Pre-eclampsiaNCT07470320
Placental Biology in Health and Disease
An observational study of Pre-eclampsia and Gestational Diabetes Mellitus (GDM), run by University of Oxford at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-eclampsia, Gestational Diabetes Mellitus (GDM), Fetal Growth Restriction (FGR)
- How many people
- 360 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Dec 2025to 31 May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will recruit a diverse cohort of pregnant and non-pregnant participants to enable analysis of placental EVs and soluble factors across different physiological and pathological conditions. Participants will include: * Pregnant women with pre-eclampsia, gestational diabetes mellitus or fetal growth restriction to allow the study of disease-specific alterations in EVs and systemic responses. * Pregnant women predisposed to pre-eclampsia to provide insights into risk factors and early-stage changes, aiding in biomarker discovery for prediction and prevention. * Pregnant women with healthy pregnancies to understand normal EV release and immune regulation. * Non-pregnant women to provide critical baseline data to differentiate the effects of pregnancy from underlying physiological processes. Pregnant participants may be recruited at any gestational stage to ensure a comprehensive coverage of pregnancy progression.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford
Clinical Research Group, +441865 221107, clinicalresearchgroup@wrh.ox.ac.uk
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Pre-eclampsia, Gestational Diabetes Mellitus (GDM), Fetal Growth Restriction (FGR), Pregnancy Induced Hypertension (PIH), Placenta, Pregnancy
- Being tested
- There are no interventions for this study
- Medical subject headings
- Pre-Eclampsia, Diabetes, Gestational, Fetal Growth Retardation, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There are no interventions for this studyOther
There are no interventions for this study
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women diagnosed with pre-eclampsia | Not described Receives: Other: There are no interventions for this study | |
| Pregnant women diagnosed with gestational diabetes mellitus | Not described Receives: Other: There are no interventions for this study | |
| Pregnant women diagnosed with fetal growth restriction | Not described Receives: Other: There are no interventions for this study | |
| Healthy pregnant women | Not described Receives: Other: There are no interventions for this study | |
| Healthy non-pregnant women | Not described Receives: Other: There are no interventions for this study | |
| Pregnant women predisposed to pre-eclampsia | Not described Receives: Other: There are no interventions for this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and at delivery
Secondary outcomes (2)
Quantitative and qualitative differences in inflammatory immune cells
Quantitative (cells/ml) and qualitative (protein and RNA composition/mg cell) will be measured
Measured: baseline and delivery
Sensitivity, specificity and predictive value of EVs for identifying PET, GDM and other pregnancy complications
Standard statistical analysis of EV parameters against clinical endpoints to derive sensitivity, specificity and PPV/NPV in these disease conditions
Measured: Baseline and delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start16 Dec 2025
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-eclampsiaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470320
- Sponsor's protocol ID
- 18939
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental Biology in Health and Disease
- ClinicalTrials.gov ID
- NCT07470320
- Acronym / sponsor ID
- 18939
- Conditions
- Pre-eclampsia, Gestational Diabetes Mellitus (GDM), Fetal Growth Restriction (FGR), Pregnancy Induced Hypertension (PIH), Placenta, Pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pregnant women diagnosed with pre-eclampsia | – | Other: There are no interventions for this study |
| Pregnant women diagnosed with gestational diabetes mellitus | – | Other: There are no interventions for this study |
| Pregnant women diagnosed with fetal growth restriction | – | Other: There are no interventions for this study |
| Healthy pregnant women | – | Other: There are no interventions for this study |
| Healthy non-pregnant women | – | Other: There are no interventions for this study |
| Pregnant women predisposed to pre-eclampsia | – | Other: There are no interventions for this study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will recruit a diverse cohort of pregnant and non-pregnant participants to enable analysis of placental EVs and soluble factors across different physiological and pathological conditions. Participants will include: * Pregnant women with pre-eclampsia, gestational diabetes mellitus or fetal growth restriction to allow the study of disease-specific alterations in EVs and systemic responses. * Pregnant women predisposed to pre-eclampsia to provide insights into risk factors and early-stage changes, aiding in biomarker discovery for prediction and prevention. * Pregnant women with healthy pregnancies to understand normal EV release and immune regulation. * Non-pregnant women to provide critical baseline data to differentiate the effects of pregnancy from underlying physiological processes. Pregnant participants may be recruited at any gestational stage to ensure a comprehensive coverage of pregnancy progression.
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There are no interventions for this studyThere are no interventions for this study | Other | Healthy non-pregnant women, Healthy pregnant women, Pregnant women diagnosed with fetal growth restriction, Pregnant women diagnosed with gestational diabetes mellitus, Pregnant women diagnosed with pre-eclampsia, Pregnant women predisposed to pre-eclampsia |
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-eclampsia and Gestational Diabetes Mellitus (GDM), run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor Manu Vatish (+441865 221009, manu.vatish@wrh.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.