The Clinical Research Group need you
Clinical Research Group is a collaborative initiative between the Nuffield Department of Women's & Reproductive Health and the Oxford University Hospitals NHS Foundation Trust (OUHFT), with support from the National Institute for Health Research (NIHR).
Volunteers wanted
Your participation is crucial in helping researchers discover more effective ways to treat, prevent, diagnose, and understand women's & reproductive health.
About us
The Clinical Research Group (CRG) delivers high-quality, inclusive research in women’s and reproductive health, advancing evidence-based care globally through dedication and adaptability, with a patient-centred approach. For further information, visit NDWRH Clinical Research Group.
Current studies
Gynaecological Studies
Fenox
Fibroids and Endometriosis in Oxford
Topic: Endometriosis
Who can participate?
Premenopausal women over 18, who are scheduled to have laparoscopic surgery for the diagnosis or removal of endometriosis/fibroids and hysterectomy.
Aims
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. Read more
The Pip Study
Topic: Fertility
Who can participate?
Women aged 39 or under attending clinics for fertility issues, including miscarriages.
Aims:
The PIP Study aims to find out how a woman’s blood and endometrial immune cells affect the likelihood of an IVF cycle working and whether or not they are different in women with subfertility, miscarriages and implantation failure.
Poise
Premature Ovarian Insufficiency Study
Topic: Premature Ovarian Insufficiency
Who can participate?
Diagnosis of premature ovarian insufficiency, between 18 and 40 years old. Not intending to become pregnant within the next 12 months and willing to stop HRT/COC for a minimum period of 4 weeks prior to randomisation.
Aims:
To find out what is the best treatment for women with POI in the short and long term. Women with POI are treated with either the combined oral contraceptive pill (COC) or hormone replacement therapy (HRT). Both are recommended treatments and there are benefits and risks of each treatment.
Regal
Recurrence of Endometriosis: A randomised controlled trial of clinical and cost-effectiveness of Gonadotrophin Releasing Hormone Analogues with add-back hormone replacement therapy versus repeat Laparoscopic surgery.
Topic: Endometriosis
Who can participate?
Women with recurrent pain following surgical treatment of endometriosis.
Aims:
The aim of this trial is to find out whether using Gonadotrophin Releasing Hormone Analogues (GnRHa) with added Hormone Replacement Therapy (HRT) can improve the quality of life for women by controlling pain when compared to repeat laparoscopic surgery to treat endometriosis. Read more.
RoadPain
Research on Adolescent Dysmenorrhea and Pain
Topic: Period pain
Who can participate?
Young people aged 11-20 years old who have periods and do not take hormone medication.
Aims
To understand the role of adolescent dysmenorrhea (period pain) as a risk factor for chronic pain. We will use what we learn about the long term risks of period pain, including how long it takes for experiencing period pain to increase your risk of chronic pain, to make sure period pain is taken seriously and to produce advice and guidance for those with period pain, health professionals, policy makers and educators. Read more.
Antenatal Studies
Azalea
Topic: Haemolytic Disease of the Fetus (HDFN)
Who can participate?
Women between 13+0 - 16+6 weeks gestation and either have a history of severe HDFN in a prior pregnancy OR there is a presence of maternal alloantibody to RhD, Kell, Rhc, RhE, or RhC antigen with titers above the critical level in a current pregnancy.
Aims:
This study is being done to help doctors and scientists understand if the study drug named nipocalimab is safe and useful for treating pregnant adults at risk for severe Haemolytic Disease of the Fetus and Newborn (HDFN). Participants will be in the study for about 55 weeks from the day they agree to participate in the study. Read more.
CAIFE
Clinical Artificial Intelligence Fetal Echocardiography
Topic: Ultrasound
Who can participate?
Anyone 18 years old and above having routine obstetric ultrasound and or fetal cardiology scan.
Aims
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.
Cape
Calcium for prevention of pre-eclampsia
Topic: Pre-eclampsia
Who can participate?
Pregnant women over 16 years old with a viable intrauterine pregnancy at a gestation of 22 weeks or less, deemed to be at high risk of pre-eclampsia by their clinician.
Aims
The aim of the CaPE trial is to find out whether taking calcium tablets, alongside usual antenatal care, reduces the risk of developing pre-eclampsia.
Participants are randomised into taking either a calcium supplement or a placebo from study enrolment to birth. Pregnancy outcome data are collected by the study team. Read more.
FERN
Topic: Twins
Who can participate?
Anyone over 18 years old diagnosed with sFGR in a monochorionic diamniotic (MC) pregnancy between 16+0 and 23+6 weeks gestation.
Aims
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. Read more.
