Actively Recruiting
UPRISE Unravelling Ultrafine Particulate Matter and Micro Nano Plastic's Mechanisms of Impact on Fetal Health
Led by Instituto de Investigacion Sanitaria La Fe · Updated on 2025-11-20
1600
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Instituto de Investigacion Sanitaria La Fe
Lead Sponsor
H
Hasselt University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how exposure to air pollution, especially ultrafine particulate matter (UFP, PM0.1) and micro and nano plastics (MNPs), affects fetal development. The study focuses on the short-term impact of these pollutants on the chance of preterm delivery and how this may increase the risk of non-communicable diseases later in life. The research involves a case-control design with newborns and their mothers from multiple locations including Greece, Spain, and Belgium. The study includes 1600 newborns, with a control group of full-term neonates recruited at a 1:2 ratio. Additionally, a personal exposure monitoring substudy involves 150 mothers aged 18 years and older, with participants from various locations. The design uses a nested case-control approach within an existing prospective cohort framework. Participants will be involved through monitoring exposures during pregnancy, with data collected on preterm birth, small for gestational age, and low birth weight at birth. The study will assess exposure to pollutants using personal sensors and analyze health outcomes of the newborns. The total observation covers pregnancy and birth outcomes, with assessments focused on early life stages.
CONDITIONS
Brief Title
Impact of UFPs and MNPs on Fetal Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agreement to sign the informed consent
- Non-smoking mothers with no exposure to second-hand smoke
- Women aged 18 years or older
- Not planning to terminate the pregnancy
- Resided in the study geographical area for at least 1 year
You will not qualify if you...
- First prenatal visit after 11 weeks of gestation
- Pregnancy complications limiting urine exposure measurements, such as gestational diabetes
- Known kidney disease
- Multiple pregnancy (twins or more pregnancies)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At the moment of birth
Participants undergo assessments around the time of birth to evaluate fetal health outcomes.
1 visit (in-person) at birth
Duration - Up to birth and shortly thereafter
Participants are observed to understand the impact of ultrafine particulate matter and micro nano plastics on fetal health.
Follow-up visits may occur depending on cohort assignment
Trial Site Locations
Total: 1 location
1
Instituto de Investigación Sanitaria La Fe
Valencia, Valencia, Spain, 46016
Actively Recruiting
Research Team
A
Alba Ruiz Gaitán, Dr
I
Imelda Ontoria Oviedo, Dr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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