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1.
  • Danielsson, Bengt, et al. (author)
  • Use of ondansetron during pregnancy and congenital malformations in the infant.
  • 2014
  • In: Reproductive Toxicology. - : Elsevier BV. - 1873-1708 .- 0890-6238. ; 50, s. 134-137
  • Journal article (peer-reviewed)abstract
    • The study investigates teratogenic risks with ondansetron (Zofran(®)). Data from the Swedish Medical Birth Register combined with the Swedish Register of Prescribed Drugs were used to identify 1349 infants born of women who had taken ondansetron in early pregnancy, 1998-2012. Presence of congenital malformations in the offspring was identified with three national health registers. In a Mantel-Haenszel analysis adjustment was made for year of delivery, maternal age, parity, smoking in early pregnancy and pre-pregnancy body mass index. Risks were expressed as odds or risk ratios with 95% confidence intervals. No statistically significantly increased risk for a major malformation was found. The risks for a cardiovascular defect and notably a cardiac septum defect were increased and statistically significant (OR=1.62, 95% CI 1.04-2.14, and RR 2.05, 95% CI 1.19-3.28, respective). The teratogenic risk with ondansetron is low but an increased risk for a cardiac septum defect is likely.
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2.
  • Källén, Bengt, et al. (author)
  • Fetal safety of erythromycin. An update of Swedish data.
  • 2014
  • In: European Journal of Clinical Pharmacology. - : Springer Science and Business Media LLC. - 1432-1041 .- 0031-6970. ; 70:3, s. 355-360
  • Journal article (peer-reviewed)abstract
    • In previous studies from the Swedish Medical Birth Register, a possible association between erythromycin therapy and an increased risk for cardiovascular defects was found. Other studies using different methodology have not verified this observation. The finding resulted in a warning for the use of erythromycin in early pregnancy, followed by a marked decline in such use. The present study was conducted to follow up on the previous observations and to find methodological explanations for the variation in results in these different published studies.
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5.
  • Källén, Karin, et al. (author)
  • Relation between oculo-auriculo-vertebral (OAV) dysplasia and three other non-random associations of malformations (VATER, CHARGE, and OEIS).
  • 2004
  • In: American Journal of Medical Genetics. Part A. - : Wiley. - 1552-4825 .- 1552-4833. ; 127A:1, s. 26-34
  • Journal article (peer-reviewed)abstract
    • Using a statistical methodology, we aimed to identify a group of probable cases of oculo-auriculo-vertebral (OAV) dysplasia and to investigate possible relationships between different patterns of congenital malformations. Among 5,260 infants with multiple malformations collected from 4 large registers of congenital malformations, we identified 312 probable OAV cases. With the same technique, we have earlier defined epidemiological delineations of three other well-known non-random associations of congenital malformations (CHARGE, VATER, and OEIS). We found convincing relationships between OAV and VATER or CHARGE but none between OAV and OEIS or between the three malformation complexes CHARGE, VATER, and OEIS. An association between two conditions indicates similarities in pathogenesis or in etiology. We suggest that the connection between OAV and CHARGE could be related to a common pathogenetic mechanism: disturbed neural crest development. (C) 2003 Wiley-Liss, Inc.
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6.
  • Källén, Karin, et al. (author)
  • VATER non-random association of congenital malformations: study based on data from four malformation registers
  • 2001
  • In: American Journal of Medical Genetics. - : Wiley. - 0148-7299 .- 1096-8628. ; 101:1, s. 26-32
  • Journal article (peer-reviewed)abstract
    • This study was undertaken to find a strict, unbiased epidemiological delineation of the VATER non-random association of congenital malformations and, based on registry information, to identify a group of probable VATER association infants suitable for etiological analyses. Information on 5,260 infants with multiple malformations was collected from four large registers of congenital malformations. Data were analyzed using a statistical method in which various putative confounders were controlled for. Our results indicate the existence of a distinct group of malformations corresponding to the VATER association: esophageal atresia, anal atresia, upper preaxial limb reduction defects, and costo-vertebral malformations. A subdivision into an upper and a lower group of VATER association was indicated, with heart malformations associated with the upper group and kidney malformations associated with the lower group. Restricting the inclusion criteria for VATER association to the above mentioned core malformations, few infants seem to belong to the VATER association, thus limiting the possibilities of carrying out etiological analyses. A relatively large number of infants may belong to a family of related conditions among which VATER association is a subgroup. In the search for risk factors, a strict definition of the VATER association is needed in order to not dilute the study material with irrelevant cases. The present study provides such strict inclusion criteria.
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7.
  • Almgren, Malin, et al. (author)
  • Population-based study of antiepileptic drug exposure in utero-Influence on head circumference in newborns
  • 2009
  • In: Seizure. - : Elsevier BV. - 1532-2688 .- 1059-1311. ; 18:10, s. 672-675
  • Journal article (peer-reviewed)abstract
    • Purpose: To study the effect of AED exposure on head circumference in the newborn. Methods: Data on all Swedish singletons births between 1995 and 2005, over 900,000 births, were obtained from the Swedish Medical Birth Registry. The effects of AEDs on birth-weight-adjusted mean head circumference (bw-adj-HC) were estimated by comparison with data from all births in an analysis which was adjusted for year of birth, maternal age, parity, maternal smoking, and maternal body mass index. Results: A significant reduction of mean bw-adj-HC was seen after both carbamazepine (CBZ) (standard deviation scores (SDS) = 0.15, p < 0.001) and valproic acid (VPA) (SDS = 0.10, p = 0.04) in monotherapy. No effect on mean bw-adj-HC was seen for phenytoin, clonazepam, lamotrigine and gabapentin. There was a significant increase in the occurrence of microcephaly (bw-adj-HC smaller than 2 SD below the mean) after any AED polytherapy (OR = 2.85, 95% CI: 1.74-4.78) but not after AED monotherapy or monotherapy with CBZ or VPA. CBZ OF VPA was taken by 71% of the pregnant mothers on AED, and the usage increased over time. Conclusions: CBZ and VPA in monotherapy during pregnancy reduce mean bw-adj-HC. AED polytherapy increases the rate of microcephaly but no significant effect is seen of AED monotherapy. The possible significance for the further development of the child is uncertain but should be explored. (C) 2009 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.
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8.
  • Asker, C, et al. (author)
  • Use of antiemetic drugs during pregnancy in Sweden
  • 2005
  • In: European Journal of Clinical Pharmacology. - : Springer Science and Business Media LLC. - 1432-1041 .- 0031-6970. ; 61:12, s. 899-906
  • Journal article (peer-reviewed)abstract
    • Background: More than one-half of all pregnant women suffer from nausea and vomiting during pregnancy (NVP), primarily during the first trimester. Methods: Prospectively ascertained information on drug use during pregnancy was obtained from the Swedish Medical Birth Register during the period July 1, 1995 to 2002. Antiemetics (antiemetic antihistamines, dopamine modulators, and ondansetron) primarily used for NVP were studied, and women reporting the use of these drugs were compared with all women who gave birth during the study period. Results: Use of these antiemetics was reported in 4.5% of the pregnant women - 86% of whom reported their use before the first antenatal visit (usually weeks 10-12). Meclozine, followed by other antihistamines, accounted for 68% of the drugs reported. Young maternal age, multiparity, non-smoking, and a period of unwanted childlessness increased the probability of using any of the antiemetics during pregnancy. Women with a low education used these drugs more often than women with a relatively higher education. Neonates born to women who used any of the antiemetics had a reduced risk for low birthweight, prematurity, being small-for-gestational age, and having a malformation. No specific differences were observed with respect to the outcome following a comparison of different antiemetic drugs. Conclusions: Women using antiemetics as a rule have a better delivery outcome than other women, probably due to an effect of a well-functioning placenta, which is associated with NVP. There were no signs of any significant teratogenicity of the drugs studied, but for some drugs the number of exposures was low.
