History and Funding
The registry joined EUROCAT in 1992.
The registry started in 1980. The years 1980-89 were funded by Ministry of Health of former German Democratic Republic. The years 1990-92 were funded by the Academy of Medicine, Magdeburg whereas the period between 1993 and 1995 was sponsored by the Ministry of Health, Federal Republic of Germany. Since 1995, the registry has been funded by the Ministry of Work, Social Affairs and Integration of the Federal State of Saxony-Anhalt.
On 12.11.2009, a new law by the parliament of Saxony-Anhalt was unanimously adopted. In § 7 states: "The Federal state of Saxony-Anhalt promotes the widespread detection of birth defects in babies under a permanent observation.
The task of this observation is to identify data on the prevalence of congenital malformations and watch over a defined period of time, to analyze the scientific data and to evaluate the effectiveness of measures for primary and secondary prevention".
Population Coverage
The registry started in 1980 in the city of Magdeburg with about 4,000 annual births. After it there was a successive enlargement of the registry from 1981 to 1986. In 1981 we expanded to include some rural districts around the city of Magdeburg and this process continued until 1987 when we registered the whole area of the former “district Magdeburg” (about 17,000 births per year). Then we had a stable system from 1987 to 1989 and in 1990 there was a dramatic political change (fall of the Berlin Wall on 9 November 1989 was the symbolic end of the fifty year East-West conflict).
Since the reunification there has been a two-third decrease in the number of births in the so-called `new` Federal states of Germany. After this reunification, a similar process of territorial enlargement took place. In year 2000, registry expanded to the entire Federal State of Saxony-Anhalt (21 districts and 3 major cities). In the year 2007 a reform reduced the 21 districts to 11 districts.
Saxony-Anhalt has 2.23 million inhabitants (31. August 2015) and annual births at a rate of about 17 000 children (2015: 17,479). Germany birth rate 2015: 737,630 (Saxony-Anhalt 2.36%). By comparison to 1987, we currently survey a much larger area in our registry with approximately twice as many inhabitants but the births rate is the same as the 1980s. Registration concerns deliveries within surveyed region excluding non-residents (Population-based III). Wave of refugees and immigration 2015 may create a demographic change?
Sources of Ascertainment
Multiple sources, such as delivery units (01.01.2016: 25 hospitals), paediatric departments, laboratories, prenatal diagnostic centres, departments of pathology and other specialities report children/fetuses with malformations and healthy children as a control group.
The registration of a child requires the informed consent of the parents. The registration sheet does not include much personal identifiable data, thus making follow-up investigations almost impossible.
Exposure information of the mother (including drug intake before and in pregnancy, including periconceptional folic acid intake) and the father is documented on a standardized documentation sheet. From 1987 onwards, cases are registered if diagnosed with a congenital anomaly up to 1 year of age.
The registry receives some results from cytogenetic labs but not through direct access or via electronic transfer. Some are received indirectly via obstetric or pediatric notes. We get notification from the paediatric cardiology department and a regional cardiology outpatient clinic via our standardized form twice a year.
Maximum Age at Diagnosis
Maximum Age at Diagnosis Up to 1 year of age.
Terminations of Pregnancy for Fetal Anomaly (TOPFA)
TOPFA is legal. Terminations of pregnancy after prenatal diagnosis of fetal anomaly (“medical indication”) there is no upper age limit by law in Germany. We have had complete information about terminations of pregnancy after prenatal diagnosis of fetal malformations since 1987. Three ultrasound scans at 10, 20 and 30 weeks of gestation are foreseen in the german protocol “Anlage 5 - der Mutterschafts-Richtlinien: Ultraschallscreening in der Schwangerschaft” from Federal Joint Committee (G-BA) 01.07.2013. G-BA is the highest decision-making body of the joint self- government of physicians, dentists, hospitals and health insurance funds in Germany.
Cytogenetic testing and a special high resolution ultrasound diagnostic is provided routinely for women over 35 years of age or if needed. After Genetic Counselling cytogenetic and genetic testing are offered independent of age. These services are free of charge. First trimester screening and cell free DNA analysis is not free of charge yet.
Stillbirth and Early Fetal Deaths
Stillbirths and spontaneous abortions with malformations from 16 weeks gestational age are registered. The stillbirth is defined as a fetus of ≥500 g that show no sign of life after birth from 1.4.1994 onwards (and ≥1000g before 1994). We do include early fetal deaths/ spontaneous abortions from 16 weeks gestation.
Exposure Data Availability
Maternal and paternal occupation, drugs in pregnancy (ATC coded), alcohol, nicotine, drug abuse. Sources: pregnancy pass filled out throughout pregnancy by the obstetrician and his staff and data collected by midwives 6-8 weeks before birth, in the planed delivery unit.
Denominators and Controls Information
Statistics on the total number of births comes from Statistical Office Saxony-Anhalt. There is the opportunity to exclude non-resident mothers with assistance of the postal code. A woman who gives birth outside Saxony-Anhalt, but is a resident in Saxony-Anhalt is included in the statistics. The denominators include only live births and stillbirths. Information about maternal age for all births is available at the level of the entire state of Saxony-Anhalt and also the single counties.
Information is obtained from fetuses with malformations and also healthy children as a control group (1:2). The two control infants are those born directly before and directly after the malformed child. The information about the control cases is the same as malformed cases because same standardized documentation sheet is used.
Additional services
Since 01.08.2006 the Malformation monitoring centre is collecting and tracking the results of the newborn hearing screening in Saxony Anhalt. The newborn hearing screening test helps to identify babies who have permanent hearing loss as early as possible and is made regular in the delivery units. We closely collaborate with the newborn screening for inborn errors of metabolism (Newborn Screening Centre Saxony-Anhalt) which is located at the Medical Faculty of Otto-von-Guericke University Magdeburg.
Every year the Registry provides a scientific convention, course for reference centres and an anuual report. The annual report is available including results of prevalence data on specific malformations and its interpretation, newborn hearing screening and newborn screening for inborn errors of metabolism (in German and English). The report can be downloaded from our website.
Registry Description References
Rißmann K. Fehlbildungsmonitoring lädt zum interdisziplinären Austausch ein. Ärzteblatt Sachsen-Anhalt 2016; 27(1/2): 16 – 17 Rißmann A, Götz D, Vogt C, Köhn A.
www.angeborene-fehlbildungen.com
26.07.2013
Rißmann A, Köhn A. Grundlagen, Bedeutung und Schlussfolgerungen des Fehlbildungsmonitoring in Deutschland und der Welt. Neonatologie Scan 2014; 03(04): 299 – 318
Ethics & Consent
The registry has the ethics committee approval from the Medical Faculty, Otto-von-Guericke University, Magdeburg. The registry is recognised as part of the Public Health system information flow and regulated by regional law of Saxony-Anhalt since 2009. Because of the data protection law in Germany, since 1992 national legislation requires informed consent in order to register a baby with a congenital anomaly. Parents have to agree to the inclusion of the child on the Register (opt-in).
Address for Further Information
Dr Anke Rissmann MD
Malformation Monitoring Centre Saxony-Anhalt Medical Faculty,
Otto-von-Guericke University,
Leipziger Strasse, Haus 39,
D-39120 Magdeburg,
Germany
Tel: +49 391 67 14174
Fax: +49 391 67 14176
Email: monz@med.ovgu.de
Web: www.angeborene-fehlbildungen.com
Last update: 13.02.2018