Pregnancy Environment and Newborn Malformations (PENEW)

May 22, 2023 updated by: Rennes University Hospital

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.

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…

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1657

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
    • Brittany
      • Brest, Brittany, France, 29609
        • Brest University Hospital
      • Brest, Brittany, France, 29200
        • Polyclinique de Keraudren
      • Lannion, Brittany, France, 22303
        • Lannion Hospital
      • Lorient, Brittany, France, 56322
        • Lorient Hospital
      • Ploermel, Brittany, France, 56804
        • Ploermel Hospital
      • Quimper, Brittany, France, 29000
        • Quimper Hospital
      • Rennes, Brittany, France
        • Rennes University Hospital
      • Saint-Brieuc, Brittany, France, 22000
        • Saint-Brieuc Hospital
      • Saint-Grégoire, Brittany, France, 35760
        • Saint-Grégoire Hospital
      • Vannes, Brittany, France, 56000
        • Clinique Oceane
      • Vannes, Brittany, France, 56000
        • Vannes Hospital

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 1 year (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.
  • 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)

Exclusion Criteria:

  • Prenatally suspected malformations, which are not confirmed by postnatal screening or clinical evolution

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Congenital malformations

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)
Other: meconium samples + maternal self-questionnaire
meconium samples + maternal self-questionnaire
Other: control
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.
Other: meconium samples + maternal self-questionnaire
meconium samples + maternal self-questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
other risk factors such as medicine intake, pregnancy illness…
Time Frame: up to 48 hours
other risk factors such as medicine intake, pregnancy illness…
up to 48 hours

Collaborators and Investigators

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

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Florence Rouget, MD, Rennes University Hospital
  • Principal Investigator: Philippe Lefevre, MD, Fougères Hospital
  • Principal Investigator: Joëlle Gueguen, MD, Saint-Grégoire Hospital
  • Principal Investigator: Isabelle Blanchot, MD, Clinique La Sagesse - Rennes
  • Principal Investigator: Maria Vernis, MD, Saint Malo hospital
  • Principal Investigator: Dominique Chaumet, MD, Vitré Hospital
  • Principal Investigator: Joseph Abi-Fadel, MD, Redon Hospital
  • Principal Investigator: Philippe Rebour, MD, Lannion Hospital
  • Principal Investigator: Michel Turban, MD, Dinan Hospital
  • Principal Investigator: Claire Combescure, MD, Saint-Brieuc Hospital
  • Principal Investigator: Joseph Magagi, MD, Polyclinique du Littoral - Saint-Brieuc
  • Principal Investigator: Michel Collet, MD, University Hospital, Brest
  • Principal Investigator: David Somerville, MD, Polyclinique de Keraudren - Brest
  • Principal Investigator: Alain Hassoun, MD, Clinique Pasteur - Brest
  • Principal Investigator: Charles Bellot, MD, Quimper Hospital
  • Principal Investigator: Philippe Tillaut, MD, Lorient Hospital
  • Principal Investigator: Hubert Journel, MD, Vannes Hospital
  • Principal Investigator: Claire Duhaut, MD, Clinique Océane - Vannes
  • Principal Investigator: Patrick Vallée, MD, Pontivy Hospital
  • Principal Investigator: Marie-Agnès Guillou, MD, Ploermel Hospital

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 (Actual)

October 5, 2012

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

May 24, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (Estimate)

June 7, 2012

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC/10-02 - PENEW
  • B110827-40 (Other Identifier: AFSSAPS)
  • 11/22-811 (Other Identifier: CPP Ouest V (Rennes))
  • 2010-A01445-34 (Other Identifier: AFSSAPS)

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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