Impact of UFPs and MNPs on Fetal Health (UPRISE)

Instituto de Investigacion Sanitaria La Fe

Status: Enrolling

Conditions: Pregnant Women

Study type: Observational

Funder types: Other

Identifiers

NCT07238608

1011566 (Other Grant/Funding Number)

UPRISE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,600 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

1,600 participants in 2 patient groups

Case-control design

Description:

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. ENVIRONAGE, Belgium, employs a nested case-control design, making use of its prospective cohort framework that is already in place.

Personal Exposure Monitoring PEM Substudy

Description:

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.