History and Funding

The Central East Registry (IEG) began in 1973 with the Rhône-Alpes region. The Auvergne was added in 1983, the Jura in 1985, the Côte d'Or & Nièvre in 1989 and the Saône-et-Loire in 1990. The register joined EUROCAT as an associate member in 1999 and sent data back to 1980. At the beginning of 2007, the Registry was renamed REMERA and limited to the Rhône-Alpes region, and further to Rhône and Loire in 2024.
REMERA is funded by the French National Public Health Agency (SPF) and the Ministry of Health.

Population Coverage

Remera is a population based I register: following a diagnosis of congenital anomaly, all pregnancy outcomes of mothers residing in the register area are recorded regardless of the place of delivery.
The Registry covers 2 French departments: Loire and Rhône, with approximately 30,000 births annually which represents about 4% of all births in France.

Sources of Ascertainment

Congenital anomalies are not included in the French Ministry of Health's list of notifiable diseases. Collaboration agreements are signed with all public and private health services involved. Cases are collected from multiple sources: Multidisciplinary Screening Centres for congenital anomalies (CPDPN), maternity unit records, paediatric records, cytogenetic laboratory, pathology laboratory, child health services, specialised departments for medical genetics, paediatric surgery departments. Active registration is performed by data collectors, assigned specifically to about 35 sources each. Confirmatory sources: every year a list of genetic abnormalities is sent by cytogenetic laboratories. Following fetal death, Pregnancy termination for fetal anomaly (TOPFA) or postnatal death, autopsy reports are systematically sent to the register. Remera also has access to all PMSI (medicalized information system program) lists.
Each case has at least 3 sources of information (from prenatal diagnosis, maternity, fetopathology, surgery, cytogenetics,…). More than 145 sources collaborate with the registry.
All congenital anomalies are recorded, with the exception of minor anomalies referenced in chapter 3.2 of the EUROCAT Guide for registration.

Maximum Age at Diagnosis

Up to 18 months of age.

Terminations of Pregnancy for Fetal Anomaly (TOPFA)

Termination of pregnancy for Fetal Anomaly is legal and there is no upper gestational age limit for any cause whatsoever. In the case of termination after diagnosis of a congenital anomaly, agreement is sought from a multidisciplinary committee. Terminations for fetal malformation have been registered since 1985. Notification of terminations of pregnancy is provided by: obstetric units, cytogenetic laboratories and pathology reports.

Stillbirth and Early Fetal Deaths

In France, legislation on stillbirths changed in 2008. The gestational age criteria is no longer taken into account. Currently still births and early fetal death/spontaneous abortions are registered by REMERA from 20 weeks gestation onward. Stillbirth and infant death certificates are not routinely available as a source.
Autopsy rates reach 90% for stillbirths, 90% for induced abortions and 80% for early neonatal deaths (0-7 days). All autopsies are performed by a foetal pathologist (unless parents object).

Exposure Data Availability

Information on maternal and paternal occupation, on maternal domestic and occupational exposures (chemical, physical, biological) is systematically collected. Maternal addresses during de 1st trimester of the pregnancy are systematically collected and automatically geocoded.

Denominators and Controls Information

Birth statistics are provided by the National Institute of Statistics (Insee). Some background information is also available from the general population statistics. Number of births per maternal age group and number of births per months are recorded. No information on controls is collected.

Ethics & Consent

The registry does require ethics committee approval in order to collect and store data and this approval comes from CNIL (Commission Nationale Informatique et Liberte) + CCTIRS (Comite Consultatif du Traitement de l’Information Recherche en Sante). Approval has to be checked or renewed when there is a change in the database.
Remera is GDPR compliant (compliance audit performed).
National legislation requires informed consent in order to register a baby with a congenital anomaly. Parents can ask to remove their child from the Register (opt-out option).

Address for Further Information

Emmanuelle Amar (leader of REMERA registry from 2007)
Registre des Malformations en Rhône Alpes
7 rue Sainte Catherine
689001 Lyon, France
Tel: +33 4 78583484
Email: emmanuelle.amar@remera.fr