| 1. |
- Cavadino, Alana, et al.
(författare)
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Signal Detection in EUROmediCAT : Identification and Evaluation of Medication-Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference
- 2021
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Ingår i: Drug Safety. - : ADIS INT LTD. - 0114-5916 .- 1179-1942. ; 44:7, s. 765-785
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Tidskriftsartikel (refereegranskat)abstract
- Introduction Knowledge on the safety of medication use during pregnancy is often sparse. Pregnant women are generally excluded from clinical trials, and there is a dependence on post-marketing surveillance to identify teratogenic medications. Aims This study aimed to identify signals of potentially teratogenic medications using EUROmediCAT registry data on medication exposure in pregnancies with a congenital anomaly, and to investigate the use of VigiBase reports of adverse events of medications in the evaluation of these signals. Methods Signals of medication-congenital anomaly associations were identified in EUROmediCAT (21,636 congenital anomaly cases with 32,619 medication exposures), then investigated in a subset of VigiBase (45,749 cases and 165,121 exposures), by reviewing statistical reporting patterns and VigiBase case reports. Evidence from the literature and quantitative and qualitative aspects of both datasets were considered before recommending signals as warranting further independent investigation. Results EUROmediCAT analysis identified 49 signals of medication-congenital anomaly associations. Incorporating investigation in VigiBase and the literature, these were categorised as follows: four non-specific medications; 11 likely due to maternal disease; 11 well-established teratogens; two reviewed in previous EUROmediCAT studies with limited additional evidence; and 13 with insufficient basis for recommending follow-up. Independent investigations are recommended for eight signals: pregnen (4) derivatives with limb reduction; nitrofuran derivatives with cleft palate and patent ductus arteriosus; salicylic acid and derivatives with atresia or stenosis of other parts of the small intestine and tetralogy of Fallot; carbamazepine with atrioventricular septal defect and severe congenital heart defect; and selective beta-2-adrenoreceptor agonists with posterior urethral valve and/or prune belly. Conclusion EUROmediCAT data should continue to be used for signal detection, accompanied by information from VigiBase and review of the existing literature to prioritise signals for further independent evaluation.
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| 2. |
- Colmorn, Lotte B., et al.
(författare)
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The Nordic Obstetric Surveillance Study: a study of complete uterine rupture, abnormally invasive placenta, peripartum hysterectomy, and severe blood loss at delivery
- 2015
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 1600-0412 .- 0001-6349. ; 94:7, s. 734-744
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To assess the rates and characteristics of women with complete uterine rupture, abnormally invasive placenta, peripartum hysterectomy, and severe blood loss at delivery in the Nordic countries. Design: Prospective, Nordic collaboration. Setting: The Nordic Obstetric Surveillance Study (NOSS) collected cases of severe obstetric complications in the Nordic countries from April 2009 to August 2012. Sample and methods: Cases were reported by clinicians at the Nordic maternity units and retrieved from medical birth registers, hospital discharge registers, and transfusion databases by using International Classification of Diseases, 10th revision codes on diagnoses and the Nordic Medico-Statistical Committee Classification of Surgical Procedure codes. Main outcome measures: Rates of the studied complications and possible risk factors among parturients in the Nordic countries. Results: The studied complications were reported in 1019 instances among 605362 deliveries during the study period. The reported rate of severe blood loss at delivery was 11.6/10000 deliveries, complete uterine rupture was 5.6/10000 deliveries, abnormally invasive placenta was 4.6/10000 deliveries, and peripartum hysterectomy was 3.5/10000 deliveries. Of the women, 25% had two or more complications. Women with complications were more often >35years old, overweight, with a higher parity, and a history of cesarean delivery compared with the total population. Conclusion: The studied obstetric complications are rare. Uniform definitions and valid reporting are essential for international comparisons. The main risk factors include previous cesarean section. The detailed information collected in the NOSS database provides a basis for epidemiologic studies, audits, and educational activities.
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| 3. |
- Daltveit, Dagrun Slettebo, et al.
