No evidence of adverse pregnancy outcome after exposure to ibuprofen in the first trimester – Evaluation of the national Embryotox cohort

Dathe, Katarina; Fietz, Anne‐Katrin; Pritchard, Lucas William; Padberg, Stephanie; Hultzsch, Stefanie; Meixner, Katja; Meister, Reinhard; Schaefer, Christof

doi:10.1016/j.reprotox.2018.05.003

Cited by 28 publications

(17 citation statements)

References 38 publications

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“…Consistent with our results, increased risk of preterm birth and miscarriage has been associated with analgesic consumption during pregnancy 28–31 , while others reported no associations with miscarriage, stillbirth or preterm delivery 20,28,29,32 . Similarly, increased risk for offspring cryptorchidism, hypospadias, neural tube defects, amniotic band defects and gastroschisis have been shown by many studies 7–9,33–40 , although, again, a lack of associations with major birth defects have been reported 13–17,41,42 . Compared to our analysis, all these studies used a smaller cohort, considered a shorter study time and there was frequent disagreement with respect to the choices of adjusted confounding factors.…”

Section: Discussionmentioning

confidence: 80%

“…However, current evidence is largely conflicting regarding the safety of gestational analgesic use both for the pregnancy and offspring health 6 . Several studies have reported increased risks for multiple adverse outcomes including hypospadias, cryptorchidism, amniotic band defects and neural tube defects 7–11 , whilst others have not found significant associations 12–17 . Taken overall, this has led to significant concern that postnatal health is adversely affected by maternal analgesic use during pregnancy 18 .…”

Section: Introductionmentioning

confidence: 99%

“…The use of small cohorts in the current epidemiological studies makes it difficult to draw firm conclusions and definite recommendations 12,17,19,20 . There are other aspects of analgesic use that have to be taken into account.…”

Section: Introductionmentioning

confidence: 99%

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Over-the-counter Analgesics in Pregnancy and Offspring Neonatal Outcomes: A Retrospective Cohort Study

Zafeiri

Raja

Mitchell

et al. 2020

Preprint

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Objective To identify associations between in utero exposure to 5 over-the-counter (OTC) analgesics and adverse neonatal outcomes. Design Retrospective cohort study Setting Aberdeen UK Population 151,141 singleton deliveries, 1985 to 2015 Methods Self-reported, non-prescription, consumption of paracetamol, aspirin, ibuprofen, diclofenac and naproxen during pregnancy and neonatal outcomes were obtained from the Aberdeen Maternity and Neonatal Databank (AMND). Univariable and multivariable regression analyses were performed to investigate associations between analgesic use and offspring neonatal outcomes. Crude (cORs) and adjusted odds ratios (aORs) with 95% confidence intervals (CIs) were reported, indicating the strength of association. Main Outcome Measures Premature delivery (<37 weeks), stillbirth, neonatal death, birthweight, standardised birthweight score, neonatal unit admission, APGAR score at 1 and 5 minutes, cryptorchidism, neural tube and amniotic band defects, hypospadias and gastroschisis. Results Pregnancies exposed to at least one of the 5 analgesics were significantly independently associated with increased odds for premature delivery <37 weeks (aOR=1.50, 95%CI 1.43-1.58), stillbirth (aOR=1.33, 95%CI 1.15-1.54), neonatal death (aOR=1.56, 95%CI 1.27-1.93), birthweight <2500g (aOR=1.28, 95%CI 1.20-1.37), birthweight >4000g (aOR=1.09, 95%CI 1.05-1.13), admission to neonatal unit (aOR=1.57, 95%CI 1.51-1.64), APGAR score <7 at 1 minute (aOR=1.18, 95%CI 1.13-1.23) and 5 minutes (aOR=1.48, 95%CI 1.35-1.62), neural tube defects (aOR=1.64, 95%CI 1.08-2.47) and hypospadias (aOR=1.27, 95%CI 1.05-1.54 males only). Conclusions There was a high prevalence of OTC analgesics use during pregnancy, which steeply increased during the 30-year study period. Analgesic consumption was independently associated with multiple adverse neonatal offspring outcomes. The use of paracetamol in combination with other NSAIDs conferred the highest risk.

