COVID‐19 in pregnancy—what study designs can we use to assess the risk of congenital anomalies in relation to COVID‐19 disease, treatment and vaccination?

Helen Dolk; Christine Damase‐Michel; Joan K Morris; Maria Loane

doi:10.1111/ppe.12840

journal article Open Access Mar 02, 2022

COVID‐19 in pregnancy—what study designs can we use to assess the risk of congenital anomalies in relation to COVID‐19 disease, treatment and vaccination?

Helen Dolk

Christine Damase‐Michel Joan K Morris

Maria Loane

Paediatric and Perinatal Epidemiology Vol. 36 No. 4 pp. 493-507 · Wiley

View at Publisher Save 10.1111/ppe.12840

Abstract

AbstractBackgroundThe COVID‐19 pandemic has accelerated pregnancy outcome research, but little attention has been given specifically to the risk of congenital anomalies (CA) and first trimester exposures.ObjectivesWe reviewed the main data sources and study designs used internationally, particularly in Europe, for CA research, and their strengths and limitations for investigating COVID‐19 disease, medications and vaccines.PopulationWe classify research designs based on four data sources: a) spontaneous adverse event reporting, where study subjects are positive for both exposure and outcome, b) pregnancy exposure registries, where study subjects are positive for exposure, c) congenital anomaly registries, where study subjects are positive for outcome and d) population healthcare data where the entire population of births is included, irrespective of exposure and outcome.Study DesignEach data source allows different study designs, including case series, exposed pregnancy cohorts (with external comparator), ecological studies, case‐control studies and population cohort studies (with internal comparator).MethodsThe quality of data sources for CA studies is reviewed in relation to criteria including diagnostic accuracy of CA data, size of study population, inclusion of terminations of pregnancy for foetal anomaly, inclusion of first trimester COVID‐19‐related exposures and use of an internal comparator group. Multinational collaboration models are reviewed.ResultsPregnancy exposure registries have been the main design for COVID‐19 pregnancy studies, but lack detail regarding first trimester exposures relevant to CA, or a suitable comparator group. CA registries present opportunities for improving diagnostic accuracy in COVID‐19 research, especially when linked to other data sources. Availability of inpatient hospital medication use in population healthcare data is limited. More use of ongoing mother‐baby linkage systems would improve research efficiency. Multinational collaboration delivers statistical power.ConclusionsChallenges and opportunities exist to improve research on CA in relation to the COVID‐19 pandemic and future pandemics.

Topics

No keywords indexed for this article. Browse by subject →

References

86

[1]

10.1136/bmj.m2107

[2]

10.15585/mmwr.mm6938e1

[3]

10.1111/aogs.13901

[4]

10.1136/bmj.m3320

[5]

10.1056/nejmsb031395.2

[6]

10.1016/j.ijid.2020.04.065

[7]

10.1016/j.ajogmf.2020.100118

[8]

10.1097/aog.0000000000003983

[9]

10.1016/j.eclinm.2020.100446

[10]

10.1111/jth.14856

[11]

10.1111/bjh.16849

[12]

10.1016/j.ajog.2020.07.045

[13]

10.1016/j.ajog.2010.12.033

[14]

Pierce‐Williams RAM "Clinical course of severe and critical COVID‐19 in hospitalized pregnancies: a US cohort study" Am J Obstet Gynecol (2020)

[15]

10.1097/aog.0000000000003979

[16]

10.1016/s0140-6736(20)30311-1

[17]

10.1001/jamapediatrics.2016.3982

[18]

10.15585/mmwr.mm6839a5

[19]

10.1002/bdra.20277

[20]

10.1055/s-0040-1710050

[21]

10.1038/s41467-020-17436-6

[22]

Patanè L "Vertical transmission of COVID‐19: SARS‐CoV‐2 RNA on the fetal side of the placenta in pregnancies with COVID‐19 positive mothers and neonates at birth" Am J Obstet Gynecol (2020)

[23]

10.1002/pd.57654

[24]

10.1111/1471-0528.16362

[25]

10.1093/ajcp/aqaa089

[26]

10.1111/1471-0528.16403

[27]

10.1177/1093526620925569

[28]

10.21203/rs.3.rs‐615203/v1

[29]

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf

[30]

10.1002/ajmg.c.30313

[31]

10.1080/14767058.2020.1774875

[32]

10.1080/14787210.2020.1782742

[33]

10.1016/j.ejphar.2020.173372

[34]

10.1056/nejmoa2023184

[35]

10.1016/j.ajogmf.2020.100159

[36]

10.1093/aje/kwab109

[37]

10.1016/j.therap.2020.05.004

[38]

10.1016/j.reprotox.2021.01.006

[39]

10.1371/journal.pone.0227908

[40]

10.1001/jama.2021.15494

[41]

10.1056/nejmc2113891

[42]

CiapponiA BardachA MazzoniA AlconadaT AndersonS ArgentoFJ et al.Safety of COVID‐19 vaccines their components or their platforms for pregnant women: A rapid review. medRxiv [Preprint].2021. doi:10.1101/2021.06.03.21258283.6.

[43]

10.1056/nejmoa2104983

[44]

10.1016/s0190‐9622(84)80142‐5

[45]

10.1002/bdra.20525

[46]

10.1212/wnl.0000000000008001

[47]

10.1002/pds.4150

[48]

COROPREG Covid‐19 in Pregnancy: a French Population‐based Cohort of Women and Newborns (Coropreg)https://www.clinicaltrials.gov/ct2/show/NCT04463758

[49]

10.1002/tera.1071

[50]

10.1016/s0140‐6736(20)30981‐8.7

Showing 50 of 86 references

Metrics

14

Citations

86

References

Details

Published: Mar 02, 2022
Vol/Issue: 36(4)
Pages: 493-507
License: View

Authors

H

Helen Dolk

Ulster University United Kingdom

C

Christine Damase‐Michel

INSERM Centre Hospitalier Universitaire de Toulouse France

J

Joan K Morris

St George’s University of London United Kingdom

M

Maria Loane

Ulster University United Kingdom

Cite This Article

Helen Dolk, Christine Damase‐Michel, Joan K Morris, et al. (2022). COVID‐19 in pregnancy—what study designs can we use to assess the risk of congenital anomalies in relation to COVID‐19 disease, treatment and vaccination?. Paediatric and Perinatal Epidemiology, 36(4), 493-507. https://doi.org/10.1111/ppe.12840

COVID‐19 in pregnancy—what study designs can we use to assess the risk of congenital anomalies in relation to COVID‐19 disease, treatment and vaccination?

You May Also Like