Australia: National
Australian Congenital Malformation Monitoring System

History:
The mechanism for national monitoring of birth defects in Australia was established in 1981. The national programme became an associate member of the Clearinghouse in 1982 and full member in 1984. Australia has not contributed national data to the Clearinghouse for the last 2 years. In Australia, the data have been provided to the national program by the state and territory health authorities primarily from their birth defects registers and perinatal data collections. However there are variations among state and territory data collections, in the definitions and classifications used, the duration of collection and the level of ascertainment. Therefore Australia has reviewed the existing system and has undertaken a project to develop a new system. They anticipate the resumption of data contribution to the ICBDSR in the foreseeable future.
Size and coverage:
All births of at least 20 weeks gestation or at least 400 grams birthweight in Australia are covered. In 2005, there were 272,419 births in Australia, an increase of 5.9% from the number reported in 2004.
Legislation and funding:
There is no national legislation requiring the reporting of birth defects at the national level. In some States, notification to their birth defect registry is required as part of their respective Public Health Acts. In some States and Territories, birth defect data is collected as part of another collection, and funding, if any is determined by the jurisdiction. The State and Territory Health Departments report to the AIHW National Perinatal Statistics Unit which is the national data custodian of the congenital anomalies data collection. The current funding for development of a national minimum dataset for the congenital anomalies is from the Australian Health Ministers Advisory Committee.
Sources of ascertainment:
The State and Territory birth defect data collections operate independently and there is enormous variation in the breadth of notification sources and level of ascertainment. Other sources of notification may include death certificates, autopsies, hospital morbidity databases, notification from health professionals, cytogenetic and prenatal screening. At the minimum, State and Territory birth defect registries and perinatal data collections send electronic notification to the central data custodian annually.
Exposure information:
Currently not available.
Background information:
In the absence of national legislation, there is variation in the scope, quality of data and ascertainment between the States and Territories. Under the current development project, Australia is working on development of an agreed national minimum data set for congenital anomalies. It’s program of work also includes the development of clinical definitions for congenital anomalies a review of the scope of the collection and development of a nationally consistant classification system.
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Australia: VBDR
Victoria Birth Defects Registry

History:
In 1979 the Commonwealth Government agreed in principle to collect more information about births and birth defects. It was decided that the States would be responsible for setting up their own systems and the Commonwealth would establish a National Perinatal Statistics Unit, to collate information from all the states and provide an overall picture. The Victorian Perinatal Data Collection Unit (VPDCU), established under the Health Act of 1958, operates under the aegis of the Consultative Council on Obstetric and Paediatric Mortality and Morbidity (the Council). One of the fundamental purposes of the VPDCU was the establishment and maintenance of the Victorian Birth Defects Register (VBDR). The VPDCU and VBDR were established in 1982.
Size and coverage:
The VBDR collects information on all birth defects for livebirths, stillbirths and terminations of pregnancy pre 20 wks gestation and children up to 18 yrs of age (irrespective of the age at diagnosis). Approximately 3.8% of babies are born with a birth defect at or after 20 weeks gestation. We also follow up terminations for birth defects before 20 weeks, once these are included the overall prevalence is approximately 4%. Birth defects are notified to the register for those babies/fetus’ who were born in Victoria.
Legislation and funding:
The ongoing maintenance of the VBDR is enshrined in the legislation pertaining to the VPDCU (Health Act 1958) and is an ongoing function of the VPDCU, however notification of birth defects outside the reporting period on the Perinatal Morbidity Statistics form (28 days) is a voluntary process. There is a section for reporting of birth defects on the Perinatal form which is completed at the time of birth. Several measures are taken to ensure the ascertainment of birth defects outside this reporting period which will be specified in ‘sources of ascertainment’. The VPDCU & VBDR are funded by the Department of Human Services (State Government).
Sources of ascertainment:
Perinatal forms (approx 48.8%)
Hospital listings* (aPprox 28.8%)
Perinatal death certificates/autopsy reports (approx 7.8%)
Cytogenetic reports (approx 9.3%)
Maternal & Child Health Nurse (approx 4.2%)
Other professionals/parents (approx 1.1%)
* These include obtaining annual inpatient listings from the two major paediatric teaching hospitals detailing all children up to the age of five years who have been subsequently admitted to these hospitals each year with a birth defect. We also obtain annual listings from specialist clinics at these hospital for all children up to the age of five years who have visited either as an inpatient or an outpatient. This procedure has also been adopted for Monash Medical Centre. Other listings are also received from Newborn Screening Services and Genetic Health Services Victoria.
Exposure information:
No exposure information is available.
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Australia: WABDR
Australia Western Birth Defects Registry

History:
The Registry was established in 1980, and is currently located in a teaching obstetric hospital. The objectives of the Registry have always been to establish how often birth defects occur, to conduct research into causes and prevention of birth defects, to provide health professionals and the public with information about birth defects, and to monitor and evaluate screening, treatment and prevention programs.
Size and coverage:
Population-based in the state of Western Australia. 30,000 birth a year, ~6% reported with a birth defect. Birth defects diagnosed prenatally and up to the age of 6 years, in stillbirths, terminations of pregnancy and livebirths are included.
Legislation and funding:
Following a period of short term funding from both Federal and State sources, the Registry is now wholly funded by the Western Australian Department of Health. There are several statutory sources of information (birth, death and hospital data collections), and a large number of voluntary sources. Statutory notification is being considered by the Department of Health.
Sources of ascertainment:
Statutory sources: Midwives’ Notification of Birth Forms (all births over 20 weeks gestation), Death Certificates (perinatal, infant and childhood); Hospital Morbidity (all hospital discharges in Western Australia). Voluntary sources: Maternity and paediatric hospitals, Obstetricians, paediatricians, orthopaedic surgeons,  Community and Child Health Nurses, Cytogenetic laboratories, Pathology services (including prenatal screening services), Ultrasound practices Genetic Services, Disability services.
Exposure information:
No exposure information is routinely collected.
Background information:
The data on the Registry are routinely linked to the linked dataset of all births, deaths and hospital admissions for Western Australia. This linkage provides information on variables such as maternal and paternal age, labour and delivery data, and maternal illnesses, for both cases of birth defects (numerators) and all births in Western Australia (denominators). Data from the Registry are provided to the
National Perinatal Statistics Unit for monitoring birth defects in Australia as a whole.
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Canada: CCASN
Canadian Congenital Anomalies Surveillance Network (CCASN)

History:
The Programme was started in 1966. The Programme was a full member until 1987, when it became an associate member. The Programme was discontinued as an associate member of the ICBDMS in the early 1990s, and reinstated its associate member status in 1996.
Size and coverage:
This system presently monitors about 330,000 births annually, which captures virtually all births in the 10 provinces and 3 territories of Canada. Live births to 1 year of age and registered stillbirths (a birth weight of greater or equal to 500 grams, or greater than or equal to 20 weeks in pregnancy) were captured until 2000.  Since 2001, all data provided by Canadian Institute for Health Information (CIHI) only include a 30 days followup period.
Legislation and funding:
Reporting is based on an agreement between the Canadian Institute for Health Information (CIHI), a non-profit organization, which collects and disseminates data on hospital admission/separation in Canada, and the central registry, which is run and funded by the Public Health Agency of Canada. The Alberta Congenital Anomalies Surveillance System and Med-Echo (Système de maintenance et d’exploitation des données pour l’étude de la clientèle hospitalière) for the province of Québec provide their data separately.
Sources of ascertainment:
Cases from most provinces and territories are ascertained from hospital admission/separation summary records collected by the Canadian Institute for Health Information (CIHI) and Med-Echo. The Alberta Congenital Anomalies Surveillance System provides its own separate provincial data. All data sources had a one year follow-up period until 2000.  Since 2001, all data provided by Canadian Institute for Health Information (CIHI) only include a 30 days followup period.
Exposure information:
No exposure information is routinely collected in the central registry.
Background information:
Background information is based on hospital admission/separation summary records from the Canadian Institute for Health Information (CIHI) and Med-Echo. Alberta Congenital Anomalies Surveillance provides its own background information.  Interpretation of trends should be done cautiously, since 2001 an increasing percentage of records are being coded using ICD-10 CA and may cause discrepancies from previously used ICD-9 coding.  Also, as mentioned previously the variation in the follow-up period is another factor which may alter reporting of trends.
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Canada-Alberta: ACASS
Alberta Congenital Anomalies Surveillance System

