Evidence map›Paper›PMID 37156596›Full record

ArticleBMJ open2023

Pregnancy exposure registries for drugs and vaccines in low-income and middle-income countries: scoping review protocol.

Rahmeh AbuShweimeh, Sophie Knudson, Sonia Chaabane, Shanthi Narayan Pal, Becky Skidmore, Andy Stergachis, Niranjan Bhat

Abstract read
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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.

Rahmeh AbuShweimehSchool of Public Health, University of Washington, Seattle, Washington, USA.
Sophie KnudsonCenter for Vaccine Innovation and Access, PATH, Seattle, Washington, USA.
Sonia ChaabaneRegulation and Prequalification, World Health Organization, Geneve, Switzerland.
Shanthi Narayan PalRegulation and Prequalification, World Health Organization, Geneve, Switzerland.
Becky SkidmoreIndependent Information Specialist, Ottawa, Ontario, Canada.
Andy StergachisSchool of Public Health, University of Washington, Seattle, Washington, USA stergach@uw.edu.ORCID 0000-0003-0057-6627
Niranjan BhatCenter for Vaccine Innovation and Access, PATH, Seattle, Washington, USA.

Funding

Bill & Melinda Gates Foundation INV-037810World Health Organization 001
6 · The paper itself

Abstract

introductionData regarding the safety of drugs and vaccines in pregnant women are typically unavailable before licensure. Pregnancy exposure registries (PERs) are an important source of postmarketing safety information. PERs in low-income and middle-income countries (LMICs) are uncommon but can provide valuable safety data regarding their distinct contexts and will become more relevant as the introduction and use of new drugs and vaccines in pregnancy increase worldwide. Strategies to support PERs in LMICs must be based on a better understanding of their current status. We developed a scoping review protocol to assess the landscape of PERs that operate in LMICs and characterise their strengths and challenges. METHODS AND ANALYSIS: This scoping review protocol follows the Joanna Briggs Institute manual for scoping reviews. The search strategy will be reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews Checklist. We will search PubMed, Embase, CINAHL and WHO's Global Index Medicus, as well as the reference lists of retrieved full-text records, for articles published between 2000 and 2022 that describe PERs or other resources that systematically record exposures to medical products during pregnancy and maternal and infant outcomes in LMICs. Title and abstracts will be screened by two authors and data extracted using a standardised form. We will undertake a grey literature search using Google Scholar and targeted websites. We will distribute an online survey to selected experts and conduct semistructured interviews with key informants. Identified PERs will be summarised in tables and analysed. ETHICS AND DISSEMINATION: Ethical approval is not required for this activity, as it was determined not to involve human subjects research. Findings will be submitted to an open access peer-reviewed journal and may be presented at conferences, with underlying data and other materials made publicly available.

Indexed as

Developing CountriesVaccinesFemaleHumansPregnancyResearch DesignScoping Reviews as TopicVaccinesCLINICAL PHARMACOLOGYEPIDEMIOLOGYMaternal medicine

Identifiers

PMID37156596
PMCPMC10174003

What Socratic 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 Socratic graph.