NCT07238608

Impact of UFPs and MNPs on Fetal Health

UPRISE Unravelling Ultrafine Particulate Matter and Micro Nano Plastic's Mechanisms of Impact on Fetal Health

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,600 (estimated)
• Sponsor: Instituto de Investigacion Sanitaria La Fe · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This project aims at unravelling mechanisms by which exposure to air pollution (in particular Ultrafine Particulate (UFP, PM0.1), and micro nano plastic's) interferes with the normal foetus development, with a short-term causal effect in higher likeliness of preterm delivery which, in consequence, precondition a higher likeliness to suffer non-communicable diseases (NCD) later in the life.

Detailed description

The characteristics of this study population are as follows: 1. Case-control design The study includes 1600 participants, providing a substantial sample for analysis. The focus is on newborns (age 0), making the study particularly relevant for understanding factors and outcomes related to this very early stage of life. The sex of the participants is expected to be randomly distributed. A control arm of full-term neonates (\>37 weeks) will be recruited for a 1:2 ratio in Greece and Spain. 2. Personal Exposure Monitoring PEM Substudy: The study consists of 150 mothers, with 50 from each location. All participants are females aged over 18 years. The sex of the participants is expected to be randomly distributed.

Conditions

• Pregnant Women

Timeline

• Start date: 2026-01-01
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2025-11-20
• Last updated: 2025-11-20

Locations

1 site across 1 country: Spain