MedicalResearch.com Interview with:
Dr. Sophie Graner
Department of Women’s and Childrens Health
Karolinska Institute, Stockholm, Sweden
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Pregnant women are at increased risks of severe disease and death due to influensa infection, as well as hospitalization. Also influenza and fever increase the risk of adverse pregnancy outcomes for their infants such as intrauterine death and preterm birth. Due to this, the regulatory agencies in Europe and the US recommended post exposure prophylaxis and treatment for pregnant women with neuraminidase inhibitors during the last influenza pandemic 2009-10. Despite the recommendations, the knowledge on the effect of neuraminidase inhibitors on the infant has been limited. Previously published studies have not shown any increased risk, but they have had limited power to assess specific neonatal outcomes such as stillbirth, neonatal mortality, preterm birth, low Agar score, neonatal morbidity and congenital malformations.
MedicalResearch.com: What should readers take away from your report?
Response: This study is the largest to date, almost twice as big as all previously studies combined and our results confirm and expand on the previous findings of no association between neuraminidase inhibitors during pregnancy and a broad range adverse neonatal outcomes or congenital malformations. In conclusion physicians that are considering to prescribe neuraminidase inhibitors to pregnant women have more information to ensure women that the treatment is not associated with risks for their infant.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Our study included 1125 infants exposed to neuraminidase during the first trimester, and we found no association between exposure and congenital malformations.
However we included infants born after 22 weeks of gestation, and we did not have information on terminations of pregnancy before that gestational age. If exposure to neuraminidase inhibitors are associated with miscarriage or termination of pregnancy due to congenital malformations in the beginning of the pregnancy our results may have been biased. However in a smaller study from France, no cases of termination of pregnancy due to malformations were seen in women who had taken oseltamivir during early pregnancy.
To be able to study the effect on congenital malformations and exposure to neuraminidase inhibitors more in depth a study including pregnancy outcomes before 22 weeks of gestation is recommended.
MedicalResearch.com: Is there anything else you would like to add?
Response: We defined exposure to neuraminidase inhibitors as having filled a prescription during pregnancy. Hence there is the possibility that women filled the prescription and then did not take the medication, this may have biased our results, leading to an underestimation of the risks.
There are no disclosures related to the current work.
Unrelated disclosures: Anders Hviid is supported by a Hallas-Moller stipend from Novo Nordisk Foundation and Björn Pasternak is supported by a research grant from the Danish Medical Research Council.
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Neuraminidase inhibitors during pregnancy and risk of adverse neonatal outcomes and congenital malformations: population based European register study
BMJ 2017; 356 doi: https://doi.org/10.1136/bmj.j629 (Published 28 February 2017)Cite this as: BMJ 2017;356:j629
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