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  • Aspberg, Sara, et al. (author)
  • Confirmed association between neonatal phototherapy or neonatal icterus and risk of childhood asthma
  • 2010
  • In: Pediatric Allergy and Immunology. - : Wiley. - 0905-6157 .- 1399-3038. ; 21:4, s. 733-739
  • Journal article (peer-reviewed)abstract
    • We have previously demonstrated an association between neonatal phototherapy and/or neonatal icterus and risk of hospitalization for childhood asthma. This study included children who were prescribed anti-asthmatic medication on a population basis to study exposures during the foetal and neonatal period and risk of childhood asthma. The Swedish Medical Birth Register was linked to the Swedish Prescribed Drug Register. Perinatal data for singleton children who were prescribed anti-asthmatic medication (n = 61 256) were compared with corresponding data for all singleton children born in Sweden from 1 January 1990 to 30 June 2003 and surviving to 1 July 2005 (n = 1 338 319). Mantel-Haenszel's odds ratios were calculated after adjustment for various known confounders. Being the first-born child, maternal age above 44 yr, involuntary childlessness for more than 1 yr, maternal smoking during pregnancy, maternal diabetes mellitus of any kind, pre-eclampsia, caesarean section, and instrumental vaginal delivery were all associated with an increased prescription of anti-asthmatic medication during childhood. Preterm birth, low birth weight, being small for gestational age, respiratory problems, mechanical ventilation, and sepsis and/or pneumonia were also associated with increased drug prescriptions. Neonatal phototherapy and/or icterus were risk determinants for children who developed asthma before the age of 12. After controlling for confounders, the odds ratio for phototherapy and/or icterus remained at 1.30 (95% confidence interval 1.16-1.47). In conclusion, this large population-based study confirms an association between some maternal and perinatal factors and childhood asthma, including neonatal phototherapy and/or icterus.
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11.
  • Aspberg, Sara, et al. (author)
  • Fetal and perinatal risk factors for inflammatory bowel disease
  • 2006
  • In: Acta Pædiatrica. - : Wiley. - 1651-2227 .- 0803-5253. ; 95:8, s. 1001-1004
  • Journal article (peer-reviewed)abstract
    • Aim: To study the influence of specific factors and events during pregnancy and the perinatal period on the risk of children developing inflammatory bowel disease. Methods: Population-based national register study. Linkage between the Swedish Medical Birth Register and the Swedish Hospital Discharge Register during the period 1987 to 2000 identified 455 singleton infants who later developed inflammatory bowel disease. Data for these children were compared with data for all children born in Sweden during the same period. Results: Smoking during early pregnancy reduced the risk of inflammatory bowel disease ( odds ratio ( OR) 0.71, 95% CI 0.55-0.91). For ulcerative colitis the odds ratio was 0.70 ( 95% CI 0.56-0.86), and for Crohn's disease 0.73 ( 95% CI 0.58 - 0.94). Infections during the neonatal period seemed to increase the risk of inflammatory bowel disease ( OR 17.6, 95% CI 3.6 - 51.6), but the number of observed events was small. The other factors examined did not influence the risk of inflammatory bowel disease. Conclusion: Maternal smoking during early pregnancy reduces the risk for the child to be hospitalized with a diagnosis of inflammatory bowel disease. Severe neonatal infections may increase the risk. Thus, some exposures during the fetal and neonatal period seem to affect the risk of inflammatory bowel disease later in life.
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12.
  • Aspberg, Sara, et al. (author)
  • Is neonatal phototherapy associated with an increased risk for hospitalized childhood bronchial asthma?
  • 2007
  • In: Pediatric Allergy and Immunology. - : Wiley. - 0905-6157 .- 1399-3038. ; 18:4, s. 313-319
  • Journal article (peer-reviewed)abstract
    • This population-based register study examined if factors during the fetal and neonatal period influence the risk for the child to develop bronchial asthma (asthma). From the Swedish Hospital Discharge Register we identified children, born between 1987 and 1999, who had been hospitalized for asthma up to 2001. Thus, the outcome measure contains only hospitalized cases, not all children with asthma. Children younger than 2 yr at admission were excluded because of the uncertainty about the diagnosis of asthma in younger children. The remaining 14,803 children were compared with all children born the same years, recorded in the Swedish Medical Birth Registry, for information on pre- and perinatal characteristics. Odds ratios (ORs) were calculated with Mantel-Haenszel technique and 95% confidence intervals (CIs) with Miettinen's test-based method. The presence of various maternal and neonatal confounders were identified and adjusted for in the analyses. The association between some known factors and childhood asthma were confirmed: young maternal age, maternal smoking, period of unwanted childlessness, low maternal level of education, maternal diabetes, preterm birth, low birth weight, small-for-gestational age, caesarean section, and instrumental vaginal delivery. A number of neonatal characteristics were shown to be independent risk factors: sepsis or pneumonia, neonatal respiratory problems and treatments, neonatal icterus, and/or neonatal phototherapy. The association with icterus and phototherapy remained after exclusion of cases showing other neonatal risk factors and after adjustment for maternal factors (OR 1.27, 95% CI: 1.08-1.50), and increased to 1.5 if the children had been hospitalized for asthma more than once. In conclusion, our results suggest an association between neonatal icterus and/or treatment with neonatal phototherapy and hospitalized childhood asthma. This association needs further exploration.
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  • Becker, Magnus, et al. (author)
  • Birth weight, body length, and cranial circumference in newborns with cleft lip or palate
  • 1998
  • In: Cleft Palate Journal. - 0009-8701. ; 35:3, s. 255-261
  • Journal article (peer-reviewed)abstract
    • OBJECTIVE: This paper reports on birth weight, body length, body mass index, and cranial circumference at birth of infants with cleft lip and/or palate born between 1973 and 1992. METHODS: Data were obtained from two nationwide Swedish health registries. Infants with syndromes, twins, and infants with immigrant parentage were excluded from the study. Comparisons were made with all singleton births with the same exclusion criteria (n = 2,031,140). RESULTS: The body dimensions of infants with isolated cleft lip (n = 865) were found not to differ from those of control subjects, but infants with isolated cleft palate (n = 811) or cleft lip and palate (n = 1139) were found to be lighter and shorter than control subjects. Also, infants with the Pierre Robin sequence (n = 121) had a tendency to be lighter and shorter than control subjects, but these differences did not reach statistical significance despite the large study population.
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14.
  • Blomberg, Marie I., et al. (author)
  • Maternal Obesity and Morbid Obesity: the Risk for Birth Defects in the Offspring
  • 2010
  • In: Birth Defects Research. Part A: Clinical and Molecular Teratology. - : Wiley. - 1542-0760 .- 1542-0752. ; 88:1, s. 35-40
  • Journal article (peer-reviewed)abstract
    • BACKGROUND: The objective of this study was to assess, in a large data set from Swedish Medical Health Registries, whether maternal obesity and maternal morbid obesity were associated with an increased risk for various structural birth defects. METHODS: The study population consisted of 1,049,582 infants born in Sweden from January 1, 1995, through December 31, 2007, with known maternal weight and height data. Women were grouped in six categories of body mass index (BMI) according to World Health Organization classification. Infants with congenital birth defects were identified from three sources: the Swedish Medical Birth Registry, the Register of Birth Defects, and the National Patient Register. Maternal age, parity, smoking, and year of birth were thought to be potential confounders and were included as covariates in the adjusted odds ratio analyses. RESULTS: Ten percent of the study population was obese. Morbid obesity (BMI >= 40) occurred in 0.7%. The prevalence of congenital malformations was 4.7%, and the prevalence of relatively severe malformations was 3.2%. Maternal prepregnancy morbid obesity was associated with neural tube defects OR 4.08 (95% CI 1.87-7.75), cardiac defects OR 1.49 (95% CI 1.24-1.80), and orofacial clefts OR 1.90 (95% CI 1.27-2.86). Maternal obesity (BMI >= 30) significantly increased the risk of hydrocephaly, anal atresia, hypospadias, cystic kidney, pes equinovarus, omphalocele, and diaphragmatic hernia. CONCLUSION: The risk for a morbidly obese pregnant woman to have an infant with a congenital birth defect is small, but for society the association is important in the light of the ongoing obesity epidemic. Birth Defects Research (Part A) 88:35-40, 2010. (C) 2009 Wiley-Liss, Inc.
