Pregnancy Environment and Newborn Malformations

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

Interventions

OTHER

meconium samples + maternal self-questionnaire

meconium samples + maternal self-questionnaire

Sponsors & Collaborators

• Rennes University Hospital

  lead OTHER

Principal Investigators

• Florence Rouget, MD · Rennes University Hospital

• Philippe Lefevre, MD · Fougères Hospital

• Joëlle Gueguen, MD · Saint-Grégoire Hospital

• Isabelle Blanchot, MD · Clinique La Sagesse - Rennes

• Maria Vernis, MD · Saint Malo hospital

• Dominique Chaumet, MD · Vitré Hospital

• Joseph Abi-Fadel, MD · Redon Hospital

• Philippe Rebour, MD · Lannion Hospital

• Michel Turban, MD · Dinan Hospital

• Claire Combescure, MD · Saint-Brieuc Hospital

• Joseph Magagi, MD · Polyclinique du Littoral - Saint-Brieuc

• Michel Collet, MD · University Hospital, Brest

• David Somerville, MD · Polyclinique de Keraudren - Brest

• Alain Hassoun, MD · Clinique Pasteur - Brest

• Charles Bellot, MD · Quimper Hospital

• Philippe Tillaut, MD · Lorient Hospital

• Hubert Journel, MD · Vannes Hospital

• Claire Duhaut, MD · Clinique Océane - Vannes

• Patrick Vallée, MD · Pontivy Hospital

• Marie-Agnès Guillou, MD · Ploermël Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

12 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-10-05

Primary Completion

2018-12-31

Completion

2020-12-31

Countries

• France

Study Locations