OSPREA & Gynae Team Trials
CURRENT TRIALS
The Oxford Safer Pregnancy Alliance (OSPREA) and Gynae Team is a team of doctors, scientists, researchers, midwives, nurses and support staff who work together with women to lead research into women’s health in the areas of reproduction, obstetrics and gynaecology. We conduct high quality studies for women before pregnancy, women and their babies during and after pregnancy, as well as general women’s health studies.
We are primarily supported by the Nuffield Department of Women's & Reproductive Health, (part of the University of Oxford) the Oxford University Hospitals NHS Foundation Trust, and the Thames Valley & South Midlands Clinical Research Network, part of the National Institute for Health Research.
You can read about our current trials on this page below or find out more about OSPREA by clicking here.
PREGNANCY STUDIES
Oxford Placental Ultrasound OxPLUS Study
Who can participate? Pregnant women aged 18 years or above who are in the first few months of pregnancy and attending their routine 11-14-week (‘first trimester’) ultrasound scan at the John Radcliffe Hospital, Women’s Centre, Oxford.
Summary: The aim of this study is to establish if a new piece of computer software, called the ‘OxNNet toolkit’ can predict which babies will not grow as well as they should using the information gained from the 3D ultrasound scan about the size of the placenta and its blood flow, together with other known risk factors.
View the study webpage to find out more
PURE (Pregnancy Ultrasound ResourcE)
Who can participate? Any pregnant women, over 18 years old at their ultrasound appointments.
Summary: We are working to create automatic ultrasound systems requiring minimal control by a health professional so that the scan machine will automatically identify and take measurements of babies. In order to do so, we are asking volunteers for their permission to have their scan images recorded, and for the sonographer to track her/his eye-movements while the scan is being performed. This study will benefit women living in disadvantaged areas where there is a lack of skilled ultrasound operators, meaning scans are not available as part of routine clinical care.
PURFECT- Perception Ultrasound for Reassuring Fetal Echo Clinical Trainees
Who can participate? Pregnant women who attend for their anomaly ultrasound appointment (18+0 – 20+6wks).
Summary: We are working to develop ultrasound assistive software (PURFECT) to aid sonographers in gaining the best possible images and measurements when scanning a baby. It is hoped that this tool will reassure newly qualified sonographers and also support more experienced sonographers to scan more efficiently.
We are asking volunteers to have an extra scan which is recorded, to enable sonographers to use the assistive software. Sonographers are being asked to scan using this new tool which will provide visual guidance during the examination. It will also record where sonographers are looking on the screen while performing the scan. The sonographers are then asked for feedback as to how useful they found it.
CAIFE- Clinical Artificial Intelligence Fetal Echocardiography
Who can participate? Pregnant women (aged 18 years or above), attending an ultrasound scan and/or fetal cardiology appointment in the Obstetric Ultrasound Department at the collaborating hospitals.
Summary: We are working to create an ultrasound systems which can recognise the difference between a healthy and unhealthy fetal heart using machine learning. Detection of congenial heart defects during pregnancy allows early diagnosis and planning for treatment post-delivery.
The INSIGHT Study – Investigating hormones triggering the onset of sustained lactation
Who can participate? Pregnant women intending to breastfeed in Oxfordshire area.
Summary: Hormones such as prolactin and progesterone play a major role in the breastfeeding process and trigger the onset of milk production within the first few days after childbirth. However, the hormone levels required to stimulate milk production are unknown. At LRF OCEHL we are running this vital study to develop normal ranges for milk producing hormones. This study will help us understand why some breastfeeding mothers have delayed milk production or produce limited quantities of milk. View the INSIGHT Study leaflet.
Visit the study webpage to find out more
Giant PANDA - Pregnancy ANtihypertensive Drugs: which Agent is best?
Who can participate? Pregnant women between 11+0 – 34+6 weeks, over 18 years old with a diagnosis of pregnancy hypertension (Chronic/pregnancy induced hypertension/Pre-eclampsia).Clinicians’ decision to initiate antihypertensive medication. Women who have a contraindication to either Labetalol or Nifedipine and are already taking both medications are excluded from participating in this study.
Summary: The aim of this study is to evaluate the effect of different antihypertensive drugs in women with chronic/gestational hypertension or pre-eclampsia on maternal and fetal/neonatal outcomes. The primary objective is to evaluate if treatment with nifedipine (calcium channel blocker), compare to labetalol (mixed alpha/beta blocker) in women with pregnancy hypertension, reduces severe maternal hypertension without increasing fetal or neonate adverse events.
HYPATIA – A prospective randomised controlled trial of Hydroxychoroquine to improve Pregnancy outcome in women with Antiphospholipid Antibodies.
Who can participate? Women aged 18 to 45 with persistent antiphospholipid antibodies who are planning a pregnancy.
Summary: The trial assesses whether the tablet hydroxychloroquine in addition to standard treatment in mothers with antiphospholipid antibodies leads to more mothers having successful pregnancies.
MRC Study for understanding and predicting pre-eclampsia
Who can participate? Pregnant women both with and without pre-eclampsia and also non pregnant women.