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  • Cedergren, Marie, 1963-, et al. (author)
  • Chlorination byproducts and nitrate in drinking water and risk for congenital cardiac defects
  • 2002
  • In: Environmental Research. - : Elsevier BV. - 1096-0953 .- 0013-9351. ; 89:2, s. 124-130
  • Journal article (peer-reviewed)abstract
    • Drinking water disinfection byproducts have been associated with an increased risk for congenital defects including cardiac defects. Using Swedish health registers linked to information on municipal drinking water composition, individual data on drinking water characteristics were obtained for 58,669 women. Among the infants born, 753 had a cardiac defect. The risk for a cardiac defect was determined for ground water versus surface water, for different chlorination procedures, and for trihalomethane and nitrate concentrations. Ground water was associated with an increased risk for cardiac defect when crude rates were analyzed but after suitable adjustments this excess rate was found to be determined by chlorination procedures including chlorine dioxide. Chlorine dioxide appears itself as an independent risk factor for cardiac defects (adjusted odds ratio 1.61 (95% CI 1.00-2.59)). The risk for cardiac defects increased with increasing trihalomethane concentrations (P = 0.0005). There was an indicated but statistically nonsignificant excess risk associated with nitrate concentration. The individual risk for congenital cardiac defect caused by chlorine dioxide and trihalomethanes is small but as a large population is exposed to public drinking water, the attributable risk for cardiac defects may not be negligible. (C) 2002 Elsevier Science (USA).
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  • Cedergren, Marie, 1963-, et al. (author)
  • Geographic variations in possible risk factors for severe cardiac malformations
  • 2002
  • In: Acta Pædiatrica. - : Wiley. - 1651-2227 .- 0803-5253. ; 91:2, s. 222-228
  • Journal article (peer-reviewed)abstract
    • The aim of this study was to investigate various putative risk factors in a county in Sweden, described as having a 28% increased prevalence of cardiovascular malformations, and to compare them with the risk factors in two reference counties. Women giving birth in the studied counties differed in age and parity distribution, smoking, and educational level but these differences could not explain the increased risk of cardiovascular malformations in the county, since after stratification for these variables, the risk, estimate did not change substantially. A number of potential risk factors were studied in a case/control design: spontaneous abortions, involuntary childlessness, maternal disease, body mass index, medical drug use, alcohol use, parental employment, paternal age, and urban/rural residency. No single factor could be attributed to the increased rate, with the exception of living in a rural district, Nearly all risk factors, however, were stronger in the county studied than those in the reference counties (0.02 > p > 0.01). Conclusion: The only single putative risk factor that could have contributed to the increased risk for cardiac defects described in the county Studied was maternal residency in a rural district. Notably, nearly all potential risk factors studied were stronger in the counts studied compared with those in the reference area. A conceivable explanation is that one or more unidentified factors related to rural residency could potentiate prevalent and weak teratogenic risk factors for cardiac defects.
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  • Cedergren, Marie, 1963-, et al. (author)
  • Maternal obesity and infant heart defects
  • 2003
  • In: Obesity Research. - 1071-7323 .- 1550-8528. ; 11:9, s. 1065-1071
  • Journal article (peer-reviewed)abstract
    • Objective: This study determined whether obese women have an increased risk of cardiovascular defects in their offspring compared with average weight women. Research Methods and Procedures: In a case-control study, prospectively collected information was obtained from Swedish medical health registers. The study included 6801 women who had infants with a cardiovascular defect and, as controls, all delivered women (N = 812,457) during the study period (1992 to 2001). Infants with chromosomal anomalies or whose mothers had pre-existing diabetes were excluded. Obesity was defined as BMI >29 kg/m2, and morbid obesity was defined as BMI >35 kg/m2. Comparisons were made with average weight women (BMI = 19.8 to 26 kg/m2). Results: In the group of obese mothers, there was an increased risk for cardiovascular defects compared with the average weight mothers [adjusted odds ratio (OR) = 1.18, 95% CI, 1.09 to 1.27], which was slightly more pronounced for the severe types of cardiovascular defects (adjusted OR = 1.23, 95% CI, 1.05 to 1.44). With morbid obesity, the OR for cardiovascular defects was 1.40 (95% CI, 1.22 to 1.64), and for severe cardiovascular defects, the OR was 1.69 (95% CI, 1.27 to 2.26). There was an increased risk for all specific defects studied among the obese women, but only ventricular septal defects and atrial septal defects reached statistical significance. Discussion: In this sample, a positive association was found between maternal obesity in early pregnancy and congenital heart defects in the offspring. A suggested explanation is undetected type 2 diabetes in early pregnancy, but other explanations may exist.
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  • Cedergren, Marie, 1963-, et al. (author)
  • Maternal obesity and the risk for orofacial clefts in the offspring
  • 2005
  • In: The Cleft Palate - Craniofacial Journal. - : SAGE Publications. - 1545-1569 .- 1055-6656. ; 42:4, s. 367-371
  • Journal article (peer-reviewed)abstract
    • Objective: To estimate whether obese women have an increased risk of orofacial clefts in their offspring, compared with average-weight women. Design and Participants: The study was based on information on maternal body mass index (BMI) collected in early pregnancy and on the existence of orofacial clefts in the offspring, ascertained from multiple sources. The study included 1686 women who had infants with an orofacial cleft and as controls all delivered women (n = 988,171) during the study period, 1992 through 2001. Infants with chromosome anomalies were excluded. The women were divided into underweight (BMI < 19.8), average weight (reference group, BMI 19.8 to 26), overweight (BMI 26.1 to 29), and obese (BMI > 29). Adjustments were made for year of birth, maternal age, parity, and maternal smoking. Results: Obese (BMI >29) mothers had an overall increased risk for having an infant with orofacial clefts: odds ratio 1.30 (95% confidence interval 1.11 to 1.53). This increased risk was higher when the cleft was associated with other major malformations than when it was isolated. There was no statistically significant difference between the risk estimates for cleft lip and cleft palate. Conclusions: In this large sample, a positive association appears between maternal obesity in early pregnancy and orofacial clefts in the offspring. The explanation for this association is not known, but a relationship with undetected type 2 diabetes is one possibility.
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  • Cedergren, Marie, 1963-, et al. (author)
  • Obstetric outcome of 6346 pregnancies with infants affected by congenital heart defects
  • 2006
  • In: European Journal of Obstetrics, Gynecology, and Reproductive Biology. - : Elsevier BV. - 0301-2115 .- 1872-7654. ; 125:2, s. 211-216
  • Journal article (peer-reviewed)abstract
    • Objective: To evaluate whether pregnancies with infants affected by congenital heart defects are associated with adverse obstetric and perinatal outcome. Study design: In a prospective population-based cohort study from Sweden (1992-2001), 6346 singleton pregnancies with infants affected by congenital heart defects were, after suitable adjustments, compared to all delivered women. Results: The prevalence of cardiovascular defects was 9.1 per 1000 births. Among them, mothers of 6346 infants (71%) had information on maternal smoking habits and maternal height and weight in early pregnancy that enabled the calculation of BMI. All cases with known chromosomal abnormalities and/or maternal pre-existing diabetes were excluded. Eighty-four percent (n = 5338) had an isolated cardiovascular defect. Severe types occurred in 21.7% (n = 1378). In the group of pregnancies with infants affected by congenital heart defects as compared to all delivered women, there was an increased risk of the following outcomes (adjusted OR (95%Cl)): pre-eclampsia (1.21 (1.06-1.37)), cesarean section (1.91 (1.79-2.03)), instrurnental delivery (1.21 (1.10-1.34)), pre-term delivery (2.58 (2.39-2.79)), small-for gestational age (1.96 (1.77-2.16)), meconium aspiration (1.51 (1.28-1.77)), and fetal distress (1.38 (1.17-1.63)). Conclusions: Pregnancies with infants affected by congenital heart defects are associated with several obstetric and neonatal complications. (c) 2005 Elsevier Ireland Ltd. All rights reserved.
