NCT07238608

Brief Summary

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 Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Jan 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Jan 2026Dec 2029

First Submitted

Initial submission to the registry

November 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

4 years

First QC Date

November 15, 2025

Last Update Submit

November 15, 2025

Conditions

Pregnant Women

Keywords

non-communicable diseasesUltrafine Particulatemicro nano plastics

Outcome Measures

Primary Outcomes (3)

  • PreTerm Birth

    at the moment of birth

  • Small for Gestational Age

    at the moment of birth

  • Low Birth Weigth

    at the moment of birth

Study Arms (2)

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. 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

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.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Investigación Sanitaria La Fe

Valencia, Valencia, 46016, Spain

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

PBMNCs from cord blood samples

MeSH Terms

Conditions

Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Alba Ruiz Gaitán, Dr

CONTACT

0034961246690alba_ruiz@externos.iislafe.es

Imelda Ontoria Oviedo, Dr

CONTACT

0034961246690imelda_ontoria@iislafe.es

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 15, 2025

First Posted

November 20, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

November 20, 2025

Record last verified: 2025-10

Locations

ES(1)