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1. Signal Detection in EUROmediCAT: Identification and Evaluation of Medication–Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference

Author

Cavadino, Alana, Sandberg, Lovisa, Öhman, Inger, Bergvall, Tomas, Star, Kristina, Dolk, Helen, Loane, Maria, Addor, Marie-Claude, Barisic, Ingeborg, Cavero-Carbonell, Clara, Garne, Ester, Gatt, Miriam, Khoshnood, Babak, Klungsøyr, Kari, Latos-Bielenska, Anna, Lelong, Nathalie, Lutke, Reneé, Materna-Kiryluk, Anna, Nelen, Vera, Nevill, Amanda, O’Mahony, Mary, Mokoroa, Olatz, Pierini, Anna, Randrianaivo, Hanitra, Rissmann, Anke, Tucker, David, Wiesel, Awi, Yevtushok, Lyubov, and Morris, Joan K

Published
2021
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2. Spectrum of congenital anomalies among VACTERL cases: a EUROCAT population-based study

Author

van de Putte, Romy, van Rooij, Iris A. L. M., Marcelis, Carlo L. M., Guo, Michel, Brunner, Han G., Addor, Marie-Claude, Cavero-Carbonell, Clara, Dias, Carlos M., Draper, Elizabeth S., Etxebarriarteun, Larraitz, Gatt, Miriam, Haeusler, Martin, Khoshnood, Babak, Klungsoyr, Kari, Kurinczuk, Jenny J., Lanzoni, Monica, Latos-Bielenska, Anna, Luyt, Karen, O’Mahony, Mary T., Miller, Nicola, Mullaney, Carmel, Nelen, Vera, Neville, Amanda J., Perthus, Isabelle, Pierini, Anna, Randrianaivo, Hanitra, Rankin, Judith, Rissmann, Anke, Rouget, Florence, Schaub, Bruno, Tucker, David, Wellesley, Diana, Wiesel, Awi, Zymak-Zakutnia, Natalya, Loane, Maria, Barisic, Ingeborg, de Walle, Hermien E. K., Roeleveld, Nel, and Bergman, Jorieke E. H.

Published
2020
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3. Epidemiology of septo-optic dysplasia with focus on prevalence and maternal age – A EUROCAT study

Author

Garne, Ester, Rissmann, Anke, Addor, Marie-Claude, Barisic, Ingeborg, Bergman, Jorieke, Braz, Paula, Cavero-Carbonell, Clara, Draper, Elizabeth S., Gatt, Miriam, Haeusler, Martin, Klungsoyr, Kari, Kurinczuk, Jennifer J., Lelong, Nathalie, Luyt, Karen, Lynch, Catherine, O'Mahony, Mary T., Mokoroa, Olatz, Nelen, Vera, Neville, Amanda J., Pierini, Anna, Randrianaivo, Hanitra, Rankin, Judith, Rouget, Florence, Schaub, Bruno, Tucker, David, Verellen-Dumoulin, Christine, Wellesley, Diana, Wiesel, Awi, Zymak-Zakutnia, Nataliia, Lanzoni, Monica, and Morris, Joan K.

Published
2018
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4. Toward the Effective Surveillance of Hypospadias

Author

Dolk, Helen, Vrijheid, Martine, Addor, Marie-Claude, Botting, Bev, de Vigan, Catherine, de Walle, Hermien, Garne, Ester, Loane, Maria, Pierini, Anna, Garcia-Minaur, Sixto, Physick, Nigel, Tenconi, Romano, Wiesel, Awi, Calzolari, Elisa, and Stone, David

Published
2004

5. Beta-Blocker Use in Pregnancy and Risk of Specific Congenital Anomalies: A European Case-Malformed Control Study

Author

Bergman, Jorieke E. H., Lutke, L. Renée, Gans, Rijk O. B., Addor, Marie-Claude, Barisic, Ingeborg, Cavero-Carbonell, Clara, Garne, Ester, Gatt, Miriam, Klungsoyr, Kari, Lelong, Nathalie, Lynch, Catherine, Mokoroa, Olatz, Nelen, Vera, Neville, Amanda J., Pierini, Anna, Randrianaivo, Hanitra, Rissmann, Anke, Tucker, David, Wiesel, Awi, Dolk, Helen, Loane, Maria, and Bakker, Marian K.

Published
2018
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7. Amniotic band syndrome and limb body wall complex in Europe 1980–2019

Author

Bergman, Jorieke E. H., primary, Barišić, Ingeborg, additional, Addor, Marie‐Claude, additional, Braz, Paula, additional, Cavero‐Carbonell, Clara, additional, Draper, Elizabeth S., additional, Echevarría‐González‐de‐Garibay, Luis J., additional, Gatt, Miriam, additional, Haeusler, Martin, additional, Khoshnood, Babak, additional, Klungsøyr, Kari, additional, Kurinczuk, Jennifer J., additional, Latos‐Bielenska, Anna, additional, Luyt, Karen, additional, Martin, Danielle, additional, Mullaney, Carmel, additional, Nelen, Vera, additional, Neville, Amanda J., additional, O'Mahony, Mary T., additional, Perthus, Isabelle, additional, Pierini, Anna, additional, Randrianaivo, Hanitra, additional, Rankin, Judith, additional, Rissmann, Anke, additional, Rouget, Florence, additional, Sayers, Gerardine, additional, Schaub, Bruno, additional, Stevens, Sarah, additional, Tucker, David, additional, Verellen‐Dumoulin, Christine, additional, Wiesel, Awi, additional, Gerkes, Erica H., additional, Perraud, Annie, additional, Loane, Maria A., additional, Wellesley, Diana, additional, and de Walle, Hermien E. K., additional

Published
2022
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8. Gastroschisis in Europe – A Case‐malformed‐Control Study of Medication and Maternal Illness during Pregnancy as Risk Factors

Author

Given, Joanne E., Loane, Maria, Garne, Ester, Nelen, Vera, Barisic, Ingeborg, Randrianaivo, Hanitra, Khoshnood, Babak, Wiesel, Awi, Rissmann, Anke, Lynch, Catherine, Neville, Amanda J., Pierini, Anna, Bakker, Marian, Klungsoyr, Kari, Latos Bielenska, Anna, Cavero‐Carbonell, Clara, Addor, Marie‐Claude, Zymak‐Zakutnya, Natalya, Tucker, David, and Dolk, Helen

Published
2017
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9. Age at school entry and reported symptoms of attention-deficit/hyperactivity in first graders: results of the prospective cohort study ikidS.

