| 1. |
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| 2. |
- de Brun, Maryam, 1991-, et al.
(författare)
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Changing diagnostic criteria for gestational diabetes (CDC4G) in Sweden : A stepped wedge cluster randomised trial
- 2024
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Ingår i: PLoS Medicine. - : Public Library of Science (PLoS). - 1549-1277 .- 1549-1676. ; 21:7
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The World Health Organisation (WHO) 2013 diagnostic criteria for gestational diabetes mellitus (GDM) has been criticised due to the limited evidence of benefits on pregnancy outcomes in different populations when switching from previously higher glycemic thresholds to the lower WHO-2013 diagnostic criteria. The aim of this study was to determine whether the switch from previous Swedish (SWE-GDM) to the WHO-2013 GDM criteria in Sweden following risk factor-based screening improves pregnancy outcomes.METHODS AND FINDINGS: A stepped wedge cluster randomised trial was performed between January 1 and December 31, 2018 in 11 clusters (17 delivery units) across Sweden, including all pregnancies under care and excluding preexisting diabetes, gastric bypass surgery, or multifetal pregnancies from the analysis. After implementation of uniform clinical and laboratory guidelines, a number of clusters were randomised to intervention (switch to WHO-2013 GDM criteria) each month from February to November 2018. The primary outcome was large for gestational age (LGA, defined as birth weight >90th percentile). Other secondary and prespecified outcomes included maternal and neonatal birth complications. Primary analysis was by modified intention to treat (mITT), excluding 3 clusters that were randomised before study start but were unable to implement the intervention. Prespecified subgroup analysis was undertaken among those discordant for the definition of GDM. Multilevel mixed regression models were used to compare outcome LGA between WHO-2013 and SWE-GDM groups adjusted for clusters, time periods, and potential confounders. Multiple imputation was used for missing potential confounding variables. In the mITT analysis, 47 080 pregnancies were included with 6 882 (14.6%) oral glucose tolerance tests (OGTTs) performed. The GDM prevalence increased from 595/22 797 (2.6%) to 1 591/24 283 (6.6%) after the intervention. In the mITT population, the switch was associated with no change in primary outcome LGA (2 790/24 209 (11.5%) versus 2 584/22 707 (11.4%)) producing an adjusted risk ratio (aRR) of 0.97 (95% confidence interval 0.91 to 1.02, p = 0.26). In the subgroup, the prevalence of LGA was 273/956 (28.8%) before and 278/1 239 (22.5%) after the switch, aRR 0.87 (95% CI 0.75 to 1.01, p = 0.076). No serious events were reported. Potential limitations of this trial are mainly due to the trial design, including failure to adhere to guidelines within and between the clusters and influences of unidentified temporal variations.CONCLUSIONS: In this study, implementing the WHO-2013 criteria in Sweden with risk factor-based screening did not significantly reduce LGA prevalence defined as birth weight >90th percentile, in the total population, or in the subgroup discordant for the definition of GDM. Future studies are needed to evaluate the effects of treating different glucose thresholds during pregnancy in different populations, with different screening strategies and clinical management guidelines, to optimise women's and children's health in the short and long term.TRIAL REGISTRATION: The trial is registered with ISRCTN (41918550).
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| 3. |
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| 4. |
- Fadl, Helena, 1965-, et al.
