Placental Biology in Health and Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: There are no interventions for this study.
- Who it may be relevant to
- Registry conditions: Pre-eclampsia, Gestational Diabetes Mellitus (GDM), Fetal Growth Restriction (FGR), Pregnancy Induced Hypertension (PIH). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Other There are no interventions for this study
There are no interventions for this study
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Quantitative and qualitative differences in inflammatory immune cells [Time frame: baseline and delivery]
- Sensitivity, specificity and predictive value of EVs for identifying PET, GDM and other pregnancy complications [Time frame: Baseline and delivery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United Kingdom · 1 center
- Oxford University Hospitals NHS Foundation Trust — Oxford
Identifiers
NCT: NCT07470320 · 18939