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>

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

Herbal Medicines Used During the First Trimester and Major Congenital Malformations

Drug Safety ◽  
2006 ◽  
Vol 29 (6) ◽  
pp. 537-548 ◽  
Author(s):  
Chao-Hua Chuang ◽  
Pat Doyle ◽  
Jung-Der Wang ◽  
Pei-Jen Chang ◽  
Jung-Nien Lai ◽  
...  
Keyword(s):  
Congenital Malformations ◽  
Herbal Medicines ◽  
First Trimester ◽  
Major Congenital Malformations

scholarly journals P07 Roxithromycin in early pregnancy and the risk of major congenital malformation: a register based nationwide cohort study

2019 ◽  
Vol 104 (6) ◽  
pp. e20.1-e20
Author(s):  
RH Olsen ◽  
HE Poulsen ◽  
JT Andersen
Keyword(s):  
Cohort Study ◽  
Congenital Malformation ◽  
Congenital Malformations ◽  
Safety Data ◽  
First Trimester ◽  
Adverse Outcomes ◽  
Sensitivity Analyses ◽  
Multiple Birth ◽  
Major Congenital Malformation ◽  
Major Congenital Malformations

BackgroundMedicine use during pregnancy often causes concern for fetal harm. Roxithromycin, a macrolide antibiotic, is regarded as inadvisable to use during pregnancy due to lack of safety data. However, alternative macrolides have been associated with adverse outcomes in pregnancy. We conducted a register-based nationwide cohort study testing the hypothesis that use of roxithromycin in the first trimester is associated with major congenital malformations.MethodsWe included all Danish women giving live birth from 1997 to 2012. Women with at least one redeemed receipt of roxithromycin during first trimester were regarded as exposed. Multivariable logistic regression adjusting for maternal age, multiple birth, parity, year of conception, smoking, educational length, and household income was performed, supplemented by sensitivity analyses comparing unexposed with exposure to increasing accumulated doses of roxithromycin.ResultsThe study included 966,372 pregnancies of which 2,430 children were born to an exposed mother, 78 (3.34%) of the exposed children were diagnosed with a major congenital malformation compared with 33,609 (3.49%) among children born to unexposed mothers. The odds ratio for the occurrence of a major congenital malformation after exposure to roxithromycin was 0.96 (95% CI 0.76–1.20) and multifactorially adjusted 0.94 (0.74–1.18). Sensitivity analyses comparing unexposed with exposure to increasing accumulated doses of roxithromycin showed no dose response relationship. Further, no differences in the type of major malformation according to the EUROCAT subgrouping system were seen.ConclusionsWe found no association between exposure to roxithromycin in the first trimester of pregnancy and major congenital malformations.Disclosure(s)Nothing to disclose

scholarly journals Birth outcomes following antiretroviral exposure during pregnancy: Initial results from a pregnancy exposure registry in South Africa

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Ushma C. Mehta ◽  
Cari Van Schalkwyk ◽  
Prineetha Naidoo ◽  
Arthi Ramkissoon ◽  
Otty Mhlongo ◽  
...  
Keyword(s):  
Birth Outcomes ◽  
Congenital Malformations ◽  
First Trimester ◽  
First Year ◽  
Increased Risk ◽  
Bivariable Analysis ◽  
Major Congenital Malformations ◽  
Clinical Records ◽  
Surface Examination ◽  
The Impact

Background: In 2013, a pregnancy exposure registry and birth defects surveillance (PER/BDS) system was initiated in eThekwini District, KwaZulu-Natal (KZN), to assess the impact of antiretroviral treatment (ART) on birth outcomes.Objectives: At the end of the first year, we assessed the risk of major congenital malformations (CM) and other adverse birth outcomes (ABOs) detected at birth, in children born to women exposed to ART during pregnancy.Method: Data were collected from women who delivered at Prince Mshiyeni Memorial Hospital, Durban, from 07 October 2013 to 06 October 2014, using medicine exposure histories and birth outcomes from maternal interviews, clinical records and neonatal surface examination. Singleton births exposed to only one ART regimen were included in bivariable analysis for CM risk and multivariate risk analysis for ABO risk.Results: Data were collected from 10 417 women with 10 517 birth outcomes (4013 [38.5%] HIV-infected). Congenital malformations rates in births exposed to Efavirenz during the first trimester (T1) (RR 0.87 [95% CI 0.12–6.4; p = 0.895]) were similar to births not exposed to ART during T1. However, T1 exposure to Nevirapine was associated with the increased risk of CM (RR 9.28 [95% CI 2.3–37.9; p = 0.002]) when compared to the same group. Other ABOs were more frequent in the combination of HIV/ART-exposed births compared to HIV-unexposed births (29.9% vs. 26.0%, adjusted RR 1.23 [1.14–1.31; p 0.001]).Conclusion: No association between T1 use of EFV-based ART regimens and CM was observed. Associations between T1 NVP-based ART regimen and CM need further investigation. HIV- and ART-exposed infants had more ABOs compared to HIV-unexposed infants.

Sign in / Sign up

Export Citation Format

Share Document