Summary: The purpose of the study is to find out more about what causes pre-eclampsia and how to predict it. We compare the results of certain tests on blood, urine and placental samples from pregnant women with pre-eclampsia and those without. We also study blood and urine from non pregnant, healthy women.
FERN - (Intervention or Expectant Management for Early Onset Selective Fetal Growth Restriction in Monochorionic Twin Pregnancy)
Who can participate? Women who are currently pregnant (16-23 weeks) with a monochorionic (identical sharing one placenta) twin pregnancy complicated by sFGR/sIUGR (one of the babies is smaller) or have had a sFGR/sIUGR affected monochorionic twin pregnancy in the last 3 years to take part in this study.
Summary: The UK has approximately 11,000 twin pregnancies per year with a third of these sharing a placenta (MC twins). MC twin pregnancy presents extra risks to both the mother and the babies, with some babies dying during pregnancy or shortly after birth. Often this is due to a complication called selective Fetal Growth Restriction (sFGR), where one twin is smaller than the other. This study aims to gain a better understanding of the outcomes for sFGR in MC twin pregnancies managed in a variety of ways.
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RaDaR - Kidney disease and pregnancy. Who can participate? Women with chronic kidney disease who have, or have had, a pregnancy. Summary: The National Registry of Rare Kidney Diseases (RaDaR) is a research initiative by UK kidney specialist (the Renal Association and the UK Renal Registry). It is designed to gather information from patients with rare kidney disease and in particular women with chronic kidney disease (CKD). The group aims to look into how women with CKD cope with pregnancy and what can be done to improve care. Read more |
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Pre-eclampsia Study - Study of placental particle shedding and the maternal inflammatory response in pre-eclampsia Who can participate? Women with pre-eclampsia and women without pre-eclampsia. Summary: The Purpose of the study is to find out more about what causes and how to predict pre-eclampsia. We need to compare the results of certain tests on blood and placental samples from pregnant women with pre-eclampsia with those of women without pre-eclampsia. Read more |
BIRTH STUDIES
Spinal Muscular Atrophy (SMA) Study
The aim of this population-based research study on newborn genetic screening for spinal muscular atrophy (SMA) is to evaluate the uptake and feasibility in the UK.
Who can participate? We are inviting women who are more than 18 weeks pregnant, or have given birth in the last 28 days, to be part of this study with their newborn babies.
Summary: Our newborn screening study aims to make it possible to detect SMA within days of birth, before symptoms develop, so that any affected newborn can receive diagnosis and treatment at the earliest possible opportunity. SMA is not currently screened for as part of the newborn screening programme. This screening test can be done on the blood spot that is already being taken as part of the standard newborn screening programme. This means no extra blood samples will be needed.
POST NATAL STUDIES
COPE- (The Carboprost or Oxytocin Postpartum haemorrhage Effectiveness Study)
Who can participate? Those 16 years and over of age and who require medical treatment for primary PPH
Summary: The aim of this study is to compare intramuscular Carboprost 250mcg with intravenous Oxytocin 5 IU for caesarean section, 10 IU following vaginal delivery for the initial treatment for women with clinically diagnosed PPH.
Secondary objective: To explore the views of participants and their carers about their experiences of the two treatments and the consent process.
Cleft Study - The Cleft Collective Cohort Studies
Who can participate? Women who have received a diagnosis of cleft palate/lip during their pregnancy.
Summary: The Cleft Collective is the world’s largest cleft lip and palate research programme. We are developing two cohort studies. We will follow each family as their child grows up and keep in touch along the way.
WOMEN'S STUDIes
LOCI Trial - Have PCOS and trying for a baby?
Who can participate? Women with a formal diagnosis of polycystic ovary syndrome (PCOS) who are trying to conceive and and evidence of anovulation (not releasing an egg each month).
Summary: This trial is investigating the effectiveness of two different drugs (letrozole and clomifene) on fertility, pregnancy and successful births. Both of these drugs aim to induce or ‘switch on’ ovulation, which is often disrupted in women with PCOS. Improved ovulation should increase the chances of becoming pregnant. Women in the study will take part in up to 6 treatment cycles where letrozole or clomifene is taken with or without (placebo) the drug metformin. These drugs are already widely used and considered safe, but the results of the LOCI trial will provide important insights on which combination of drugs works best – something which is still unknown. By taking part in this trial you will be helping our research team move science forwards and giving many women with PCOS a better chance of getting pregnant and giving birth in future.
FENOX - Fibroids and Endometriosis in Oxford.
Who can participate? Women having a laparoscopy for pelvic pain/ treatment or diagnosis of Endometriosis/ Fibroids, sub-fertility or sterilisation aged 18 years or above (before menopause), this study is not suitable for women who are pregnant or who have a history of cancer/diagnosis of current cancer.
Summary: Millions of women suffer from the consequences of endometriosis and uterine fibroids. These include pelvic and abdominal pain, abnormal uterine bleeding, infertility and miscarriages. As such, these conditions not only affect women and their families in their everyday lives, but also have been shown to have an enormous socioeconomic impact for society in general.
This study aims to improve our understanding of the underlying mechanisms of endometriosis and uterine fibroids and their associated symptoms to improve the outcome of affected women.