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NCT04068389 Clinical Trial

Ultrafine Particles and Fetal Contamination

Pollution; Exposure Clinical Trial

— FOETOPUF  

Official title:
Study of the Permeability of Atmospheric Particles Placenta (Fine and Ultrafine Particles): Analysis of Fetal Retention

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04068389
Other study ID # CHUBX 2008/04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 22, 2009
Est. completion date November 9, 2012

Study information
Verified date August 2019
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date November 9, 2012
Est. primary completion date November 9, 2012
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Pulmonary Tissue Collection
Pulmonary Tissue Collection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Bordeaux

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of fine particles in fetal lung samples yes/no Analysis in electron microscopy At the screening
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