History and Funding
The Polish Registry of Congenital Malformations (PRCM) has been in operation since 1997. It was founded as a scientific project ordered by the Polish Ministry of Health and financed by the State Committee for Scientific Research.
PRCM was a part of the Government Program of Monitoring and Primary Prophylaxis of Congenital Malformations in Poland, between years 2000-2008, financed by the Polish Ministry of Health. In 2003 it was decided that data for the Wielkopolska Region, which is part of the territory covered by the PRCM, would be transferred to EUROCAT separately and treated as full member registry data.
From 1 January 2009 to 31 November 2010 PRCM was carrying out tasks under the “Program of comprehensive diagnostics and intrauterine therapy in the prevention of consequences and complications of malformations and fetal diseases - as an element of improving the health of fetuses and newborns for the years 2009-2010”.
In years 2010, 2013-2014 and 2016-2019 PRCM received funds from the National Centre for Healthcare Information Systems. From 2020 PRCM has been financed by the Ministry of Health.
Population Coverage
The PRCM is a population-based registry of Type I (all mothers resident in defined geographic area). In years 1998-2000 data for Poland (Associate Registry) came from 9 provinces of Poland: Pomorskie, Zachodniopomorskie, Warminsko-Mazurskie, Kujawsko-Pomorskie, Wielkopolskie, Lubuskie, Lodzkie, Dolnoslaskie and Opolskie. In 2000 the Slaskie province (Silesia) was added, in 2001 the Lubelskie and Podkarpackie regions joined the Registry and in 2003 Mazowieckie.
In 2005 next two provinces joined the PRCM – Swietokrzyskie and Podlaskie. In 2007 Malopolskie province joined the PRCM. Since year 2007 the whole Poland has been covered by the Polish Registry and in 2010 data for 15 provinces has been transferred to the EUROCAT (the data for the 16th province - Wielkopolska – has been sent separately). In 2021, Poland (15 provinces without Wielkopolska) registered 297,999 live births and 1,092 still-births.
Sources of Ascertainment
Till 2019 the main source of entries was a double‐sided paper notifications form filled out by a physician responsible for diagnosing the malformations. The notification forms were sent immediately to the PRCM Central Working Group. In 2005, with the progress of technology a parallel method of submitting forms has been introduced, which is electronic and web based data capture. From the year 2020 the main source of entries is online submission by the PRCM website: www.rejestrwad.pl.
Since 19 December 2014, in accordance with the Regulation of the Minister of Health of 5th December 2014 on the Polish Register of Congenital Malformations, there is an obligation to report birth defects by medical entities. The currently binding legal act is the Regulation of the Minister of Health of 12 June 2018 on the Polish Register of Congenital Malformations. In accordance to this act voivodship branches of the National Health Fund, who collect information from hospitals, are obligated to send data to PRCM in every case of a stay of the child in the ward until the age of 18 with the diagnosis of congenital malformation according to ICD10 (Q00.0-Q99.9) or ORPHANET.
PRCM receives data from many sources. The sources include entities providing health services in the field of neonatology, obstetrics, clinical genetics, pediatric surgery, orthopedics, pediatrics, pediatric cardiology, ophthalmology, pediatric neurology, pediatric otolaryngology, intensive pediatric therapy, primary care, pathomorphology, lung diseases, endocrinology and pediatric diabetes, child and adolescent psychiatry and voivodship branches of the National Health Fund.
Maximum Age at Diagnosis
Since 2018 PRCM has been collecting information on children with birth defects diagnosed up to the age of 18, while between 1999 and 2017 the Registry included only children with congenital malformations diagnosed before the age of 2.
Terminations of Pregnancy for Fetal Anomaly (TOPFA)
Until January 26, 2021 termination of pregnancy was legal only when:
- a pregnancy poses danger to health or life of the pregnant women;
- prenatal diagnosis or other medical evidence indicates high probability of serious and irreversible damage to a fetus or it is an untreatable life-threatening disease;
- there is a plausible suspicion the pregnancy has arisen from a prohibited act. The upper gestational age limit for termination of a severe congenital anomaly affected pregnancy is 24 week.
From January 27, 2021 termination of pregnancy has been legal only when a pregnancy poses danger to health or life of the pregnant women or there is a plausible suspicion the pregnancy has arisen from a prohibited act (point 1 and 3 from the above).
Although the termination of pregnancy is legal, in Poland there is public pressure not to perform such a procedure and that is why the data on pregnancy terminations might be underestimated. Hence, the registry currently does not register terminations of pregnancy following prenatal diagnosis.
Stillbirth and Early Fetal Deaths
The official stillbirth definition is as follows: the complete expulsion or extraction from its mother of an foetus, if the pregnancy duration reached 22 weeks, that after such expulsion or exctraction does not breath or show any other sign of life, such as beating of the heart, pulsation of the umbilical cord or muscle contractions depending on the will.
We do not include early fetal deaths or spontaneous abortions.
Exposure Data Availability
The following data is gathered by way of registration forms, although its availability may be limited, depending on the source of registration: duration, number of pregnancies and children, prenatal tests and their results, moment of diagnosis of congenital malformation, type of malformation with exact description, chronic illness in mother, pregnancy induced conditions in mother, acute maternal illness during pregnancy, therapeutic and recreational drugs taken during pregnancy, invasive tests in pregnancy, folic acid use in pregnancy, smoking habits, alcohol use, mother's obstetric history, family history of congenital malformations, and genetic conditions in family members, father's and mother's occupational and environmental hazards, informations about parents age as well as mothers place of residence.
Denominators and Controls Information
Information on all births (live and stillbirths) is available from birth certificates, gathered by the Central Statistical Office for Poland. Since 2005 information on controls has been gathered by the Registry.
Registry Description References
Latos-Bielenska A, Materna-Kiryluk A, PRCM Working Group: Polish Registry of Congenital Malformations - aims and organization of the registry monitoring 300 000 births a year. J Appl Genet. 2005;46(4):341-8.
Ethics & Consent
The Registry doesn’t require ethics committee approval for all studies based on the Registry data solely, but requires an approval for other projects (using Registry data but focusing on e.g. genetic or clinical studies).
Based on Regulations of the Minister of Health of June 12, 2018 regarding the Polish Register of Congenital Malformations, notifications are obligatory. This means that parents of children do not have to agree to include their child’s data in the Register. However, their consent is needed, so that we can contact and invite them to participate in our research projects.
Address for Further Information
Polish Registry of Congenital Malformations
Prof Anna Latos-Bielenska, Registry Director;
Dr. Anna Materna-Kiryluk, Organizing Co-ordinator
Tel: + 4861 854 7345
or + 4861 854 7349
mobile: +4860 156 1407
Fax: + 4861 854 7349
Email: info@rejestrwad.pl
Updated 03.03.2023