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NCT Number: NCT07238608

Impact of UFPs and MNPs 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Instituto de Investigación Sanitaria La Fe

Valencia, 46016, Spain

Location status: Recruiting

Location contact

Alba Ruiz Gaitán, Dr

CONTACT

[email protected]

0034961246690

About this study

The characteristics of this study population are as follows:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. PreTerm Birth

    Time frame: at the moment of birth

  2. Small for Gestational Age

    Time frame: at the moment of birth

  3. Low Birth Weigth

    Time frame: at the moment of birth

Study contacts

Contact information is provided by the study sponsor or research team.

Alba Ruiz Gaitán, Dr

CONTACT

[email protected]

0034961246690

Imelda Ontoria Oviedo, Dr

CONTACT

[email protected]

0034961246690

Sponsors and collaborators

Lead sponsor

Instituto de Investigacion Sanitaria La Fe

Other

Collaborators

  • Aristotle University Of Thessaloniki
  • Hasselt University

Registry information

Official study title

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

Acronym: UPRISE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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