No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
1,600 (estimated)
Sponsor
Instituto de Investigacion Sanitaria La Fe · Other
Who this trial is looking for
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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.
Trial Locations
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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 …
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).
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