Author

Diefenbach, Christiane, Schmidt, Martina F., Huss, Michael, König, Jochem, Urschitz, Michael S., The ikidS Study Group, Hoffmann, Dietmar, Blettner, Maria, Queisser-Wahrendorf, Annette, Wiesel, Awi, Zepp, Fred, Faber, Jörg, Gehring, Stephan, Mildenberger, Eva, Letzel, Stephan, Elflein, Heike, Schuster, Alexander K., Willershausen, Brita, Weusmann, Jens, and Matthias, Christoph

Subjects
PARENT attitudes, AGE distribution, PSYCHOLOGY of teachers, ATTENTION-deficit hyperactivity disorder, QUESTIONNAIRES, DESCRIPTIVE statistics, SCHOOL children, SECONDARY analysis, SYMPTOMS, CHILDREN
Abstract

Young age at school entry (ASE) is related to attention-deficit/hyperactivity disorder in higher grades. The reason for this association is unclear, but medical oversupply and stress-related factors are discussed. We aimed to investigate whether ASE is associated with reported symptoms of attention-deficit/hyperactivity (ADH) already in first grade. Data of a population-based prospective cohort study (N = 2003; Mainz-Bingen region; Rhineland-Palatinate; Germany) with baseline assessments prior to school entry and two follow-ups during first grade were analysed. ADH symptoms were assessed by parent and teacher versions of the Strengths and Difficulties Questionnaire. Associations between ASE and scores of the hyperactivity/inattention subscale (range 0–10) were investigated by regression analysis and adjusted for potential confounders and baseline symptoms prior to school entry. In total, 1633 children (52% boys, mean ASE 6.5 years) were included. There were no relationships between ASE and parent-reported scores of the hyperactivity/inattention subscale prior to school entry and 3 months thereafter. However, at the end of first grade, ASE was negatively associated with the hyperactivity/inattention subscale in parent (− 0.7 subscale points per year ASE, standard error = 0.16, p < 0.0001) and teacher reports (− 1.2 subscale points per year ASE, standard error = 0.25, p < 0.0001). This ASE effect appeared more pronounced in girls than in boys. Young ASE is related to more reported symptoms of ADH at the end of first grade, but not before. The evolvement of this effect during first grade may be a clue to ASE-related stress factors. [ABSTRACT FROM AUTHOR]

Published
2022
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13. Lifetime impact of achondroplasia in Europe (LIAISE): findings from a multinational observational study

Author

Maghnie, Mohamad, primary, Semler, Oliver, additional, Guillen-Navarro, Encarna, additional, Wiesel, Awi, additional, Maria Allegri, Anna Elsa, additional, Selicorni, Angelo, additional, Lopez, Antonio Gonzalez-Meneses, additional, Heath, Karen, additional, Zampino, Giuseppe, additional, Haeusler, Gabriele, additional, Hagenäs, Lars, additional, Leiva-Gea, Antonio, additional, González, Vanesa López, additional, Raimann, Adalbert, additional, Simarro, Fernando Santos, additional, Tajè, Silvia, additional, Ertl, Diana-Alexandra, additional, Gregersen, Pernille Axél, additional, Pimenta, Jeanne M., additional, Cohen, Shelda, additional, Jarrett, James, additional, Rowell, Richard, additional, Shediac, Renée, additional, Mukherjee, Swati, additional, and Mohnike, Klaus, additional

Published
2021
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14. Health-related quality of life (HRQoL) in achondroplasia: findings from a multinational, observational study

Author

Maghnie, Mohamad, primary, Semler, Oliver, additional, Guillen-Navarro, Encarna, additional, Wiesel, Awi, additional, Maria Allegri, Anna Elsa, additional, Selicorni, Angelo, additional, Lopez, Antonio Gonzalez-Meneses, additional, Heath, Karen, additional, Zampino, Giuseppe, additional, Haeusler, Gabriele, additional, Hagenäs, Lars, additional, Leiva-Gea, Antonio, additional, González, Vanesa López, additional, Raimann, Adalbert, additional, Simarro, Fernando Santos, additional, Tajè, Silvia, additional, Ertl, Diana-Alexandra, additional, Gregersen, Pernille Axél, additional, Landfeldt, Erik, additional, Causin, Luiz, additional, Jarrett, James, additional, Quinn, Jennifer, additional, Shediac, Renée, additional, Mukherjee, Swati, additional, and Mohnike, Klaus, additional

Published
2021
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16. Maternal risk factors for the VACTERL association: A EUROCAT case–control study