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  • Cedergren, Marie, 1963-, et al. (author)
  • Risk factors for cardiovascular malformation - a study based on prospectively collected data
  • 2002
  • In: Scandinavian Journal of Work, Environment and Health. - : Scandinavian Journal of Work, Environment and Health. - 0355-3140 .- 1795-990X. ; 28:1, s. 12-17
  • Journal article (peer-reviewed)abstract
    • Objectives The aim of this study was to identify risk factors for cardiovascular malformation. Methods In a case-referent study prospectively collected data were obtained from original medical records. The study included 277 woman who had infants with a severe cardiac defect, and for each case two referents (medical records study) were included. Data on parental age, maternal reproductive history, disease in early pregnancy, reported maternal use of drugs and alcohol, smoking habits, parental occupation, and maternal body mass index (BMI) were extracted. When data were available from Swedish medical health registers, a comparison was made (register study) between all infants with cardiovascular defects (2208) and all infants born (175 768). Results Maternal diabetes mellitus was associated with an increased risk for cardiovascular malformation [odds ratio (OR) 2.38, 95% confidence interval (95% CI) 1.36-4.15], as was a high BMI (> 29) (OR 1.46, 95%CI 1.12-1.90). A tendency towards an increased risk was found for involuntary childlessness, spontaneous abortion, thyroid drugs, and nonsteroid anti-inflammatory drugs. Conclusions Some known risk factors for cardiac defects (eg, maternal diabetes mellitus and the use of antiepileptics) could be identified. Other postulated risk factors could not be verified, for example, paternal age and parental occupation. The use of medicinal drugs seems not to be a major factor in the etiology of cardiac defects. It is possible, however, that there is an association with the use of nonsteroid anti-inflammatory drugs or drugs for thyroid disease. The relationship between a high BMI and cardiovascular malformation observed in this study may be explained by impaired maternal glucose tolerance.
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22.
  • Cleary, Brian J., et al. (author)
  • Early Pregnancy Azathioprine Use and Pregnancy Outcomes
  • 2009
  • In: Birth Defects Research. Part A: Clinical and Molecular Teratology. - : Wiley. - 1542-0760 .- 1542-0752. ; 85:7, s. 647-654
  • Journal article (peer-reviewed)abstract
    • BACKGROUND: Azathioprine (AZA) is used during pregnancy by h omen with inflammatory bowel disease (IBD), other autoimmune disorders, malignancy, and organ transplantation. Previous studies have demonstrated potential risks. METHODS: The Swedish Medical Birth Register was used to identify 476 women who reported the use of AZA in early pregnancy. The effect of AZA exposure on pregnancy outcomes was Studied after adjustment for maternal characteristics that could act as confounders. RESULTS: The most common indication for AZA use was IBD. The rate of congenital malformations was 6.2% in the AZA group and 4.7% among all infants born (adjusted OR: 1.41, 95% CI: 0.98-2.04). An association between early pregnancy AZA exposure and ventricular/atrial septal defects was found (adjusted OR: 3.18, 95% CI: 1.45-6.04)Exposed infants were also more likely to be preterm, to weigh <2500 gm, and to be small for gestational age compared to all infants born. This effect remained for preterm birth and low birth weight when infants of women with IBD but without AZA exposure were used as a comparison group. A trend toward an increased risk of congenital malformations was found among infants of women with IBD using AZA compared to women with IBD not using AZA (adjusted OR: 1.42, 95% CI: 0.93-2.18). CONCLUSIONS: Infants exposed to AZA in early pregnancy may be at a moderately increased risk of congenital malformations, specifically ventricular/atrial septal defects. There is also an increased risk of growth restriction and preterm delivery. These associations may be confounded by the severity of maternal illness. Birth Defect: Research (Part A) 85:647-654, 2009. (C) 2009 Wiley-Liss, Inc.
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23.
  • Dahlquist, Gisela, et al. (author)
  • Hospitalization for vascular complications in childhood onset type 1 diabetes - effects of gender and age at onset
  • 2008
  • In: Acta Pædiatrica. - : Wiley. - 1651-2227 .- 0803-5253. ; 97:4, s. 483-488
  • Journal article (peer-reviewed)abstract
    • Aims: To study the cumulative incidence of hospitalization for severe diabetic vascular complications in childhood onset type 1 diabetes patients with special regards to age at onset and gender. Methods: The Swedish Childhood Diabetes Register (SCDR) was linked to the Swedish Hospital Discharge Register up to 31 December 2004. The following diagnoses were traced: diabetic kidney disease, myocardial infarction, stroke, lower limb arterial disease and diabetes with multiple complications. Cox proportional hazards survival method was applied with the following covariates: maternal age, birthweight deviation from gestational week standard, age at onset and gender. Results: Until 31 December 9974 children had been followed for at least 10 years corresponding to 141 839 person years at risk and 103 (7.3 per 1000 person years) had been hospitalized at least once at the maximum duration of follow-up of 26 years. Diabetic kidney disease was the most common cause of hospitalization and 63 patients had more than one diabetic complication. Female gender (RR = 2.02, 95% CI = 1.05-3.89) and age at onset of diabetes (RR = 1.37, 95% CI = 1.20-1.56) were significant risk factors for severe complication. Conclusions: Hospitalization for severe diabetic complications at a maximum follow-up of 26 years is rather low in Sweden. There is a higher hospitalization rate among females than among males, and also among patients diagnosed with diabetes after 10 years of age than among patients diagnosed before the age of 10 years.
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25.
  • Dahlquist, G, et al. (author)
  • Mortality in childhood-onset type 1 diabetes
  • 2005
  • In: Diabetes Care. - 1935-5548. ; 28:10, s. 2384-2387
  • Journal article (peer-reviewed)abstract
    • OBJECTIVE - To describe the age- and sex-specific mortality in a cohort of young type 1 diabetic patients and to analyze the causes of death with special focus on suicide, accidents, and unexplained deaths. RESEARCH DESIGN AND METHODS - A population-based incident childhood diabetes register, covering onset cases since 1 July 1977, was linked to the Swedish Cause of Death Register up to 31 December 2000. The official Swedish population register was used to calculate age- and sex-standardized mortality rates (SMRs), excluding neonatal deaths. To analyze excess risks for specific diagnoses, case subjects were compared with five nondiabetic control subjects, matched by age, sex, and year of death. Death certificates were collected for all case and control subjects. For case subjects with an unclear diagnosis, hospital records and/or forensic autopsy reports were obtained. RESULTS - Mean age- and sex-SMR was 2.15 (95% CI 1.70-2.68) and tended to be higher among females (2.65 vs. 1.93, P = 0.045). Mean age at death was 15.2 years (range 1.2-27.3) and mean duration 8.2 years (0-20.7). Twenty-three deaths were clearly related to diabetes; 20 died of diabetic ketoacidosis. Only two case subjects died with late diabetes complications (acute coronary infarction). Thirty-three case subjects died with a diagnosis not directly related to diabetes; 7 of them committed suicide, and 14 died from accidents. There was no significant difference in traffic accidents (odds ratio 1.02 [95% CI 0.40-2.37]). Obvious suicide tended to be increased but not statistically significantly so (1.55 [0.54-3.89]). Seventeen diabetic case subjects were found deceased in bed without any cause of death found at forensic autopsy. Only two of the control subjects died of similar unexplained deaths. CONCLUSIONS - in a well-developed health care system, there is still a significant excess mortality in young type 1 diabetic patients. We confirm a very large proportion of unexplained deaths in bed, which should be further studied. There is no clear excess death rate caused by suicide or traffic accidents among young diabetic subjects.
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26.
  • Dahlquist, Gisela, et al. (author)
  • Mortality in childhood-onset type 1 diabetes : a population-based study.