History:
The Programme began in 1966 as a general Registry for Handicapped Children. This was disbanded in 1980 and continued as a surveillance Programme for live and stillborn infants with congenital anomalies who were born in the Province of Alberta.
Size and coverage:
All live and stillbirths in the province are covered which at present comprises about 40,000 births per year. The definition of stillbirth is 20 weeks or more or 500 grams or more. The vast majority of births occur in hospital (approximately 97%). In 1997 a special fetal congenital anomalies surveillance system was started to include those fetuses with congenital anomalies who were either spontaneously lost prior to 20 weeks or where there was termination as a result of prenatal diagnosis.
Legislation and funding:
Reporting is voluntary. The system is run by members of the Department of Medical Genetics, Alberta Children’s Hospital/University of Calgary reporting to Alberta Vital Statistics and Alberta Health. Funding is from Alberta Ministry of Health.
Sources of ascertainment:
Reports are obtained from physician’s notice of birth, live birth and stillbirth registrations, death registrations and a special congenital anomalies reporting form (CARF) from hospitals. This is based on discharge diagnosis, including readmissions for any reason up to one year of age. Additional sources are speciality clinics, such as medical genetics and cytogenetics laboratories.
Exposure information:
None is routine.
Background information:
Linkage studies are possible with other statistical data from Alberta Health.
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Canada: British Columbia
British Columbia Health Status Registry (BCHSR)
Congenital Anomalies Surveillance Programme

History:
The Programme was established in 1952 as the Crippled Children’s Registry. Until 1959 the Programme had an age limit of 21, but this was removed in 1960 and the name was changed to the Registry for Handicapped Children and Adults and included all familial conditions and congenital malformations. In 1975, the Registry’s name was changed to the Health Surveillance Registry as risk registers for amniocentesis, rubella, hyaline membrane disease, and fetal alcohol syndrome were added. In 1991, the Royal Commission Report on Health Care and Costs contained a recommendation that Vital Statistics should develop and maintain a registry of individuals with disabilities to assist in the development of long-range plans and to monitor the changing needs of the population. Subsequently, in September 1992, amendments to the Health Act established the legislative mandate and responsibilities for the HSR. The Registry’s current name, Health Status Registry, was acquired in 1992. In order to refocus the Registry’s emphasis on children, the criteria for registration of individuals with long-term physical, mental and/or emotional problems was restricted to persons under the age of 20 years old, however registration of persons with genetic conditions was not age limited. By 2000 there were approximately 215,000 records in the Registry.
Size and coverage:
The registry covers all births in the province approximately 45,000 births annually including stillbirths with at least 20 weeks gestation or birth weight 500 grams or more.
Legislation and funding:
In 1992, amendments to the Health Act established the legislative mandate and responsibilities for the BC HSR. Funding comes from the British Columbia Vital Statistics Agency.
Sources of ascertainment:
Sources include: Notice of Live and Stillbirth, Death registrations, Hospital Admission/Discharge Abstracts, Children’s Hospital, Sunnyhill Hospital, UBC and Victoria General Medical Genetics Clinics, Child Development Centres, Health Regions, the Asante Centre for Fetal Alcohol Syndrome.
Exposure information:
Information on complications of pregnancy, labour or delivery is available on Vital Statistics birth registrations and environmental/occupational and drug/alcohol/smoking lifestyle related information can be obtained from the death registrations for the deceased.
Background information:
The registry data are regularly matched to Vital Statistics birth registrations to obtain birth particulars of the registrants and maternal/paternal information, and also matched to death registrations to get the date of death and causes of death if the registered person was deceased. The registry also registers cases of medically terminated pregnancies due to congenital anomalies.
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Chile, Maule: RRMC-SSM
Regional Register Congenital Malformational Maule Health Service

History:
The register started in 2001 defined by order of Director Maule Health Service and assesored for South America.ECLAMC, Eduardo Castilla. RRMCSSM became an associated member of ICBDSR in 2003.
Size and coverage:
RRMC-SSM is located in a Region in the center of Chile, in Talca Maule Region. Maule Region is situated between 34º 41’ & 36º 33’ S and 70º 20’ & 72º 44’ W. The surface is 30.535 kms2 (4 % of Chile). 930,306 habitants. 37,4% rurality. Cellulosa producer and agricultural products. The number of participating are 13 public hospitals from 2001 and since 2005 will included the unique private maternity of the region. There are around 13.130 births annually (2005). The information about livebirths and stillbirths are collected from 13 maternity hospitals in the region for pediatricians and midwives. Stillbirths of at least 500g birthweight have been included since 2001.
Legislation and funding:
The registry is based on the information of births and notification of congenital malformation ECLAMC from 2001 and funded by the Maule Health Service.
Sources of ascertainment:
Reporting is made by collaborating pediatricians and midwives at the delivery units of partcipating hospitals.
Exposure information:
Detailed information on various risk factor exposures, maternal and paternal occupation, diseases and other information available.
Background information:
Epidemiological information on all births is available from participating hospitals and statisticals units.
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China: BDSS-Beijing
Birth Defect Surveillance System in Thirty Counties of Four Provinces,
People's Republic of China

History:
The Programme began in 1992. It became a full member of the ICBDSR in 1997.
Size and coverage:
This is a population based monitoring system. Reports were obtained from all hospitals and village health stations, which together cover all geographically defined population. Total number of population in these areas is around 17 millions and total number of births per year is around 150,000.
Legislation and funding:
Funding is from China Ministry of Health and local health authorities.
Sources of ascertainment:
Reports are obtained from delivery units, paediatric clinics, ultrasound departments, pathology departments and perinatal health care departments of different level hospitals, MCH institutes and village health stations in the participating counties and cities.
Exposure information:
Exposure information is obtained from the perinatal health care surveillance system (PHCSS) in the same areas for all women and their babies from pre-marital examination till six weeks after birth. BDSS data is linked with PHCSS data by using an ID number assigned to each woman.
Background information:
Background information is also obtained from PHCSS data.
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China: CBDMN
Chinese Birth Defects Program of Sichuan Province, China (until 1994)
Chinese Birth Defects Monitoring Network

History:
The Programme began in 1984. It became an associate member of the ICBDSR in 1985 and a full member in 1987.
Size and coverage:
In 1984, reports were obtained from 100 hospitals but participation has increased. In 1985,205 hospitals participated. At present, the Programme covers approximately 260,000 births annually in 31
provinces. Since we resumed reporting data, only one part of data ( 20 provinces, I remember apprising you by email several years ago) is sent to ICBD. The nationwide programme covers approximately 450,000~500,000 births annually in provinces.
Legislation and funding:
Participation is voluntary. Funding is mainly from local health authorities, also supported by Ministry of health.
Sources of ascertainment:
Reports are obtained from delivery units, paediatric clinics, and pathology departments of the participating hospitals.
Exposure information:
Exposure information is obtained by interviews of mothers of the reported malformed infants. No information is available on exposures in controls.
Background information:
Total number of births from each participating hospital is known.
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Costa Rica: CREC
Costa Rican Birth Defects Register Center

History:
The registry was created in 1986, based in a government decret by which birth defects became subject of obligatory notification. The Programme became an ICBDSR member in September 2003.
Size and coverage:
The Programme is population based. Includes all births from the National Security System (CCSS) which covers about 98% of all births occurred in the country, and births of private hospitals. There are approximately 75000 annual births in Costa Rica.
Legislation and funding:
The Registry is financed by the government as a Programme of the Costa Rican Institute of Research and Training in Nutrition and Health (INCIENSA), Institute that depends from the Ministry of Health.
Sources of ascertainment:
Reporting is made by neonatologists, pediatricians and physicians before newborns discharge from maternity services, with biostatistics personal collaboration.
Exposure information:
None is routinely collected at present.
Background information:
Linkage studies are possible with other statistical data from the National Statistics Center and the National Security System Statistical Center.
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Cuba: RECUMAC
Cuban Register of Congenital Malformation