Author

van de Putte, Romy, primary, van Rooij, Iris A.L.M., additional, Haanappel, Cynthia P., additional, Marcelis, Carlo L.M., additional, Brunner, Han G., additional, Addor, Marie‐Claude, additional, Cavero‐Carbonell, Clara, additional, Dias, Carlos M., additional, Draper, Elizabeth S., additional, Etxebarriarteun, Larraitz, additional, Gatt, Miriam, additional, Khoshnood, Babak, additional, Kinsner‐Ovaskainen, Agnieszka, additional, Klungsoyr, Kari, additional, Kurinczuk, Jenny J., additional, Latos‐Bielenska, Anna, additional, Luyt, Karen, additional, O'Mahony, Mary T., additional, Miller, Nicola, additional, Mullaney, Carmel, additional, Nelen, Vera, additional, Neville, Amanda J., additional, Perthus, Isabelle, additional, Pierini, Anna, additional, Randrianaivo, Hanitra, additional, Rankin, Judith, additional, Rissmann, Anke, additional, Rouget, Florence, additional, Schaub, Bruno, additional, Tucker, David, additional, Wellesley, Diana, additional, Wiesel, Awi, additional, Zymak‐Zakutnia, Natalya, additional, Loane, Maria, additional, Barisic, Ingeborg, additional, de Walle, Hermien E.K., additional, Bergman, Jorieke E.H., additional, and Roeleveld, Nel, additional

Published
2020
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17. Spectrum of congenital anomalies among VACTERL cases: a EUROCAT population-based study

Author

van de Putte, Romy, primary, van Rooij, Iris A. L. M., additional, Marcelis, Carlo L. M., additional, Guo, Michel, additional, Brunner, Han G., additional, Addor, Marie-Claude, additional, Cavero-Carbonell, Clara, additional, Dias, Carlos M., additional, Draper, Elizabeth S., additional, Etxebarriarteun, Larraitz, additional, Gatt, Miriam, additional, Haeusler, Martin, additional, Khoshnood, Babak, additional, Klungsoyr, Kari, additional, Kurinczuk, Jenny J., additional, Lanzoni, Monica, additional, Latos-Bielenska, Anna, additional, Luyt, Karen, additional, O’Mahony, Mary T., additional, Miller, Nicola, additional, Mullaney, Carmel, additional, Nelen, Vera, additional, Neville, Amanda J., additional, Perthus, Isabelle, additional, Pierini, Anna, additional, Randrianaivo, Hanitra, additional, Rankin, Judith, additional, Rissmann, Anke, additional, Rouget, Florence, additional, Schaub, Bruno, additional, Tucker, David, additional, Wellesley, Diana, additional, Wiesel, Awi, additional, Zymak-Zakutnia, Natalya, additional, Loane, Maria, additional, Barisic, Ingeborg, additional, de Walle, Hermien E. K., additional, Roeleveld, Nel, additional, and Bergman, Jorieke E. H., additional

Published
2019
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18. Epidemiology of congenital cerebral anomalies in Europe: a multicentre, population-based EUROCAT study

Author

Morris, Joan K, primary, Wellesley, Diana G, additional, Barisic, Ingeborg, additional, Addor, Marie-Claude, additional, Bergman, Jorieke E H, additional, Braz, Paula, additional, Cavero-Carbonell, Clara, additional, Draper, Elizabeth S, additional, Gatt, Miriam, additional, Haeusler, Martin, additional, Klungsoyr, Kari, additional, Kurinczuk, Jennifer J, additional, Lelong, Natalie, additional, Luyt, Karen, additional, Lynch, Catherine, additional, O’Mahony, Mary T, additional, Mokoroa, Olatz, additional, Nelen, Vera, additional, Neville, Amanda J, additional, Pierini, Anna, additional, Randrianaivo, Hanitra, additional, Rankin, Judith, additional, Rissmann, Anke, additional, Rouget, Florence, additional, Schaub, Bruno, additional, Tucker, David F, additional, Verellen-Dumoulin, Christine, additional, Wiesel, Awi, additional, Zymak-Zakutnia, Natalia, additional, Lanzoni, Monica, additional, and Garne, Ester, additional

Published
2019
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19. Congenital clubfoot in Europe: A population-based study

Author

Wang, Hao, primary, Barisic, Ingeborg, additional, Loane, Maria, additional, Addor, Marie-Claude, additional, Bailey, Linda M., additional, Gatt, Miriam, additional, Klungsoyr, Kari, additional, Mokoroa, Olatz, additional, Nelen, Vera, additional, Neville, Amanda J., additional, O'Mahony, Mary, additional, Pierini, Anna, additional, Rissmann, Anke, additional, Verellen-Dumoulin, Christine, additional, de Walle, Hermien E.K., additional, Wiesel, Awi, additional, Wisniewska, Katarzyna, additional, de Jong-van den Berg, Lolkje T.W., additional, Dolk, Helen, additional, Khoshnood, Babak, additional, and Garne, Ester, additional

Published
2019
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20. eP195 - Health-related quality of life (HRQoL) in achondroplasia: findings from a multinational, observational study

Author

Maghnie, Mohamad, Semler, Oliver, Guillen-Navarro, Encarna, Wiesel, Awi, Maria Allegri, Anna Elsa, Selicorni, Angelo, Lopez, Antonio Gonzalez-Meneses, Heath, Karen, Zampino, Giuseppe, Haeusler, Gabriele, Hagenäs, Lars, Leiva-Gea, Antonio, González, Vanesa López, Raimann, Adalbert, Simarro, Fernando Santos, Tajè, Silvia, Ertl, Diana-Alexandra, Gregersen, Pernille Axél, Landfeldt, Erik, Causin, Luiz, Jarrett, James, Quinn, Jennifer, Shediac, Renée, Mukherjee, Swati, and Mohnike, Klaus

Published
2021
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21. Insulin analogues use in pregnancy among women with pregestational diabetes mellitus and risk of congenital anomaly: a retrospective population-based cohort study

