Evidence map›Paper›PMID 33410971›Full record

ArticleEuropean journal of clinical pharmacology2021

Maternal paracetamol intake and fetal ductus arteriosus constriction/closure: comprehensive signal evaluation using the Austin Bradford Hill criteria.

Manfred Hauben, Stephen Bai, Eric Hung, Kasia Lobello, Charles Tressler, Vincent P Zucal

Abstract read
PubMed Publisher
In one paragraph

Article in European journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
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

6 authors.

Manfred HaubenWorldwide Safety and Regulatory, Pfizer Inc., 235 E 42nd St, New York, NY, 10017, USA. manfred.hauben@Pfizer.com.ORCID https://orcid.org/0000-0002-3365-1374
Stephen BaiClinical Pharmacology, Pfizer Inc., 235 E 42nd St, New York, NY, 10017, USA.
Eric HungWorldwide Safety and Regulatory, Pfizer Inc., 235 E 42nd St, New York, NY, 10017, USA.
Kasia LobelloSafety Surveillance and Risk Management, Pfizer Inc., 235 E 42nd St, New York, NY, 10017, USA.
Charles TresslerSafety Surveillance and Risk Management, Pfizer Inc., 235 E 42nd St, New York, NY, 10017, USA.
Vincent P ZucalSafety Surveillance and Risk Management, Pfizer Inc., 235 E 42nd St, New York, NY, 10017, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAcetaminophen (APAP) is available over-the-counter and widely regarded as safe for use in pregnancy. APAP has been used to close a persistently patent ductus arteriosus. Fetal constriction/closure of the ductus arteriosus (FCCDA), of public health interest given the drug's widespread use during pregnancy, is being monitored globally, including by the European Medicines Agency Pharmacovigilance Risk Assessment Committee. Our objective was to share a comprehensive signal evaluation of FCCDA with in utero APAP exposure to determine if the totality of evidence is sufficiently more consistent with one of the following two possibilities: (1) APAP never contributes to FCCDA (null hypothesis or H

methodsTo assess the relative support for H

resultsWhile residual uncertainty remains, the totality of information is more compatible with H

conclusionIt is reasonably possible that APAP may sometimes be at least a contributory cause of FCCDA, and this should therefore be communicated to stakeholders.

trial registrationCLINICALTRIALS. GOV REGISTRATION: NOT APPLICABLE.

Indexed as

AcetaminophenAnalgesics, Non-NarcoticConstrictionDuctus ArteriosusFemaleHumansPregnancyPrenatal Exposure Delayed EffectsAcetaminophenAnalgesics, Non-NarcoticAcetaminophenDrug exposureFetal ductus arteriosus closureIn uteroSignal evaluation

Identifiers

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.