History:
The program started in 1985 and has grown in size and coverage. The registry became a member of ICBDMS in 2003.
Size and coverage:
Reports are obtained from hospitals distributed all over Cuba. The number of partecipating hospitals has grown in 1986 to 54 at the present time. The annual number of birth is approximately 140 000 representing almost 95% of all births.
Legislation and funding:
RIt is a research programme with voluntary participation of hospitals. The registry is associated with the National Centre of Medical Genetics, and is financed by Health Public Ministery of Cuba.
Sources of ascertainment:
Reports are obtained from delivery units paediatric departments of the partecipating hospitals. Mothers are also interviewed directly to gather information and fill in the RECUMAC standard protocols.
Exposure information:
The mother of each reported infant and the mother of a control infant, the next non malformed infant born at the hospital with the same sex as the proband are interviwed on various exposures, including drug usage and parental occupation.
Background information:
Total number of birth by sex and number of twin pairs in each participating hospital are known. Other background information is obtained partly from summarizing tables of births in each participating hospital, partly from the control material.
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Czech Republic
Czech Republic National Registry of Congenital Anomalies of the Czech Republic

History:
A registration of congenital malformation began in 1961 and regular monitoring started in 1964. The programme was a founding member of the Clearinghouse and is a full member.
Size and coverage:
All births in the Czech Republic (Bohemia, Moravia and Silesia regions) are covered, at present comprising approximately 110,000 annual births. Stillbirths weighting at least 1,000g are included. The information about prenatally diagnosed cases is available from 1994.
Legislation and funding:
Reporting is compulsory. The registration is financed and run by the government in the Institute of Health Information and Statistics of the Czech Republic. Analysis of data is supported by Grant projects (currently none available).
Sources of ascertainment:
Reports are obtained from delivery units, neonatal, paediatric, child surgery, pathology departments and cytogenetic laboratories. Reporting to the central registry occurs via Regional Department of Institute of Health Information and Statistics.
Exposure information:
Some exposure information is available on malformed infants, at present none on controls.
Background information:
Information’s on all births are available in the Institute of Health Information and Statistics of the Czech Republic. Website: http://www.uzis.cz/
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England and Wales
Congenital Malformation Monitoring Programme of England and Wales.

History:
The monitoring Programme was started in 1964. It was a founding member of the Clearinghouse and is a full member.
Size and coverage:
All births in England and Wales are covered, at present approximately 625,000 annually. Stillbirths of 24 weeks or more gestation are registered.
Legislation and funding:
Reporting is voluntary. The governmental Office for National Statistics finances the National Congenital Anomaly System.
Sources of ascertainment:
Reports are mainly based on notifications of births prepared by attendants at birth, either physicians or midwives by means of a paper form (the SD56 form). This form contains a written description of the anomaly and details of the birth, along with some demographic information about the parents. In areas covered by local congenital anomaly registers this information is supplemented by other reports from neonatal intensive care units, special care baby units etc.
It has long been recognised, however, that there is under reporting in NCAS. Therefore NCAS has embarked on an on-going programme of improving the level of reporting to the system. Since 1998, local congenital anomaly registers have begun to provide data to NCAS in each of the years detailed below:
1998 CARIS (Wales)
1999 East Midlands & South Yorkshire Congenital Anomaly Register
2000 North Thames (West) Congenital Malformation Register
2000 Merseyside and Cheshire COngenital Anomaly Survey
2002 Wessex Antenatally Detected Anomalies Register (WANDA)
2002 Congenital Anomaly Register for Oxfordshire, Berkshire & Buckinghamshire
        (Oxforshire only prior to 2004)
2003 Northern Congenital Abnormality Survey
2003 South West Congenital Anomaly Register
In 2004, congenital anomaly notifications are now received for all births in Wales and 45 per cent of births in England. For areas for which NCAS relies solely on SD56 notification forms recording is likely to be less complete. Reports of terminations of pregnancy have been compiled from notifications of abortions that are completed by the operating practitioners under the 1967 Abortion Act and are sent to the Chief Medical Officers of England and Wales. The tables sent to the International Clearinghouse only include notifications of abortions performed under Grounds E of the Act. An abortion may be performed under Grounds E if ‘there is substantial risk that if the child were born it would suffer from such physical or mental abnormalities as to be seriously handicapped’. Since April 2002, the Department of Health has been responsible for the processing of the abortions notification forms and information has been made accessible to the Office for National Statistics (ONS) for statistical purposes.
Exposure information:
Parents’ occupation is known.
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Finland
The Finnish Register of Congenital Malformations

History:
The registry was established in 1963 and regular monitoring started in 1977. It was a founding member of the ICBDSR and is a full member. In 1998 the registry became an associate member of EUROCAT. The registry system (data collection etc.) has been changed twice, in 1985 and in 1993.
Size and coverage:
The registry is national and population based. All births in Finland are covered, at present approximately 59,000 annually. Stillbirths of 22 weeks / 500 g or more are registered. Information on malformations is principally collected up to 1 year of age, but later information is also included. Selective terminations of pregnancy and spontaneous abortions with malformations have been included since 1993.
Legislation and funding:
Reporting is compulsory. The registry is regulated by the act and statute on the national health care registers with personal data. The registry is run and financed by STAKES, the governmental National Research and Development Centre for Welfare and Health (under the Ministry of Social Affairs and Health).
Sources and ascertainment:
Reports are obtained from delivery units, neonatal, paediatric and pathology departments, death certificates and cytogenetic laboratories. Case information is also received from the national Medical Birth Register, Abortion Register and Hospital Discharge Register. The diagnoses of the malformation cases received from other sources are confirmed from the hospitals.
Exposure information:
Until 1986, extensive exposure information was obtained from maternity health centres and by personal interviews for cases with selected malformations and their controls. In 1987-1992 only parental occupation was reported. Exposure information, like maternal occupation, medication, X-rays and diseases, etc., has been obtained since 1993. Some exposure information on all births is also available in the Medical Birth Register since 1987.
Background information:
Epidemiological background data are available on all births in the Medical Birth Register and in the Statistics Finland.
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France: Paris

History:
The Programme was initiated in 1975, but the registry really started in 1981. It became an associate member of the Clearinghouse in 1982. It is also a member of EUROCAT.
Size and coverage:
The registry covers 38.000 annual births (about 5% of all births in France), that is all births (live and still births of 22 weeks or more) and terminations of pregnancy in the population of Greater Paris delivering in Paris maternity units. The estimation of the coverage of the registry is around 95%.
Legislation and funding:
Reporting is volontary. The registry is part of a research unit of INSERM (National Institute of Health and Medical Research). The registry has been officially recognized by the French National Comity of Registries, and is renewed for four years (2001-2004) and supported by an annual grant from INSERM and Institut de la Veille Sanitaire (Institute for Health Surveillance).
Sources of ascertainment:
Reports are actively collected from delivery units, pediatric departments, cytogenetic laboratories, pathology departments. Terminations of pregnancy are included. Case information is also received from the health certificates of the first week.
Exposure information:
Information on maternal drug use, maternal and paternal diseases and occupations, outcome of previous pregnancies, is available for the malformed cases. Data about techniques of prenatal screening (ultrasound, serum markers) and prenatal diagnosis are systematically collected.
Background information:
Background data on births are available from the National Institute of Statistics (INSEE).
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France: REMERA
Central-East France Register of Congenital Malformation (until 2006)

History:
The registry began in 1973 within the Rhone-Alps area -the Auvergne region was added in 1983, the Jura area in 1985, the Côte d’Or & Nièvre in 1989 and Saône-et-Loire in 1990. The Programme
was a founding member of the ICBDSR and is a full member. In 1998 the registry was split up and the Auvergne region, became financially independent, under the responsibility of Christine Francannet. The collaboration between Auvergne and the rest of the FCE-registry is maintained and common results are published. In December 2006, France Central-East Register was closed. A new register (REMERA) was created, covering part of the previous one.
Size and coverage:
The registry covers all births in the area approximately 56,000 births annually, which represents about 7% of all births in France. Stillbirths of 22 weeks or more gestation are included.
Legislation and funding:
REMERA received agreement from the French Comité National des Registres It has only public sources of funding: Ministry of Health, Region, Health authorities.
Sources of ascertainment:
The registry is population based and covers 4 French departments of Rhône-Alpes region : Rhône, Loire, Isère, Savoie. Data collection is actively performed in private ant public maternity wards and pediatric units. Other sources of information include cytogenetic laboratories, pathology laboratories, departments of medical genetics, birth certificates and data set called “Résumé Standardisé de Sortie” (similar to a “Standardized Discharge Summary”). Data is registered on a dediacated and secured server. The maximum age at postnatal diagnosis is 1 year. For children born in year x, notifications are taken into account until March x+2. We have no followup procedure. Are excluded from registration: balanced chromosomal anomalies, pyloric stenosis, metabolic disorders, minor malformations (small angiomas or naevi, hip subdislocation, small foot deformities, ill-defined facial anomalies, inguinal and umbilical hernias). Our official stillbirth definition is 22 w (28 w before 1997), which is our lower gestational age limit to include early fetal deaths/spontaneous abortions. Terminations are registered since 1985 (TOP can be performed up to full term in case of lethal or severe foetal abnormalities).
Exposure information:
Our exposure data includes drug intake in 1 st trimester of pregnancy, biological, physical and chemical hazards, medically assisted procreation, occupation. Denominators information is obtained from National institute of Statistics. We collect no controls.
Background information:
Some background information is available from the general population statistics.
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France: Strasbourg 
Strasbourg Prospective Study of Congenital Malformations

