scholarly journals Risk of Major Congenital Malformations or Perinatal or Neonatal Death With Insulin Detemir Versus Other Basal Insulins in Pregnant Women With Preexisting Diabetes: The Real-World EVOLVE Study

Diabetes Care ◽  
2021 ◽  
pp. dc210472
Author(s):  
Elisabeth R. Mathiesen ◽  
Norsiah Ali ◽  
Amra C. Alibegovic ◽  
Eleni Anastasiou ◽  
Katarzyna Cypryk ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Real World ◽  
Congenital Malformations ◽  
Neonatal Death ◽  
Insulin Detemir ◽  
The Real ◽  
Major Congenital Malformations

172-LB: Risk of Major Congenital Malformations, Perinatal or Neonatal Death with Insulin Detemir Compared with Other Basal Insulins in Pregnant Women with Preexisting Diabetes: The EVOLVE Study

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 172-LB
Author(s):  
ELISABETH R. MATHIESEN ◽  
AMRA CIRIC ALIBEGOVIC ◽  
LISE LOTTE N. HUSEMOEN ◽  
PRANAV KELKAR ◽  
DAVID R. MCCANCE ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Congenital Malformations ◽  
Neonatal Death ◽  
Insulin Detemir ◽  
Major Congenital Malformations

scholarly journals Risk of Major Congenital Malformations or Perinatal or Neonatal Death With Insulin Detemir Versus Other Basal Insulins in Pregnant Women With Preexisting Diabetes: The Real-World EVOLVE Study

2021 ◽  
Author(s):  
Elisabeth R. Mathiesen ◽  
Norsiah Ali ◽  
Amra C. Alibegovic ◽  
Eleni Anastasiou ◽  
Katarzyna Cypryk ◽  
...  
Keyword(s):  
Congenital Malformations ◽  
Neonatal Death ◽  
Insulin Detemir ◽  
First Trimester ◽  
Risk Difference ◽  
Adjusted Risk ◽  
Adverse Pregnancy ◽  
Major Congenital Malformations ◽  
Design And Methods ◽  
Similar Risk

<p>OBJECTIVE: To compare the risk of severe adverse pregnancy complications in women with pre-existing diabetes.</p> <p>RESEARCH DESIGN AND METHODS: Multinational, prospective cohort study to assess the prevalence of newborns free from major congenital malformations, perinatal or neonatal death (primary endpoint) following treatment with insulin detemir (detemir) vs other basal insulins.</p> <p>RESULTS: Of 1,457 women included, 727 received detemir and 730 received other basal insulins. The prevalence of newborns free from major congenital malformations, perinatal or neonatal death was similar between detemir (97.0%) and other basal insulins (95.5%) (crude risk difference 0.015 [95% CI −0.01,0.04]; adjusted risk difference −0.003 [95% CI −0.03,0.03]). The crude prevalence of ≥1 congenital malformation (major + minor) was 9.4% vs 12.6%, with a similar risk difference before (−0.032 [95% CI −0.064,0.000]) and after (−0.036 [95% CI –0.081,0.009]) adjustment for confounders. Crude data showed lower maternal HbA<sub>1c</sub> during the first trimester (6.5% vs 6.7% [48 vs 50 mmol/mol]; estimated mean difference −0.181 [95% CI −0.300,−0.062]) and the second trimester (6.1% vs 6.3% [43 vs 45 mmol/mol]; −0.139 [95% CI −0.232,−0.046]), and a lower prevalence of major hypoglycemia (6.0% vs 9.0%; risk difference −0.030 [95% CI −0.058,−0.002]), pre-eclampsia (6.4% vs 10.0%; −0.036 [95% CI −0.064,−0.007]), and stillbirth (0.4% vs 1.8%; −0.013 [95% CI −0.024,−0.002],) with detemir compared to other basal insulins. However, differences were not significant post-adjustment.</p> <p>CONCLUSION: Insulin detemir was associated with a similar risk to other basal insulins of major congenital malformations, perinatal or neonatal death, hypoglycemia, pre-eclampsia and stillbirth. </p>

scholarly journals Risk of Major Congenital Malformations or Perinatal or Neonatal Death With Insulin Detemir Versus Other Basal Insulins in Pregnant Women With Preexisting Diabetes: The Real-World EVOLVE Study

2021 ◽  
Author(s):  
Elisabeth R. Mathiesen ◽  
Norsiah Ali ◽  
Amra C. Alibegovic ◽  
Eleni Anastasiou ◽  
Katarzyna Cypryk ◽  
...  
Keyword(s):  
Congenital Malformations ◽  
Neonatal Death ◽  
Insulin Detemir ◽  
First Trimester ◽  
Risk Difference ◽  
Adjusted Risk ◽  
Adverse Pregnancy ◽  
Major Congenital Malformations ◽  
Design And Methods ◽  
Similar Risk

<p>OBJECTIVE: To compare the risk of severe adverse pregnancy complications in women with pre-existing diabetes.</p> <p>RESEARCH DESIGN AND METHODS: Multinational, prospective cohort study to assess the prevalence of newborns free from major congenital malformations, perinatal or neonatal death (primary endpoint) following treatment with insulin detemir (detemir) vs other basal insulins.</p> <p>RESULTS: Of 1,457 women included, 727 received detemir and 730 received other basal insulins. The prevalence of newborns free from major congenital malformations, perinatal or neonatal death was similar between detemir (97.0%) and other basal insulins (95.5%) (crude risk difference 0.015 [95% CI −0.01,0.04]; adjusted risk difference −0.003 [95% CI −0.03,0.03]). The crude prevalence of ≥1 congenital malformation (major + minor) was 9.4% vs 12.6%, with a similar risk difference before (−0.032 [95% CI −0.064,0.000]) and after (−0.036 [95% CI –0.081,0.009]) adjustment for confounders. Crude data showed lower maternal HbA<sub>1c</sub> during the first trimester (6.5% vs 6.7% [48 vs 50 mmol/mol]; estimated mean difference −0.181 [95% CI −0.300,−0.062]) and the second trimester (6.1% vs 6.3% [43 vs 45 mmol/mol]; −0.139 [95% CI −0.232,−0.046]), and a lower prevalence of major hypoglycemia (6.0% vs 9.0%; risk difference −0.030 [95% CI −0.058,−0.002]), pre-eclampsia (6.4% vs 10.0%; −0.036 [95% CI −0.064,−0.007]), and stillbirth (0.4% vs 1.8%; −0.013 [95% CI −0.024,−0.002],) with detemir compared to other basal insulins. However, differences were not significant post-adjustment.</p> <p>CONCLUSION: Insulin detemir was associated with a similar risk to other basal insulins of major congenital malformations, perinatal or neonatal death, hypoglycemia, pre-eclampsia and stillbirth. </p>

Antidepressant use During Pregnancy and the Risk of Major Congenital Malformations in a Cohort of Depressed Pregnant Women: A Re-analysis of the Quebec Pregnancy Cohort

2017 ◽  
Vol 41 (S1) ◽  
pp. S155-S155
Author(s):  
A. Bérard ◽  
J.P. Zhao ◽  
O. Sheehy
Keyword(s):  
Pregnant Women ◽  
Serotonin Reuptake ◽  
Congenital Malformations ◽  
Selective Serotonin Reuptake Inhibitors ◽  
First Trimester ◽  
Pregnancy Cohort ◽  
Organ Specific ◽  
Antidepressant Use ◽  
Major Congenital Malformations ◽  
First Year Of Life

ObjectiveTo quantify the association between first-trimester antidepressant exposure and the risk of major congenital malformations (MCM) in a cohort of depressed women.MethodData were obtained from the Quebec pregnancy cohort. All pregnancies with a diagnosis of depression or anxiety, or exposed to antidepressants in the 12 months before pregnancy, and ending with a live-born singleton were included. Antidepressant classes (selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), tricyclic antidepressants (TCA), and other antidepressants), and types were individually compared to non-exposure during the first-trimester (depressed untreated). MCM overall and organ-specific malformations in the first year of life were identified.ResultEighteen thousand four hundred and eighty-seven depressed pregnant women were included. Citalopram use during the first-trimester was increasing the risk of MCM (aOR 1.36, 95%CI 1.08, 1.73; 88 exposed cases). Antidepressants with serotonin reuptake inhibition effect (SSRI, SNRI, amitriptyline (the most used TCA)) were increasing the risk of certain organ specific defects: paroxetine was increasing the risk of cardiac defects (aOR 1.45, 95%CI 1.12, 1.88), and ventricular/atrial septal defects (aOR 1.39, 95%CI 1.00. 1.93); citalopram was increasing the risk of musculoskeletal defects (aOR 1.92, 95%CI 1.40. 2.62), and cranyosynostosis (aOR 3.95, 95%CI 2.08, 7.52); TCA was associated with eye, ear, face and neck defects (aOR 2.45, 95%CI 1.05, 5.72), and digestive defects (aOR 2.55, 95%CI 1.40. 4.66); and venlafaxine was associated with respiratory defects (aOR 2.17, 95%CI 1.07, 4.38).ConclusionAntidepressants with effects on serotonin reuptake during embryogenesis are increasing the risk of some organ specific malformations in a cohort of pregnant women with depression.Disclosure of interestCOI: Disclosures and acknowledgments: AB is a consultant for plaintiffs in litigations involving antidepressants and birth defects. All other authors report no financial relationships with commercial interests. All authors have completed the ICMJE uniform disclosure form.

scholarly journals Development of EpiRisk: An online clinical tool for estimating the risk of major congenital malformations in pregnant women treated for epilepsy

2018 ◽  
Vol 3 (2) ◽  
pp. 281-285
Author(s):  
Gabriel Davis Jones ◽  
Alison Hitchcock ◽  
Frank Vajda ◽  
John Craig ◽  
Terence J. O'Brien ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Congenital Malformations ◽  
Clinical Tool ◽  
Major Congenital Malformations

Current Issues: Evidence-Based Practice for the Real World: Thoughts on Clinical Education in Communication Disorders

2010 ◽  
Vol 20 (3) ◽  
pp. 100-105 ◽  
Author(s):  
Anne K. Bothe
Keyword(s):  
Clinical Education ◽  
Real World ◽  
Evidence Based Practice ◽  
Communication Disorders ◽  
University Faculty ◽  
Evidence Based ◽  
Speech Language Pathology ◽  
Basic Principles ◽  
The Real ◽  
Language Pathology

This article presents some streamlined and intentionally oversimplified ideas about educating future communication disorders professionals to use some of the most basic principles of evidence-based practice. Working from a popular five-step approach, modifications are suggested that may make the ideas more accessible, and therefore more useful, for university faculty, other supervisors, and future professionals in speech-language pathology, audiology, and related fields.

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