  • 2005
  • In: Diabetes Care. - 0149-5992. ; 28:10, s. 2384-7
  • Journal article (peer-reviewed)abstract
    • OBJECTIVE: To describe the age- and sex-specific mortality in a cohort of young type 1 diabetic patients and to analyze the causes of death with special focus on suicide, accidents, and unexplained deaths. RESEARCH DESIGN AND METHODS: A population-based incident childhood diabetes register, covering onset cases since 1 July 1977, was linked to the Swedish Cause of Death Register up to 31 December 2000. The official Swedish population register was used to calculate age- and sex-standardized mortality rates (SMRs), excluding neonatal deaths. To analyze excess risks for specific diagnoses, case subjects were compared with five nondiabetic control subjects, matched by age, sex, and year of death. Death certificates were collected for all case and control subjects. For case subjects with an unclear diagnosis, hospital records and/or forensic autopsy reports were obtained. RESULTS: Mean age- and sex-SMR was 2.15 (95% CI 1.70-2.68) and tended to be higher among females (2.65 vs. 1.93, P = 0.045). Mean age at death was 15.2 years (range 1.2-27.3) and mean duration 8.2 years (0-20.7). Twenty-three deaths were clearly related to diabetes; 20 died of diabetic ketoacidosis. Only two case subjects died with late diabetes complications (acute coronary infarction). Thirty-three case subjects died with a diagnosis not directly related to diabetes; 7 of them committed suicide, and 14 died from accidents. There was no significant difference in traffic accidents (odds ratio 1.02 [95% CI 0.40-2.37]). Obvious suicide tended to be increased but not statistically significantly so (1.55 [0.54-3.89]). Seventeen diabetic case subjects were found deceased in bed without any cause of death found at forensic autopsy. Only two of the control subjects died of similar unexplained deaths. CONCLUSIONS: In a well-developed health care system, there is still a significant excess mortality in young type 1 diabetic patients. We confirm a very large proportion of unexplained deaths in bed, which should be further studied. There is no clear excess death rate caused by suicide or traffic accidents among young diabetic subjects.
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27.
  • Dahlquist, G, et al. (author)
  • School marks for Swedish children whose mothers had diabetes during pregnancy: a population-based study
  • 2007
  • In: Diabetologia. - : Springer Science and Business Media LLC. - 1432-0428 .- 0012-186X. ; 50:9, s. 1826-1831
  • Journal article (peer-reviewed)abstract
    • Aims/hypothesis To study, at a population level, school performance when leaving compulsory school of Swedish children whose mothers had diabetes during pregnancy compared with a reference population. Mehtohds We linked the Swedish Medical Birth Register with the Swedish School Mark Register, which contains school marks for all children in Sweden when leaving compulsory school. A total of 6,397 children were identified whose mothers had a diagnosis of diabetes during pregnancy in the years 1973 to 1986. Data on these children were compared with 1,300,683 children whose mothers had no diagnosis of diabetes during pregnancy. Risks were estimated as odd ratios (ORs) after adjustment for year of birth, maternal age, parity and educational level of the mother. Results The children's average numerical school marks (for children leaving school between 1988 and 1997) were statistically significantly lower among children born to mothers with diabetes in pregnancy compared with reference children (3.13 +/- 0.01 vs 3.23, p < 0.001). The effect was similar among boys and girls. There was also an effect of maternal diabetes during pregnancy on the risk of the child not completing compulsory school (OR 1.25; 95% CI 1.10-1.43, and after exclusion of infants with certain perinatal characteristics an OR of 1.25; 95% CI 1.02-1.53). When sports and the core subjects mathematics, English and Swedish were studied, there were increased risks of having scores below pass level and decreased probabilities of having scores above pass level for children of mothers with diabetes during pregnancy. Conclusions/interpretation Children of mothers with diabetes during pregnancy performed slightly but significantly less well than reference children when leaving compulsory school at about 16 years old; this was also seen after adjustment for some putative perinatal and social confounders.
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28.
  • Dahlquist, Gisela, et al. (author)
  • School performance in children with type 1 diabetes - a population-based register study
  • 2007
  • In: Diabetologia. - : Springer Science and Business Media LLC. - 1432-0428 .- 0012-186X. ; 50:5, s. 957-964
  • Journal article (peer-reviewed)abstract
    • Aims/hypothesis We examined the school marks of diabetic children in Sweden at the time of leaving compulsory education. Marks were examined in comparison with non-diabetic children and with special regard to age at onset of diabetes. Subjects and methods The study involved 5,159 children who developed diabetes between 1 July 1977 and 1 July 2000, and 1,330,968 non-diabetic children. We linked the nationwide Swedish Childhood Diabetes Register to the Swedish School-Mark Register, which contains school marks for all children in Sweden at the time of leaving compulsory education (usually at 16 years old). Adjustment was made for potential confounders such as year of birth, maternal age, parity and educational level. Results The mean of all numerical school marks for diabetic children was slightly but statistically significantly lower than those of the referent children (3.15 +/- 0.01 [mean + SD] vs 3.23, p < 0.001). The lowest mean score was among children with diabetes diagnosis before the age of 2 years (2.97 +/- 0.09 vs 3.08-3.17 in the older age groups, p = 0.10). When individual subjects were studied (sports, mathematics, English and Swedish), a more complex picture emerged. In four subjects (mathematics, English, Swedish and sports) the risk of a diabetic child not getting a school mark or not passing was increased; in sports and English the diabetic children had significantly reduced odds of getting a high mark. Conclusions/interpretation Despite a well-developed diabetes care system, we have not succeeded in preventing the disease from affecting school achievements. Among children with a young age at onset and therefore longer duration, the negative effects tend to be greater.
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29.
  • Danielsson, N, et al. (author)
  • Hospitalization in Sweden of children born to immigrants
  • 2003
  • In: Acta Pædiatrica. - : Wiley. - 1651-2227 .- 0803-5253. ; 92:2, s. 228-232
  • Journal article (peer-reviewed)abstract
    • Aim: To study whether excess hospitalization occurs among certain groups of children born in Sweden to immigrant parents. Methods: The study was based on linkage of the Swedish Medical Birth Register 1987-1997 and the Swedish Hospital Discharge Register 1987-1998. Results: Among children whose parents were of Swedish nationality excess hospitalization was found for children of young mothers, parity 3 or more, and if the mother smoked in early pregnancy. These factors were controlled for in the further analysis. Ten years after birth, a large percentage of children born to parents with foreign nationality could not be followed owing to death or emigration (19.9% vs 1.77% of children with Swedish parents). An excess hospitalization of immigrant children up to the age of about 5 y was seen but after that, if anything, these children were hospitalized less. For the whole group of children born to parents of non-Swedish nationality there was no difference in hospitalization rate after stratification for risk factors and age. When analysis was performed for specific nationalities significantly reduced rates were found for several western European countries while significantly increased rates were seen for the Middle East, north Africa and especially sub-Saharan Africa (odds ratio 1.57, 95% confidence interval 1.49-1.64). Conclusion: A moderately increased rate of child hospitalization was only observed for some selected immigrant groups.
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30.
  • Ericson, A, et al. (author)
  • Hospital care utilization of infants born after IVF
  • 2002
  • In: Human Reproduction. - : Oxford University Press (OUP). - 0268-1161 .- 1460-2350. ; 17:4, s. 929-932
  • Journal article (peer-reviewed)abstract
    • BACKGROUND: Infants born after IVF are often twins, and singleton IVF babies have an increased risk for preterm birth. Both conditions are likely to increase morbidity. We examined the frequency and duration of hospitalization required by babies born after IVF, and compared this information with all infants born in Sweden during the same time period. METHODS: We used a nationwide registration of IVF pregnancies from 1984 to 1997 and a nationwide register of all in-patient care up to the end of 1998. We identified 9056 live born infants after IVF treatment and compared them with 1 417 166 non-IVF live born infants. RESULTS: The highest odds ratio (OR similar to3) was seen for neonatal hospitalization, but an increased OR (1.2-1.3) was noted for children up to 6 years of age. The OR for being hospitalized after IVF was 1.8, but when the analysis was restricted to term infants it was 1.3 and this excess was then explainable by maternal subfertility. Statistically significant increased ORs were seen for hospitalization for cerebral palsy (1.7), epilepsy (1.5), congenital malformation (1.8) or tumour (1.6), but also for asthma (1.4) or any infection (1.4). When information from the Swedish Cancer Registry was used, no excess risk for childhood cancer was found. The average number of days spent in hospital by IVF and non-IVF children was 9.5 and 3.6 respectively. CONCLUSIONS: The increased hospitalization of IVF children is, to a large extent, due to the increased incidence of multiple births. Therefore, the increased costs associated with this may be reduced by the use of single embryo transfers, with the savings in health care costs being offset against the increased number of embryo transfer cycles required to maintain the pregnancy rate.
