How the placenta affects maternal and fetal health
Placental Biology in Health and Disease
This project will test whether tiny particles released by the placenta differ in pregnancies with pre-eclampsia, gestational diabetes, or fetal growth restriction compared with healthy pregnancies and non-pregnant women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Oxford) |
| Trial ID | NCT07470320 on ClinicalTrials.gov |
What this trial studies
This single-site, non-interventional observational project collects blood and placental samples from pregnant people with pre-eclampsia, gestational diabetes, fetal growth restriction, predisposed pregnancies, healthy pregnancies, and non-pregnant controls. Laboratory analyses will focus on extracellular vesicles and soluble placental factors to characterize their number, contents, and signaling properties. Researchers will compare molecular signatures across groups to identify markers linked to placental dysfunction. The ultimate goals are to find biomarkers for earlier detection and molecular targets that could inform future treatments.
Who should consider this trial
Good fit: Ideal candidates include pregnant people with pre-eclampsia, gestational diabetes, fetal growth restriction, those at high risk for pre-eclampsia, healthy pregnant people, and healthy non-pregnant women willing to provide consent and samples at the Oxford site.
Not a fit: People whose pregnancy issues are caused by non-placental conditions or who cannot attend the single Oxford site are unlikely to benefit directly from participation.
Why it matters
Potential benefit: If successful, the findings could enable earlier blood-based detection of placental problems and point to new targets for therapies that reduce maternal and fetal complications.
How similar studies have performed: Previous research has reported altered placental extracellular vesicles in pre-eclampsia and gestational diabetes, but translating those findings into clinical tests or treatments remains largely unproven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oxford
- Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Professor Manu Vatish
- Email: manu.vatish@wrh.ox.ac.uk
- Phone: +441865 221009
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.