Congenital MalformationPENEWNCT01613638
Pregnancy Environment and Newborn Malformations
A study testing meconium samples + maternal self-questionnaire in people with Congenital Malformation, run by Rennes University Hospital at 11 sites in France.
Trial summary
Congenital malformations rate is about 3% in France. There are already 5 registries in France, covering about 16% of French births: Paris Registry, (about 38 000 births /year), Alsace Registry, (about 23 000 births/year), Rhône-Alpes Registry, (about 56 000 births/year), Auvergne Registry, (about 14 000 births/year)… Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Congenital Malformation
- What is being tested?
- meconium samples + maternal self-questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,657 participants
- Where
- 11 sitesFrance
- Study dates
- 5 Oct 2012to 31 Dec 2020
- 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 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All live births, fetal deaths with gestational age (GA) ≥22 weeks and terminations of pregnancy for medical reasons (IMG) from 20 weeks of amenorrhea (SA) included.
- born from mothers living in Brittany at delivery
- with a congenital anomaly according to Eurocat criteria, diagnosed or suspected (and then confirmed) at birth
- or with mild congenital heart defects, genital anomalies or hip dislocation diagnosed after birth (and before the age of one) Suspicion of chromosomal abnormality or genetic syndrome on purely clinical criteria but not yet authenticated by genetic analyzes. If the chromosomal or genetic abnormalities are secondarily authenticated, these cases will be excluded a posteriori.
- Non inclusion criteria :
- Spontaneous abortion before 22 weeks gestational age.
Show all 9Show fewer
- IMG before the 20 week term amenorrhea
- Chromosomal abnormalities or syndromes genetic authenticated by karyotype or analysis in molecular biology, in antenatal
- Mother with legal protection (guardianship)
Who cannot join
- Prenatally suspected malformations, which are not confirmed by postnatal screening or clinical evolution
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Polyclinique de Keraudren
Brest, Brittany Region, 29200
Brest University Hospital
Brest, Brittany Region, 29609
Lannion Hospital
Lannion, Brittany Region, 22303
Lorient Hospital
Lorient, Brittany Region, 56322
Ploermel Hospital
Ploërmel, Brittany Region, 56804
Quimper Hospital
Quimper, Brittany Region, 29000
Rennes University Hospital
Rennes, Brittany Region
Saint-Brieuc Hospital
Saint-Brieuc, Brittany Region, 22000
Saint-Grégoire Hospital
Saint-Grégoire, Brittany Region, 35760
Clinique Océane
Vannes, Brittany Region, 56000
Vannes Hospital
Vannes, Brittany Region, 56000
About this study
Official title: Congenital Malformations and Intrauterine Pollutants Exposure (Alcohol, Solvents and Pesticides) in Brittany. Population Based Case-control Study Short Title : Malformations and Environment Acronym : PENEW for "Pregnancy Environment and Newborn Malformations"
Congenital malformations rate is about 3% in France. There are already 5 registries in France, covering about 16% of French births: Paris Registry, (about 38 000 births /year), Alsace Registry, (about 23 000 births/year), Rhône-Alpes Registry, (about 56 000 births/year), Auvergne Registry, (about 14 000 births/year), and la Réunion Registry. The aim of malformation registries is to carry out epidemiologic surveillance of congenital anomalies. The objectives are mainly to provide essential epidemiologic information on congenital anomalies, to facilitate the early warning of teratogenic exposures, to act as an information and resource centre regarding clusters, to provide data for research related to the causes and prevention of congenital anomalies.
A previous study was carried out in Brittany in 2008-2009, by the perinatal network of Ille et Vilaine, in collaboration with two research teams (Inserm U1085 and Inserm U 936), to record all cases of 4 types of congenital anomalies: congenital heart disease, spina bifida, diaphragmatic hernia and hypospadia. The results showed prevalence rates similar to those observed by Eurocat for spina bifida and diaphragmatic hernia, but a higher prevalence regarding congenital heart diseases and hypospadia. In this study the investigators could not determine whether this was due to a real higher frequency or to a particular exhaustiveness in the recording methodology.
