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

scholarly journals Congenital Malformations and Perinatal Deaths among the Children of Atomic Bomb Survivors: A Reappraisal

2021 ◽  
Author(s):  
Michiko Yamada ◽  
Kyoji Furukawa ◽  
Yoshimi Tatsukawa ◽  
Keiko Marumo ◽  
Sachiyo Funamoto ◽  
...  
Keyword(s):  
Pregnancy Outcomes ◽  
Congenital Malformations ◽  
Radiation Effects ◽  
Atomic Bomb ◽  
Perinatal Deaths ◽  
Neonatal Deaths ◽  
Atomic Bomb Survivors ◽  
Parental Exposure ◽  
Increased Risk ◽  
Major Congenital Malformations

Abstract From 1948 to 1954, the Atomic Bomb Casualty Commission conducted a study of pregnancy outcomes of children of atomic bomb survivors who had received radiation doses from zero to near-lethal levels. Past reports (1956, 1981, and 1990) on the cohort did not identify significant associations of radiation exposure with untoward pregnancy outcomes such as major congenital malformations, stillbirths, or neonatal deaths, individually or in aggregate. We have re-examined the risk of major congenital malformations and perinatal deaths in the children of the atomic bomb survivors (N=71,603) using fully reconstructed data to minimize the potential for bias, with refined estimates of the gonadal dose from the Dosimetry System 2002 and refined analytical methods for characterizing dose-response relationships. The analyses show that parental exposure is associated with increased risk for major congenital malformations and perinatal deaths, but the estimates are imprecise for direct radiation effects and most are not statistically significant. Nonetheless, the uniformly positive estimates for untoward pregnancy outcomes among children of both maternal and paternal survivors are useful for risk assessment purposes, although extending them to circumstances other than atomic bomb survivors comes with uncertainty as to the generalizability of the Hiroshima and Nagasaki populations.

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