Evidence map›Paper›PMID 36542272›Full record

ArticleClinical drug investigation2023

Use of Methotrexate in Girls and Women of Childbearing Age, Occurrence of Methotrexate-Exposed Pregnancies and Their Outcomes in Germany: A Claims Data Analysis.

Nadine Wentzell, Bianca Kollhorst, Jonas Reinold, Ulrike Haug

Open access · hybridAbstract read
In one paragraph

Article in Clinical drug investigation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.6field-weighted citation impact, top 17% 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

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
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 2 institutions in 1 country.

Nadine WentzellDepartment of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Achterstraße 30, 28359, Bremen, Germany. wentzell@leibniz-bips.de.ORCID http://orcid.org/0000-0002-2983-0222
Bianca KollhorstDepartment of Biometry and Data Management, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Achterstraße 30, 28359, Bremen, Germany.ORCID http://orcid.org/0000-0001-5964-954X
Jonas ReinoldDepartment of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Achterstraße 30, 28359, Bremen, Germany.ORCID http://orcid.org/0000-0001-8266-2574
Ulrike HaugDepartment of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Achterstraße 30, 28359, Bremen, Germany.ORCID http://orcid.org/0000-0002-1886-2923
Leibniz Institute for Prevention Research and Epidemiology - BIPS · DEUniversity of Bremen · DE

Funding

Bundesinstitut für Arzneimittel und Medizinprodukte V-18281/ 68605 / 2019-2020
6 · The paper itself

Abstract

BACKGROUND AND

objectiveMethotrexate should be withdrawn before pregnancy because of its teratogenic potential. We aimed to describe the use of methotrexate in women of childbearing age in Germany and the occurrence and outcomes of pregnancies exposed to methotrexate.

methodsUsing the German Pharmacoepidemiological Research Database (GePaRD, covering ~ 20% of the German population), we determined the age-specific and age-standardized prevalence of methotrexate use for each year between 2004 and 2019 among women aged 13-49 years (cross-sectional analyses). In a cohort analysis, we assessed the number and outcomes of pregnancies exposed to methotrexate in the critical time window. Exposure was defined as a dispensation overlapping with the onset of pregnancy or a dispensation in the first 8 weeks of pregnancy. For children born from exposed pregnancies, the mother's and children's data were linked and the occurrence of malformations was assessed by reviewing all available data of these children.

resultsThe age-standardized prevalence of methotrexate use per 1000 females increased from 1.5 in 2004 to 2.3 in 2019, i.e., by 52%. Overall, we identified 184 pregnancies exposed to methotrexate. Of these, 53% ended in a live birth (21% preterm) and 11% in an induced abortion. Among 81 live-born children linked to their mothers, five children (6%) had relevant malformations including congenital heart defects and musculoskeletal malformations.

conclusionsIn Germany, the use of methotrexate in women of childbearing age has substantially increased since 2004. Despite the known teratogenic effect, there was a considerable number of exposed pregnancies.  Also, malformations likely associated with methotrexate and thus avoidable were observed.

Indexed as

MethotrexatePregnancy OutcomeChildCohort StudiesCross-Sectional StudiesFemaleGermanyHumansInfant, NewbornPregnancyMethotrexate

Identifiers

PMID36542272
PMCPMC9902307
OpenAlexW4312066971

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.