Read more
There are hypothesis about the role of intrauterine exposure to pesticides, known as endocrine disruptors, and the risk of congenital genital anomalies. Brittany is an intensive agricultural area, and it is thus worth studying the impact of pesticides exposure on congenital anomalies.
There are also hypothesis on the impact of occupational exposure to solvents on congenital anomalies (Garlantezec 2009), and on the role of alcohol exposure (which concerns about 8% pregnant women in France) on oro-facial clefts and congenital heart diseases.
The Registry of congenital anomalies in Brittany was set up in 2010. The main aim is to study the impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk of congenital malformations diagnosed at births, by measuring the exposure both directly in meconium, and indirectly by questionnaires.
Secondary objectives are to study other risk factors such as medicine intake, pregnancy illness…
Read the detailed description
Population based case-control study:
2 controls per case will be included, corresponding to the first 2 births without congenital anomalies, with same sex and same birth place, following the case.
INVESTIGATION METHODOLOGY :
All maternity in Brittany were proposed to participate. In each maternity, the referent practitioner informs the parents and includes the cases.
For each case and control, meconium samples and a mother's lock are collected by nurses or midwives, medical data are collected from medical reports by the registry investigator, and a self-questionnaire is filled by the mother.
Meconium samples are immediately stored in a freezer (-20°C), secondarily transported to a biological storage centre at the university hospital and then dispatched to specialised laboratories for toxicological analyses: INERIS (for solvents and pesticides) and Toxicology Unit, University hospital Rennes (for Alcohol).
For dead fetuses (stillbirths or termination of pregnancy), meconium will be collected by the pathologist in charge of the autopsy, after parents' consent.
Evaluation of exposure:
- direct evaluation: by toxicological analyses in meconium samples: Alcohol, Solvents and pesticides
- indirect evaluation: by maternal self-questionnaire including data on occupational and domestic exposures, hobbies, life habits…, precise address (for spatial location)
Particular cases: mild congenital heart defects, genital anomalies and hip dislocation diagnosed later after birth (after the period oh meconium and before the age of one): these cases will be spotted through the Registry, there won't be any biological sample for them, but mothers will be contacted by main investigator and medical data and mother questionnaires will be collected. There won't be any control included for those cases included after birth.
Associations between exposure risk factors (alcohol, solvents and pesticides) and the risk of congenital malformations will be estimated by a multivariate analysis.
- Exposure to solvents will be estimated by assay in meconium and by occupational questionnaire
- Exposure to alcohol will be estimated by assay of Ethylglucuronide et de Ethylsulfate in meconium.
- Exposure to pesticides will be estimated by assay in meconium, by questionnaire and by spatial location.
- Conditions
- Congenital Malformation
- Being tested
- meconium samples + maternal self-questionnaire
- Keywords
- congenital malformation, pollutants
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meconium samples + maternal self-questionnaireOther
meconium samples + maternal self-questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Congenital malformations | Other | All livebirths, fetal deaths with gestational age (GA) ≥22 weeks and terminations of pregnancy (at any gestational age) after prenatal diagnosis of malformation.
* born from mothers living in Brittany at delivery
* with a congenital anomaly according to Eurocat criteria, diagnosed or suspected (and then confirmed) at birth
* or with mild congenital heart defects, genital anomalies or hip dislocation diagnosed after birth (and before the age of one) Receives: Other: meconium samples + maternal self-questionnaire |
| control | Other | 2 controls per case will be included, corresponding to the first 2 births without congenital anomalies, with same sex and same birth place, following the case. Receives: Other: meconium samples + maternal self-questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk of congenital malformations diagnosed at births, by measuring the exposure both directly in meconium, and indirectly by questionnaires.
impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk of congenital malformations diagnosed at births, by measuring the exposure both directly in meconium, and indirectly by questionnaires.