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Section: Discussionmentioning

confidence: 80%

Section: Introductionmentioning

confidence: 99%

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Over-the-counter Analgesics in Pregnancy and Offspring Neonatal Outcomes: A Retrospective Cohort Study

Zafeiri

Raja

Mitchell

et al. 2020

Preprint

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“…Quando foi avaliado a porcentagem do uso de AINE específicos observou-se que a nimesulida (53,3%) foi o mais utilizado, seguido do diclofenaco (33,7%) e ibuprofeno (9,78%). Outros estudos também relataram o uso frequente do ibuprofeno (Källén & Olausson, 2003;Cleves, et al, 2004;Damase-Michel & Hurault-Delarue, 2014;Interrante, et al, 2017;Dathe, et al, 2018) e do diclofenaco (Ericson & Källén, 2001;Nezvalová-Henriksena, Spigsetb, & Nordeng, 2013;Damase-Michel & Hurault-Delarue, 2014).…”

Section: Discussionunclassified

“…Além disso, em humanos o uso do ibuprofeno foi associado a ocorrência da espinha bífida ( (Hernandez, et al, 2017). De forma contrária, um estudo alemão analisou 1117 mulheres (CC BY 4.0) | ISSN 2525-3409 | DOI: http://dx.doi.org/10.33448/rsd-v9i8.5671 expostas ao ibuprofeno no 1º trimestre e 2229 mulheres não expostas ao ibuprofeno e não relatou o aumento significativo do risco de defeitos congênitos graves (Dathe, et al, 2018).…”

Section: Discussionunclassified

Efeitos do uso dos anti-inflamatórios não esteroides na prevalência de malformações estruturais fetais

Tacon

Melo

Moraes

et al. 2020

RSD

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Objetivo: Avaliar o uso dos anti-inflamatórios não esteroidais (AINEs) na prevalência de malformações congênitas (MC) estruturais. Métodos: Estudo do tipo caso-controle, realizado em um hospital público referência em medicina fetal. Foi aplicado um questionário para avaliar os fatores sociodemográficos e obstétricos. A avaliação da morfologia fetal foi realizada através da avaliação ultrassonográfica. Resultados: Das 282 gestantes avaliadas, 28,72% (81/282) relataram uso de anti-inflamatórios durante a gravidez, sendo 75,1% (n = 60) do grupo caso e 25,9% (n = 21) do grupo controle. Entre os anti-inflamatórios, os mais utilizados foram nimesulida (17,38%; n = 49), diclofenaco (10,99%; n = 31) e ibuprofeno (3,19%; n = 9). O uso de AINEs em geral e específico (nimesulida, diclofenaco, ibuprofeno) não apresentou diferença entre os grupos. No entanto, foi observado o maior uso de ibuprofeno no grupo caso (4,46%; n = 9) vs controle (0%; n = 0) com OR = 7,904, p = 0,05. O uso de AINEs foi maior em gestantes que apresentavam fetos com MC da face (55,6%), parede abdominal (38,10%) e do sistema nervoso central (SNC) (30,30%). Conclusão: Embora não tenham sido observadas diferenças entre os grupos, o uso de AINES foi considerável em pacientes que tiveram feto com malformações fetais da face, parede abdominal e SNC. Devido à alta frequência de algumas malformações, especialmente as da face, deve-se ter o cuidado com a indicação e principalmente com a automedicação dessa classe medicamentosa durante a gravidez.

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Management of Pain During Maternal Critical Illness

Zaphiratos

Richebé

2020

Principles and Practice of Maternal Critical Care

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No evidence of adverse pregnancy outcome after exposure to ibuprofen in the first trimester – Evaluation of the national Embryotox cohort

Cited by 28 publications

References 38 publications

Over-the-counter Analgesics in Pregnancy and Offspring Neonatal Outcomes: A Retrospective Cohort Study

Over-the-counter Analgesics in Pregnancy and Offspring Neonatal Outcomes: A Retrospective Cohort Study

Efeitos do uso dos anti-inflamatórios não esteroides na prevalência de malformações estruturais fetais

Management of Pain During Maternal Critical Illness

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