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31.
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32.
  • Finnström, Orvar, et al. (author)
  • Maternal and child outcome after in-vitro fertilization-a review of 25 years population based data from Sweden.
  • 2011
  • In: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 1600-0412 .- 0001-6349. ; 90:5, s. 494-500
  • Journal article (peer-reviewed)abstract
    • Objective. To summarize data on deliveries after IVF performed in Sweden up to 2006. Design. Cohort study of women and children, conceived after IVF with comparisons of deliveries after IVF before and after April 1, 2001. Setting. Study based on Swedish health registers. Population. Births registered in the Swedish Medical Birth Register with information on IVF from all IVF clinics in Sweden. Methods. Results from the second study period are summarized and outcomes between the two periods are compared. Long term follow-up is based on data from both periods. Main outcome measures. Maternal and perinatal outcomes, long term sequels. Results. Some maternal pregnancy complications decreased in rate, notably preeclampsia and PROM. The rate of multiple births and preterm births decreased dramatically with a better neonatal outcome, including neonatal mortality. No difference in outcome existed between IVF and ICSI or between the use of fresh and cryopreserved embryos, but children born after blastocyst transfer had a slightly higher risk for preterm birth and congenital malformations than children born after cleavage stage transfer. An increased risk for cerebral palsy, possibly for attention deficit and hyperactivity disorder, for impaired visual acuity, and for childhood cancer was noted but these outcomes were rare also after IVF. An increased risk for asthma was demonstrated. No effect on maternal cancer risk was seen. Conclusions. A marked decrease in multiple births was the main reason for better pregnancy and neonatal outcome and may also have a beneficial effect on long-term results, notably cerebral palsy.
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33.
  • Forsberg, Lisa, et al. (author)
  • School performance at age 16 in children exposed to antiepileptic drugs in utero-A population-based study.
  • 2011
  • In: Epilepsia. - : Wiley. - 0013-9580 .- 1528-1167. ; Dec, s. 364-369
  • Journal article (peer-reviewed)abstract
    • Purpose: In order to evaluate long-term effects on neurodevelopment in children born to women with epilepsy during pregnancy we studied the children's school grades at age 16. Methods: We used the Patient Register, the Medical Birth Register, and a local study at South Hospital, Stockholm, to identify women with epilepsy in Sweden who had given birth between 1973 and 1986. The Swedish School Mark Registry was used to obtain information about school grades from the last year of compulsory school, at age 16. Exposed children were compared to all other children born in Sweden between 1973 and 1986. Key Findings: Medical records were analyzed for 1,235 children. Six hundred forty-one children had been exposed in utero to antiepileptic drugs (AEDs) in monotherapy, 429 in polytherapy, and 165 to no known AED. Children exposed to polytherapy had an increased risk of not receiving a final grade-odds ratio (OR) 2.99 [95% confidence interval (CI) 2.14-4.17]. Children exposed to monotherapy, mainly carbamazepine or phenytoin, did not have a significantly increased risk of not receiving a final grade-OR 1.19 (95% CI 0.79-1.80). Children born to women with epilepsy had a decreased chance of getting a "pass with excellence." Significance: Exposure to several AEDs in utero may have negative effects on neurodevelopment, and polytherapy should, if possible, be avoided in pregnant women.
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34.
  • Hildebrand, Eric, et al. (author)
  • Maternal obesity and risk of Down syndrome in the offspring
  • 2014
  • In: Prenatal Diagnosis. - : John Wiley & Sons. - 0197-3851 .- 1097-0223. ; 34:4, s. 310-315
  • Journal article (peer-reviewed)abstract
    • OBJECTIVE: The objective of this article is to determine if maternal obesity is associated with an increased risk of Down syndrome in the offspring and whether the risk estimates for trisomy 21 based on combined screening is affected by maternal body mass index (BMI).METHODS: Study group I consisted of a nationwide cohort of 168 604 women giving birth; outcome was infants born with Down syndrome. Adjustment was made for maternal age. Study group II consisted of 10 224 women undergoing 1st trimester combined screening. Outcome was risk assessment for Down syndrome. All women were divided into six BMI groups, and outcomes were evaluated over the BMI strata with BMI 18.5 to 24.9 as reference and correcting for maternal age.RESULTS: Obese women had an increased risk for giving birth to an infant with Down syndrome compared with normal-weight women, BMI 30 to 34.9 odds ratio (OR) 1.31 [95% confidence interval (CI) 1.10-1.55], BMI 35 to 39.9 OR 1.12 (95% CI 0.82-1.53), BMI ≥ 40 OR 1.56 (95% CI 1.00-2.43). The observed and the expected numbers of women with a risk of Down syndrome >1/300 based on 1st trimester combined screen and maternal age were similar in each BMI group.CONCLUSION: Maternal obesity seems to increase the risk for Down syndrome births. The risk estimate for Down syndrome with 1st trimester combined screening is unaffected by BMI. © 2013 John Wiley & Sons, Ltd.
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35.
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36.
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37.
  • Källén, Bengt, et al. (author)
  • Antidepressant use during pregnancy: comparison of data obtained from a prescription register and from antenatal care records.
  • 2011
  • In: European Journal of Clinical Pharmacology. - : Springer Science and Business Media LLC. - 1432-1041 .- 0031-6970. ; 67, s. 839-845
  • Journal article (peer-reviewed)abstract
    • PURPOSE: To compare interview data on drug use during pregnancy with data identified from a register of prescriptions. MATERIALS: We compared information from the Swedish Prescribed Drug Register with the Swedish Medical Birth Register on antidepressant use. In order to evaluate the clinical significance of the difference in ascertainment with the two methods, the rate of preterm births among singletons and of neonatal symptoms were studied. RESULTS: During the year before the last menstrual period, 1.5% of the women filled prescriptions for antidepressants each month. Already before the pregnancy was known, the rate of filled prescriptions decreased and reached 0.5% towards the end of the pregnancy. Twenty-two percent of first-trimester use of antidepressants was unidentified using interview data and prescriptions during the 2nd and 3rd pregnancy months covered only 55% of actual use. When women who filled prescriptions 1 or 3 months before the last menstrual period were included, 17 and 43% respectively of women were included who probably did not use the drugs in the first trimester. Prescriptions gave a more complete ascertainment of drug use after the first trimester than data from antenatal care, which seemed to overestimate drug use. CONCLUSIONS: Interview data seem to give the most valid results on early use. When interview data are not available, prescription data could be used, but should not include prescriptions given earlier than 1 month before the last menstrual period. Studies of drug use later in pregnancy are best based on prescription data in the absence of interview data.
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38.
  • Källén, Bengt (author)
  • Antiobesity drugs in early pregnancy and congenital malformations in the offspring.
  • 2014
  • In: Obesity Research and Clinical Practice. - : Elsevier BV. - 1878-0318 .- 1871-403X. ; 8:6, s. 571-576
  • Journal article (peer-reviewed)abstract
    • Little information exists on the possible teratogenic effect of modern antiobesity drugs. The present study refers to orlistat, sibutramine, and rimonabant. Data in the Swedish Medical Birth Register were utilised. During the years 1998-2011, among 392,126 infants born, 509 had been exposed to antiobesity drugs in early pregnancy: 248 to orlistat, 242 to sibutramine, 12 to rimonabant, 13 to unspecified antiobesity drugs. Simultaneous use of orlistat and sibutramine occurred in six cases. No increase in major malformation risk was seen after orlistat (relative risk=0.42, 95% confidence interval 0.11-1.07) but a significantly high risk was seen after sibutramine (relative risk=1.81, 95% confidence interval 1.02-2.99). The latter effect, which seemed to be mainly due to an increased risk for a cardiovascular defects, may be related to the capacity of the drug to prolong QT-time. Sibutramine has been withdrawn in Europe but is still available on the Internet and is a component in some slimming preparations. Among the 12 infants exposed to rimonabant, two which were in a twin pair were malformed.
