women of reproductive age.
The trial will provide information on which treatment is the most cost effective in terms of symptom relief, side effects, acceptability and costs.
QUIDS
Quantitative Fibronectin to help Decision-making in women with Symptoms of Preterm Labour.
Up to 80% of women who have signs and symptoms of preterm labour remain pregnant after 7 days. This means that many women unnecessarily receive therapies aimed at preventing complications in preterm babies, to ensure benefit for the few babies that are actually born preterm. The main aim of this research is to see if qfFN can accurately rule out spontaneous preterm delivery within 7 days of testing.
Through analysis of previous research data and data collected in our cohort study we will see if qfFN is likely to be a useful test – either on its own, or in combination with clinical features. We will then develop a decision support tool, to help women and clinicians assess how likely preterm delivery is, and decide whether to start treatment or not.
SLEEP EASY
Sleep disordered breathing in pregnancy: an observational study examining prevalence and potential mechanisms influencing maternal and offspring outcomes.
There is growing evidence to suggest sleep has an important role in pregnancy health. Breathing problems during sleep, known as sleep disordered breathing, have been linked to an increased risk of serious pregnancy complications including pregnancy-related diabetes (gestational diabetes), high blood pressure and delivery before 37 weeks of pregnancy. The reasons for this possible link are not well understood.
The aim of this study is to look for evidence of sleep disordered breathing in a group of 60 pregnant women, and consider how this impacts on pregnancy. Information about sleeping patterns will be gathered using overnight sleep tests and questionnaires in early and late pregnancy. Following delivery, samples of blood from the umbilical cord and placenta will be examined. Together, this information will allow us to gain a deeper understanding of how sleep disordered breathing impacts on pregnancy.
STOPPIT-2
An open randomised trial of the Arabin pessary to prevent preterm birth in twin pregnancy, with health economics and acceptability – STOPPIT-2
This study aims to determine whether the Arabin cervical pessary prevents preterm birth in women with a twin pregnancy and a short cervix. Women with a twin pregnancy are at high risk of preterm labour. The extra risk of preterm labour in twin pregnancy is the main reason why twin babies are five times more likely to die, both within the first month or the first year of life. Preterm babies who survive are at increased risk of long term disability, and often require extensive and costly health care, so if preterm birth could be prevented in twins this would be extremely beneficial.
UCON
Ulipristal acetate versus conventional management of heavy menstrual bleeding (HMB; including uterine fibroids): a randomised controlled trial and exploration of mechanism of action.
Aim of the study
Determine if Ulipristal acetate (UPA) is more effective at reducing the burden of HMB symptoms than LNG-IUS after 12 months of treatment.
Study design
A multicentre, randomised controlled trial of UPA compared to LNG-IUS with a concurrent mechanistic evaluation of UPA. 220 participants will be recruited.