(författare)
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Changing diagnostic criteria for gestational diabetes in Sweden-a stepped wedge national cluster randomised controlled trial-the CDC4G study protocol
- 2019
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Ingår i: Bmc Pregnancy and Childbirth. - : Springer Science and Business Media LLC. - 1471-2393. ; 19:1
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Tidskriftsartikel (refereegranskat)abstract
- Background The optimal criteria to diagnose gestational diabetes mellitus (GDM) remain contested. The Swedish National Board of Health introduced the 2013 WHO criteria in 2015 as a recommendation for initiation of treatment for hyperglycaemia during pregnancy. With variation in GDM screening and diagnostic practice across the country, it was agreed that the shift to new guidelines should be in a scientific and structured way. The aim of the Changing Diagnostic Criteria for Gestational Diabetes (CDC4G) in Sweden () is to evaluate the clinical and health economic impacts of changing diagnostic criteria for GDM in Sweden and to create a prospective cohort to compare the many long-term outcomes in mother and baby under the old and new diagnostic approaches. Methods This is a stepped wedge cluster randomised controlled trial, comparing pregnancy outcomes before and after the switch in GDM criteria across 11 centres in a randomised manner. The trial includes all pregnant women screened for GDM across the participating centres during January-December 2018, approximately two thirds of all pregnancies in Sweden in a year. Women with pre-existing diabetes will be excluded. Data will be collected through the national Swedish Pregnancy register and for follow up studies other health registers will be included. Discussion The stepped wedge RCT was chosen to be the best study design for evaluating the shift from old to new diagnostic criteria of GDM in Sweden. The national quality registers provide data on the whole pregnant population and gives a possibility for follow up studies of both mother and child. The health economic analysis from the study will give a solid evidence base for future changes in order to improve immediate pregnancy, as well as long term, outcomes for mother and child.
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| 5. |
- Valgeirsdóttir, Inga Rós, 1984-, et al.
(författare)
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Metformin as treatment of GDM
- 2023
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Background: Whether metformin should be used as treatment for gestational diabetes mellitus (GDM) is a matter of controversy. Concerns about the effects on neonatal birth weight (mainly small for gestational age, SGA) have been raised in one randomized controlled trial in type 2 diabetes in pregnancy. [1] The aim of this study was to evaluate pregnancy outcomes based on different GDM treatment modalities with focus on metformin.Methods: A cohort study, based on data from the stepped wedge cluster randomized trial; CDC4G (Changing diagnostic criteria for GDM in Sweden - www.cdc4g.se). Screening for GDM involved repeated random plasma glucose measurements and/or clinical risk factors. [2] Data were collected from electronic case record forms, and national health and quality registers. Singleton pregnancies during 2018 (last birth in August 2019) from eight clusters were included. Women with pregestational diabetes and/or previous gastric bypass surgery were excluded. Pregnancy outcomes for different treatment regimens were analyzed for women with GDM compared to the background population without GDM. Logistic regression analyzes with adjustments for confounders (body mass index, age, smoking, country of birth, chronic hypertensive disease and cluster) was performed (adjusted odds ratio (aOR) with 95% confidence interval (CI)) for all outcomes. Results: Of the 54 678 pregnancies included, 2 169 (4.0%) were diagnosed with GDM; of whom 1 076 (49.6%) were treated with diet only (dGDM), 668 (30.8%) with metformin only (mGDM), 116 (5.3%) with insulin only (iGDM), and 309 (14.2%) with both metformin and insulin (miGDM). Pregnancy outcomes were as follows: SGA (10th percentile) was significantly decreased in the mGDM group [aOR 0.57 (95% CI 0.41-0.79)] compared to the background population and no significant difference was found in the miGDM group [aOR 0.78 (95% CI 0.51-1.18)] compared to the background population. No significant difference in SGA (10th percentile) was found in the dGDM group [aOR 1.02 (CI 0.83-1.25)] compared to the background population. There was significant difference in neonates born large for gestational age (LGA, 90th percentile) in both mGDM and miGDM groups compared to the background population [aOR 2.29 (95% CI 1.88-2.78) and aOR 2.32 (95% CI 1.76-3.07), respectively]. There was not significant difference in LGA (90th percentile) in dGDM compared to the background population [aOR 0.90 (95% CI 0.73-1.12].Conclusions: These preliminary unpublished results show no increase in SGA for metformin treated GDM compared to the background population. Outcomes in the diet treated GDM group were similar to the background population. Further analyzes are needed to compare outcomes between pharmacologic treatment groups and assess whether specific treatment regimens lead to similar outcomes in different subgroups (eg ethnicity, obesity and glucose values on diagnostic oral glucose tolerance test).References:1.Feig DS, Donovan LE, Zinman B, Sanchez JJ, Asztalos E, Ryan EA, et al. Metformin in women with type 2 diabetes in pregnancy (MiTy): a multicentre, international, randomised, placebo-controlled trial. The lancet Diabetes & endocrinology. 2020;8(10):834-44.2.Fadl H, Saeedi M, Montgomery S, Magnuson A, Schwarcz E, Berntorp K, et al. Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol. BMC pregnancy and childbirth. 2019;19(1):398.