History:
The registry was started in 1979. The Programme became an associate member of the Clearinghouse in 1982.
Size and coverage:
All births in an area including and around Strasbourg and the Bas-Rhin are covered -13,000 to 13,500 annually, or 1,8% of all births in France.
Legislation and funding:
The Programme is a research Programme, recognised by the local health authorities and funded by Social Security, Ministry of Health, and INSERM.
Sources of ascertainment:
Reports are obtained from pediatricians examining the newborn infants. A control infant is selected for each malformed one: the next infant of the same sex as the proband born at that hospital.
Exposure information:
Detailed information on various exposures is obtained by interview of the mothers of the malformed infants and their controls. The children are followed to the age of one year.
Background information:
General demographic information is obtained from the National Institute of Statistics. Further information is obtained from Social Security Records and Health Sheets.
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Germany: Saxony- Anhalt
Malformation Monitoring Saxony-Anhalt

History:
Since 1980 in the city of Magdeburg all live- and stillbirths, abortions after the 16th week of gestation (spontaneous and induced abortions according to medical evidence based on prenatal diagnoses of congenital defects), and postnatal anomalies or congenital defects have been recorded up to the first week of life. After the reunification of Germany and the creation of the Federal state of Saxony-Anhalt, the survey of congenital defects included approximately two-thirds of all births with postnatal anomalies and congenital defects in the same federal state. Since 1 January 2000 the survey region includes the entire state of Saxony-Anhalt. Saxony-Anhalt has 2.38 million inhabitants (31.12.2008) and annual births at a rate of about 17 000 children (2008). The survey system is multi-centric and based on population.
Legislation and funding:
1980 to 1989: Ministry of Health of the former German Democratic Republic 1990 to 1992: Medical Faculty, Magdeburg 1993 to 1995: Ministry of Health, Federal Republic of Germany since 1995: Ministry of Labour, Women, Health and Social Security of the Federal State of Saxony-Anhalt. The Malformation Monitoring is working in order of Ministry of Labour, Women, Health and Social Security of the Federal State of Saxony-Anhalt.
Sources:
The co-operation partner are (1.1.2010):
- 27 obstetrics departments
- 24 children hospitals
- 10 institutions of prenatal diagnostic
- 6 departments of pathology
Exposure information:
Maternal and paternal occupation (in groups); occupation risk; drugs in pregnancy (ATC-code); alcohol, nicotine, drug abuse.
Background information:
Population based registry (Federal State Saxony-Anhalt); written informed consent of the mother (parents); name and address don't registered; two healthy "controls" per one malformed child; inclusion of terminations of pregnancy, spontaneous abortions after 16th week of gestation, live and stillborn babies; definition of stillbirth: >/= 500 grams; maximum age to include diagnoses: 1 year (almost 1th week of life); annual report (in German).
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Hungary
Hungarian Congenital Abnormality Registry

History:
Centralized registration of congenital abnormalities began in Hungary in 1962, and came under our co-ordination in 1970. Monitoring began in 1973. The Programme was a founding member of the International Clearinghouse.
Size and coverage:
The registry covers all births in Hungary, approximately 100,000 annually. Criteria to define stillbirth was changed in 1998. At present, stillbirths of at least 24 weeks gestation or 500 grams are registered. Prenatally diagnosed and terminated fetuses are also registered.
Legislation and funding:
Reporting is compulsory. The registry is currently run and financed by the National Center for Healthcare Audit and Improvement; formerly by the National Center for Epidemiology, and the National Institute of Public Health.
Sources of ascertainment:
Reports are obtained from multiple sources, such as delivery units, neonatal and pediatric surgery, pathology, and prenatal diagnostic centers. Abnormalities detected before the age of one are reported Variations in figures (especially in the1990s) may reflect incomplete notification.
Exposure information:
Exposure information has been available since 1980, when a case-control system was initiated. Mothers of selected malformed infants and controls are interviewed by community nurses to collect information.
Background information:
General background information on all births is available from central statistics.  The online notification  (instead of paper-based) has started since 15th of October 2009.
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Iran: TROCA
Tabriz Registry of Congenital Anomalies (TROCA)

History:
The programme was initiated in 2000, but the registry started in 2003. It was then accepted as a member of the ICBDSR in the 2006 annual meeting in Uppsala, Sweden.
Size and coverage:
TROCA is a hospital-based registry and situated in the North-West of Iran covering all births and children in three university hospitals in the city of Tabriz. This city is one of the three major cities in the country. The programme is based on approximately 60-70% of all births (15000 births per year) in the area.
Legislation and funding:
The programme has been financially supported by the National Public Health Management Centre (NPMC) as a research grant. TROCA is located in the Alzahra University hospital of Tabriz University of Medical Sciences.
Exposure information:
Some exposure information are currently available of mothers of all malformed infants. Other women giving births in all university hospitals with normal newborns routinely complete a similar form. They might be considered as matched control group.
Background information:
General epidemiological data and basic characteristic information are available for all births.
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Ireland
Dublin EUROCAT Registry

History:
Register began in September 1979 and joined EUROCAT at the same time. Joined International Clearinghouse in 1997.
Size and coverage:
The Registry is population-based and situated in the East of Ireland covering the counties of Dublin, Wicklow and Kildare. About one third (22,000 births) of all births in Ireland occur in this region.
Legislation and funding:
The Registry is located within the Public Health Department of Eastern Health Board. Staffing includes a full time nurse/researcher and a part time secretary plus a part-time public health specialist. Funding is provided by the Department of Health through the Eastern Health Board. There is a Steering Committee comprising specialists from each of Maternity and Paediatric Hospitals in the catchment plus a representative from the Department of Health.
Exposure information:
For each malformed infant reported, limited information is given on certain exposures. No information is available on controls.
Sources of ascertainment:
All live and still births included. Termination of pregnancy is not legal in Ireland.
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Israel: IBDSP
Israel Birth Defects Surveillance Program (IBDSP)

History:
The Programme started in one hospital in 1966 and was a founding member of the Clearinghouse. It was a full member until 1986, when it became an associate member.
Size and coverage:
Reports are now obtained from three hospitals located in the central region of the country, with approximately 20,000 (more than 15% of all births in Israel). Stillbirths of 20 weeks gestation or more and 500 g or more are included. The registry of termination of pregnancy began in 1995.
Legislation and funding:
The Programme is a research Programme supported by research grants without any governmental support.
Sources of ascertainment:
Reporting is voluntary. Reports are obtained from delivery units and neonatal departments in the participating hospitals. The three included hospitals are: Rabin Medical Center, Beilinson Campus' Petah Tikva; Kaplan Hospital, Rehovot (Dr, Kohan Dr, Shinwell) and Lis Medical Center, Tel Aviv (Prof. Mimouni, Dr. Dolberg). These hospitals are affiliated to Sackler School of Medicine, Tel-Aviv University.
Exposure information:
Completeness is obtained by interviews of mothers of all malformed infants. All the other women with normal newborns complete a similar form at discharge.
Background information:
Epidemiological information on all birth occuring in the participating hospitals is available.
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Italy Campania: BDRCam
Birth Defects Registry of Campania (BDRCam)

History:
The Registry started in 1991and became a full member of the ICBDSR in 1996.
Size and coverage:
The Registry is based on reporting from hospitals distributed in Campania, a region in southern Italy. Naples is the main city. Initially 38 hospitals reported and the annual number of births was 38.000. Until 2001 the registry is hospital-based covering approximately 50.000 annual births. Actually beginning from 2002, the registry is population based covering approximately 100% of all births. Stillbirths and induced abortions are included. In 2002 is started officially a link with birth regional registry.
Legislation and funding:
The Registry is a surveillance Programme supported by grants from Regional Health Authorities. Participation was voluntary up to 1995. From 1996 participation is mandatory.
Sources of ascertainment:
Reports are obtained from delivery units and pediatric clinics at the participating hospitals. For selected malformations multiple sources are used with follow-up to one year using specific records from pediatric specialties departments dealing with malformed infants.
Exposure information:
For each malformed infant reported, information is given on certain exposures, including maternal drug usage and parental occupation. Beginning from 2002 informations on controls are available but only partially on induced abortions.
Background information:
Always from 2002 background information is given on certain exposures, including maternal drug usage and parental occupation. Informations on controls are available.
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Italy Emillia-Romagna: IMER
Emilia-Romagna Registry of Congenital Malformations (IMER).

