Risk of pre-term births and major birth defects resulting from paternal intake of COVID-19 medications prior to conception

Abstract Objective With the ongoing COVID-19 pandemic, large numbers of people will receive one of the several medications proposed to treat COVID-19, including patients of reproductive age. Given that some medications have shown adverse effects on sperm quality, there might be a transgenerational concern. We aim at examining the association between drugs proposed to treat COVID-19 when taken by the father around conception and any pre-term birth or major birth defects in offspring in a nation-wide cohort study using Danish registry data. Offspring whose father filled at least one prescription of the following medications in the 3 months preceding conception were considered exposed: chloroquine, hydroxychloroquine, losartan, azithromycin, naproxen, dexamethasone and prednisone. Results For azithromycin and naproxen, large numbers of offspring were exposed (> 1800 offspring), and we found no association with adverse birth outcomes. For chloroquine, losartan and dexamethasone, exposure was intermediate (~ 900 offspring), and there was no statistically significant association with birth defects. For hydroxychloroquine and prednisone, exposure was limited (< 300 offspring). Our evidence suggests that azithromycin and naproxen are safe with respect to pre-term birth and birth defects. For the other drugs investigated larger exposures are needed for conclusive statements.

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Risk of pre-term births and major birth defects resulting from paternal intake of COVID-19 medications prior to conception

10.21203/rs.3.rs-59420/v1 ◽

2020 ◽

Cited By ~ 1

Author(s):

Silvia Rizzi ◽

Maarten Jan Wensink ◽

Rune Lindahl-Jacobsen ◽

Lu Tian ◽

Ying Lu ◽

...

Keyword(s):

Cohort Study ◽

Birth Outcomes ◽

Birth Defects ◽

Sperm Quality ◽

The Other ◽

Reproductive Age ◽

Adverse Birth Outcomes ◽

Term Birth ◽

Large Numbers ◽

Term Births

Abstract Objective. With the ongoing COVID-19 pandemic, large numbers of people will receive one of the several medications proposed to treat COVID-19, including patients of reproductive age. Given that some medications have shown adverse effects on sperm quality, there might be a transgenerational concern. We aim at examining the association between drugs proposed to treat COVID-19 when taken by the father around conception and any pre-term birth or major birth defects in offspring in a nation-wide cohort study using Danish registry data. Offspring whose father filled at least one prescription of the following medications in the three months preceding conception were considered exposed: chloroquine, hydroxychloroquine, losartan, azithromycin, naproxen, dexamethasone and prednisone. Results. For azithromycin and naproxen, large numbers of offspring were exposed (> 1800 offspring), and we found no association with adverse birth outcomes. For chloroquine, losartan and dexamethasone, exposure was intermediate (~ 900 offspring), and there was no statistically significant association with birth defects. For hydroxychloroquine and prednisone, exposure was limited (< 300 offspring). There is strong evidence that azithromycin and naproxen are safe with respect to pre-term birth and birth defects. With some caution, the other drugs investigated can be considered safe.

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Risk of pre-term births and major birth defects resulting from paternal intake of COVID-19 medications prior to conception

10.21203/rs.3.rs-59420/v2 ◽

2020 ◽

Author(s):

Silvia Rizzi ◽

Maarten Jan Wensink ◽

Rune Lindahl-Jacobsen ◽

Lu Tian ◽

Ying Lu ◽

...

Keyword(s):

Cohort Study ◽

Birth Outcomes ◽

Birth Defects ◽

Sperm Quality ◽

The Other ◽

Reproductive Age ◽

Adverse Birth Outcomes ◽

Term Birth ◽

Large Numbers ◽

Term Births

Abstract Objective. With the ongoing COVID-19 pandemic, large numbers of people will receive one of the several medications proposed to treat COVID-19, including patients of reproductive age. Given that some medications have shown adverse effects on sperm quality, there might be a transgenerational concern. We aim at examining the association between drugs proposed to treat COVID-19 when taken by the father around conception and any pre-term birth or major birth defects in offspring in a nation-wide cohort study using Danish registry data. Offspring whose father filled at least one prescription of the following medications in the three months preceding conception were considered exposed: chloroquine, hydroxychloroquine, losartan, azithromycin, naproxen, dexamethasone and prednisone. Results. For azithromycin and naproxen, large numbers of offspring were exposed (> 1800 offspring), and we found no association with adverse birth outcomes. For chloroquine, losartan and dexamethasone, exposure was intermediate (~900 offspring), and there was no statistically significant association with birth defects. For hydroxychloroquine and prednisone, exposure was limited (<300 offspring). Our evidence suggests that azithromycin and naproxen are safe with respect to pre-term birth and birth defects. For the other drugs investigated larger exposures are needed for conclusive statements.

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Live birth and adverse birth outcomes in women with ulcerative colitis and Crohn's disease receiving assisted reproduction: a 20-year nationwide cohort study

Gut ◽

10.1136/gutjnl-2015-311246 ◽

2016 ◽

Vol 65 (5) ◽

pp. 767-776 ◽

Cited By ~ 21

Author(s):

B M Nørgård ◽

P V Larsen ◽

J Fedder ◽

P S de Silva ◽

M D Larsen ◽

...

