Evidence map›Paper›PMID 31302868›Full record

ArticleInfection2020

Pregnancy outcome after first-trimester exposure to fosfomycin for the treatment of urinary tract infection: an observational cohort study.

Wayan Philipps, Anne-Katrin Fietz, Katja Meixner, Tobias Bluhmki, Reinhard Meister, Christof Schaefer, Stephanie Padberg

Abstract read
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In one paragraph

Article in Infection, 2020. 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
1.1field-weighted citation impact, top 22% 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, 17 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

7 authors at 2 institutions in 1 country.

Wayan PhilippsCharité, Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Pharmakovigilanzzentrum Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Augustenburger Platz 1, 13353, Berlin, Germany.
Anne-Katrin FietzCharité, Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Pharmakovigilanzzentrum Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Augustenburger Platz 1, 13353, Berlin, Germany.
Katja MeixnerCharité, Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Pharmakovigilanzzentrum Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Augustenburger Platz 1, 13353, Berlin, Germany.
Tobias BluhmkiInstitute of Statistics, Ulm University, Ulm, Germany.
Reinhard MeisterBeuth Hochschule für Technik Berlin, University of Applied Sciences, Berlin, Germany.
Christof SchaeferCharité, Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Pharmakovigilanzzentrum Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Augustenburger Platz 1, 13353, Berlin, Germany.
Stephanie PadbergCharité, Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Pharmakovigilanzzentrum Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Augustenburger Platz 1, 13353, Berlin, Germany. stephanie.padberg@charite.de.ORCID http://orcid.org/0000-0002-2780-7598
Humboldt-Universität zu Berlin · DEBerliner Hochschule für Technik · DE

Funding

German Research Foundation 1749/3-1German Research Foundation BE 4500/3-1German Research Foundation ME 910/2-1
6 · The paper itself

Abstract

purposeThe primary aim of our study was to assess pregnancy outcome after first-trimester exposure to fosfomycin.

methodsWe performed an observational cohort study analysing prospectively ascertained pregnancies including 152 women exposed to fosfomycin in the first trimester of pregnancy in comparison with a randomly selected cohort comprising 456 pregnancies not exposed to fosfomycin. All pregnancies were identified through risk consultations using structured questionnaires between January 2000 and December 2016 by the German Embryotox pharmacovigilance institute in Berlin. Primary objectives were the risks of major birth defects and spontaneous abortion.

resultsOnly 1 out of 146 exposed infants was affected by a major birth defect (0.7%, 95% CI 0.04-4.33%) in comparison to 15/399 in the non-exposed cohort (3.8%, 95% CI 2.2-6.26%). Spontaneous abortions were observed in 5/152 cases in the fosfomycin cohort vs. 53/456 cases in the comparison cohort (cumulative incidence 6.2% vs. 23.1%; HR adjusted 0.35, 95% CI 0.14-0.90).

conclusionThis is the first study specifically examining the teratogenic risk of fosfomycin. The study results do not indicate an increased risk of adverse pregnancy outcome after fosfomycin exposure during early pregnancy. However, larger studies are needed to confirm the safety of fosfomycin during the first trimester.

Indexed as

Abortion, SpontaneousAdultAnti-Bacterial AgentsBerlinCohort StudiesCongenital AbnormalitiesFemaleFosfomycinHumansIncidencePregnancyPregnancy OutcomePregnancy Trimester, FirstRisk FactorsUrinary Tract InfectionsAnti-Bacterial AgentsFosfomycinBirth defectsFosfomycinPregnancySpontaneous abortionUrinary tract infection

Identifiers

PMID31302868
OpenAlexW2958114923

What OpenQuestion holds

Textmetadata
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.