Evidence map›Paper›PMID 35234297›Full record

ReviewPaediatric and perinatal epidemiology2022

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

Open access · hybridAbstract readReview
In one paragraph

Review in Paediatric and perinatal epidemiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
3.1field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 18 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 2 countries.

Helen DolkUlster University, United Kingdom.ORCID 0000-0001-6639-5904
Christine Damase-MichelINSERM, Centre Hospitalier Universitaire de Toulouse, France.ORCID 0000-0001-5018-0108
Joan K MorrisSt George's University of London, United Kingdom.ORCID 0000-0002-7164-612X
Maria LoaneUlster University, United Kingdom.ORCID 0000-0002-1206-3637
University of Ulster · GBInserm · FRSt George's, University of London · GB

Funding

Medical Research Council MR/T039132/1
6 · The paper itself

Abstract

backgroundThe 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. 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

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.

Indexed as

COVID-19FemaleHumansPandemicsPregnancyPregnancy OutcomeRegistriesResearch DesignRisk FactorsVaccinationcongenital anomaliesCOVID-19healthcare databasespregnancy cohortsregistriesstudy design

Identifiers

PMID35234297
PMCPMC9115419
OpenAlexW4214937926

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.