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39.
  • Källén, Bengt, et al. (author)
  • Association between preterm birth and intrauterine growth retardation and child asthma
  • 2013
  • In: European Respiratory Journal. - : European Respiratory Society: ERJ. - 0903-1936 .- 1399-3003. ; 41:3, s. 671-676
  • Journal article (peer-reviewed)abstract
    • An association between preterm birth and an increased risk of childhood asthma has been demonstrated, but the importance of intrauterine growth retardation on asthma risk is unclear. less thanbrgreater than less thanbrgreater thanUsing data from Swedish health registers, infant characteristics and childhood asthma were studied. Analyses were made using Mantel-Haenszel methodology with adjustment for year of birth, maternal age, parity, smoking in early pregnancy and maternal body mass index. Preterm birth, birth weight and birth weight for gestational week were analysed and childhood asthma was evaluated from prescriptions of anti-asthmatic drugs. Neonatal respiratory problems and treatment for them were studied as mediating factors. less thanbrgreater than less thanbrgreater thanBoth short gestational duration and intrauterine growth retardation appeared to be risk factors and seemed to act separately. The largest effect was seen from short gestational duration. Use of mechanical ventilation in the newborn period and bronchopulmonary dysplasia were strong risk factors. A moderately increased risk was also seen in infants born large for gestational age. less thanbrgreater than less thanbrgreater thanWe conclude that preterm birth is a stronger risk factor for childhood asthma than intrauterine growth disturbances; however, the latter also affects the risk, and is also seen in infants born at term.
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40.
  • Källén, Bengt, et al. (author)
  • Asthma in Swedish children conceived by in vitro fertilisation
  • 2013
  • In: Archives of Disease in Childhood. - : BMJ Publishing Group. - 0003-9888 .- 1468-2044. ; 98:2, s. 92-96
  • Journal article (peer-reviewed)abstract
    • Objectives To investigate a proposed association between in vitro fertilisation (IVF) and child asthma. less thanbrgreater than less thanbrgreater thanDesign The risk for asthma after IVF was estimated as ORs using Mantel-Haenszel analysis. less thanbrgreater than less thanbrgreater thanSetting The Swedish Medical Birth Register. less thanbrgreater than less thanbrgreater thanPatients Of the 2 628 728 children born in 1982-2007 and surviving the perinatal period, 31 918 were conceived by IVF. Presence of asthma was defined as at least five prescriptions of antiasthmatic drugs during the period 1 July 2005-31 December 2009 according to the Swedish Prescribed Drug Register (115 767 children, 2323 of whom were born after IVF). less thanbrgreater than less thanbrgreater thanResults A significantly increased risk for asthma, albeit small, was found in children conceived by IVF (aOR 1.28, 95% CI 1.23 to 1.34), increasing the absolute risk from 4.4% to 5.6%. The risk increase for asthma was the same in boys and girls, in singletons and twins, and after caesarean section and vaginal delivery. The risk was higher for preterm than term singletons. For children with a low Apgar score, respiratory diagnoses, mechanical ventilation, continuous positive airway pressure or neonatal sepsis, the effect of IVF on asthma risk was low and statistically non-significant. Adjustment for length of involuntary childlessness eliminated the effect, and removal of infants whose mothers had used antiasthmatics in early pregnancy reduced the risk. less thanbrgreater than less thanbrgreater thanConclusions This study verifies an association between IVF and asthma in children. This can be partly explained by neonatal morbidity and by maternal asthma acting as mediators, but the main risk factor is parental subfertility. The mechanism for this is unclear.
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41.
  • Källén, Bengt, et al. (author)
  • Blastocyst versus cleavage stage transfer in in vitro fertilization: differences in neonatal outcome?
  • 2010
  • In: FERTILITY AND STERILITY. - : Elsevier Science B.V., Amsterdam.. - 0015-0282 .- 1556-5653. ; 94:5, s. 1680-1683
  • Journal article (peer-reviewed)abstract
    • Objective: To compare neonatal outcome of blastocyst and cleavage stage embryo transfers after IVF. Design: Register study. Setting: Births recorded in the Swedish Medical Birth Register after IVF performed, 2002-2006. Patient(s): Treatments reported from all Swedish IVF clinics. Intervention(s): None. Main Outcome Measure(s): Some neonatal characteristics were compared in 1,311 infants born after blastocyst-stage transfer and 12,562 infants born after cleavage-stage transfer. Comparisons were also made with all births, 2002-2007 (n = 598,687). Result(s): After adjusting for year of birth, maternal age, parity, smoking habits, and body mass index, the risk of preterm birth among singletons was significantly greater after blastocyst-stage transfer than after cleavage-stage transfer. The risk of congenital malformations was also significantly higher. When the analysis was restricted to clinics where blastocyst transfers were made, the risk estimates increased for preterm birth, low birth weight, low APGAR score, and respiratory diagnoses, but did not change for congenital malformations. Conclusion(s): The results indicate a small increase in risk associated with blastocyst transfer, perhaps owing to the longer period of in vitro culture. There is a possibility that this effect is due, at least in part, to a selection of women for blastocyst transfers. Further studies are needed either to verify or to refute the found associations.
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42.
  • Källén, Bengt, et al. (author)
  • Cancer Risk in Children and Young Adults Conceived by In Vitro Fertilization
  • 2010
  • In: PEDIATRICS. - : American Academy of Pediatrics; 1999. - 0031-4005 .- 1098-4275. ; 126:2, s. E270-E276
  • Journal article (peer-reviewed)abstract
    • OBJECTIVES: Studies conducted so far have found no statistically significant increased risk for cancer among children who are born after in vitro fertilization (IVF). METHODS: We followed 26 692 children who were born after IVF during the years 1982-2005 by using the Swedish Cancer Register and compared the number of children who had cancer and were born after IVF with children who were not conceived by IVF. Adjustment was made for year of birth. RESULTS: Maternal age, parity, smoking, subfertility, previous miscarriages, BMI, and multiple births did not significantly affect cancer risk in offspring. High birth weight, premature delivery, and the presence of respiratory diagnoses and low Apgar score were risk factors for cancer. We identified 53 cases of cancer in children who were born after IVF against 38 expected cases: 18 of them with hematologic cancer (15 of them acute lymphoblastic leukemia), 17 with eye or central nervous system tumors, and 12 with other solid cancers. There were 6 cases of Langerhans histiocytosis against 1.0 expected. The total cancer risk estimate was 1.42 (95% confidence interval: 1.09-1.87). CONCLUSIONS: We found a moderately increased risk for cancer in children who were conceived by IVF. Putative intermediary factors could be preterm birth and neonatal asphyxia.
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43.
  • Källén, Bengt, et al. (author)
  • Cerebral palsy in children born after in vitro fertilization. Is the risk decreasing?
