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NCT Number: NCT07470320

Placental Biology in Health and Disease

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, voice, 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.

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Key information

Conditions

Pre-eclampsia Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Restriction (FGR) Fetal Growth Retardation Gestational Diabetes Mellitus (GDM) Glucose Metabolism Disorders Growth Disorders Hypertension Hypertension, Pregnancy-Induced Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Placenta Pregnancy Pregnancy Complications Pregnancy Induced Hypertension (PIH) Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Location status: Recruiting

Location contact

Clinical Research Group

CONTACT

[email protected]

+441865 221107

About this study

The study is a non-interventional, observational study focused on sample collection and laboratory-based analyses to investigate the role of placental EVs and soluble factors in maternal and fetal health. The study will focus on understanding the molecular mechanisms underlying pre-eclampsia, gestational diabetes mellitus and fetal growth restriction, with the ultimate aim of identifying biomarkers and therapeutic targets. To achieve this, the study will recruit participants with healthy, pathological and predisposed pregnancies alongside non-pregnant healthy controls.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

There are no interventions for this study

Other

There are no interventions for this study

Primary outcomes

  1. Enhanced understanding of the molecular and cellular mechanisms linking placental EVs to maternal systemic inflammation in PET and GDM.

    Time frame: Baseline and at delivery

    Quantitative (number of particles/ml) and qualitative differences (protein cargo) in EV profiles

Secondary outcomes

  1. Quantitative and qualitative differences in inflammatory immune cells

    Time frame: baseline and delivery

    Quantitative (cells/ml) and qualitative (protein and RNA composition/mg cell) will be measured

  2. Sensitivity, specificity and predictive value of EVs for identifying PET, GDM and other pregnancy complications

    Time frame: Baseline and delivery

    Standard statistical analysis of EV parameters against clinical endpoints to derive sensitivity, specificity and PPV/NPV in these disease conditions

Study contacts

Contact information is provided by the study sponsor or research team.

Professor Manu Vatish

CONTACT

[email protected]

+441865 221009

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Mar 13, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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