Impact of UFPs and MNPs on Fetal Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pregnant Women. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
UPRISE Unravelling Ultrafine Particulate Matter and Micro Nano Plastic's Mechanisms of Impact on Fetal Health
Overview
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.
Primary outcome measures
- PreTerm Birth [Time frame: at the moment of birth]
- Small for Gestational Age [Time frame: at the moment of birth]
- Low Birth Weigth [Time frame: at the moment of birth]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Spain · 1 center
- Instituto de Investigación Sanitaria La Fe — Valencia
Identifiers
NCT: NCT07238608 · UPRISE · 1011566