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| 6. |
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| 7. |
- Hildén, Karin, 1978-, et al.
(författare)
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Author reply
- 2024
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Ingår i: British Journal of Obstetrics and Gynecology. - : Wiley-Blackwell Publishing Inc.. - 1470-0328 .- 1471-0528.
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
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| 8. |
- Hildén, Karin, 1978-, et al.
(författare)
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Avvikande fostervattenmängd
- 2021. - 3
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Ingår i: Obstetrik. - : Studentlitteratur AB. - 9789144142609 ; , s. 381-386
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Bokkapitel (refereegranskat)
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| 9. |
- Hildén, Karin, 1978-, et al.
(författare)
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Born over 4500 g : the trends in birth trauma and mode of delivery in women with GDM and type 1 diabetes in Sweden between 1998-2012
- 2018
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Konferensbidrag (refereegranskat)abstract
- Background: We have previously shown that during the years 1998-2012, the overall incidence of LGA and birthweight decreased in both women with and without GDM in Sweden, and unpublished preliminary results show that there is a converse trend among women with T1DM. The incidence of Erbs palsy also decreased in the GDM and background population, but remained unchanged for women with T1DM. Since macrosomia is one of the most prominent risk factors for Erb´s palsy and delivery complications, the aim of the study was to evaluate trends in incidence of Erb´s palsy and delivery mode in the macrosomic group defined as weight ≥4500g and we present here our preliminary results.Method: This is a cohort study in Sweden 1998-2012 , including singleton macrosomic (≥4500 g) births. Vaginal deliveries were selected for the analyses relating to Erb´s plasy. Poisson regression was used to evaluate trends per year in both the GDM, T1DM and the background population. Results were partly stratified on BMI, to be able to detect any group differences in trends. P-value of <0.05 was considered statistically significant.Results: In total there were 57 2015 macrosomic infants, of whom (n= 36 933, 64,6%) were delivered vaginally. Of these, only 2.1 % (n=798) were vaginally delivered by women with GDM, (1.4%) type 2 diabetes (0.1%) or T1DM (0.7%). The trend in Erb´s palsy decreased significantly in the background population at a rate of OR 0.954 (95% CI 0.936-0.973) per year. For women with GDM or T1DM there was no significant change in incidence of trends over these years for Erb´s palsy. As for Caesarean section (CS) there was a significant increase per year for GDM pregnancies (OR 1.028, 95% CI 1.007-1.049) and in the background population (1.018 95% CI 1.013-1.022). No change was seen for CS in pregnancies with T1DM.Conclusion: Even though the rates of LGA and birthweight have decreased in Sweden over this time period for women with GDM and the background population, we could not see a significant decrease in Erb´s palsy among women with vaginal births in either the GDM group or for women with T1DM in the macrosomic infants. However, a decrease was seen in the incidence of Erb´s palsy in the macrosomic babies in the background population. The rates of CS have significantly increased in the background population and for GDM pregnancies, but been stable for T1DM. We conclude that the disparity in risk of Erbs has grown over this time period. Further work is needed to ascertain whether this is due to the need for improved surveillance, a higher CS rate, and/or improved glycaemic management (or other factors).