  • 2010
  • In: European journal of paediatric neurology. - : Elsevier Science B.V., Amsterdam. - 1090-3798 .- 1532-2130. ; 14:6, s. 526-530
  • Journal article (peer-reviewed)abstract
    • Background: Infants born after in vitro fertilization (IVF) differ from spontaneously conceived infants in a number of aspects which could increase the risk for future cerebral palsy (CP), e.g., multiple births, preterm births, neonatal complications. Aims: To follow up children conceived by IVF with respect to risk for CP. Methods: Infants born after IVF were identified from all IVF clinics in Sweden 1982-2007. Perinatal characteristics were obtained by linkage with the Medical Birth Register. The presence of CP in children born after IVF and in other children was identified from the Patient Register which contains diagnoses given at hospitalizations or specialist outpatient clinics. The risk for CP after IVF was studied after adjustment for year of birth, maternal age, parity, and smoking, all factors which co-vary both with IVF and with CP. Stratification was made for singletons and multiple births and for various neonatal outcomes. Results: The adjusted odds ratio for CP after IVF was 1.81 (95% confidence interval, 95% CI 1.52-2.13), lower and not statistically significant when singletons or when unlike-sexed twins were analyzed. Stratification for various neonatal characteristics also reduced odds ratios to non-significant levels. For the last few years of the study (2004-2007) when the twinning rate after IVF was less than10%, the odds ratio for CP was 0.97 (95% CI 0.57-1.66). Conclusions: The moderately increased risk for CP was most likely a consequence of an increased risk of neonatal morbidity, notably associated with multiple births.
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44.
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45.
  • Källén, Bengt, et al. (author)
  • Congenital Malformations in Infants Born after In Vitro Fertilization in Sweden
  • 2010
  • In: BIRTH DEFECTS RESEARCH PART A-CLINICAL AND MOLECULAR TERATOLOGY. - : John Wiley andamp; Sons, Ltd. - 1542-0752 .- 1542-0760. ; 88:3, s. 137-143
  • Journal article (peer-reviewed)abstract
    • BACKGROUND: The risk for congenital malformations is increased in infants born after in vitro fertilization (IVF). Some specific malformations appear to be more affected than others. METHODS: The presence of congenital malformations in 15,570 infants born after IVF with an embryo transfer between April 1, 2001, and the end of 2006 were compared with all infants born in Sweden during 2001 to 2007 (n = 689,157). Risk estimates were made after adjusting for year of birth, maternal age, parity, smoking, and body mass index. The risks of specific malformations were compared with data from a previous study (1982 to March 31, 2001) of 16,280 infants born after IVF. Different IVF methods were compared to respect to malformation risk. RESULTS: Increased risks of a similar magnitude were found for most cardiovascular malformations and limb reduction defects for both study periods. For neural tube defects, cardiac septal defects, and esophageal atresia, there was still an increased risk, but it was lower during the second than during the first period. For small bowel atresia, anal atresia, and hypospadias, the risk increase observed during the first study period had disappeared during the second period. An increased risk was seen for some syndromes that have been associated with imprinting errors. No difference in malformation risk according to IVF method was apparent. CONCLUSIONS: A slightly increased risk for congenital malformations after IVF persists. A decreasing risk is seen for some specific malformations, either true or the result of multiple testing.
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46.
  • Källén, Bengt (author)
  • Congenital malformations in infants whose mothers reported the use of folic acid in early pregnancy in Sweden. A prospective population study
  • 2007
  • In: Congenital Anomalies. - : Wiley. - 0914-3505 .- 1741-4520. ; 47:4, s. 119-124
  • Journal article (peer-reviewed)abstract
    • The use of folic acid prior to conception is generally recommended for the prevention of birth defects, notably neural tube defects. In a previous study from Sweden, based on interviews of women in early pregnancy, no such effect was found on the general malformation rate, but data for neural tube defects were scarce. Using data from the Swedish Medical Birth Register for the years 1995-2004, 20 891 women were identified who reported the use of folic acid in early pregnancy, but not of anticonvulsants. These women were compared to all other women who gave birth during the study period. Malformations in the infants born were identified from multiple sources. No reduction in the general malformation rate was seen among infants born to women who reported the use of folic acid (OR = 1.09, 95% CI 1.02-1.17) and no effect of neural tube defect rate was seen (RR = 1.35, 95% CI 0.82-2.22), based on 16 infants with neural tube defect whose mother reported the use of folic acid. No effect was seen on the rates of other malformations except for cardiac defects, where a statistically significant increased risk (notably for severe defects) was found (OR = 1.19, 95% CI 1.05-1.35). The effect of various deficiencies in data collection is discussed, but is unlikely to explain the lack of protective effect noticed. So far, it has not been possible to demonstrate a beneficial effect of folic acid supplementation on malformation risk in Sweden. A more complete ascertainment and detailed timing and dosage of folic acid use in a prospective study is recommended.
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47.
  • Källén, Bengt, et al. (author)
  • Delivery outcome after maternal use of drugs for migraine: a register study in sweden.
  • 2011
  • In: Drug Safety. - : Springer Science and Business Media LLC. - 1179-1942 .- 0114-5916. ; 34:8, s. 691-703
  • Journal article (peer-reviewed)abstract
    • Background: The use of drugs for migraine during pregnancy may have adverse effects on delivery outcome, and warnings exist for such drugs regarding use during pregnancy. Most information in the literature concerns triptans. Objective: The aim of the study was to describe the delivery outcome when a woman had used drugs for migraine during pregnancy. Study Design: A register study where exposure for drugs was obtained partly by interview conducted by the attending antenatal care midwife and medical records from antenatal care (1995-2008) and partly by linkage to the Prescribed Drug Register (2005-8). Setting: All deliveries in Sweden (1 211 670 women) recorded in the Medical Birth Register with data from antenatal care. Patients: Women using triptans or ergots during pregnancy were identified and compared with all women who did not use drugs for migraine. Main Outcome Measures: Pregnancy complications, pregnancy duration and birthweight, neonatal morbidity and mortality, and congenital malformations. Results: Use of ergots or triptans during early pregnancy (first trimester) occurred in 3286 women with 3327 infants, while use after the first trimester occurred in 1394 women with 1419 infants. Women using such drugs for migraine were older than other women, were more often of parity 1 (no previous infant) and more often had a high body mass index. Women using drugs for migraine had not previously had more miscarriages than expected. There was an increased risk for pre-eclampsia (odds ratio [OR] 1.44; 95% CI 1.17, 1.76). An increased risk for preterm birth was seen after use of drugs for migraine later in pregnancy (OR 1.50; 95% CI 1.22, 1.84). There was no increased risk for stillbirth or early neonatal death. No certain signs of teratogenicity were found for any of the drug types when compared with women not using such drugs (OR for any malformation 0.95; 95% CI 0.80, 1.12). Conclusions: Our data suggest that the risk of adverse effects on pregnancy outcome associated with the use of drugs for migraine is low but data for triptans other than sumatriptan are still few.
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48.
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49.
  • Källén, Bengt (author)
  • Drugs during pregnancy : Methodological aspects
  • 2016
  • Book (peer-reviewed)abstract
    • This book addresses methodological aspects of epidemiological studies on maternal drug use in pregnancy. Discussing the existing sources of error and how they can produce incorrect conclusions, it examines various epidemiological techniques and assesses their strengths and weaknesses. These refer both to the identification of outcomes (with special emphasis on congenital malformations) and to the types of exposure (drug use). Further, the book discusses the problem of confounding and how to handle it, and provides a simple introduction to statistics. Special situations, e.g. different types of parental exposure, are examined. Lastly, the book discusses pharmacovigilance and the information problem, concluding with a short list of aspects to consider when one wants to evaluate a published paper in the field. Though the book is primarily intended for pharmacologists, gynecologists and obstetricians, it will benefit all doctors working in perinatal care.
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50.
  • Källén, Bengt (author)
  • Drugs in pregnancy - the dilemma of labeling
  • 1999
  • In: Therapeutic Innovation and Regulatory Science. - : Springer Science and Business Media LLC. - 2168-4790. ; 33:4, s. 1135-1143
  • Journal article (peer-reviewed)abstract
    • The paper discusses the problems with pregnancy labeling of drugs. The Swedish, United States, and Australian labeling systems are briefly summarized. Data on drug use in early pregnancy in Sweden (1996) are presented according to pregnancy labeling category and with details on drugs thought to be teratogenic or where animal data suggest hazards. The various situations when drug teratogenicity are of interest are reviewed and the difficulties in presenting detailed pregnancy warnings valid for all situations are stressed. The amount of data needed for information in the different situations is discussed and exemplified. Finally, suggestions are made on how texts referring to drug use during pregnancy can be structured for different drug categories.
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