Author

Wang, Hao, primary, Wender-Ozegowska, Ewa, additional, Garne, Ester, additional, Morgan, Margery, additional, Loane, Maria, additional, Morris, Joan K, additional, Bakker, Marian K, additional, Gatt, Miriam, additional, de Walle, Hermien, additional, Jordan, Susan, additional, Materna-Kiryluk, Anna, additional, Nelen, Vera, additional, Thys, Guy, additional, Wiesel, Awi, additional, Dolk, Helen, additional, and de Jong-van den Berg, Lolkje T W, additional

Published
2018
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22. EUROmediCAT signal detection: a systematic method for identifying potential teratogenic medication

Author

Luteijn, Johannes M., Morris, Joan K., Garne, Ester, Given, Joanne, de Jong-van den Berg, Lolkje, Addor, Marie-Claude, Bakker, Marian, Barisic, Ingeborg, Gatt, Miriam, Klungsoyr, Kari, Latos- Bielenska, Anna, Lelong, Nathalie, Nelen, Vera, Neville, Amanda, O'Mahony, Mary, Pierini, Anna, Tucker, David, de Walle, Hermien, Wiesel, Awi, Loane, Maria, Dolk, Helen, PharmacoTherapy, -Epidemiology and -Economics, and Reproductive Origins of Adult Health and Disease (ROAHD)

Subjects
Adult, pharmacoepidemiology, drug safety, Databases, Factual, Congenital Abnormalities, Young Adult, Pregnancy, adverse drug reactions, congenital anomalies, pharmacovigilance, pregnancy, BIRTH-DEFECTS, DRUGS, Adverse Drug Reaction Reporting Systems, Humans, Registries, Pharmacoepidemiology, Abnormalities, Drug-Induced, FALSE DISCOVERY RATE, Europe, Teratogens, PHARMACOVIGILANCE, REGISTRY, Case-Control Studies, ACID, Female
Abstract

AIMS: Information about medication safety in pregnancy is inadequate. We aimed to develop a signal detection methodology to routinely identify unusual associations between medications and congenital anomalies using data collected by 15 European congenital anomaly registries.METHODS: EUROmediCAT database data for 14 950 malformed foetuses/babies with first trimester medication exposures in 1995-2011 were analyzed. The odds of a specific medication exposure (coded according to chemical substance or subgroup) for a specific anomaly were compared with the odds of that exposure for all other anomalies for 40 385 medication anomaly combinations in the data. Simes multiple testing procedure with a 50% false discovery rate (FDR) identified associations least likely to be due to chance and those associations with more than two cases with the exposure and the anomaly were selected for further investigation. The methodology was evaluated by considering the detection of well-known teratogens.RESULTS: The most common exposures were genitourinary system medications and sex hormones (35.2%), nervous system medications (28.0%) and anti-infectives for systemic use (25.7%). Fifty-two specific medication anomaly associations were identified. After discarding 10 overlapping and three protective associations, 39 associations were selected for further investigation. These associations included 16 which concerned well established teratogens, valproic acid (2) and maternal diabetes represented by use of insulin (14).CONCLUSIONS: Medication exposure data in the EUROmediCAT central database can be analyzed systematically to determine a manageable set of associations for validation and then testing in independent datasets. Detection of teratogens depends on frequency of exposure, level of risk and teratogenic specificity.

Published
2016
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23. Beta-Blocker Use in Pregnancy and Risk of Specific Congenital Anomalies: A European Case-Malformed Control Study

Author

Bergman, Jorieke E. H., primary, Lutke, L. Renée, additional, Gans, Rijk O. B., additional, Addor, Marie-Claude, additional, Barisic, Ingeborg, additional, Cavero-Carbonell, Clara, additional, Garne, Ester, additional, Gatt, Miriam, additional, Klungsoyr, Kari, additional, Lelong, Nathalie, additional, Lynch, Catherine, additional, Mokoroa, Olatz, additional, Nelen, Vera, additional, Neville, Amanda J., additional, Pierini, Anna, additional, Randrianaivo, Hanitra, additional, Rissmann, Anke, additional, Tucker, David, additional, Wiesel, Awi, additional, Dolk, Helen, additional, Loane, Maria, additional, and Bakker, Marian K., additional

Published
2017
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24. Gastroschisis in Europe – A prevalence and case-malformed control study

Author

Given, Joanne E., primary, Loane, Maria, additional, Garne, Ester, additional, Nelen, Vera, additional, Barisic, Ingeborg, additional, Randrianaivo, Hanitra, additional, Khoshnood, Babak, additional, Wiesel, Awi, additional, Rissmann, Anke, additional, Lynch, Catherine, additional, Neville, Amanda J., additional, Pierini, Anna, additional, Bakker, Marian, additional, Klungsoyr, Kari, additional, Bielenska, Anna Latos, additional, Cavero-Carbonell, Clara, additional, Addor, Marie-Claude, additional, Zymak-Zakutnya, Natalya, additional, Tucker, David, additional, and Dolk, Helen, additional

Published
2017
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25. Use of insulin analogs in pregestational diabetes and risk of congenital anomalies

Author

Wang, Hao, Wender-Ozegowska, Ewa, Garne, Ester, Morgan, Margery, Loane, Maria, Materna-Kiryluk, Anna, Wiesel, Awi, Jordan, Sue, Gatt, Miriam, Thys, Guy, Nelen, Vera, Bakker, Marian, De Walle, Hermien, and De Jong-Van Den Berg, Lolkje

Subjects
diabetes mellitus *risk *congenital malformation *pharmacoepidemiology *risk management prevalence pregnancy first trimester pregnancy risk factor human female exposure classification congenital heart malformation register European population glycemic control fetus death spontaneous abortion *insulin derivative human insulin
Abstract

