Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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 population

Pregnant mothers will be recruited at the first antenatal visit (around eight weeks of gestation).

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,600 Participants
are grouped into 2 trial groups
Group A: Case-control design
Group B: Personal Exposure Monitoring PEM Substudy

Trial outcomes

Primary outcomes

1

PreTerm Birth

Time frame
at the moment of birth
2

Small for Gestational Age

Time frame
at the moment of birth
3

Low Birth Weigth

Time frame
at the moment of birth

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto de Investigacion Sanitaria La Fe

Lead sponsor

Hasselt University

Collaborator

Aristotle University Of Thessaloniki

Collaborator

Source ClinicalTrials.gov
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