History and Funding
The registry was created in 2010 and the first complete birth year of collect was 2011. It was validated by the French National Committee of Registries first in 2012, and renewed in 2015. The Registry joined EUROCAT as full member in 2014 and it has transmitted the data for all the birth years since 2011. It joined the International Clearinghouse for Birth Defects as full member in 2017.
Funding comes from:
- the National Institute of Public Health (Santé Publique France),
- the National Institute of Health and Medical Research (INSERM),
- the Brittany Regional Health Agency (Agence Régionale de Santé Bretagne),
- the Brittany Regional Council (Conseil Régional de Bretagne).
The registry is hosted and administrated by the pediatric department of the University Hospital of Rennes. It collaborates with the other French Registries and reports aggregated data to the French National Institute of Public Health. Annual reports are transmitted to the French National Institute of Public Health and to the Brittany Regional Health Agency.
Research projects are conducted in collaboration with the “Epidemiological Research on the Environment, Reproduction and Development” INSERM-IRSET team (U1085).
The registry covers the whole region of Brittany, including four departments: Ille-et-Vilaine (major city Rennes), Côtes d'Armor (major city Saint-Brieuc), Finistère (major city Quimper), Morbihan (major city Vannes). The registry includes the population based I as defined by EUROCAT (All mothers resident in the region Brittany). It covers 33 026 annual births (in 2016), which represents 4.2 % of annual births in France.
Sources of Ascertainment
The ascertainment of cases relies on 105 sources of information, including:
- Prenatal screening
- Maternity units
- Neonatologist and Paediatric departments
- Medical genetics
- Paediatric surgery
- Echocardiology labs
- Pathology labs
- Cytogenetic labs
- Paediatric radiology
- Patient Care Classification System Database: as completeness control tool
Cases notification is both passive and active. Notification to the registry is voluntary. Potential cases are notified online to registry by clinicians in charge of a birth defect. There is also an active searching for cases by Registry staff. Data are actively collected by Registry staff from medical reports. All cases are validated by the registry leader.
Maximum Age at Diagnosis
Cases are included up to one year of age.
Terminations of Pregnancy for Fetal Anomaly (TOPFA)
Termination of pregnancy is legal (since 1975) and there is no upper gestational age limit for termination after diagnosis of congenital anomaly. All terminations of pregnancy regardless of the gestational age at termination are registered.
Sources of information are: Multidisciplinary Committee of Prenatal Diagnosis (CPDP), Maternity unit and Pathology labs. Completeness for TOPFAS is estimated close to 100%, as all TOPFAS must be authorized by a multidisciplinary committee of prenatal diagnosis.
Stillbirth and Early Fetal Deaths
Stillbirths are included and defined by births of dead fetuses occuring >= 22 weeks gestational age (after the last menstrual period). Early fetal deaths/spontaneous abortions are not registered.
We have access to all autopsy reports for cases of congenital anomalies, when performed.
Exposure Data Availability
Information is recorded on: maternal residence, outcome of previous pregnancies, maternal medication during all pregnancy, assisted reproduction methods, maternal smoking, alcohol and drug abuse, maternal diseases before and during pregnancy, paternal diseases, maternal and parental occupations.
Denominators and Controls Information
Background data on births are available from the National Institute of Statistics and Economics Studies (INSEE).
Ethics & Consent
The registry requires ethics committee approval from the French National Committee of Freedom and Informatics (CNIL) in order to collect and store data. The Brittany Registry has the approval of the CNIL (N°910138 V3).
Information to parents is required but the registry is allowed to register cases without explicit written consent of parents. Information letters and notices are available in maternities in order to inform parents that anonymous data are recorded for cases of congenital anomalies.
Address for Further Information
Leader: F. Rouget, MD, paediatrician,
department of Pediatrics, University Hospital, Rennes,
Associate leader: P. Pladys, MD, PHD, paediatrician neonatologist, chairman of Pediatrics department,
University Hospital, Rennes
Administration: E. Nicolas, midwife, regional administrator
IT staff: JP. Sinteff, IT engineer, Department of Medical Information, University Hospital, Rennes (Part time)
Field investigators (Part time): A Lemaitre, MN Beaudouin, C. De Brassier, B. Donarier, S. Fabre, D. Le Pol, S. Levesque, C. Merel, E Nicolas, E. Patey
Registre des malformations congénitales de Bretagne Annexe pédiatrique - Hôpital Sud
16, bd de Bulgarie,
35203 RENNES Cedex2,
Tel : +33 2 99 26 59 13/ +33 2 99 26 59 14
Last update: 13.11.2018