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Ultrafine Particles and Fetal Contamination (FOETOPUF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068389
Recruitment Status : Completed
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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

Condition or disease Intervention/treatment
Lung; Premature Pollution; Exposure Procedure: Pulmonary Tissue Collection

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.

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Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Permeability of Atmospheric Particles Placenta (Fine and Ultrafine Particles): Analysis of Fetal Retention
Actual Study Start Date : December 22, 2009
Actual Primary Completion Date : November 9, 2012
Actual Study Completion Date : November 9, 2012

Intervention Details:
  • Procedure: Pulmonary Tissue Collection
    Pulmonary Tissue Collection


Primary Outcome Measures :
  1. Presence of fine particles in fetal lung samples yes/no [ Time Frame: At the screening ]
    Analysis in electron microscopy


Biospecimen Retention:   Samples Without DNA
Fetal lung samples


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnacy women
Sampling Method:   Non-Probability Sample
Study Population
Women with a medical termination of pregnancy
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068389


Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Olivia OCHRYMCZUK, Dr University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04068389    
Other Study ID Numbers: CHUBX 2008/04
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Bordeaux:
Atmospheric particles