Impact of UFPs and MNPs on Fetal Health
ConditionPregnant Women
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorInstituto de Investigacion Sanitaria La Fe
About this trial
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
Qualifiers
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);
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Not listed
Trial groups
1,600 Participants
are grouped into 2 trial groupsSponsors and collaborators
Instituto de Investigacion Sanitaria La Fe
Lead sponsor
Hasselt University
Collaborator
Aristotle University Of Thessaloniki
Collaborator
Source ClinicalTrials.gov