NCT04068389

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2009

Typical duration for all trials

Status
completed

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 Start

First participant enrolled

December 22, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2012

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Last Updated

June 18, 2026

Status Verified

August 1, 2019

Enrollment Period

2.9 years

First QC Date

August 23, 2019

Last Update Submit

June 16, 2026

Conditions

Lung; PrematurePollution; Exposure

Keywords

Atmospheric particles

Outcome Measures

Primary Outcomes (1)

  • Presence of fine particles in fetal lung samples yes/no

    Analysis in electron microscopy

    At the screening

Interventions

Pulmonary Tissue CollectionPROCEDURE

Pulmonary Tissue Collection

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnacy women
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with a medical termination of pregnancy

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28493984RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fetal lung samples

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Olivia OCHRYMCZUK, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

December 22, 2009

Primary Completion

November 9, 2012

Study Completion

November 9, 2012

Last Updated

June 18, 2026

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share