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| 10. |
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| 11. |
- Hildén, Karin, 1978-
(författare)
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Gestational diabetes, obesity and pregnancy outcomes in Sweden
- 2018
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- The overall aim of the thesis was to evaluate maternal and fetal outcomes in relation to gestational diabetes mellitus (GDM) in both a shortand long term perspective.Study I was a population based cohort study including 1 249 908 pregnancies during the years 1998-2012. Maternal outcomes and fetal size were studied in relation to BMI and presence/absence of GDM. The conclusions were that maternal overweight and obesity are associated with similar increments in risks of adverse maternal outcomes and delivery of large-for-gestational-age infants in women with and without gestational diabetes. Study II was a population based cohort study using the same cohort as in study I. Fetal outcomes were studied in relation to GDM-status and BMI. Interaction between GDM and BMI for the outcomes was also analyzed. Conclusions were that excess maternal weight and GDM were, both major independent risk factors for adverse, perinatal outcomes, there were no intercation. In study III the same cohort was used to study time trends 1998-2012 in maternal and perinatal outcomes in women with GDM. Trends were also analyzed in women without GDM for comparison. This study showed that there have been improvements in fetal outcomes for women with GDM. But since the improvements were similar or less than the changes in the background population this was probably not due to better medical care for women with GDM alone. The conlusion is that there is still a lot to do to improve outcomes for women with GDM. Study IV was a case control study aiming to evaluate if there was an interaction between GDM and preeclampsia (PE) or if the conditions were independent risk factors for later cardio vascular disease (CVD). We also wanted to analyze how BMI influenced the association between PE and later CVD. We showed that GDM and PE are independently associated with elevated risk for CVD. The association of PE and CVD is not affected by BMI to a great extent as is the case in GDM and CVD.
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| 12. |
- Hildén, Karin, 1978-, et al.
(författare)
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Overweight and obesity : a remaining problem in women treated for severe gestational diabetes
- 2016
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Ingår i: Diabetic Medicine. - Hoboken, USA : Wiley-Blackwell Publishing Inc.. - 0742-3071 .- 1464-5491. ; 33:8, s. 1045-1051
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Tidskriftsartikel (refereegranskat)abstract
- Aim: To analyse the impact of overweight and obesity on the risk of adverse maternal outcomes and fetal macrosomia in pregnancies of women treated for severe gestational diabetes.Methods This was a population-based cohort study including all singleton pregnancies in Sweden without pre-existing diabetes in the period 1998-2012. Only mothers with an early- pregnancy BMI of ≥18.5 kg/m² were included. Logistic regression analysis was used to determine odds ratios with 95% CIs for maternal outcomes and fetal growth. Analyses were stratified by maternal gestational diabetes/non-gestational diabetes to investigate the impact of overweight/obesity in each group.Results: Of 1 249 908 singleton births, 13 057 were diagnosed with gestational diabetes (1.0%). Overweight/obesity had the same impact on the risks of caesarean section and fetal macrosomia in pregnancies with and without gestational diabetes, but the impact of maternal BMI on the risk of preeclampsia was less pronounced in women with gestational diabetes. Normal-weight women with gestational diabetes had an increased risk of caesarean section [odds ratio 1.26 (95% CI 1.16-1.37)], preeclampsia [odds ratio 2.03 (95% CI 1.71-2.41)] and large-for-gestational-age infants [odds ratio 2.25 (95% CI 2.06-2.46)]. Risks were similar in the overweight group without gestational diabetes, caesarean section [odds ratio 1.34 (1.33-1.36)], preeclampsia odds ratio [1.76 (95% CI 1.72-1.81)], large-for-gestational-age [odds ratio 1.76 (95% CI 1.74-1.79)].Conclusions: Maternal overweight and obesity is associated with similar increments in risks of adverse maternal outcomes and delivery of large-for-gestational-age infants in women with and without gestational diabetes. Obese women with gestational diabetes are defined as a high-risk group. Normal-weight women with gestational diabetes have similar risks of adverse outcomes to overweight women without gestational diabetes.
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| 13. |
- Hildén, Karin, 1978-, et al.