Measured: up to 48 hours
Secondary outcomes (1)
other risk factors such as medicine intake, pregnancy illness…
other risk factors such as medicine intake, pregnancy illness…
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study start5 Oct 2012
- Primary completion31 Dec 2018
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Congenital MalformationStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,657 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Rouget, MD, Principal investigator, Rennes University HospitalPhilippe Lefevre, MD, Principal investigator, Fougères HospitalJoëlle Gueguen, MD, Principal investigator, Saint-Grégoire HospitalIsabelle Blanchot, MD, Principal investigator, Clinique La Sagesse - RennesMaria Vernis, MD, Principal investigator, Saint Malo hospitalDominique Chaumet, MD, Principal investigator, Vitré HospitalJoseph Abi-Fadel, MD, Principal investigator, Redon HospitalPhilippe Rebour, MD, Principal investigator, Lannion Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613638
- Sponsor's protocol ID
- PHRC/10-02 - PENEW
- Other IDs
- B110827-40, 11/22-811, 2010-A01445-34
- Acronym
- PENEW
- Status last verified
- May 2023
- First submitted
- 24 May 2012
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Meyer-Monath M, Beaumont J, Morel I, Rouget F, Tack K, Lestremau F. Analysis of BTEX and chlorinated solvents in meconium by headspace-solid-phase microextraction gas chromatography coupled with mass spectrometry. Anal Bioanal Chem. 2014 Jul;406(18):4481-90. doi: 10.1007/s00216-014-7836-2. Epub 2014 May 18.
PubMed 24838489Meyer-Monath M, Chatellier C, Cabooter D, Rouget F, Morel I, Lestremau F. Development of liquid chromatography methods coupled to mass spectrometry for the analysis of substances with a wide variety of polarity in meconium. Talanta. 2015 Jun 1;138:231-239. doi: 10.1016/j.talanta.2015.02.058. Epub 2015 Mar 19.
PubMed 25863396Meyer-Monath M, Chatellier C, Rouget F, Morel I, Lestremau F. Development of a multi-residue method in a fetal matrix: analysis of meconium. Anal Bioanal Chem. 2014 Dec;406(30):7785-97. doi: 10.1007/s00216-014-8243-4. Epub 2014 Nov 9.
PubMed 25381610Rouget F, Bihannic A, Cordier S, Multigner L, Meyer-Monath M, Mercier F, Pladys P, Garlantezec R. Petroleum and Chlorinated Solvents in Meconium and the Risk of Hypospadias: A Pilot Study. Front Pediatr. 2021 Jun 2;9:640064. doi: 10.3389/fped.2021.640064. eCollection 2021.
PubMed 34150682
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congenital Malformations and Intrauterine Pollutants Exposure (Alcohol, Solvents and Pesticides) in Brittany. Population Based Case-control Study Short Title : Malformations and Environment Acronym : PENEW for "Pregnancy Environment and Newborn Malformations"
- ClinicalTrials.gov ID
- NCT01613638
- Acronym / sponsor ID
- PENEW / PHRC/10-02 - PENEW
- Conditions
- Congenital Malformation
- Keywords
- congenital malformation, pollutants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,657 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 5 Oct 2012 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Jun 2012 (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.
Congenital malformations rate is about 3% in France. There are already 5 registries in France, covering about 16% of French births: Paris Registry, (about 38 000 births /year), Alsace Registry, (about 23 000 births/year), Rhône-Alpes Registry, (about 56 000 births/year), Auvergne Registry, (about 14 000 births/year), and la Réunion Registry. The aim of malformation registries is to carry out epidemiologic surveillance of congenital anomalies. The objectives are mainly to provide essential epidemiologic information on congenital anomalies, to facilitate the early warning of teratogenic exposures, to act as an information and resource centre regarding clusters, to provide data for research related to the causes and prevention of congenital anomalies.
A previous study was carried out in Brittany in 2008-2009, by the perinatal network of Ille et Vilaine, in collaboration with two research teams (Inserm U1085 and Inserm U 936), to record all cases of 4 types of congenital anomalies: congenital heart disease, spina bifida, diaphragmatic hernia and hypospadia. The results showed prevalence rates similar to those observed by Eurocat for spina bifida and diaphragmatic hernia, but a higher prevalence regarding congenital heart diseases and hypospadia. In this study the investigators could not determine whether this was due to a real higher frequency or to a particular exhaustiveness in the recording methodology.
