How ultrafine particles and micro‑nano plastics affect fetal development

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

This project will test whether pregnant women’s exposure to ultrafine particulate matter and micro‑nano plastics increases the chance of preterm birth and later non‑communicable diseases in their children.

Quick facts

• Study type: Observational
• Enrollment: 1600 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Instituto de Investigacion Sanitaria La Fe (Academic / other)
• Locations: 1 site (Valencia, Valencia)
• Trial ID: NCT07238608 on ClinicalTrials.gov

What this trial studies

This is an observational case‑control study of 1,600 newborns comparing preterm and full‑term births, with a 1:2 control ratio in participating countries. A nested personal exposure monitoring substudy will equip 150 pregnant mothers (50 per location) with sensors to measure individual ultrafine particle and micro‑plastic exposure and collect biological samples including urine. Participants are non‑smoking women aged 18 or older who have lived in the study area at least one year and enroll early in pregnancy; exclusions include multiple pregnancy, known kidney disease, significant pregnancy complications, or late first visit. Data will be used to link measured exposures in pregnancy to timing of delivery and early‑life markers that may predispose to later non‑communicable diseases.

Who should consider this trial

Good fit: Ideal candidates are non‑smoking pregnant women aged 18 or older who have lived in the study area for at least one year and can enroll early in pregnancy.

Not a fit: Women who smoke, have multiple pregnancies, known kidney disease, late presentation after the first trimester, or who plan to terminate the pregnancy are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the project could identify specific prenatal exposures that raise preterm birth risk and support actions to reduce exposure during pregnancy to improve child health.

How similar studies have performed: Prior epidemiological work has linked general air pollution (PM2.5/PM10) to preterm birth, but the specific roles of ultrafine particles and micro‑nano plastics are less established and personal exposure monitoring in pregnancy remains relatively novel.

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).

Where this trial is running

Valencia, Valencia

• Instituto de Investigación Sanitaria La Fe — Valencia, Valencia, Spain (Recruiting)

Study contacts

• Study coordinator: Alba Ruiz Gaitán, Dr

Conditions Pregnant Women; non-communicable diseases; Ultrafine Particulate; micro nano plastics