Infant, NewbornMecoExpoNCT02899819
MecoExpo Study Protocol
A study testing meconium in people with Infant, Newborn, run by Centre Hospitalier Universitaire, Amiens at 11 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 2 days
- Conditions the study is for
- Infant, Newborn
- What is being tested?
- meconium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,020 participants
- Where
- 11 sitesFrance
- Study dates
- Feb 2011to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Newborns with foetal distress
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CH Abbeville
Abbeville, 80142
CHU Amiens
Amiens, 80054
Groupe Santé Victor Pauchet
Amiens, 80094
CH Beauvais
Beauvais, 60021
CH Chateau-Thierry
Château-Thierry, 02405
CH Chauny
Chauny, 02303
Clinique Saint Come
Compiègne, 60200
CH Compiegne
Compiègne, 60321
Groupe Hospitalier Public Sud Oise
Creil, 60109
CH Laon
Laon, 02001
CH Peronne
Péronne, 80201
About this study
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).
Read more
Thus, the MecoExpo project will enable the investigators to:
- 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.).
- map pesticide exposure across the Picardie region.
- create a meconium bank in Picardie (the first ever meconium bank in France).
- Conditions
- Infant, Newborn
- Being tested
- meconium
- Keywords
- pesticides, exposure, in utero
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meconiumOther
The meconium will be sampled in the first 2 days of life
| Study group | Role | What they receive |
|---|---|---|
| meconium | Experimental | The meconium will be sampled in the first 2 days of life Receives: Other: meconium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startFeb 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline DEGUINES, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899819
- Sponsor's protocol ID
- PI10-PR-BACH
- Acronym
- MecoExpo
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2016
- Last updated
- 19 Sep 2025
- Results posted
- No
Publications
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.
PubMed 24949871
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MecoExpo Study Protocol
- ClinicalTrials.gov ID
- NCT02899819
- Acronym / sponsor ID
- MecoExpo / PI10-PR-BACH
- Conditions
- Infant, Newborn
- Keywords
- pesticides, exposure, in utero
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,020 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.).
- map pesticide exposure across the Picardie region.
- create a meconium bank in Picardie (the first ever meconium bank in France).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| meconium | Experimental | Other: meconiumThe meconium will be sampled in the first 2 days of life |
Who may qualify
- Ages
- Up to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Newborns with foetal distress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| meconiumThe meconium will be sampled in the first 2 days of life | Other | meconium |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publication: PubMed 24949871Mayhoub 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.
Related trials for Infant, Newborn
RecruitingObservational study
Impact of Delivery Mode on Infant Gut Microbiota, Visceral Sensitivity, and the Neuroenteric System
Healthy Newborn Infants
RecruitingPhase 1
A Study of AIR-001 in Adults With Alpha-1 Antitrypsin Deficiency (AATD)
Alpha 1 Antitrypsin Deficiency
RecruitingObservational study
Cerebral Monitoring Using Pulsatile Near Infrared Spectroscopy in Neonates
Neonatal Disease
Not yet recruiting
Postpartum Care in the NICU Multi-Site Breastfeeding
Postpartum Complication, Postpartum
Active, not recruiting
Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Respiratory Distress Syndrome, Newborn, Infant, Premature
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline DEGUINES, MD principal investigator
CHU Amiens
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing meconium in people with Infant, Newborn, run by Centre Hospitalier Universitaire, Amiens at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fœtal vs mother exposure - term (time frame: Day 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02899819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025; AzTrials last refreshed its copy on 29 Oct 2026.