History:
The registry was started in 1978 in a few hospitals and has increased in size to now include 45 delivery units. The Programme became an associate member of the Clearinghouse in 1985.
Size and coverage:
The Programme is based on approximately 90% of all births in the Emilia-Romagna region, or approximately 25,000 annual births (4% of all births in Italy). Stillbirths of 28 weeks or more gestation are included.
Legislation and funding:
The Programme is recognised and financed by the health authorities, the National Research Council, and the Regional Health Council. Hospital participation is voluntary.
Sources of ascertainment:
Reporting is made by neonatologists and pediatricians during the first week of the infant's life. Selected malformations are followed up.
Exposure information:
Detailed exposure information is obtained by interviews of the mothers of malformed infants. For each malformed infant, a control is chosen (the baby born before or after the malformed case in the same hospital) and its mother is interviewed in a similar way.
Background information:
Some general demographic information is known for all births in the area. For each participating hospital, the number of livebirths and stillbirths are known.
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Italy: Lombardy
Congenital Malformation Registry of Northern Lombardy

History:
The Registry started in 2000 and is located in National Cancer Institute of Milan. It has been a ICBDSR full member since 2007, when it became associate member.
Size and Coverage:
The Registry is population-based and registers about 16 600 births annually, constituting 100% of the total annual births in the Provinces of Sondrio, Varese and the northern part of Milan (HLA1). This is about 18.2% of the total annual births in the Region of Lombardy, and the 3.1% of total births in Italy.
Legislation and Funding:
The Registry is a research programme approved by the Italian Ministry of Health and supported by funding from the Italian National Cancer Institute.
Source of Ascertainment:
The registry uses active data collection methods from multiple sources (death certificates, hospital discharge records, pathology reports, birth certificates, outpatient drug prescription records, outpatient records, the social security list of the Region of Lombardy and clinical records).
The registry data are routinely cross-checked with the social security list of the Lombardy Region to up-date case (vital status) and parent information (age, vital status, etc.).
Exposure Information:
Information on exposure is not collected routinely can be collected on specific indications.
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Italy: North-East
North East Italy Registry of Congenital Malformations

History:
The Registry was established in 1981 to include the Veneto, Friuli Venezia Giulia and Trentino Alto Adige regions. The Registry became a member of Eurocat in 1985, and an associate member of Clearinghouse in 1997.
Size and coverage:
Reports are obtained from 78 participating hospitals, with a total of approximately 57,000 annual births; the actual coverage is estimated at 99%.
Legislation and funding:
Reporting is voluntary. The Programme is partly run by privately funded research organisations and partly by Regional Health Authorities.
Sources of ascertainment:
Reports are obtained on specific forms from delivery units, induced abortion units, pediatric, cardiology, ophthalmology and pathology departments, regional induced abortion database and cytogenetic laboratories. 32 selected malformations are recorded within 7 days from birth (within 3 years of age for cardiovascular and ophthalmological anomalies only). In induced abortions all fetal anomalies are recorded. Two control infants are selected for each malformed one.
Exposure information:
Detailed information on various exposures, including maternal or paternal occupation, diseases and drug use is obtained by interview of the mothers at the birth of the malformed nfants and controls. Only selected malformations are collected.
Background information:
Some epidemiological background data of all births are available. For each participating hospital the number of livebirths and stillbirths by sex and number of twin pairs are known.
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Italy Sicily: ISMAC
Sicilian Registry of Congenital Malformations (ISMAC)

History:
The registry started in 1991 and became an associate member of the Clearinghouse in 1996.
Size and coverage:
The Programme is hospital based and actually collaborates with four south-east provinces (Catania, Enna, Ragusa and Siracusa) of the nine Sicilian provinces, with a covering rate higher than 75% and with more than 19,000 controlled newborns for year. Stillbirths are included.
Legislation and funding:
The Programme is a surveillance programme with a voluntary participation, supported by ASMAC-Associazione per la Prevenzione Sociale e per il Trattamento delle Malformazioni Congenite.
Sources of ascertainment:
Reports are obtained from delivery units, pediatric units and other specialistic departments.
Exposure information:
For each malformed infant reported, information is given on certain exposures, including maternal drug usange and parental occupation. Up to now no information on controls is available.
Background information:
Up to now little background information is available and no information on controls is available.
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Italy: Tuscany
Tuscany Registry of Congenital Defects (RTDC)

History:
The registry started in 1979 in the province of Florence and from 1992 in the whole Tuscany region. The Programme became a full member of the Clearinghouse in 1998.
Size and coverage:
The Programme is population based, involves all the regional hospitals and the coverage is around 95% of all births in the Tuscany region (approximately 3.5 millions inhabitants and 25,000 births/year). Stillbirths of 20 weeks or more gestation and induced abortions after prenatal diagnosis of birth defects are systematically included. Malformed babies diagnosed within the first year of life are also registered.
Legislation and funding:
The Registry is a surveillance Programme included in the Regional Statistics System; it is formally recognised and supported by the Tuscany Region Health Authority.
Sources and ascertainment:
Multiple sources are used to ascertain malformed infants; records are obtained from all obstetrical and maternity units, pediatric departments, neonatal and pediatric surgery units, prenatal diagnostic centers and pathology services. Mothers are interviewed by using a standardized questionnaire.
Exposure information:
Exposure information on maternal and paternal occupation, life-style, and socio-economical characteristics are obtained by interviews of mothers of malformed infants.
Background information:
Vital statistics and other epidemiological information are obtained by the birth medical records collected by the Regional Bureau of Statistics. Selected information is obtained from the control material collected.
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Japan: JAOG
Japan Association of Obstetricians and Gynaecologists (JAOG)

History:
The Programme started in 1972 and became a full member of the Clearinghouse in 1988.
Size and coverage:
The Programme is based on reports from 270 hospitals throughout Japan. At present approximately 100,000 births are covered, representing about 9% of all Japanese births. Stillbirths of 22 weeks or more gestation are included.
Legislation and funding:
The Programme is a research Programme acknowledged by the Ministry of Welfare and supported by the Japanese Association of Obstetricians and Gynecologists.
Sources of ascertainment:
Reports are obtained from delivery units and pediatric clinics of the participating hospitals.
Exposure information:
Exposure to drugs, X-ray and viral infections are available.
Background information:
Basic epidemiological information on all births is available from each participating hospital.
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Malta
Malta Congenital Anomalies Register (MCAR)

History:
The register started in 1985 as a research project of the University of Malta. It started as a hospital based register collecting data regarding congenital anomalies diagnosed in babies born at the main general hospital. It became a member of EUROCAT in 1986. Funding for the research project was stopped in 1995 and in 1997 the Department of Health Information assumed the functions of data collection increasing coverage to all hospitals on the islands making it a population based register. The Register was accepted as an associate member of the International Clearinghouse in 2000.
Size and coverage:
The registry is population based and covers just under 5000 births per year.
Legislation and funding:
The registry is run and funded by the state Department of Health Information. Reporting is not statutory.
Sources of ascertainment:
The registry employs active data collection from multiple sources including labour and postnatal wards, doctors' reporting, cardiac lab records, genetics clinic records, National Mortality Register, National Obstetric Systems database, Hospital Activity Analysis database, National Cancer Register and the hypothyroid screening Programme.
Exposure information:
Information regarding maternal exposure to medicinal drugs, smoking, alcohol and drug abuse as well as parental occupation are collected for all malformed infants.
Background information:
Epidemiological background data on all births are available from the National Obstetric Information Systems database and vital statistics.
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Mexico: RYVEMCE
Mexican Registry and Epidemiological Surveillance
of External Congenital Malformations (RYVEMCE)

