Ultrafine Particles and Fetal Contamination | NCT04068389

Studies
Ultrafine Particles and Fetal Contamination

NCT04068389

Sponsor

University Hospital, Bordeaux

Status

Completed

Last Update Posted

Jun 18, 2026Actual

Enrollment

62Actual

Phase

Not provided

Conditions

Lung; Premature
Pollution; Exposure

Interventions

Pulmonary Tissue Collection

Countries

Not provided

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

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 22, 2009Actual

Primary Completion Date

Nov 9, 2012Actual

Completion Date

Nov 9, 2012Actual

First Submitted Date

Aug 23, 2019

First Submission Date that Met QC Criteria

Aug 23, 2019

First Posted Date

Aug 28, 2019Actual

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

Jun 16, 2026

Last Update Posted Date

Jun 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The objective of this study is to evaluate the transplacental passage of fine and ultrafine particles (nanoparticles) inhaled by the mother.

Detailed Description

Epidemiological studies have demonstrated the harmful effects of particulate air pollution on the progress of pregnancy and postnatal health.

Experimental studies have suggested the transplacental passage of asbestos fibers, but despite the strong growth in the use and production of fine and ultrafine particles, no study has examined the permeability of the placenta to these compounds or the exposures fetuses that may result.

The objective of this study is to evaluate the transplacental passage of fine and ultrafine particles (nanoparticles) inhaled by the mother.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

62Actual

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary Tissue Collection	Procedure	Pulmonary Tissue Collection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of fine particles in fetal lung samples yes/no	Analysis in electron microscopy	At the screening

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- All women volunteers for whom a medical termination of pregnancy is proposed for a fetus older than 22 weeks (weight over 500g).

Exclusion Criteria:

Refusal of participation of the patient.
Fetus with malformation syndrome affecting pulmonary perfusion.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnacy women

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Women with a medical termination of pregnancy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olivia OCHRYMCZUK, Dr	University Hospital, Bordeaux	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28493984	Result	Fayon M, Lacoste-Rodrigues A, Barat P, Helbling JC, Nacka F, Berger P, Moisan MP, Corcuff JB. Nasal airway epithelial cell IL-6 and FKBP51 gene expression and steroid sensitivity in asthmatic children. PLoS One. 2017 May 11;12(5):e0177051. doi: 10.1371/journal.pone.0177051. eCollection 2017.

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications