| 1. |
- Fadl, Helena, 1965-, et al.
(författare)
-
Changing diagnostic criteria for gestational diabetes in Sweden-a stepped wedge national cluster randomised controlled trial-the CDC4G study protocol
- 2019
-
Ingår i: Bmc Pregnancy and Childbirth. - : Springer Science and Business Media LLC. - 1471-2393. ; 19:1
-
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.
|
|
| 2. |
- Wennerholm, Ulla-Britt, 1948, et al.
(författare)
-
Induction of labour at 41 weeks versus expectant management and induction of labour at 42 weeks (SWEdish Post-term Induction Study, SWEPIS) : multicentre, open label, randomised, superiority trial
- 2019
-
Ingår i: The BMJ. - : BMJ Publishing Group Ltd. - 1756-1833 .- 0959-8138. ; 367
-
Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To evaluate if induction of labour at 41 weeks improves perinatal and maternal outcomes in women with a low risk pregnancy compared with expectant management and induction of labour at 42 weeks.DESIGN: Multicentre, open label, randomised controlled superiority trial.SETTING: 14 hospitals in Sweden, 2016-18.PARTICIPANTS: 2760 women with a low risk uncomplicated singleton pregnancy randomised (1:1) by the Swedish Pregnancy Register. 1381 women were assigned to the induction group and 1379 were assigned to the expectant management group.INTERVENTIONS: Induction of labour at 41 weeks and expectant management and induction of labour at 42 weeks.MAIN OUTCOME MEASURES: The primary outcome was a composite perinatal outcome including one or more of stillbirth, neonatal mortality, Apgar score less than 7 at five minutes, pH less than 7.00 or metabolic acidosis (pH <7.05 and base deficit >12 mmol/L) in the umbilical artery, hypoxic ischaemic encephalopathy, intracranial haemorrhage, convulsions, meconium aspiration syndrome, mechanical ventilation within 72 hours, or obstetric brachial plexus injury. Primary analysis was by intention to treat.RESULTS: The study was stopped early owing to a significantly higher rate of perinatal mortality in the expectant management group. The composite primary perinatal outcome did not differ between the groups: 2.4% (33/1381) in the induction group and 2.2% (31/1379) in the expectant management group (relative risk 1.06, 95% confidence interval 0.65 to 1.73; P=0.90). No perinatal deaths occurred in the induction group but six (five stillbirths and one early neonatal death) occurred in the expectant management group (P=0.03). The proportion of caesarean delivery, instrumental vaginal delivery, or any major maternal morbidity did not differ between the groups.CONCLUSIONS: This study comparing induction of labour at 41 weeks with expectant management and induction at 42 weeks does not show any significant difference in the primary composite adverse perinatal outcome. However, a reduction of the secondary outcome perinatal mortality is observed without increasing adverse maternal outcomes. Although these results should be interpreted cautiously, induction of labour ought to be offered to women no later than at 41 weeks and could be one (of few) interventions that reduces the rate of stillbirths.TRIAL REGISTRATION: Current Controlled Trials ISRCTN26113652.
|
|
| 3. |
- Arntyr Hellgren, P., et al.
(författare)
-
Birth trauma in babies born to women with and without type 1 diabetes in Sweden 1998-2012 : relationship with maternal and baby weight
- 2017
-
Ingår i: 49th Annual Meeting of the Diabetic Pregnancy Study Group. ; , s. 66-67
-
Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- We compared birth trauma rates in pregnancies among women with and without type 1 diabetes (DM1) and tested the relationship with maternal body mass index (BMI) and large for gestational age (LGA) as a risk factor. This is a population-based cohort study 1998-2012 using the Swedish Medical Birth Registry (MBR) which includes 99% of Swedish pregnancies. All pregnancies up until gestational week 41 were included. We excluded mothers with other types of diabetes, duplex pregnancies and all pregnancies ending with a caesarean section (51.1% and 16.5% in women with and without DM1 respectively). The incidence of birth trauma was adjusted for BMI, maternal age, parity, Nordic or non-Nordic origin, smoking, chronic hypertensive disease, LGA and the baby ́s sex using logistic regression. This left 2,758 and 783,412 births with complete data among DM1 and control mothers respectively. The mean BMI, maternal age and gestational age at birth in full weeks was 25.6 (SD 4.5), 30.0 (SD 5.1) and 37.9 (SD 1.9) respectively among women with DM1 and 24.2 (SD 4.3), 29.7 (SD 5.1) and 38.9 (SD 1.5) respectively among controls. Preliminary results show that birth trauma rates did not vary significantly with increasing BMI compared with the reference BMI (18.50-24.9 kg/m2) among women with DM1 (odds ratios (OR) with increasing BMI (<18.49, 25.0-29.9, 30.0-34.9, >35.0 kg/m2) were 1.9 (95%CI 0.2-15.7), 1.0 (95%CI 0.7-1.5), 0.5 (95%CI 0.2-1.0), 1.1 (95%CI 0.5-2.4) respectively). Conversely, among controls, the OR for birth trauma increasedwith increasing BMI: 0.7 (95%CI 0.6-0.9), 1.4 (95%CI 1.3-1.5), 1.8 (95%CI 1.6-2.0), and 2.2 (95%CI 1.9-2.4) respectively. However, birth trauma was 3.9 (95%CI 2.7-5.7) and 7.0 (95%CI 6.5-7.5) fold more common after adjustment with LGA among women with andwithout DM1 respectively. We conclude that birth trauma rates are associated with LGA with comparatively greater impact among women without, than with, DM1. LGA is clearly an important outcome in its own right and a predictor of birth trauma. We hypothesise that the reduced risk of birth trauma from LGA among women with DM1 is due to increased monitoring with multiple ultrasounds to determine the fetal growth rate, along with earlier planned delivery (including earlier induction with vaginal delivery ata lower birthweight or caesarean section). While more research is needed to find better ways to reduce LGA in DM1, many of the obese control women would have undiagnosed/untreated GDM due to the Swedish criteria at the time (2 hours >=9.0mmol/l). Besidestreating lower levels of hyperglycaemia during pregnancy, the frequency of growth monitoring in obese mothers to reduce their babies’ risk of birth trauma due to LGA, needs to be evaluated. Life course cost effectiveness analyses would be useful.
|
|
| 4. |
|
|
| 5. |
- Fadl, Helena E., 1965-, et al.
(författare)
-
Randomized controlled study in pregnancy on treatment of marked hyperglycemia that is short of overt diabetes
- 2015
-
Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley-Blackwell. - 0001-6349 .- 1600-0412. ; 94:11, s. 1181-1187
-
Tidskriftsartikel (refereegranskat)abstract
- Introduction: A randomized multicenter study was conducted in the Stockholm-orebro areas in Sweden to evaluate how treatment aiming at normoglycemia affects fetal growth, pregnancy and neonatal outcome in pregnant women with severe hyperglycemia.Material and methods: Pregnant women with hyperglycemia defined as fasting capillary plasma glucose <7.0 mmol/L and a two-hour plasma glucose value 10.0 and <12.2 mmol/L following a 75-g oral glucose tolerance test (OGTT) diagnosed before 34 weeks of gestation were randomized to treatment (n=33) or controls (n=36). Women assigned to the control group were blinded for the OGTT results and received routine care. The therapeutic goal was fasting plasma glucose 4-5 mmol/L, and <6.5 mmol/L after a meal. Primary outcomes were size at birth and number of large-for-gestational age (>90th percentile) neonates. Secondary outcomes were pregnancy complications, neonatal morbidity and glycemic control.Results: The planned number of participating women was not reached. There was a significantly reduced rate of large-for-gestational age neonates, 21 vs. 47%, P<0.05. Group differences in pregnancy complications and neonatal morbidity were not detected because of limited statistical power. In total, 66.7% of the women in the intervention group received insulin. Of all measured plasma glucose values, 64.1% were in the target range, 7.2% in the hypoglycemic range and 28.7% above target values. There were no cases of severe hypoglycemia.Conclusions: Aiming for normalized glycemia in a pregnancy complicated by severe hyperglycemia reduces fetal growth but is associated with an increased rate of mild hypoglycemia.
|
|
| 6. |
- Fadl, Helena E., 1965-, et al.
(författare)
-
Trends in diabetes in pregnancy in Sweden 1998-2012
- 2016
-
Ingår i: BMJ Open Diabetes Research & Care. - : BMJ Publishing Group Ltd. - 2052-4897. ; 4:1
-
Tidskriftsartikel (refereegranskat)abstract
- Objective: Diabetes in pregnancy has been shown to increase in parallel with the increasing prevalence of obesity. In this national population-based study, we analyzed the trends for gestational diabetes mellitus (GDM), type 1 diabetes in pregnancy, and type 2 diabetes in pregnancy in Sweden between 1998 and 2012.Research design and methods: A population-based cohort study using the Swedish national medical birth registry data. The time periods were categorized into 3-year intervals and adjusted for maternal body mass index (BMI), ethnicity, and age in a logistic regression.Results: Each type of diabetes increased over the studied 15-year period. Type 1 diabetes increased by 33.2% (22.2-45.3) and type 2 diabetes by 111% (62.2-174.4) in the adjusted model. Nordic women had the highest prevalence of type 1 diabetes (0.47%) compared with other ethnic groups. The increase in GDM and, to a lesser extent, type 2 diabetes was explained by country of birth, BMI, and maternal age. The prevalence of GDM in Nordic women (0.7-0.8%) did not increase significantly over the time period.Conclusions: All types of diabetes in pregnancy increased over the 15-year time period in Sweden. Maternal pre-pregnancy BMI remains the key factor explaining the increase in GDM/type 2 diabetes. How to turn around the growing prevalence of diabetes in pregnancy, with its short-term and long-term health effects on both mother and child, requires population-based interventions that reduce the likelihood of entering pregnancy with a raised BMI.
|
|
| 7. |
|
|
| 8. |
- Hildén, Karin, 1978-, et al.
(författare)
-
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
-
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).
|
|
| 9. |
- Hildén, K., et al.
(författare)
-
Gestational diabetes and adiposity are independent risk factors for perinatal outcomes : a population based cohort study in Sweden
- 2019
-
Ingår i: Diabetic Medicine. - : Wiley-Blackwell Publishing Inc.. - 0742-3071 .- 1464-5491. ; 36:2, s. 151-157
-
Tidskriftsartikel (refereegranskat)abstract
- AIMS: To evaluate the interaction effects of gestational diabetes (GDM) with obesity on perinatal outcomes.METHODS: A population-based cohort study in Sweden excluding women without pre-gestational diabetes with a singleton birth between 1998 and 2012. Logistic regression was performed to evaluate the potential independent associations of GDM and BMI with adverse perinatal outcomes as well as their interactions. Main outcome measures were malformations, stillbirths, perinatal mortality, low Apgar score, fetal distress, prematurity and Erb's palsy.RESULTS: ) had significantly increased risks of all outcomes including stillbirth 1.51 (1.40-1.62) to 2.85 (2.52-3.22) and perinatal mortality 1.49 (1.40-1.59) to 2.83 (2.54-3.15).CONCLUSIONS: There is no interaction effect between GDM and BMI for the studied outcomes. Higher BMI and GDM are major independent risk factors for most serious adverse perinatal outcomes. More effective pre-pregnancy and antenatal interventions are required to prevent serious adverse pregnancy outcomes among women with either GDM or high BMI.
|
|
| 10. |
- Hildén, Karin, 1978-
(författare)
-
Gestational diabetes, obesity and pregnancy outcomes in Sweden
- 2018
-
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.
|
|