Background: The use of insulin analogs in pregnancy is increasing, but information on teratogenic risks is lacking. Available studies on insulin analogs during pregnancy are not sufficiently powered to evaluate the risk of specific major malformations. Objectives: The aim of this study was to evaluate the risk of major congenital anomalies associated with insulin analogs use in women with pregestational diabetes. Methods: A population-based cohort of pregestational diabetic pregnancies was established retrospectively from seven European regions covered by EUROCAT congenital anomaly registries. Major congenital malformations were defined according the EUROCAT classification. Results: A total of 1877 births to women with pregestational diabetes were enrolled in the study during 1996-2012. During the first trimester, 870 births (46.3%) were exposed to only human insulin, 397 births (21.2%) to only insulin analogs, and 394 births (20.1%) to both human insulin and insulin analogs. The proportion of still birth and spontaneous abortion (4.0%) is higher among only insulin analog group compared with only human insulin group (1.4%). Overall, 132 births (7.0%) with major congenital malformation were detected, of which seven were chromosomal. The prevalence of major congenital anomalies in births exposed to only insulin analogs (3.8%) during the first trimester was significantly lower than those exposed to only human insulin (8.6%); relative risk=0.42 (95%CI 0.24-0.73). This is largely due to the decreased prevalence of non-chromosomal congenital heart defects (CHD): relative risk=0.18 (95%CI 0.05-0.58). The decreased prevalence remained after adjusting for glycemic control, planned pregnancy, and region. The prevalence of non-CHD congenital anomalies among births exposed to only insulin analogs in the first trimester (3.0%) was lower than those exposed to only human insulin (4.0%), but not statistically significant. Conclusions: This study shows that first trimester exposure to insulin analogs did not increase the risk of congenital anomalies compared with exposure to human insulin. The decrease risk of congenital anomalies was driven by CHDs. The higher risk of fetal death in relation to insulin analogs warranted further investigation.

Published
2015
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26. Lamotrigine use in pregnancy and risk of orofacial cleft, an update of eurocat lamotrigine study

Author

Wang, Hao, Loane, Maria, Garne, Ester, Morris, Joan, Nelen, Vera, Khoshnood, Babak, Rissmann, Anke, Wiesel, Awi, O Mahony, Mary, Anna Pierini, Calzolari, Elisa, Gatt, Miriam, Bakker, Marian, Addor, Marie-Claude, Tucker, David, Klungsoyr, Kari, Latos-Bielenska, Anna, Pmejnartowicz, Jan, Kallen, Karin, Barisic, Ingeborg, Verellen-Dumoulin, Christine, Doray, Berenice, Arriola, Larraitz, Wellesley, Diana, Neville, Amanda, Jong-Van Den Berg, Lolkje T. W., Dolk, Helen, and Reproductive Origins of Adult Health and Disease (ROAHD)

Subjects
cleft palate, therapy, register, pharmacoepidemiology, congenital malformation, anticonvulsive agent, first trimester pregnancy, population, risk management, live birth, registration, exposure, data base, monotherapy, stillbirth, lamotrigine, pregnancy, human, population based case control study, food and drug administration, risk
Abstract

Background: Lamotrigine (LTG) is increasingly used during pregnancy. A FDA warning was issued for an association of LTG exposure and increased risk of orofacial clefts (OCs), based on data from the North American Antiepileptic Drug Pregnancy Registry (Holmes, 2006; Holmes et al., 2008). The signal was examined in the European Surveillance of Congenital Anomalies (EUROCAT) antiepileptic-study database (Dolk, 2008). No significantly increased risk of OCs was found relative to other malformations, either for isolated orofacial clefts or for isolated cleft palate. There has been no independent confirmation of increased risk of OCs in relation to LTG from all studies in the literature combined (Dolk et al., 2012). Objectives: To investigate whether first trimester exposure to LTG monotherapy is specifically associated with an increased risk of OCs, using the EUROCAT antiepilepticstudy database including birth years up to 2010. Methods: A population-based case-control study with malformed controls was performed. The updated EUROCAT antiepileptic-study dataset included 226,806 live births, stillbirths, or terminations with malformations among 7.6 million births in 20 European countries from 1995 to 2010, more than twice the population of the original study. Cases were 10,523 nonsyndromic OC registrations, of whom 8,771 were isolated, and 3,789 cleft palate (CP) of whom 2,984 were isolated. Controls were 144,914 non-chromosomal, non-OC registrations. We compared first trimester LTG vs no antiepileptics (non- AED use), for mono and polytherapy. Results: There were 181 LTG exposed (109 mono- and 72 polytherapy) registrations. Thematernal age adjusted odds ratios (ORs) for LTG monotherapy vs non-AED use were 0.84 (95% CI 0.37-1.92) for OC relative to other malformations, 1.01 (95% CI 0.44-2.30) for isolated OC; 1.18 (95% CI 0.38-3.72) for CP, and 1.49 (95% CI 0.47-4.72) for isolated CP. Conclusions: This update does not change the conclusion of the original study: we found no evidence of an increased risk of isolated orofacial clefts relative to other malformations for LTG monotherapy exposure in the first trimester, nor any evidence of an increased risk for isolated cleft palate.