There are hypothesis about the role of intrauterine exposure to pesticides, known as endocrine disruptors, and the risk of congenital genital anomalies. Brittany is an intensive agricultural area, and it is thus worth studying the impact of pesticides exposure on congenital anomalies.
There are also hypothesis on the impact of occupational exposure to solvents on congenital anomalies (Garlantezec 2009), and on the role of alcohol exposure (which concerns about 8% pregnant women in France) on oro-facial clefts and congenital heart diseases.
The Registry of congenital anomalies in Brittany was set up in 2010. The main aim is to study the impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk of congenital malformations diagnosed at births, by measuring the exposure both directly in meconium, and indirectly by questionnaires.
Secondary objectives are to study other risk factors such as medicine intake, pregnancy illness…
Detailed description
Population based case-control study:
2 controls per case will be included, corresponding to the first 2 births without congenital anomalies, with same sex and same birth place, following the case.
INVESTIGATION METHODOLOGY :
All maternity in Brittany were proposed to participate. In each maternity, the referent practitioner informs the parents and includes the cases.
For each case and control, meconium samples and a mother's lock are collected by nurses or midwives, medical data are collected from medical reports by the registry investigator, and a self-questionnaire is filled by the mother.
Meconium samples are immediately stored in a freezer (-20°C), secondarily transported to a biological storage centre at the university hospital and then dispatched to specialised laboratories for toxicological analyses: INERIS (for solvents and pesticides) and Toxicology Unit, University hospital Rennes (for Alcohol).
For dead fetuses (stillbirths or termination of pregnancy), meconium will be collected by the pathologist in charge of the autopsy, after parents' consent.
Evaluation of exposure:
- direct evaluation: by toxicological analyses in meconium samples: Alcohol, Solvents and pesticides
- indirect evaluation: by maternal self-questionnaire including data on occupational and domestic exposures, hobbies, life habits…, precise address (for spatial location)
Particular cases: mild congenital heart defects, genital anomalies and hip dislocation diagnosed later after birth (after the period oh meconium and before the age of one): these cases will be spotted through the Registry, there won't be any biological sample for them, but mothers will be contacted by main investigator and medical data and mother questionnaires will be collected. There won't be any control included for those cases included after birth.
Associations between exposure risk factors (alcohol, solvents and pesticides) and the risk of congenital malformations will be estimated by a multivariate analysis.
- Exposure to solvents will be estimated by assay in meconium and by occupational questionnaire
- Exposure to alcohol will be estimated by assay of Ethylglucuronide et de Ethylsulfate in meconium.
- Exposure to pesticides will be estimated by assay in meconium, by questionnaire and by spatial location.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Congenital malformations | Other | Other: meconium samples + maternal self-questionnaireAll livebirths, fetal deaths with gestational age (GA) ≥22 weeks and terminations of pregnancy (at any gestational age) after prenatal diagnosis of malformation. * born from mothers living in Brittany at delivery * with a congenital anomaly according to Eurocat criteria, diagnosed or suspected (and then confirmed) at birth * or with mild congenital heart defects, genital anomalies or hip dislocation diagnosed after birth (and before the age of one) |
| control | Other | Other: meconium samples + maternal self-questionnaire2 controls per case will be included, corresponding to the first 2 births without congenital anomalies, with same sex and same birth place, following the case. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- All live births, fetal deaths with gestational age (GA) ≥22 weeks and terminations of pregnancy for medical reasons (IMG) from 20 weeks of amenorrhea (SA) included.
- born from mothers living in Brittany at delivery
- with a congenital anomaly according to Eurocat criteria, diagnosed or suspected (and then confirmed) at birth
- or with mild congenital heart defects, genital anomalies or hip dislocation diagnosed after birth (and before the age of one) Suspicion of chromosomal abnormality or genetic syndrome on purely clinical criteria but not yet authenticated by genetic analyzes. If the chromosomal or genetic abnormalities are secondarily authenticated, these cases will be excluded a posteriori.