Generation
Topic: 'Typical' Pregnancies
Who can participate?
To be eligible for the study, you need to be pregnant, have an NHS number, be 16+ years old, not be having twins, triplets, not be a surrogate or planning to give the baby up for adoption, and be registered with a GP in England.
This study has two main goals: find rare genetic conditions early, so affected babies can get treatment fast and learn more about genes and health, so we can improve testing and treatment for genetic conditions in the future. Find out more on https://www.generationstudy.co.uk/
Summary:
Sign up during pregnancy. A blood sample from your baby will be collected shortly after birth to test for 200+ conditions and you will receive results a few months later. The blood sample and data will be stored and used for approved healthcare research. When your child is around 16 years old, we'll ask them if they’d like to stay in the study. Read more.
Hypatia
Topic: Antiphospholipid
Who can participate?
Women with antyiphospholipid syndrome who are planning a pregnancy, aged 18 to 44.
Summary:
The purpose of the HYPATIA study is to find out whether hydroxychloroquine may help improve pregnancies in women with antiphospholipid antibodies. Participants are randomised to receive either hydroxychloroquine or placebo throughout their pregnancy in addition to their usual medications, and pregnancy outcomes are compared.
MRC
Topic: Diabetes & other conditions
Who can participate?
Anyone over 18 years old with pre-eclampsia.
Aims
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.
Panda WS3
Primary prevention of maternal ANaemia to avoid preterm Delivery and other Adverse outcomes
Topic: Early 'Typical' Pregnancy
Who can participate?
Anyone over 18 years old and less than 16 weeks gestation who is non-anaemic at booking or screening with a singleton pregnancy. Read more.
Protect
Topic: Diabetes & other conditions
Who can participate?
Anyone with type 2 diabetes (T2D), over 16 years old and less than 14 weeks gestation. HbA1c of ≥43 mmol/mol (6.1%) in pregnancy. Willingness to use the study devices throughout the trial.
Aims
The purpose of this study is to examine whether using continuous glucose monitoring leads to improved glucose levels and better baby outcomes in pregnant women with type 2 diabetes. Read more.
Pure-First
Topic: Ultrasound
Who can participate?
Anyone over 18 years old, attending their scan appointment 11 – 14 weeks pregnant.
Aims
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. 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. Read more.
SMA
Spinal Muscular Atrophy
Topic: Pregnancy >18 weeks
Who can participate?
Anyone over 16 years old and at least 18 weeks pregnant with a baby due before 31 Dec 2024 or born less than 28 days ago.
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. Read more.
The Cleft Collective
Topic: Cleft Palate
Who can participate?
Women whose babies 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. Read more.
Postnatal Studies
Divo
Topic: Baby Scan
Who can participate?
All babies undergoing newborn NIPE screening. Recruiting is taking place on level 5 (postnatal ward). Read more.
Insight
INveStIGation Hormones Triggering the onset of sustained lactation
Topic: Breastfeeding
Who can participate?
Women in the third trimester of pregnancy, who are intending to breastfeed and residing in the Oxfordshire area.
Aims
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 Read more.
Prestige
Topic: Pre-term birth
Who can participate?
Anyone over 18 years old who had a spontaneous preterm birth between 16+0 and 36+6 weeks of gestation in either their current or previous pregnancies. This includes preterm births complicated by PPROM regardless of whether the subsequent preterm birth was spontaneous or iatrogenic
Aims
To find out which genetic features in people from different ethnic backgrounds are linked to Spontaneous Pre-Term Birth, using Whole Genome Sequencing technology. We hope that our study can help us better predict and understand Spontaneous Pre-Term Birth, so that health complications can be avoided or reduced.
Recruitment closed
Data is currently being analysed for the following studies and no longer require participants.
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.
OXPLUS
Oxford Placental Ultrasound Study
Who participated? Pregnant women aged 18 years or above who were 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 information gained from a 3D ultrasound scan about the size of the placenta and its blood flow, together with other known risk factors.
REPOX
Who participated?
The purpose of the study is to gain a clearer understanding of polycystic ovarian syndrome (PCOS). Specifically in this part of the study we want to know why some women develop PCOS, how it can be diagnosed more effectively and how we can better treat the other conditions often linked to PCOS.
Stoppit-3
Topic: Twins
Who participated?
Women aged >16 years old with Twin pregnancy (monochorionic or dichorionic). Planned birth scheduled between 35+0 and 38+6 weeks gestation.
Summary:
This trial aimed to find out if the drug corticosteroids given to women with a twin pregnancy prior to a planned birth of twins after 35 weeks of pregnancy reduces breathing difficulties in the twin babies. Read more.