Published
2014

28. Prevalence of microcephaly in Europe: population based study

Author

Morris, Joan K, primary, Rankin, Judith, additional, Garne, Ester, additional, Loane, Maria, additional, Greenlees, Ruth, additional, Addor, Marie-Claude, additional, Arriola, Larraitz, additional, Barisic, Ingeborg, additional, Bergman, Jorieke E H, additional, Csaky-Szunyogh, Melinda, additional, Dias, Carlos, additional, Draper, Elizabeth S, additional, Gatt, Miriam, additional, Khoshnood, Babak, additional, Klungsoyr, Kari, additional, Kurinczuk, Jennifer J, additional, Lynch, Catherine, additional, McDonnell, Robert, additional, Nelen, Vera, additional, Neville, Amanda J, additional, O’Mahony, Mary T, additional, Pierini, Anna, additional, Randrianaivo, Hanitra, additional, Rissmann, Anke, additional, Tucker, David, additional, Verellen-Dumoulin, Christine, additional, de Walle, Hermien E K, additional, Wellesley, Diana, additional, Wiesel, Awi, additional, and Dolk, Helen, additional

Published
2016
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29. EUROmediCAT signal detection: an evaluation of selected congenital anomaly‐medication associations

Author

Given, Joanne E., primary, Loane, Maria, additional, Luteijn, Johannes M., additional, Morris, Joan K., additional, de Jong van den Berg, Lolkje T.W., additional, Garne, Ester, additional, Addor, Marie‐Claude, additional, Barisic, Ingeborg, additional, de Walle, Hermien, additional, Gatt, Miriam, additional, Klungsoyr, Kari, additional, Khoshnood, Babak, additional, Latos‐Bielenska, Anna, additional, Nelen, Vera, additional, Neville, Amanda J., additional, O'Mahony, Mary, additional, Pierini, Anna, additional, Tucker, David, additional, Wiesel, Awi, additional, and Dolk, Helen, additional

Published
2016
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30. Lamotrigine use in pregnancy and risk of orofacial cleft and other congenital anomalies

Author

Dolk, Helen, primary, Wang, Hao, additional, Loane, Maria, additional, Morris, Joan, additional, Garne, Ester, additional, Addor, Marie-Claude, additional, Arriola, Larraitz, additional, Bakker, Marian, additional, Barisic, Ingeborg, additional, Doray, Berenice, additional, Gatt, Miriam, additional, Kallen, Karin, additional, Khoshnood, Babak, additional, Klungsoyr, Kari, additional, Lahesmaa-Korpinen, Anna-Maria, additional, Latos-Bielenska, Anna, additional, Mejnartowicz, Jan P., additional, Nelen, Vera, additional, Neville, Amanda, additional, O'Mahony, Mary, additional, Pierini, Anna, additional, Rißmann, Anke, additional, Tucker, David, additional, Wellesley, Diana, additional, Wiesel, Awi, additional, and de Jong-van den Berg, Lolkje T.W., additional

Published
2016
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31. Insulin analogues use in pregnancy among women with pregestational diabetes mellitus and risk of congenital anomaly: a retrospective population-based cohort study.

Author

Hao Wang, Wender-Ozegowska, Ewa, Garne, Ester, Morgan, Margery, Loane, Maria, Morris, Joan K., Bakker, Marian K., Gatt, Miriam, de Walle, Hermien, Jordan, Susan, Materna-Kiryluk, Anna, Nelen, Vera, Thys, Guy, Wiesel, Awi, Dolk, Helen, and de Jong-van den Berg, Lolkje T. W.

Abstract

Objectives To evaluate the risk of major congenital anomaly associated with first-trimester exposure to insulin analogues compared with human insulin in offspring of women with pregestational diabetes. Design and setting A population-based cohort of women with pregestational diabetes (n=1661) who delivered between 1996 and 2012 was established retrospectively from seven European regions covered bythe European Surveillance of Congenital Anomalies (EUROCAT) congenital anomaly registries. Primary outcome measures The risk of nonchromosomal major congenital anomaly in live births, fetal deaths and terminations for a fetal anomaly exposed to insulin analogues in the first trimester of pregnancy was compared with the risk in those exposed to human insulin only. Results During the first trimester, 870 fetuses (52.4%) were exposed to human insulin only, 397 fetuses (23.9%) to insulin analogues only and 394 fetuses (23.7%) to both human insulin and insulin analogues. The risk of major congenital anomaly in fetuses exposed to insulin analogues only was lower than those exposed to human insulin only; the relative risk adjusted for glycaemic control and region was 0.56 (95% CI 0.29 to 1.06). The significantly lower risk related to exposure of insulin analogues only was observed in congenital heart defects: adjusted relative risk 0.14 (95% CI 0.03 to 0.62). Conclusions In this retrospective population-based cohort study across Europe, first-trimester exposure to insulin analogues did not increase the risk of major congenital anomaly compared with exposure to human insulin. A possible lower risk of congenital heart defects among fetuses exposed to insulin analogues only deserves further investigation. [ABSTRACT FROM AUTHOR]

Published
2018
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32. The potential of the European network of congenital anomaly registers (EUROCAT) for drug safety surveillance:A descriptive study

Author

Meijer, Willemijn M., Cornel, Martina C., Dolk, Helen, de Walle, Hermien E.K., Armstrong, Nicola C., de Jong-van den Berg, Lolkje T.W., Abramsky, Lenore, Addor, Marie Claude, Baena, Neus, Bakker, Marian, Barisic, Ingeborg, Bianca, Sebastiano, Boyd, Patricia, De Vigan, Catherine, Draper, Elizabeth, Garne, Ester, Gatt, Miriam, Gener, Blanca, Haeusler, Martin, Irgens, Lorentz, Jordan, Hilary, Loane, Maria, O'Mahony, M. T., Martínez-Frías, Maria Luisa, Berjemo, Eva, Mc Donnel, Bob, Nelen, Vera, Neville, Amanda, Clabrese, Olga, Rivieri, Francesca, Pierini, Anna, Bianchi, Fabrizio, Riaño Galán, Isolina, Ritvanen, Annukka, Robert-Gnansia, Elisabeth, Stoll, Claude, Soares, Maria, Tenconi, Romano, Wellesley, Diana, Wiesel, Awi, Human genetics, Groningen University Institute for Drug Exploration (GUIDE), Science in Healthy Ageing & healthcaRE (SHARE), and Reproductive Origins of Adult Health and Disease (ROAHD)

