Impact of UFPs and MNPs on Fetal Health | NCT07238608

Studies
Impact of UFPs and MNPs on Fetal Health

NCT07238608

Sponsor

Instituto de Investigacion Sanitaria La Fe

Status

Recruiting

Last Update Posted

Nov 20, 2025Actual

Enrollment

1,600Estimated

Phase

Not provided

Conditions

Pregnant Women

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1011566	Other Grant/Funding Number	European Union

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2026Estimated

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Nov 15, 2025

First Submission Date that Met QC Criteria

Nov 15, 2025

First Posted Date

Nov 20, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2025

Last Update Posted Date

Nov 20, 2025Actual

Name	Class
Hasselt University	OTHER
Aristotle University Of Thessaloniki	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The characteristics of this study population are as follows:

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.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PreTerm Birth		at the moment of birth
Small for Gestational Age		at the moment of birth
Low Birth Weigth		at the moment of birth

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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 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).

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alba Ruiz Gaitán, Dr	Contact	0034961246690		alba_ruiz@externos.iislafe.es
Imelda Ontoria Oviedo, Dr	Contact	0034961246690		imelda_ontoria@iislafe.es

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto de Investigación Sanitaria La Fe	Recruiting	Valencia	Valencia	46016	Spain

Label	URL
Related Info	View source

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000073296	Noncommunicable Diseases

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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