MecoExpo Study Protocol

Not Applicable

Completed

• Conditions: Infant, Newborn
• Interventions: Other: meconium

• Registration Number: NCT02899819
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-14
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1020

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
fœtal vs mother exposure - length	Day 2	evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and length at birth
fœtal vs mother exposure - term	Day 2	evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and term at birth
fœtal vs mother exposure - weight	Day 2	evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and weight at birth

Trial Locations

Locations (11)

CH Abbeville; 🇫🇷 Abbeville, France

Groupe Santé Victor Pauchet; 🇫🇷 Amiens, France

CH Beauvais; 🇫🇷 Beauvais, France

CH Chateau-Thierry; 🇫🇷 Chateau-thierry, France

CH Compiegne; 🇫🇷 Compiegne, France

Groupe Hospitalier Public Sud Oise; 🇫🇷 Creil, France

CH Laon; 🇫🇷 Laon, France

CH Peronne; 🇫🇷 Peronne, France

Clinique Saint Come; 🇫🇷 Compiegne, France

CHU Amiens; 🇫🇷 Amiens, France

CH Chauny; 🇫🇷 Chauny, France