History:
The Programme was started in 1978. The Programme became a full member of the Clearinghouse in 1980.
Size and coverage:
Reports are obtained from 21 hospitals in 11 cities in Mexico. Participation is voluntary. The annual number of births is approximately 62,000, about 3.5% of all births in Mexico. Stillbnirths of 20 weeks or more gestation and/or at least 500g birthweight are included.
Legislation and funding:
The Programme is a research Programme and is funded by research grants.
Sources of ascertainment:
Reports are obtained from the delivery units and pediatric departments of the participating hospitals.
Exposure information:
The mother of each reported infant and the mother of a control infant-the next non-malformed infant born at that hospital with the same sex as the proband - are interviewed on various exposures, including drug usage and parental occupation.
Background information:
The total number of births in the hospitals is known.
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New Zealand
New Zealand Birth Defects Monitoring Programme

History:
The Programme began in 1975 and became a full member of the ICBDSR in 1979.
Size and coverage:
The Programme covers all livebirths (approximately 58,000 per year) delivered or treated in a New Zealand publicly funded hospital. Only these data are included in the quarterly and annual reports to the ICBDSR. Data on stillbirths are retrospectively added to the database together with additional cases derived from the national perinatal and mortality databases. In late 1995 the definition of stillbirth was changed from 28 weeks completed gestation to 20 weeks or more gestation and/or 400g birthweight.
Legislation and funding:
The Programme is run and funded by the Centre for Public Health Research, Massey University.
Sources of ascertainment:
Ascertainment is from discharge records of publicly funded hospitals and stillbirth notification forms. Data on voluntary terminations of pregnancy are being added to the database.
Exposure information:
No exposure information are currently available, but attempts are being made to obtain such data as well as increase the level of ascertainment.
Background information:
General epidemiological characteristics for all births are available.
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Northern Netherlands
EUROCAT registration Northern Netherlands

History:
The Programme started in 1981, and became a Clearinghouse member in 1993.
Size and coverage:
In the beginning the Programme covered 7,500 births annually in the province of Groningen and northern Drenthe. Coverage was gradually increased to 19,000 births annually in the provinces Groningen, Friesland and Drenthe from 1989 onwards. Home deliveries (35% of births) are included.
Legislation and funding:
The Programme is funded by the Dutch Ministry of Public Health, Welfare and Sports. The registry is carried out in the Department of Medical Genetics of the State University of Groningen.
Sources of ascertainment:
The physician reporting the child is asked to fill out questions on parental drug use and other exposures. Furthermore, since 1997 parents are asked to fill out a questionnaire including questions on occupational activities and drug use. Besides, data from community pharmacies are used to collect maternal drug exposure data. to the registry on a voluntary basis. Informed consent of the parents is needed. Obstetricians, pediatricians, clinical geneticist, surgeons, general practitioners, midwives, well-baby clinics, pathologists and the national obstetric registry send information to the registry. Registry personnel is actively involved in data collection. No age limits are applied.
Exposure information:
Questions on parental drug use, maternal and paternal occupation, diseases etc. are present at the standard notification form. The general practitioner is asked to complete this information in cases where the physician reporting the child did not fill in these questions.
Background information:
General statistics are available from the Dutch Central Bureau of Statistics (CBS).
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Norway
Medical Birth Registry of Norway

History:
The Programme was started in 1967. The Programme was a founding member of the ICBDSR and is a full member.
Size and coverage:
The Programme covers all births in Norway, approximately 60,000 annual births. 1999-2000: Stillbirths of 16 weeks or more gestation are included. Abortions from 12 weeks are included. 2001-today: Stillbirths and abortions from 12 weeks or more are included.
Legislation and funding:
The Programme is run and funded by the governmental National Institute of Public Health. Reporting is compulsory.
Sources of ascertainment:
The registry is based on the notification of births from the delivery units and since 1999 also from the neonatal units.
Exposure information:
Some basic information, such as maternal disease and since 1999: smoking and occupation, is collected on all infants, malformed or not.
Background information:
All information available for the reported malformed infants is also available for the total population of births.
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Russia: MRRCM
Moscow Regional Registry of Congenital malformation

History:
Moscow Regional Registry of Congenital malformation started the activity in 1999 and legally defined by the order of the Ministry of Health Care of Russian Federation. MRRCM became a Member of ICBDSR in 2001.
Size and coverage:
MRRCM be located as a section of Moscow Regional Medical genetic consultation by The Moscow Regional Research institute of Obstetrics and Gynecology (MONIIAG). Director of the MONIIAG is Professor Vladislav Krasnopolsky. The Head of the Moscow Regional Medical genetic consultation and Director of the Programme of MRRCM is Ludmila Joutchenko. The Programme of Monitoring of Birth defects covers all births in Moscow Region. In 1999 MRRCM observed 45,000 birth. There are about 64,000 births today (2007). The information about babies and fetuses with Birth defects collect from 54 maternity hospitals also from all women consultations and clinics, children clinics. Prenatal diagnosed and terminated fetuses are register also.
Legislation and funding:
Monitoring of the birth of fetuses and babies with congenital malformations is legally defined by the Order of the Ministry of Health Care of Russian Federation in 1999.
Sources of ascertainment:
Reporting is made by neonatologist during the first week of the infant’s life in maternity hospitals and by pediatricians during the first year – in pediatric clinics and departments. Reports are collected from cytogenetic laboratories, pathology departments.
Exposure information:
No exposure information is routinely collected in the registry.
Background information:
Background information on all births is available from statistics department.
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Slovak Republic
Teratologic Information Centre, Slovak Medical University

History:
In Slovakia the collection of reports from delivery units and processing of data performs the National Health Information Centre of SR (NHIC). The obligation of reporting all groups of congenital malformations results from valid legislation norms. Reporting of congenital malformations began in 1964. The Programme of Slovak Teratological Information Center (STIC) was established in 2003 year and consists in cooperation of the Slovak Medical University, NHIC and the enter of Medical Genetics. Research collaboration began from 1995 year, under the responsibility of Dr. Elena Szabova, PhD.
Size and coverage:
The registry covers all births in the area approximately 55.000 births annually according to the Reports of birth defects from delivery units. The detailed information about cases of CM are collected in the Center of Medical Genetics, Bratislava from western regions of Slovakia (cca 15.000 births ) by Eva Veghova, MD or under the running research projects at the Slovak Medical University.
Legislation and funding:
Reporting is compulsory. Analysis of data is supported by grant projects.
Sources of ascertainment:
Reports are received from NHIC, delivery units, neonatal, pediatric clinics, or departments of clinical genetics.
Exposure Information:
Detailed information on maternal and paternal occupation, drug use, etc. are collected by interviews of case´s and control´s mothers only according to running research projects.
Background information:
Some background information is available from the general population statistics.
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South Africa: SABDSS
South Africa Birth Defects Surveillance Systems (SABDSS).

