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

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Abstract

Background
The 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.

Objectives
We 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.

Population
We 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 Design
Each 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).

Methods
The 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.

Results
Pregnancy 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.

Conclusions
Challenges and opportunities exist to improve research on CA in relation to the COVID-19 pandemic and future pandemics.
Original languageEnglish
Pages (from-to)1-15
Number of pages15
JournalPaediatric and Perinatal Epidemiology
Early online date2 Mar 2022
DOIs
Publication statusE-pub ahead of print - 2 Mar 2022

Bibliographical note

Funding Information:
This study was partially funded by MRC grant no. MR/T039132/1 and EU H2020 733001

Publisher Copyright:
© 2022 The Authors. Paediatric and Perinatal Epidemiology published by John Wiley & Sons Ltd.

Keywords

  • congenital anomalies
  • COVID- 19
  • healthcare databases
  • pregnancy cohorts
  • registries
  • study design
  • COVID-19

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