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MecoExpo Study Protocol (MecoExpo)

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ClinicalTrials.gov Identifier: NCT02899819
Recruitment Status : Completed
First Posted : September 14, 2016
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

The MecoExpo project seeks to evaluate the in utero exposure of newborns in the Picardie region to commonly used pesticides. These pesticides were selected in a pilot study (the Mecopic study) on the basis of their toxicity (effects on foetal development, endocrine perturbation, neurological toxicity and carcinogenicity) and a certain number of indicators of pesticide use and the presence of pesticide in the environment in Picardie.

These substances (or their metabolites) will be measured in the each newborn's meconium (the first faeces after birth) and each newborn's mother's hair in the Picardie region during the study period. The mother's exposure will also be assessed using a retrospective questionnaire (filled out within a few days of the delivery).

Thus, the MecoExpo project will enable the investigators to:

  1. evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and clinical parameters measured at birth (term, length, weight, etc.).
  2. map pesticide exposure across the Picardie region.
  3. create a meconium bank in Picardie (the first ever meconium bank in France).

Condition or disease Intervention/treatment Phase
Infant, Newborn Other: meconium Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1020 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: MecoExpo Study Protocol
Study Start Date : February 2011
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: meconium
The meconium will be sampled in the first 2 days of life
Other: meconium
The meconium will be sampled in the first 2 days of life




Primary Outcome Measures :
  1. fœtal vs mother exposure - term [ Time Frame: Day 2 ]
    evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and term at birth

  2. fœtal vs mother exposure - length [ Time Frame: Day 2 ]
    evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and length at birth

  3. fœtal vs mother exposure - weight [ Time Frame: Day 2 ]
    evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and weight at birth



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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All newborns in Picardie will be eligible. Good command of the French language by a least one of the two people with responsibility for the child will be required for filling out the questionnaire.
  • The mother's place of residence must have been in Picardie during the last two trimesters of pregnancy.

Exclusion Criteria:

  • Newborns with foetal distress

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): NCT02899819


Locations
France
CH Abbeville
Abbeville, France, 80142
CHU Amiens
Amiens, France, 80054
Groupe Santé Victor Pauchet
Amiens, France, 80094
CH Beauvais
Beauvais, France, 60021
CH Chateau-Thierry
Chateau-thierry, France, 02405
CH Chauny
Chauny, France, 02303
Clinique Saint Come
Compiegne, France, 60200
CH Compiegne
Compiegne, France, 60321
Groupe Hospitalier Public Sud Oise
Creil, France, 60109
CH Laon
Laon, France, 02001
CH Peronne
Peronne, France, 80201
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Caroline DEGUINES, MD CHU Amiens

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02899819     History of Changes
Other Study ID Numbers: PI10-PR-BACH
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

Keywords provided by Centre Hospitalier Universitaire, Amiens:
pesticides
exposure
in utero