(författare)
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Sex differences in childhood cancer risk among children with major birth defects : a Nordic population-based nested case-control study
- 2023
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Ingår i: International Journal of Epidemiology. - : Oxford University Press. - 0300-5771 .- 1464-3685. ; 52:2, s. 450-465
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Tidskriftsartikel (refereegranskat)abstract
- Background Childhood cancer is more common among children with birth defects, suggesting a common aetiology. Whether this association differs by sex is unclear. Methods We performed a population-based nested case-control study using nationwide health registries in four Nordic countries. We included 21 898 cancer cases (0-19 years) and 218 980 matched population controls, born 1967-2014. Associations between childhood cancer and major birth defects were calculated as odds ratios (ORs) with 95% confidence intervals (CIs) using logistic regression models. Effect modification was evaluated using a counterfactual framework to estimate confidence intervals and P-values for the natural indirect effects. Results Birth defects were present for 5.1% (1117/21 898) of childhood cancer cases and 2.2% (4873/218 980) of controls; OR of cancer was higher for chromosomal (OR = 10, 95% CI = 8.6-12) than for non-chromosomal defects (OR = 1.9, 95% CI = 1.8-2.1), strongest between genetic syndromes/microdeletion and renal tumours, Down syndrome and leukaemia, and nervous system defects and central nervous system tumours. The association between birth defects and cancer was stronger among females (OR = 2.8, 95% CI = 2.6-3.1) than males (OR = 2.1, 95% CI = 1.9-2.2, P-interaction <0.001). Male sex was an independent risk factor for childhood cancer, but very little of the overall association between sex and childhood cancer was mediated through birth defects (4.8%, P-NIE <0.001), although more at younger ages (10% below years and 28% below 1 year). Conclusions The birth defect-cancer associations were generally stronger among females than males. Birth defects did not act as a strong mediator for the modest differences in childhood cancer risk by sex, suggesting that other biological pathways are involved.
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| 4. |
- DeRoo, Lisa, et al.
(författare)
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Placental abruption and long-term maternal cardiovascular disease mortality : a population-based registry study in Norway and Sweden
- 2016
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Ingår i: European Journal of Epidemiology. - : Springer Science and Business Media LLC. - 0393-2990 .- 1573-7284. ; 31:5, s. 501-511
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Tidskriftsartikel (refereegranskat)abstract
- Women with preeclamptic pregnancies have increased long-term cardiovascular disease (CVD) mortality. We explored this mortality risk among women with placental abruption, another placental pathology. We used linked Medical Birth Registry and Death Registry data to study CVD mortality among over two million women with a first singleton birth between 1967 and 2002 in Norway and 1973 and 2003 in Sweden. Women were followed through 2009 and 2010, respectively, to ascertain subsequent pregnancies and mortality. Cox regression analysis was used to estimate associations between placental abruption and cardiovascular mortality adjusting for maternal age, education, year of the pregnancy and country. There were 49,944 deaths after an average follow-up of 23 years, of which 5453 were due to CVD. Women with placental abruption in first pregnancy (n = 10,981) had an increased risk of CVD death (hazard ratio 1.8; 95 % confidence interval 1.3, 2.4). Results were essentially unchanged by excluding women with pregestational hypertension, preeclampsia or diabetes. Women with placental abruption in any pregnancy (n = 23,529) also had a 1.8-fold increased risk of CVD mortality (95 % confidence interval 1.5, 2.2) compared with women who never experienced the condition. Our findings provide evidence that placental abruption, like other placental complications of pregnancy, is associated with women's increased risk of later CVD mortality.
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| 5. |
- Jakobsson, Maija, et al.