Subjects
Drug, Pediatrics, medicine.medical_specialty, drug exposure, LACTATION, Databases, Factual, Drug-Related Side Effects and Adverse Reactions, Epidemiology, media_common.quotation_subject, International Cooperation, Population, Postmarketing surveillance, Pharmacy, post-marketing surveillance, medicine, media_common.cataloged_instance, Adverse Drug Reaction Reporting Systems, Humans, Pharmacology (medical), MALFORMATIONS, Registries, EXPOSURE, European union, education, media_common, Safety surveillance, education.field_of_study, business.industry, congenital anomalies, Infant, Newborn, Abnormalities, Drug-Induced, WOMEN, Pharmacoepidemiology, medicine.disease, Europe, PREGNANCY, Pharmaceutical Preparations, REGISTRATION, CLASSIFICATION-SYSTEM, Medical emergency, Descriptive research, business
Abstract

Background European Surveillance of Congenital Anomalies (EUROCAT) is a network of population-based congenital anomaly registries in Europe surveying more than I million births per year, or 25% of the births in the European Union. This paper describes the potential of the EUROCAT collaboration for pharmacoepidemiology and drug safety surveillance.Methods The 34 full members and 6 associate members of the EUROCAT network were sent a questionnaire about their data sources on drug exposure and on drug coding. Available data on drug exposure during the first trimester available in the central EUROCAT database for the years 1996-2000 was summarised for 15 out of 25 responding full members.Results Of the 40 registries, 29 returned questionnaires (25 full and 4 associate members). Four of these registries do not collect data on maternal drug use. Of the full members, 15 registries use the EUROCAT drug code, 4 use the international ATC drug code, 3 registries use another coding system and 7 use a combination of these coding systems. Obstetric records are the most frequently used sources of drug information for the registries, followed by interviews with the mother. Only one registry uses pharmacy data. Percentages of cases with drug exposure (excluding vitamins/minerals) varied from 4.4% to 26.0% among different registries. The categories of drugs recorded varied widely between registries.Conclusions Practices vary widely between registries regarding recording drug exposure information. EUROCAT has the potential to be an effective collaborative framework to contribute to post-marketing drug surveillance in relation to teratogenic effects, but work is needed to implement ATC drug coding more widely, and to diversify the sources of information used to determine drug exposure in each registry. Copyright (c) 2006 John Wiley & Sons, Ltd.

Published
2006
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33. Evidence for a teratogenic risk in the offspring of health personnel exposed to ionizing radiation?!

Author

Wiesel, Awi, Stolz, Gabriela, and Queisser‐Wahrendorf, Annette

Abstract

Background The evidence concerning safety of occupational exposure to ionizing radiation on teratogenic effects mainly relies on animal models, disaster epidemiology and experience in cancer etiology. Following an explorative result on maternal exposure in medical occupations we conducted a feasibility study, addressing congenital anomalies (CA) in the offspring of health workers potentially exposed to radiation. Methods In a prospective follow-up study, we enrolled women, identified by mandatory registration at the office of radiation protection as wearing a dosimeter. The participating women answered a questionnaire and if pregnant agreed to an examination of their infant. CA were diagnosed and categorized, and demographic and anamnestic findings (including dosimeter values) were ascertained. Mainz Birth Registry data were used for comparison, and a nonresponder analysis was performed. Results Answers were received from 286 of 604 (51%) women exposed and 183 (30.3%) of them participated in the study including 88 nonparticipants who provided exposure data only. Further sources of ionizing radiation and other factors relevant for CA did not differ between the groups. Thirty pregnancies occurred among the participants. Eight of the resulting 27 infants were diagnosed with CA (30%) compared with 6.2% of the comparison group. Conclusion Previous explorative findings were corroborated by this feasibility study. The increased prevalence for CA could not be explained by any other factor. A preferable prospective active design is achievable, and the participation rate is essential to calculate valid results and answer this important issue. Birth Defects Research (Part A) 106:475-479, 2016. © 2016 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

Published
2016
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34. Spectrum of congenital anomalies in pregnancies with pregestational diabetes

Author

Garne, Ester, primary, Loane, Maria, additional, Dolk, Helen, additional, Barisic, Ingeborg, additional, Addor, Marie‐Claude, additional, Arriola, Larraitz, additional, Bakker, Marian, additional, Calzolari, Elisa, additional, Matias Dias, Carlos, additional, Doray, Berenice, additional, Gatt, Miriam, additional, Melve, Kari Klyungsoyr, additional, Nelen, Vera, additional, O'Mahony, Mary, additional, Pierini, Anna, additional, Randrianaivo‐Ranjatoelina, Hanitra, additional, Rankin, Judith, additional, Rissmann, Anke, additional, Tucker, David, additional, Verellun‐Dumoulin, Christine, additional, and Wiesel, Awi, additional

Published
2012
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36. Prevalence of microcephaly in Europe : population based study

Author

Morris, Joan K, Rankin, Judith, Garne, Ester, Loane, Maria, Greenlees, Ruth, Addor, Marie-Claude, Arriola, Larraitz, Barisic, Ingeborg, Bergman, Jorieke E H, Csaky-Szunyogh, Melinda, Dias, Carlos, Draper, Elizabeth S, Gatt, Miriam, Khoshnood, Babak, Klungsoyr, Kari, Kurinczuk, Jennifer J, Lynch, Catherine, McDonnell, Robert, Nelen, Vera, Neville, Amanda J, O’Mahony, Mary T, Pierini, Anna, Randrianaivo, Hanitra, Rissmann, Anke, Tucker, David, Verellen-Dumoulin, Christine, de Walle, Hermien E K, Wellesley, Diana, Wiesel, Awi, and Dolk, Helen

