Ultrafine Particles and Fetal Contamination (FOETOPUF)

August 26, 2019 updated by: University Hospital, Bordeaux

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

62

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with a medical termination of pregnancy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Olivia OCHRYMCZUK, Dr, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2009

Primary Completion (Actual)

November 9, 2012

Study Completion (Actual)

November 9, 2012

Study Registration Dates

First Submitted

August 23, 2019

First Submitted That Met QC Criteria

August 23, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHUBX 2008/04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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