History and Funding
The registry was created in 1981 and it has been a member of EUROCAT since 1982. The registry is part of a research unit of INSERM (National Institute of Health and Medical Research). The registry has been officially recognised by the French National Committee of Evaluation of Registries, and regularly renewed, most recently in 2022 for five years (2022-2026). The activities of the Registry are partially supported by an annual grant from INSERM and Santé Publique France.
Population Coverage
Until 2000, the registry population included all women residing in greater Paris (Paris and its surrounding suburbs) who delivered in Paris maternity units (38,000 annual births). Beginning in 2001, the Paris population data for Eurocat include only women residing in Paris and delivering in a Parisian maternity unit. The estimation of the coverage of the registry is around 95%.
Sources of Ascertainment
Notification to the registry is voluntary. Reports are actively collected from delivery units, paediatric departments, cytogenetic laboratories, and pathology departments. Terminations of pregnancy are included. Case information is also received from the health certificates of the first week of life and this is the maximum age at diagnosis. Birth certificates include notification of congenital anomaly and are used as a source of notification. The registry systematically (at least once a year) consults the three main cytogenetic laboratories in Parisian hospitals.
By far, most cases of major CHD are diagnosed by specialized paediatric cardiology departments in our population or by prenatal ultrasound and/or autopsy reports for pregnancy terminations and foetal deaths. In addition, paediatric cardiology centres supply diagnostic confirmation when requested by the registry for specific cases.
Maximum Age at Diagnosis
Up to 1 week of age (or later if discharged from maternity at a later date).
Terminations of Pregnancy for Fetal Anomaly (TOPFA)
Termination of pregnancy is legal 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.
Stillbirth and Early Fetal Deaths
Stillbirths of 22 weeks after the last menstrual period or more are registered. Early foetal deaths/spontaneous abortions are registered and included when the gestational age is 16 weeks.
Exposure Data Availability
Information on maternal drug use, maternal and paternal diseases and occupations, outcome of previous pregnancies, is available for the malformed cases.
Denominators and Controls Information
Background data on births are available from the National Institute of Statistics (INSEE).
Registry Description References
Detailed description of the Registry may be found in the following publications:
De Vigan C, Khoshnood B, Lhomme A, Vodovar V, Goujard J, Goffinet F (2005), “Prevalence and prenatal diagnosis of congenital malformations in the Parisian population: twenty years of surveillance by the Paris Registry of congenital malformations“, J Gynecol Obstet Biol Reprod (Paris), Vol 34, no 1, Pt 1, pp 8-16.
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. Review of procedures regarding confidentiality of data of the Paris Registry is overseen by both the French National Committee of Registries and the French National Committee of Informatics and Freedom.
The registry is allowed to register cases without explicit written consent of parents. Information letters are sent to chief of services for them to post in waiting rooms, patient rooms or other areas of the maternity in order to inform parents that anonymous data are recorded for cases of congenital anomalies.
Address for Further Information
Registry Leader: Dr Babak Khoshnood, co-leader: Nathalie Lelong
Address:
Paris Registry of Congenital Malformations (Remapar)
INSERM U1153
Maternité de Port Royal, 123 bd Port-Royal
75014 Paris, France
Tel : +33 1 4234 5587
Email: babak.khoshnood@inserm.fr, regmalf.paris@inserm.fr
Last update: 01.03.2023