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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07238608

Acronym

UPRISE

Enrollment

1600

Registered

2025-11-20

Start date

2026-01-01

Completion date

2029-12-31

Last updated

2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant Women

Keywords

non-communicable diseases, Ultrafine Particulate, micro nano plastics

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

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

Countries

Spain

Contacts

Primary ContactAlba Ruiz Gaitán, Dr

alba_ruiz@externos.iislafe.es0034961246690

Backup ContactImelda Ontoria Oviedo, Dr

imelda_ontoria@iislafe.es0034961246690

Outcome results