MecoExpo Study Protocol (MecoExpo)

September 16, 2025 updated by: Centre Hospitalier Universitaire, Amiens

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1020

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Abbeville, France, 80142
        • CH Abbeville
      • Amiens, France, 80054
        • CHU Amiens
      • Amiens, France, 80094
        • Groupe Santé Victor Pauchet
      • Beauvais, France, 60021
        • CH Beauvais
      • Chauny, France, 02303
        • CH Chauny
      • Château-Thierry, France, 02405
        • CH Chateau-Thierry
      • Compiègne, France, 60321
        • CH Compiègne
      • Compiègne, France, 60200
        • Clinique Saint Come
      • Creil, France, 60109
        • Groupe Hospitalier Public Sud Oise
      • Laon, France, 02001
        • CH Laon
      • Péronne, France, 80201
        • CH Peronne

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

No older than 2 days (Child)

Accepts Healthy Volunteers

No

Description

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

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 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
Day 2
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
Day 2

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Caroline DEGUINES, MD, CHU Amiens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2011

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

September 5, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimated)

September 14, 2016

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI10-PR-BACH

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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