RecruitingNCT07470320

Placental Biology in Health and Disease


Sponsor

University of Oxford

Enrollment

360 participants

Start Date

Dec 16, 2025

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting placenta tissue and blood samples from pregnant women (including those with healthy pregnancies and those with complications such as pre-eclampsia, gestational diabetes, or fetal growth restriction) as well as non-pregnant women, to better understand how the placenta works in health and disease. **You may be eligible if...** - You are a woman aged 18 or older - You are able to read and understand English - You are either not currently pregnant and in good general health, OR you are pregnant with a healthy pregnancy or a pregnancy complication such as pre-eclampsia (high blood pressure and protein in urine), gestational diabetes, fetal growth restriction, or high risk of pre-eclampsia **You may NOT be eligible if...** - You are not pregnant but have active health conditions that could affect the study results - You are pregnant and have health conditions unrelated to pre-eclampsia, gestational diabetes, or growth restriction that could affect blood test results (such as active infections or cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERThere are no interventions for this study

There are no interventions for this study


Locations(1)

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

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NCT07470320


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