(författare)
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Previous pre-eclampsia, gestational diabetes mellitus and the risk of cardiovascular disease : A nested case-control study in Sweden
- 2023
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Ingår i: British Journal of Obstetrics and Gynecology. - : John Wiley & Sons. - 1470-0328 .- 1471-0528. ; 130:10, s. 1209-1216
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Tidskriftsartikel (refereegranskat)abstract
- ObjectivePre-eclampsia and gestational diabetes mellitus (GDM) are two common pregnancy complications that affect birth outcomes and are associated with a long-term risk of cardiovascular disease (CVD). The aims of this study were to investigate if the pre-eclampsia association with CVD is independent of GDM and modified by body mass index (BMI) or GDM.DesignCase–control study.SettingSweden.PopulationCases were women with a first CVD event between 1991 and 2008 and a previous pregnancy who were matched with controls without CVD (1:5) by year of birth, age and region of birth.MethodsConditional logistic regression was used to evaluate the associations of GDM, pre-eclampsia and maternal BMI with CVD adjusted for potential confounders and effect modifications with interaction tests.Main outcome measuresCVD.ResultsThere were 2639 cases and 13 310 controls with complete data. Pre-eclampsia and GDM were independent risk factors for CVD (adjusted odds ratio [aOR] 2.59, 95% CI 2.12–3.17 and aOR 1.47, 95% CI 1.04–2.09, respectively). After stratifying by maternal BMI, the adjusted association of pre-eclampsia with CVD did not differ notably between BMI groups: normal weight (aOR 2.65, 95% CI 1.90–3.69), overweight (aOR 2.67, 95% CI 1.52–4.68) and obesity (aOR 3.03, 95% CI 0.74–12.4). Similar findings were seen when stratifying on GDM/non-GDM.ConclusionsPre-eclampsia and GDM are independent risk factors for later CVD and having both during pregnancy is a major risk factor for later CVD. The association between pre-eclampsia and CVD is not modified by BMI. Effective CVD preventive programs for high-risk women are urgently needed in order to improve women's long-term health.
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| 14. |
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| 15. |
- Hildén, Karin, 1978-, et al.
(författare)
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Trends in pregnancy outcomes for women with gestational diabetes mellitus in Sweden 1998-2012 : a nationwide cohort study
- 2020
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Ingår i: Diabetic Medicine. - : Wiley-Blackwell Publishing Inc.. - 0742-3071 .- 1464-5491. ; 37:12, s. 2050-2057
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Tidskriftsartikel (refereegranskat)abstract
- AIM: To assess whether incidence of maternal and neonatal outcomes for women with or without gestational diabetes mellitus (GDM) have changed over time.METHODS: Population-based cohort study in Sweden including all singleton pregnancies over the period 1998-2012. GDM was diagnosed following Diabetic Pregnancy Study Group 1991 criteria. Poisson regression or negative binomial regression was used to model yearly relative change in numbers of cases and incidence of the outcomes with 95% confidence intervals (CI), and yearly absolute change in birthweight z-score.RESULTS: The study included 1 455 667 pregnancies. The number of pregnancies increased over time and the overall prevalence of GDM was 1%. For women with GDM there was a significantly decreasing trend in incidence per year for large for gestational age (LGA) (0.986, 95% CI 0.975 to 0.996), birthweight z-score (-0.012, 95% CI -0.017 to -0.007) and birth trauma (0.937, 95% CI 0.907 to 0.968). The trend for small for gestational age (SGA) among women with GDM increased by an OR per year (1.016, 95% CI 1.002 to 1.029). No significant interaction tests for maternal characteristics were found. Trends in outcomes for women without diabetes were similar to those for women with GDM.CONCLUSIONS: This study shows that there were improvements in pregnancy outcomes for women with GDM between 1998 and 2012, although the incidence of SGA increased. Improvements followed similar trends in the background population. Inequalities in obstetric outcomes between women with GDM and those without have continued unchanged over 15 years, suggesting that new management strategies are required to reduce this gap.
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| 16. |
- Hult, Peter, 1964-, et al.
