Impact of UFPs and MNPs on Fetal Health (UPRISE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnant Women

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.

• Study Type: Observational
• Enrollment (Estimated): 1600

Contacts and Locations

• Study Contact: Name: Alba Ruiz Gaitán, Dr; Phone Number: 0034961246690; Email: alba_ruiz@externos.iislafe.es
• Study Contact Backup: Name: Imelda Ontoria Oviedo, Dr; Phone Number: 0034961246690; Email: imelda_ontoria@iislafe.es

Study Locations

• Spain
  • Valencia
    • Valencia, Valencia, Spain, 46016
      • Recruiting
      • Instituto de Investigacion Sanitaria La Fe
      • Contact: Alba Ruiz Gaitán, Dr; Phone Number: 0034961246690; Email: alba_ruiz@externos.iislafe.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant mothers will be recruited at the first antenatal visit (around eight weeks of gestation).

Description

Inclusion Criteria:

• Agreement to sign the informed consent;
• Non-smoking mothers and no exposure to environmental (second-hand) smoke (smoking influences UFP measurements);
• ≥18 years old (mothers have to place sensors, mothers with childhood pregnancies may live at their parental home);
• Not expecting to terminate the pregnancy (no measurements of the child);
• Having resided in the geographical area of research for a minimum period of 1 year (to be eligible for modeling exposures).

Exclusion Criteria:

• First visit after 11 weeks of gestation (to ensure 2-week monitoring in the first trimester);
• Pregnancy complications that limit exposure measurements in urine (because it may cause polyuria, for example, gestational diabetes);
• Known kidney disease (might influence exposure measurements in urine);
• Multiple pregnancy (twin or more pregnancies may have a higher risk for complications or preterm birth, no measurements in the last trimester).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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. ENVIRONAGE, Belgium, employs a nested case-control design, making use of its prospective cohort framework that is already in place.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PreTerm Birth	at the moment of birth
Small for Gestational Age	at the moment of birth
Low Birth Weigth	at the moment of birth

Collaborators and Investigators

• Sponsor: Instituto de Investigacion Sanitaria La Fe
• Collaborators: Hasselt University; Aristotle University Of Thessaloniki

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: November 15, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: non-communicable diseases; Ultrafine Particulate; micro nano plastics
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Noncommunicable Diseases
• Other Study ID Numbers: UPRISE; 1011566 (Other Grant/Funding Number: European Union)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No