Keyword(s):

Ulcerative Colitis ◽

Cohort Study ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Birth Outcomes ◽

Assisted Reproduction ◽

Live Birth ◽

Adverse Birth Outcomes

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Epigenetic Alterations and Exposure to Air Pollutants: Protocol for a Birth Cohort Study to Evaluate the Association Between Adverse Birth Outcomes and Global DNA Methylation

JMIR Research Protocols ◽

10.2196/resprot.7114 ◽

2017 ◽

Vol 6 (2) ◽

pp. e29 ◽

Cited By ~ 7

Author(s):

Zhila Maghbooli ◽

Arash Hossein-Nezhad ◽

Majid Ramezani ◽

Syamak Moattari

Keyword(s):

Dna Methylation ◽

Cohort Study ◽

Birth Cohort ◽

Birth Outcomes ◽

Air Pollutants ◽

Birth Cohort Study ◽

Global Dna Methylation ◽

Adverse Birth Outcomes ◽

Epigenetic Alterations

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Iron deficiency during pregnancy is associated with a reduced risk of adverse birth outcomes in a malaria-endemic area in a longitudinal cohort study

BMC Medicine ◽

10.1186/s12916-018-1146-z ◽

2018 ◽

Vol 16 (1) ◽

Cited By ~ 7

Author(s):

Freya J. I. Fowkes ◽

Kerryn A. Moore ◽

D. Herbert Opi ◽

Julie A. Simpson ◽

Freya Langham ◽

...

Keyword(s):

Cohort Study ◽

Iron Deficiency ◽

Birth Outcomes ◽

Endemic Area ◽

Longitudinal Cohort Study ◽

Adverse Birth Outcomes ◽

Malaria Endemic Area ◽

Longitudinal Cohort ◽

Reduced Risk

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Dose-response relationship between maternal blood pressure in pregnancy and risk of adverse birth outcomes: Ma’anshan birth cohort study

Pregnancy Hypertension ◽

10.1016/j.preghy.2018.09.004 ◽

2019 ◽

Vol 15 ◽

pp. 16-22 ◽

Cited By ~ 2

Author(s):

Beibei Zhu ◽

Kun Huang ◽

Wei Bao ◽

Shuangqin Yan ◽

Jiahu Hao ◽

...

Keyword(s):

Blood Pressure ◽

Cohort Study ◽

Birth Outcomes ◽

Maternal Blood ◽

Birth Cohort Study ◽

Adverse Birth Outcomes ◽

Response Relationship ◽

Dose Response Relationship ◽

Maternal Blood Pressure ◽

In Pregnancy

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The University of Zimbabwe College of Health Sciences (UZ-CHS) BIRTH COHORT study: rationale, design and methods

BMC Infectious Diseases ◽

10.1186/s12879-020-05432-6 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Kerina Duri ◽

◽

Felicity Z. Gumbo ◽

Privilege T. Munjoma ◽

Precious Chandiwana ◽

...

Keyword(s):

Cohort Study ◽

Amniotic Fluid ◽

Birth Cohort ◽

Birth Outcomes ◽

Early Life ◽

Health Sciences ◽

Birth Cohort Study ◽

Adverse Birth Outcomes ◽

The University ◽

University Of Zimbabwe

Abstract Background Commencing lifelong antiretroviral therapy (ART) immediately following HIV diagnosis (Option B+), has greatly improved maternal-infant health. Thus, large and increasing numbers of HIV-infected women are on ART during pregnancy, a situation concurrently increasing numbers of HIV-exposed-uninfected (HEU) infants. Compared to their HIV-unexposed-uninfected (HUU) counterparts, HEU infants show higher rates of adverse birth outcomes, mortality, infectious/non-communicable diseases including impaired growth and neurocognitive development. There is an urgent need to understand the impact of HIV and early life ART exposures, immune-metabolic dysregulation, comorbidities and environmental confounders on adverse paediatric outcomes. Methods Six hundred (600) HIV-infected and 600 HIV-uninfected pregnant women ≥20 weeks of gestation will be enrolled from four primary health centres in high density residential areas of Harare. Participants will be followed up as mother-infant-pairs at delivery, week(s) 1, 6, 10, 14, 24, 36, 48, 72 and 96 after birth. Clinical, socio-economic, nutritional and environmental data will be assessed for adverse birth outcomes, impaired growth, immune/neurodevelopment, vertical transmission of HIV, hepatitis-B/C viruses, cytomegalovirus and syphilis. Maternal urine, stool, plasma, cord blood, amniotic fluid, placenta and milk including infant plasma, dried blood spot and stool will be collected at enrolment and follow-up visits. The composite primary endpoint is stillbirth and infant mortality within the first two years of life in HEU versus HUU infants. Maternal mortality in HIV-infected versus -uninfected women is another primary outcome. Secondary endpoints include a range of maternal and infant outcomes. Sub-studies will address maternal stress and malnutrition, maternal-infant latent tuberculosis, Helicobacter pylori infections, immune-metabolomic dysregulation including gut, breast milk and amniotic fluid dysbiosis. Discussion The University of Zimbabwe-College of Health-Sciences-Birth-Cohort study will provide a comprehensive assessment of risk factors and biomarkers for HEU infants’ adverse outcomes. This will ultimately help developing strategies to mitigate effects of maternal HIV, early-life ART exposures and comorbidities on infants’ mortality and morbidity. Trial registration ClinicalTrial.gov Identifier: NCT04087239. Registered 12 September 2019.

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