(författare)
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Detection of the third heart sound using a tailored wavelet approach : Method verification
- 2005
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Ingår i: Medical and Biological Engineering and Computing. - 0140-0118 .- 1741-0444. ; 43:2, s. 212-217
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Tidskriftsartikel (refereegranskat)abstract
- Heart sounds can be considered as mechanical fingerprints of myocardial function. The third heart sound normally occurs in children but disappears with maturation. The sound can also appear in patients with heart failure. The sound is characterised by its low-amplitude and low-frequency content, which makes it difficult to identify by the traditional use of the stethoscope. A wavelet-based method has recently been developed for detection of the third heart sound. This study investigated if the third heart sound could be identified in patients with heart failure using this detection method. The method was also compared with auscultation using conventional phonocardiography and with characterisation of the patients with echocardiography. In the first study, 87% of the third heart sounds were detected using the wavelet method, 12% were missed, and 6% were false positive. In study 2, the wavelet-detection method identified 87% of the patients using the third heart sound, and regular phonocardiography identified two (25%) of the subjects. © IFMBE: 2005.
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| 17. |
- Stenberg, Erik, 1979-, et al.
(författare)
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Pregnancy As a Risk Factor for Small Bowel Obstruction After Laparoscopic Gastric Bypass Surgery
- 2020
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Ingår i: Annals of Surgery. - : Lippincott Williams & Wilkins. - 0003-4932 .- 1528-1140. ; 272:1, s. 125-129
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To evaluate whether pregnancy is associated with increased risk for small bowel obstruction after laparoscopic gastric bypass surgery.BACKGROUND: Small bowel obstruction is a common and feared long-term complication to laparoscopic gastric bypass surgery that may be more common during pregnancy. It is unclear if the risk truly increases during pregnancy.METHODS: Women, 18 to 55 years, operated with a primary laparoscopic gastric bypass procedure from 2010 until 2015 were identified through the Scandinavian Obesity Surgery Registry (n = 25,853). Through record-linkage to the Medical Birth Registry, the National Patient Registry, and review of hospital charts, information on pregnancy periods and outcome were obtained. The main outcome was operation due to small bowel obstruction after the laparoscopic gastric bypass procedure.RESULTS: Pregnancy was associated with increased risk for small bowel obstruction following laparoscopic gastric bypass surgery (incidence rates 46.5, 95% CI 38.0-56.9/1000 person-years, vs 20.9 95% CI 19.9-22.0; adjusted-HR 1.72, 95% CI 1.39-2.12, P < 0.001). While no excess risk was observed during the first trimester, the second (adjusted-HR 1.67, 95% CI 1.17-2.39, P = 0.005) and third (adjusted-HR 2.69, 95% CI 2.02-3.59, P < 0.001) conferred increased risk. The incidence rate of small bowel obstruction during pregnancy was 42.9 (95% CI 32.4-57.0/1000 person-years) among women for whom the mesenteric defects had been closed during the primary procedure, and 53.2 (95% CI 38.9-72.8/1000 person-years) for women in whom they had been left open.CONCLUSION: Pregnancy is associated with increased risk for small bowel obstruction after laparoscopic gastric bypass surgery during the second and third trimesters.
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| 18. |
- Östling, Hanna, 1976-, et al.
(författare)
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Two cases of severe COVID-19 in gestational week 27 and 28 respectively, after which both pregnancies proceeded to term
- 2021
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Ingår i: International journal of obstetric anesthesia. - : Elsevier. - 0959-289X .- 1532-3374. ; 48
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Tidskriftsartikel (refereegranskat)abstract
- COVID-19 in pregnancy increases the risk of caesarean section. We present two cases of late gestation pregnant women with severe COVID-19. Both were successfully treated with mechanical ventilation without termination of pregnancy and, following recovery from COVID-19, had vaginal deliveries at term. These two cases demonstrate the possibility of treating pregnant women with severe COVID-19 with mechanical ventilation in the late second and early third trimesters without them having a pre-term delivery. With a multidisciplinary approach, such management could avoid the maternal risks of surgery during a severe infection and, at the same time, enable term birth with a lower risk of neonatal complications.
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