(författare)
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Emergency peripartum hysterectomy: results from the prospective Nordic Obstetric Surveillance Study (NOSS)
- 2015
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 1600-0412 .- 0001-6349. ; 94:7, s. 745-754
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To assess the prevalence and risk factors of emergency peripartum hysterectomy. Design:Nordic collaborative study. Population605362 deliveries across the five Nordic countries. Methods: We collected data prospectively from patients undergoing emergency peripartum hysterectomy within 7days of delivery from medical birth registers and hospital discharge registers. Control populations consisted of all other women delivering on the same units during the same time period. Main outcome measures: Emergency peripartum hysterectomy rate. Results: The total number of emergency peripartum hysterectomies reached 211, yielding an incidence rate of 3.5/10000 (95% confidence interval 3.0-4.0) births. Finland had the highest prevalence (5.1) and Norway the lowest (2.9). Primary indications included an abnormally invasive placenta (n=91, 43.1%), atonic bleeding (n=69, 32.7%), uterine rupture (n=31, 14.7%), other bleeding disorders (n=12, 5.7%), and other indications (n=8, 3.8%). The delivery mode was cesarean section in nearly 80% of cases. Previous cesarean section was reported in 45% of women. Both preterm and post-term birth increased the risk for emergency peripartum hysterectomy. The number of stillbirths was substantially high (70/1000), but the case fatality rate stood at 0.47% (one death, maternal mortality rate 0.17/100000 deliveries). Conclusions: A combination of prospective data collected from clinicians and information gathered from register-based databases can yield valuable data, improving the registration accuracy for rare, near-miss cases. However, proper and uniform clinical guidelines for the use of well-defined international diagnostic codes are still needed.
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| 6. |
- Langhoff-Roos, Jens, et al.
(författare)
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The Nordic medical birth registers - a potential goldmine for clinical research
- 2014
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 1600-0412 .- 0001-6349. ; 93:2, s. 132-137
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- The Nordic medical birth registers have long been used for valuable clinical research. Their collection of data for more than four decades offers unusual possibilities for research across generations. At the same time, serum and blotting paper blood samples have been stored from most neonates. Two large cohorts (approximately 100000 births) in Denmark and Norway have been described by questionnaires, interviews and collection of biological samples (blood, urine and milk teeth), as well as a systematic prospective follow-up of the offspring. National patient registers provide information on preceding, underlying and present health problems of the parents and their offspring. Researchers may, with permission from the national authorities, obtain access to individualized or anonymized data from the registers and tissue-banks. These data allow for multivariate analyses but their usefulness depends on knowledge of the specific registers and biological sample banks and on proper validation of the registers.
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| 7. |
- Pyykönen, Aura, et al.
(författare)
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Cesarean section trends in the Nordic Countries - a comparative analysis with the Robson classification
- 2017
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 0001-6349 .- 1600-0412. ; 96:5, s. 607-616
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: The cesarean rates are low but increasing in most Nordic countries. Using the Robson classification, we analyzed which obstetric groups have contributed to the changes in the cesarean rates. Material and methods: Retrospective population-based registry study including all deliveries (3 398 586) between 2000 and 2011 in Denmark, Finland, Iceland, Norway and Sweden. The Robson group distribution, cesarean rate and contribution of each Robson group were analyzed nationally for four 3-year time periods. For each country, we analyzed which groups contributed to the change in the total cesarean rate. Results: Between the first and the last time period studied, the total cesarean rates increased in Denmark (16.4 to 20.7%), Norway (14.4 to 16.5%) and Sweden (15.5 to 17.1%), but towards the end of our study, the cesarean rates stabilized or even decreased. The increase was explained mainly by increases in the absolute contribution from R5 (women with previous cesarean) and R2a (induced labor on nulliparous). In Finland, the cesarean rate decreased slightly (16.5 to 16.2%) mainly due to decrease among R5 and R6-R7 (breech presentation, nulliparous/multiparous). In Iceland, the cesarean rate decreased in all parturient groups (17.6 to 15.3%), most essentially among nulliparous women despite the increased induction rates. Conclusions: The increased total cesarean rates in the Nordic countries are explained by increased cesarean rates among nulliparous women, and by an increased percentage of women with previous cesarean. Meanwhile, induction rates on nulliparous increased significantly, but the impact on the total cesarean rate was unclear. The Robson classification facilitates benchmarking and targeting efforts for lowering the cesarean rates.
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