NCT02899819

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. 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. 2.map pesticide exposure across the Picardie region.
  3. 3.create a meconium bank in Picardie (the first ever meconium bank in France).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,020

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

4 years

First QC Date

September 5, 2016

Last Update Submit

September 16, 2025

Conditions

Infant, Newborn

Keywords

pesticidesexposurein utero

Outcome Measures

Primary Outcomes (3)

  • fœtal vs mother exposure - term

    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

    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

    evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and weight at birth

    Day 2

Study Arms (1)

meconium

EXPERIMENTAL

The meconium will be sampled in the first 2 days of life

Other: meconium

Interventions

meconiumOTHER

The meconium will be sampled in the first 2 days of life

meconium

Eligibility Criteria

AgeUp to 2 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Newborns with foetal distress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

CH Abbeville

Abbeville, 80142, France

Location

CHU Amiens

Amiens, 80054, France

Location

Groupe Santé Victor Pauchet

Amiens, 80094, France

Location

CH Beauvais

Beauvais, 60021, France

Location

CH Chauny

Chauny, 02303, France

Location

CH Chateau-Thierry

Château-Thierry, 02405, France

Location

Clinique Saint Come

Compiègne, 60200, France

Location

CH Compiegne

Compiègne, 60321, France

Location

Groupe Hospitalier Public Sud Oise

Creil, 60109, France

Location

CH Laon

Laon, 02001, France

Location

CH Peronne

Péronne, 80201, France

Location

Related Publications (1)

  • Mayhoub F, Berton T, Bach V, Tack K, Deguines C, Floch-Barneaud A, Desmots S, Stephan-Blanchard E, Chardon K. Self-reported parental exposure to pesticide during pregnancy and birth outcomes: the MecoExpo cohort study. PLoS One. 2014 Jun 20;9(6):e99090. doi: 10.1371/journal.pone.0099090. eCollection 2014.

    PMID: 24949871RESULT

Study Officials

  • Caroline DEGUINES, MD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2016

First Posted

September 14, 2016

Study Start

February 1, 2011

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

FR(11)