History:
The Programme started in 1988 and became a full member of the Clearinghouse in 1992.  Routine  systematic collection of data ceased in 2005. The program currently only covers neural tube defects.
Size and coverage:
The Programme was hospital based covering 15 sentinel sites over the country with approximately 50,000 annual birth or 5% of all births in South Africa.
Legislation and funding:
The Programme was funded by the Department of National Health, and is now funded by the University of Cape Town Participation in the Programme is voluntary.
Sources of ascertainment:
Reports are obtained from delivery units and paediatric units of the participating hospitals, as well as national mortality statistics.
Exposure information:
No exposure information is routinely available.
Background information:
Total births for some participating hospitals are not accurately known.
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South America: ECLAMC
South America Latin American Collaborative Study of Congenital Malformations (ECLAMC)

History:
The Programme started in 1967 and has grown in size and coverage. The Programme became a full member of the International Clearinghouse in 1977.
Size and coverage:
The number of participating hospitals has grown from 20 in 1977 to 70 at the present time, distributed over most South Americans countries. The annual number of births covered is at present approximately 150,000, less than 1% of all births. Stillbirths of at least 500g birthweight have been included since 1978.
Legislation and funding:
The Programme is a research Programme with voluntary participation of hospitals and funded by research grants provided from several sources, mainly the national research councils of Argentina and Brazil.
Sources of ascertainment:
Reporting is made by collaborating pediatricians at the delivery units of participating hospitals.
Exposure information:
The mother of each reported infant and the mother of a control infant - the next non-malformed infant born at that hospital with the same sex as the proband - are interviewed on various exposures, including drug usage and parental occupation.
Background information:
Background information is obtained partly from summarising tables of births in each participating hospitals, partly from the matched control newborns.
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Spain: ECEMC
Spanish Collaborative Study of Congenital Malformations (ECEMC)

History:
The programme was created in 1976 by Prof. Dr. María Luisa Martínez-Frías, as a hospital-based case-control study and surveillance system. It contributes to EUROCAT with data since 1980. In January 2002 the ECEMC Programme became integrated into the CIAC (Research Center on Congenital Anomalies), of the Instituto de Salud Carlos III (ISCIII) from the Ministerio de Sanidad y Consumo of Spain and since last year from the Ministerio de Ciencia e Innovación. It is also directed by Prof. Martínez-Frías. In 2006 the ECEMC was recognized as an excellence Research programme to be integrated into the CIBERER (Centre for Biomedical Research on Rare Diseases). The ECEMC has 2 Teratogen Information Services since 1991, one for the general population and another one for physicians.
Size and coverage:
Data are obtained from about 70 hospitals distributed all over Spain. The annual number of births surpasses 100,000, representing more than 21% of all Spanish births. Stillbirths of at least 24 weeks or 500 g. have been included since 1980. Data on terminations of pregnancy due to the presence of congenital anomalies, which can be legally performed within the first 22 weeks of gestation, can only be gathered in some participating hospitals.
Legislation and funding:
It is a research programme with voluntary participation of hospitals (but mandatory subjugation to the Operating Rules for those participating), and is financed mainly by the Spanish Administration and, partially, by non-governmental organisations.
Sources of ascertainment:
The detection period is the first 3 days of life, including major and/or minor/mild defects. The information comes from delivery units and paediatric departments of the participating hospitals. Mothers are interviewed directly by the participating physicians, during those first 3 days after infant’s delivery, to fill in the ECEMC standard protocols, which include more than 300 data for each child, whether case or control. The information for each case and its control is gathered by the same physician. Controls are defined as the next non-malformed infant born at the same hospital that the case with the same sex as the malformed infant. In many instances, photographs, imaging studies, high-resolution bands karyotypes and molecular analysis when needed (which are performed at the central group of the ECEMC), and other complementary studies are available. Biological samples are also stored in the ECEMC registry for those cases for which the collaborating physicians send them, with the informed consent of the parents.
Exposure information:
The mother of each reported infant (case or control) is interviewed within the first three days after delivery to obtain data on several exposures (parental occupation, maternal acute or chronic diseases, drug usage, illicit drugs, alcohol and tobacco maternal consumption, exposure to other chemical or physical factors), apart from the other data gathered (family history, obstetrical and demographic data, among others). It is important to note that when the pediatricians detect the cases and select the control children, they are blinded to the different maternal and family data that they are going to collect.
Background information:
Total number of births by sex and number of twin pairs in each participating hospital are gathered. Other background information is obtained from the control material.
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Sweden
The Swedish Birth Defects Register and the Medical Birth Registry

History:
The Swedish Registry of Congenital Malformations started in 1964 and changed name to The Swedish Birth Defects Register in 2007. The Swedish Medical Registry started in 1973. The programme was a founding member of the ICBDSR and contributed with data until 1994. The register has a new regime from 1999 and is since then again a full member of the ICBDSR.
Size and coverage:
All births in Sweden are included, approximately 100,000 – 120,000 annual births. The definition of a child is all children born alive and foetal deaths after 22 weeks gestation. In 1999 a special fetal surveillance system was started to include those fetuses with congenital anomalies who were terminated as a result of prenatal diagnosis.
Legislation and funding:
Reporting of birth defects in live- and stillborn infants is compulsory. Reporting of terminated pregnancies because of birth defects of the fetuses is, however, not compulsory. The registers are run by and funded by the National Board of Health and Social Welfare (Govermental).
Sources of ascertainment:
Reports are received from delivery units, paediatric clinics, pathology departments, child cardiology clinics, and cytogenetic laboratories.
Exposure information:
Some exposure information for all births is available in the Medical Birth Registry: maternal occupation, civic status, maternal smoking, drug use during pregnancy, contraceptive usage, and maternal diseases.
Background information:
Epidemiological background data are available on all birth in the Medical Birth Registry.
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Ukraine: OMNI-Net
Ukraine Birth Defects Program

History:
Population based birth defects surveillance began in 2000 in the framework of the Ukrainian-American Birth Defects Program (UABDP) funded by the United States Agency for International Development (USAID). The program became an associate member of ICBDRS in 2001. In 2005 the USAID financing of surveillance finally ended and the program was assumed by OMNI-Net, a not-for-profit international organization incorporated in Ukraine. OMNI-Net represents five resource OMNI-centers conducting birth defects surveillance, providing care for children and promoting prevention programs with participation of parental organizations, national and international partners. Program objectives include universal folic acid flour fortification, methods to reduce alcohol impact on child development in collaboration with partners and promoting international partnerships.
Size and coverage:
Birth defects surveillance concerns 25000 births in two oblasts (provinces) of Northwest of Ukraine, representing approximately 5% of births in Ukraine. The population is relatively homogeneous, stable (data is pooled from two oblasts). The northern counties (rayons) of both oblasts are contaminated from Chornobyl disaster.
Legislation and funding:
OMNI-Net personnel are financed by the Ukrainian Ministry of Health and oblast authorities. The legislation and rules by the Ministry of Health mandates the reporting of birth defects. BD data is reported by Oblast Vital Statistics Centrum who aggregates, formats and forwards the data to the Ministry of Health.
Sources of ascertainment:
Relevant hospital admission/discharge summaries are systematically reviewed. Data from specialty clinics, laboratories and other services are explored. Pregnancy, obstetrics, delivery, neonatal and pediatrics records are considered.
Exposure information:
Routine information collection is limited except when ad hoc circumstances are noted. An expansion of exposure data collection is in progress. Prenatal diagnosis information. The information is substantial regarding service providers located in regional centers, but limited regarding service providers in rural environment.
Background information:
Data regarding ionizing radiation pollution in contaminated rayons is available by special agreements. Data from a population based neonatal registry is also available by special agreements.
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UK Wessex: WANDA
Wessex Antenatally Detected Anomalies Register

History:
The Registry was formally established in 1994, and is located in the Clinical Genetics Department of the teaching hospital in Southampton. The focus of the register is antenatal and includes all fetuses suspected to have a congenital anomaly. All babies born with an anomaly, potentially detectable antenatally, are also included. There is no limit to  the age at which cases may be reported, but in reality few cases are registered after the neonatal period. The link with Genetics, however, ensures the inclusion of all unbalanced chromosome errors, whenever detected. The term ‘congenital anomaly’ is used here in its widest sense and includes chromosome errors, inborn errors of metabolism and syndromes where a gene mutation has been identified. With the clinical perspective to this register, multidisciplinary meetings are held on a regular basis in each district covered. At these, all cases that have arisen in the intervening time  period are discussed and management issues addressed. In addition, feedback from the register is used to inform local policies.
Size and coverage:
The Register is population based with approximately 27,000 deliveries per year and covers all births in the old Wessex region, Jersey and Guernsey. All miscarriages, stillbirths, TOPFAs and live births are included where an anomaly has been diagnosed.
Sources of Ascertainment:
Reporting is voluntary and multisource and includes sonographers, radiologists, obstetricians, midwives, paediatricians, paediatric surgeons, paediatric cardiologists, geneticists, genetics laboratories and pathologists.
Exposure information: 
This is anecdotally recorded only.
Background information:
The approach of the register is to focus on collecting data that is reliably available and so relatively complete. This includes maternal and child demographics, full antenatal findings, test results and the postnatal findings and diagnosis. This may include family history and maternal health and medications but data on the father are not kept unless relevant to the diagnosis of the fetus/child.
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USA-Atlanta: MACDP
Metropolitan Atlanta Congenital Defects Program

