NCT07238608 Impact of UFPs and MNPs on Fetal Health
| NCT ID | NCT07238608 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Investigacion Sanitaria La Fe |
| Condition | Pregnant Women |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,600 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2029-12-31 |
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
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).