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, 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

360

participants targeted

Target at P75+ for all trials

Timeline

46mo left

Started Dec 2025

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.5 years study duration

Study Progress14%

Dec 2025May 2030

First Submitted

Initial submission to the registry

December 10, 2025

Completed

6 days until next milestone

Study Start

First participant enrolled

December 16, 2025

Completed

3 months until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed

4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2030

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2030

Last Updated

July 23, 2026

Status Verified

December 1, 2025

Enrollment Period

4.5 years

First QC Date

December 10, 2025

Last Update Submit

July 21, 2026

Conditions

Pre-eclampsia Gestational Diabetes Mellitus (GDM)Fetal Growth Restriction (FGR)Pregnancy Induced Hypertension (PIH)Placenta Pregnancy

Outcome Measures

Primary Outcomes (1)

Enhanced understanding of the molecular and cellular mechanisms linking placental EVs to maternal systemic inflammation in PET and GDM.
Quantitative (number of particles/ml) and qualitative differences (protein cargo) in EV profiles
Baseline and at delivery