Pregnancy Environment and Newborn Malformations

NCT01613638 | Completed

• 4 other identifiers: PHRC/10-02 - PENEWB110827-4011/22-8112010-A01445-34
• Study Type: interventional
• Target: 1,657
• Locations: 1 country
• Sites: 11

Brief 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), 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…

Conditions

Congenital Malformation

Keywords

congenital malformation; pollutants

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 48 hours

Secondary Outcomes (1)

• other risk factors such as medicine intake, pregnancy illness…

  up to 48 hours

Study Arms (2)

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)

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.

Other: meconium samples + maternal self-questionnaire

Interventions

meconium samples + maternal self-questionnaire OTHER

meconium samples + maternal self-questionnaire

Congenital malformations; control

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (11)

Polyclinique de Keraudren

Brest, Brittany Region, 29200, France

Location

Brest University Hospital

Brest, Brittany Region, 29609, France

Location

Lannion Hospital

Lannion, Brittany Region, 22303, France

Location

Lorient Hospital

Lorient, Brittany Region, 56322, France

Location

Ploermel Hospital

Ploërmel, Brittany Region, 56804, France

Location

Quimper Hospital

Quimper, Brittany Region, 29000, France

Location

Rennes University Hospital

Rennes, Brittany Region, France

Location

Saint-Brieuc Hospital

Saint-Brieuc, Brittany Region, 22000, France

Location

Saint-Grégoire Hospital

Saint-Grégoire, Brittany Region, 35760, France

Location

Clinique Océane

Vannes, Brittany Region, 56000, France

Location

Vannes Hospital

Vannes, Brittany Region, 56000, France

Location

Related Publications (4)

• 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.

  PMID: 24838489 BACKGROUND

• Meyer-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.

  PMID: 25863396 BACKGROUND

• Meyer-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.

  PMID: 25381610 BACKGROUND

• Rouget 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.

  PMID: 34150682 RESULT

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• 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

  Ploermël Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: June 7, 2012
• Study Start: October 5, 2012
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2020
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

FR (11)