- Spontaneous abortion before 22 weeks gestational age.
Key exclusion criteria (1 listed)
- Prenatally suspected malformations, which are not confirmed by postnatal screening or clinical evolution
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 |
|---|---|---|
| meconium samples + maternal self-questionnairemeconium samples + maternal self-questionnaire | Other | Congenital malformations, control |
Primary outcome
impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk of congenital malformations diagnosed at births, by measuring the exposure both directly in meconium, and indirectly by questionnaires.
Time frame: up to 48 hours
impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk of congenital malformations diagnosed at births, by measuring the exposure both directly in meconium, and indirectly by questionnaires.
1 secondary outcome
other risk factors such as medicine intake, pregnancy illness…
Time frame: up to 48 hours
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 24 May 2023.
- Background: PubMed 24838489Meyer-Monath M, Beaumont J, Morel I, Rouget F, Tack K, Lestremau F. Analysis of BTEX and chlorinated solvents in meconium by headspace-solid-phase microextraction gas chromatography coupled with mass spectrometry. Anal Bioanal Chem. 2014 Jul;406(18):4481-90. doi: 10.1007/s00216-014-7836-2. Epub 2014 May 18.
- Background: PubMed 25863396Meyer-Monath M, Chatellier C, Cabooter D, Rouget F, Morel I, Lestremau F. Development of liquid chromatography methods coupled to mass spectrometry for the analysis of substances with a wide variety of polarity in meconium. Talanta. 2015 Jun 1;138:231-239. doi: 10.1016/j.talanta.2015.02.058. Epub 2015 Mar 19.
- Background: PubMed 25381610Meyer-Monath M, Chatellier C, Rouget F, Morel I, Lestremau F. Development of a multi-residue method in a fetal matrix: analysis of meconium. Anal Bioanal Chem. 2014 Dec;406(30):7785-97. doi: 10.1007/s00216-014-8243-4. Epub 2014 Nov 9.
- Results publication: PubMed 34150682Rouget F, Bihannic A, Cordier S, Multigner L, Meyer-Monath M, Mercier F, Pladys P, Garlantezec R. Petroleum and Chlorinated Solvents in Meconium and the Risk of Hypospadias: A Pilot Study. Front Pediatr. 2021 Jun 2;9:640064. doi: 10.3389/fped.2021.640064. eCollection 2021.
Related trials for Congenital Malformation
Active, not recruitingPhase 2
Pilot Study of Reduced-Intensity Hematopoietic Stem Cell Transplant of DOCK8 Deficiency
DOCK8 Deficiency
RecruitingObservational study
Natural History Evaluation of Charcot Marie Tooth Disease (CMT) Types CMT1B, CMT2A, CMT4A, CMT4C, and Others
Charcot Marie Tooth Disease
RecruitingObservational study
Blood Sampling for Research Related to Sickle Cell Disease
Sickle Cell Trait, Sickle Cell Disease
Recruiting
The Effect of Probiotics in Infantile Colic
Infantile Colic
Not yet recruitingObservational study
Multimodal Mechanical, Tissue, Architectural, and Histological Evaluation of the Bone and Sutures of the Parietal Bone in an Infant With Craniosynostosis.
Craniostenosis
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.
Florence Rouget, MD principal investigator
Rennes University Hospital
Philippe Lefevre, MD principal investigator
Fougères Hospital
Joëlle Gueguen, MD principal investigator
Saint-Grégoire Hospital
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 samples + maternal self-questionnaire in people with Congenital Malformation, run by Rennes University Hospital 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 9 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 24 May 2023. 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?
impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk of congenital malformations diagnosed at births, by measuring the exposure both directly in meconium, and indirectly by questionnaires. (time frame: up to 48 hours). 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 NCT01613638, which also lists 4 linked publications.
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 24 May 2023.