NCT07470320 Placental Biology in Health and Disease
| NCT ID | NCT07470320 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oxford |
| Condition | Pre-eclampsia |
| Study Type | OBSERVATIONAL |
| Enrollment | 360 participants |
| Start Date | 2025-12-16 |
| Primary Completion | 2030-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 360 participants in total. It began in 2025-12-16 with a primary completion date of 2030-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pre-eclampsia (PET) is a condition characterised by high blood pressure and damage to other organs, and is a leading cause of maternal and fetal complications such as fetal growth restriction (FGR). Gestational diabetes mellitus (GDM) involves abnormal blood sugar levels during pregnancy and can have both short and long-term impacts on the health of the mother and child. Both conditions are linked to placental dysfunction but the precise mechanisms behind these links remain unclear. A major focus of this study is on extracellular vesicles (EVs) which are tiny, bubble-like particles released by the placenta into the mother's and baby's bloodstreams. These EVs act as messengers, carrying proteins, lipids and genetic material that can influence how cells function, even in parts of the body far from the placenta. Notably, the number and content of these EVs change in conditions like PET and GDM, suggesting they may play a role in the development of these complications. This single-site, observational, laboratory study aims to investigate how these EVs contribute to maternal health and disease. To enable analysis across different physiological and pathological conditions pregnant participants with healthy pregnancies, pregnancies predisposed to PET and pregnancies complicated by GDM, FGR and PET will be recruited alongside healthy non-pregnant controls. Recruitment will be from the Oxford University Hospitals NHS Foundation Trust and the Nuffield Department of Women's and Reproductive Health, University of Oxford (who fund the research). Demographic and clinical data will be collected as well as blood, urine, breath, placenta, umbilical cord, umbilical cord blood, amniotic fluid and/or uterine vein blood samples. Through examining EV content and function, it is hoped a better understanding of their role in pregnancy complications will be gained, including their potential as non-invasive biomarkers for early detection and targeted treatments, improving outcomes for mothers and babies worldwide.
Eligibility Criteria
Inclusion Criteria: * Female, aged 18 years or above * Willing and able to give informed consent for participation in the study * Able to read and understand written and spoken English to comprehend study materials and give informed consent * Non-pregnant women in good general health OR pregnant women who fall into one of the following: * Healthy pregnancy * Pre-eclampsia (PET) - defined by clinical diagnostic criteria, including hypertension and proteinuria * Gestational diabetes mellitus (GDM) - diagnosed by standard glucose tolerance tests during pregnancy * Fetal growth restriction (FGR) - diagnosed based on fetal weight or Doppler abnormalities * Predisposed to PET - high-risk factors for PET such as maternal type 1 or type 2 diabetes, autoimmune diseases or multiple pregnancies Exclusion Criteria: * Non-pregnant participants with active health conditions that could confound study outcomes * Pregnant participants with conditions unrelated to PET, GDM or FGR that could influence EV profiles e.g. active infections or malignancies
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07470320 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pre-eclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07470320 currently recruiting?
Yes, NCT07470320 is actively recruiting participants. Contact the research team at manu.vatish@wrh.ox.ac.uk for enrollment information.
Where is the NCT07470320 trial being conducted?
This trial is being conducted at Oxford, United Kingdom.
Who is sponsoring the NCT07470320 clinical trial?
NCT07470320 is sponsored by University of Oxford. The trial plans to enroll 360 participants.