History:
The Programme started in 1967 and was a founding member of the ICBDSR. The Programme is a full member of the ICBDSR. Size and coverage: The Programme covers all births within a five-county area in metropolitan Atlanta, Georgia. The annual number of births in this area is approximately 50,000. Stillbirths and terminations of at least 20 weeks gestation are included. Elective terminations at any gestational age are included.
Legislation and funding:
In 1994 the Georgia Department of Human Resources (GDHR) added birth defects to the list of legally reportable conditions in Georgia. In 1997 the GDHR authorised the Birth Defects Branch at the Centers for Disease Control and Prevention (CDC) to act with and on its behalf to collect health information on children with birth defects. The Programme is funded by the Centers for Disease Control and Prevention.
Sources of ascertainment:
Multiple sources, such as delivery units, paediatric departments, neonatal intensive care units, laboratories, prenatal diagnostic centres and tertiary care centres, are used to ascertain malformed infants born in the defined area with a follow-up to age six years.
Exposure information:
Exposure information is obtained by interview for mothers of reported malformed infants who participate in various research projects.
Background information:
Number of live births and demographic information on the five counties are obtained from vital statistics.
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USA-California
California Birth Defects Monitoring Program

History:
The California Birth Defects Monitoring Program was established in 1983 to monitor rates and trends and conduct epidemiological investigations to find causes of birth defects. The Program has had both state and federal funding, and is a branch of the California Department of Public Health, within the Maternal, Child and Adolescent Health Division. The Program is an associate member of the Clearinghouse.
Size and coverage:
The Program operates a population-based registry among approximately 223,000 births. The registry includes 12 counties whose birth defects rates and trends are representative of California which reflect the state’s racial/ethnic diversity.
Legislation and funding:
The Program operates under statutory authority: Health and Safety Code Sections 103825-103855. The Program has received money from these sources in the past: Federal Block Grant Funds from Title V, State General Fund, and special funds from the Prenatal Genetic Disease Screening Program. Since July 2009, only Title V funding remains for the Registry.
Sources of ascertainment:
Staff actively ascertain data at hospitals and genetic centers by reviewing logs and identifying children with structural birth defects generally encompasses within BPA 740-759, diagnosed prenatally through age one. All diagnostic information is abstracted direct from medical records; registry files are cross-linked with vital statistics data to verify demographic information.
Background information:
Registry data, a description of Program activities, research findings, and publications are available at www.cdph.ca.gov
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USA-Texas: BDES
Texas Birth Defects Epidemiology and Surveillance Branch

History:
BDES was established after an unusual cluster of anencephaly cases that occurred in Brownsville, Texas in 1991. Epidemiologic investigations revealed a higher than expected rate of neural tube defects among children born to Hispanic mothers living in South Texas. In recognition that epidemiologic resources are routinely needed to investigate birth defects clusters, the Texas State Legislature passed the Texas Birth Defects Act in 1993, which authorized the establishment of BDES. Since 1994, BDES has maintained the Texas Birth Defects Registry, an active population-based birth defects surveillance system, which has been statewide since 1999. Through multiple sources of information, the Registry monitors all births in Texas and identifies cases of birth defects. Children identified through the Registry are referred to appropriate medical and community services. In 1996, the CDC-funded Texas Center for Birth Defects Research and Prevention was established under the auspices of BDES . The Programme is a full member of the ICBDSR.
Size and coverage:
The Programme covers all deliveries to mothers residing in Texas (approximately 380,000 annually). Stillbirths and terminations of any gestational age are included. Cases diagnosed up to age one are included (up to any age for fetal alcohol syndrome). As of 2006, there were over 100,000 birth defect cases in the Registry.
Legislation and funding:
Birth defects surveillance was mandated by the Texas Birth Defects Act in 1993, and is codified in the Texas Health and Safety Code Chapter 87. About one-half of funding for the birth defects registry is from state general revenue with the remainder from federal block grants.
Sources of ascertainment:
Birth hospitals, birthing centres, lay midwives, hospitals where affected children are treated.
Exposure information:
Limited information on maternal illnesses and conditions, limited information on maternal exposures such as medications.
Background information:
Basic demographics, reproductive history, gestational age, delivery information.
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USA-Utah: UBDN
Utah Birth Defects Network (UBDN)

History:
The Utah Birth Defect Network (UBDN) began in 1994 monitoring neural tube defects, expanding its identification of major malformations through 1999 when all major structural birth defects were identified. The program is a full member of the ICBDSR.
Size and coverage:
The UBDN is state wide population based surveillance system covering approximately 50,000 births annually. Stillbirths and terminations of at least 20 weeks gestations are included. Terminations less than 20 weeks are included for all major birth defects. Currently a pilot is ongoing to incorporate metabolic disorders (identified by newborn screening) into surveillance.
Legislation and funding:
In 1999, an Administrative Rule was enacted under the Utah Health Code Statute which mandates all delivery hospitals and laboratories to report any pregnancy or infant diagnosed with a birth defect. This administrative rule also covers health care providers and other agencies that voluntarily report a birth defect case to the UBDN. The UBDN has additional projects being funded from several sources and includes Maternal Child Health and CDC grants.
Sources of ascertainment:
Multiple sources (n=128), such as delivery units, paediatric departments, laboratories, prenatal diagnostic centers, hospital discharge data, other specialties, and champions are used to ascertained malformed infants born in Utah.  These sources include reports that are generated by the facilities, case reports submitted by individual care providers, as well as reports actively obtained by UBDN staff reviewing records or log books.
Exposure information:
Basic risk factors including medications taken during pregnancy, infections, chronic conditions are all recorded based on medical records abstraction.
Background information:
General Detailed background information including demographics, reproductive history, gestational age, prenatal diagnostics, and family history are all collected from the medical record. The number of births and basic demographic data are obtained from vital statistics.
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Wales: CARIS
Congenital Anomaly Register and Information Service

History and Funding:
Data collection commenced on 1st January 1998 and includes any baby where pregnancy ended after this date. CARIS joined EUROCAT in 1998 and ICBDSR in 2004. CARIS is based at Singleton Hospital, Swansea and is funded by the National Assembly for Wales. CARIS aims to collect data which can be used to describe the pattern of congenital anomalies across Wales. This should help:
Build up and monitor the picture of congenital anomalies in Wales
Assess interventions intended to help prevent or detect congenital anomalies
Plan and co-ordinate provision of health services for affected babies and children
Assess possible clusters of birth defects and their causes.
Population Coverage: The Registry covers the entire country of Wales (population-based = All mothers resident in defined geographic area) with an annual number of births of around 32,000.
Sources of Ascertainment:
Reporting is voluntary. The Register relies upon multi-source reporting including: antenatal clinics, delivery units, pediatric departments, ophthalmology, cytogenetics, pathology, orthopaedics, maxillo-facial and regional centres of pediatric surgery. Each delivery unit has a nominated co-ordinator to help ensure good reporting and chase for further details. CARIS staff also visit units to help with data collection. Registration covers all fetuses with prenatally diagnosed anomalies. There is no lower age of cut off, so the fetal losses and early terminations with anomalies are registered. All liveborn babies with structural anomalies are registered if diagnosed before their 1st birthday, but all chromosomal anomalies are registered, even if diagnosed later. Data exchange with the Mersey Register is also important as babies needing specialist services in North Wales are referred to Liverpool.
Termination of Pregnancy: Termination of pregnancy is legal up to 24 weeks of gestation. Terminations of pregnancy are registered. If congenital anomaly is diagnosed, there is no upper gestational age limit for termination in cases of major anomaly.
Stillbirth Definition and Early Fetal Deaths: Stillbirth definition: 24 weeks gestation (late fetal death after 23 completed weeks of gestation). Stillbirths of 24 weeks or more gestation are registered. Early fetal deaths/spontaneous abortions have no lower limit for inclusion on the register (earliest recorded go down to 8 weeks gestation). Autopsy rates were not given.
Exposure information:
Information on maternal drug use, maternal and paternal diseases and occupations, outcomes of previous pregnancies is available. Folic acid supplementation before and during pregnancy is also collected.
Denominators and Controls Information: Denominator date is obtained from the Office for National Statistics.
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