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
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/gestational or Pre-eclampsia).Clinicians’ decision to initiate antihypertensive drugs. 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 pregnancy hypertension on maternal and fetal/neonatal outcomes. The primary objective is to evaluate if treatment with nifedipine (calcium channel blocker), compared to labetalol (mixed alpha/beta blocker) in women with pregnancy hypertension, reduces severe maternal hypertension without increasing fetal or neonate adverse events.
|
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 |
|
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
Who can participate? Newborn babies to babies 12 months old who are in, or are approaching, their first RSV season. It will last approximately 12 months
Summary: RSV (Respiratory Syncytial Virus) is one of the leading causes of hospitalisation in all infants worldwide and affects 90% of children before the age of two. In recent months, there has been a resurgence of RSV following the easing of COVID-19 public health measures. The study is evaluating the efficacy of nirsevimab, a monoclonal antibody immunisation, in protecting against one of the leading causes of infant hospitalisation worldwide.
Prof Manu Vatish, leading the study at the John Radcliffe, part of Oxford University Hospitals NHS Foundation Trust, said: “The John Radcliffe Hospital is delighted to be taking part in this important study aiming to protect children against RSV.
This is the most common reason for admission to hospital for children under one and is a major cause of death and illness globally. This study aims to assess if immunisation reduces these risks. Previous smaller studies have shown immunisation to be safe. We would encourage parents to support this hugely important study.
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.
Who can participate? Women experiencing infertility or recurrent miscarriage who have a confirmed diagnosis of endometrial polyps or submucosal fibroids.
Summary: Submucosal fibroids are common benign growths in the muscle of the womb (uterus) and endometrial polyps are benign growths in the lining of the womb. Both are commonly found in women seeking treatment for fertility and recurrent pregnancy loss.
If you have small fibroids or polyps (less than 3cm) then one option is to have them removed in hospital by a surgical procedure called ‘hysteroscopic resection’. Another option is to leave them alone. Currently, we do not know whether removing or leaving small fibroids or polyps is going to improve your chances of having a baby.
This trial has been designed to establish whether removing or leaving small submucosal fibroids or endometrial polyps in place has the best effect on the chances of having a baby, for women who are seeking treatment for fertility or recurrent pregnancy loss.