37. OP094 - Lifetime impact of achondroplasia in Europe (LIAISE): findings from a multinational observational study.

Author

Maghnie, Mohamad, Semler, Oliver, Guillen-Navarro, Encarna, Wiesel, Awi, Maria Allegri, Anna Elsa, Selicorni, Angelo, Lopez, Antonio Gonzalez-Meneses, Heath, Karen, Zampino, Giuseppe, Haeusler, Gabriele, Hagenäs, Lars, Leiva-Gea, Antonio, González, Vanesa López, Raimann, Adalbert, Simarro, Fernando Santos, Tajè, Silvia, Ertl, Diana-Alexandra, Gregersen, Pernille Axél, Pimenta, Jeanne M., and Cohen, Shelda

Subjects
*ACHONDROPLASIA, *SCIENTIFIC observation
Published
2021
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38. Amniotic band syndrome and limb body wall complex in Europe 1980-2019.

Author

Bergman JEH, Barišić I, Addor MC, Braz P, Cavero-Carbonell C, Draper ES, Echevarría-González-de-Garibay LJ, Gatt M, Haeusler M, Khoshnood B, Klungsøyr K, Kurinczuk JJ, Latos-Bielenska A, Luyt K, Martin D, Mullaney C, Nelen V, Neville AJ, O'Mahony MT, Perthus I, Pierini A, Randrianaivo H, Rankin J, Rissmann A, Rouget F, Sayers G, Schaub B, Stevens S, Tucker D, Verellen-Dumoulin C, Wiesel A, Gerkes EH, Perraud A, Loane MA, Wellesley D, and de Walle HEK

Subjects
Pregnancy, Humans, Female, Infant, Newborn, Europe epidemiology, Maternal Age, Stillbirth epidemiology, Registries, Prevalence, Amniotic Band Syndrome complications, Abnormalities, Multiple epidemiology
Abstract

Amniotic band syndrome (ABS) and limb body wall complex (LBWC) have an overlapping phenotype of multiple congenital anomalies and their etiology is unknown. We aimed to determine the prevalence of ABS and LBWC in Europe from 1980 to 2019 and to describe the spectrum of congenital anomalies. In addition, we investigated maternal age and multiple birth as possible risk factors for the occurrence of ABS and LBWC. We used data from the European surveillance of congenital anomalies (EUROCAT) network including data from 30 registries over 1980-2019. We included all pregnancy outcomes, including live births, stillbirths, and terminations of pregnancy for fetal anomalies. ABS and LBWC cases were extracted from the central EUROCAT database using coding information responses from the registries. In total, 866 ABS cases and 451 LBWC cases were included in this study. The mean prevalence was 0.53/10,000 births for ABS and 0.34/10,000 births for LBWC during the 40 years. Prevalence of both ABS and LBWC was lower in the 1980s and higher in the United Kingdom. Limb anomalies and neural tube defects were commonly seen in ABS, whereas in LBWC abdominal and thoracic wall defects and limb anomalies were most prevalent. Twinning was confirmed as a risk factor for both ABS and LBWC. This study includes the largest cohort of ABS and LBWC cases ever reported over a large time period using standardized EUROCAT data. Prevalence, clinical characteristics, and the phenotypic spectrum are described, and twinning is confirmed as a risk factor., (© 2022 The Authors. American Journal of Medical Genetics Part A published by Wiley Periodicals LLC.)

Published
2023
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39. Birth defects in the vicinity of nuclear power plants in Germany.

Author

Queisser-Luft A, Wiesel A, Stolz G, Mergenthaler A, Kaiser M, Schlaefer K, Wahrendorf J, Blettner M, and Spix C

Subjects
Cohort Studies, Environmental Exposure statistics & numerical data, Female, Germany epidemiology, Humans, Infant, Infant, Newborn, Longitudinal Studies, Multivariate Analysis, Population Surveillance methods, Pregnancy, Prevalence, Risk Factors, Air Pollution, Radioactive statistics & numerical data, Congenital Abnormalities epidemiology, Nuclear Power Plants, Prenatal Exposure Delayed Effects epidemiology, Registries statistics & numerical data
Abstract

Living in the vicinity of nuclear power plants (NPP) is discussed here in terms of adverse health effects. A prospective population-based cohort study was conducted to evaluate whether the prevalence of birth defects in the vicinity of NPPs is elevated and scrutinize a possible distance correlation. A birth cohort born to mothers living within 10 km of two selected NPPs (study region) was compared to a region without NPP (comparison region), and an active surveillance of all live births, stillbirths, and induced abortions in the defined regions was performed. Between 01/2007 and 02/2008, all newborns were examined by specially trained study paediatricians according to the protocols of the Birth Registry Mainz Model. The cohort consisted of 5,273 infants (90% completeness). The outcome measure was an infant with birth defect(s). The prevalence of infants with birth defects was 4.5% in the study region and 4.7% in the comparison region, which corresponds to a relative risk (RR) of 0.94 (lower 95% confidence level (CL): 0.76). Thus, the prevalence of birth defects in the regions surrounding NPPs was not increased compared to those of the comparison region. Adjustment for potential confounders did not substantially change the result (RR 0.90, lower 95% CL 0.73). The adjusted and unadjusted distance approach (1/distance in km) did not show any correlation to vicinity to a NPP (p = 0.38). Specifically, within the study region, the prevalence of birth defects showed no upward trend with decreasing distance. Birth defect prevalence and most descriptive parameters in the comparison region were identical to those in the Birth Registry Mainz Model.

Published
2011
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