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Pregnancy exposure registries for drugs and vaccines in low-income and middle-income countries: scoping review protocol.
AbuShweimeh, Rahmeh; Knudson, Sophie; Chaabane, Sonia; Pal, Shanthi Narayan; Skidmore, Becky; Stergachis, Andy; Bhat, Niranjan.
  • AbuShweimeh R; School of Public Health, University of Washington, Seattle, Washington, USA.
  • Knudson S; Center for Vaccine Innovation and Access, PATH, Seattle, Washington, USA.
  • Chaabane S; Regulation and Prequalification, World Health Organization, Geneve, Switzerland.
  • Pal SN; Regulation and Prequalification, World Health Organization, Geneve, Switzerland.
  • Skidmore B; Independent Information Specialist, Ottawa, Ontario, Canada.
  • Stergachis A; School of Public Health, University of Washington, Seattle, Washington, USA stergach@uw.edu.
  • Bhat N; School of Pharmacy, University of Washington, Seattle, Washington, USA.
BMJ Open ; 13(5): e070543, 2023 05 08.
Article in English | MEDLINE | ID: covidwho-2312161
ABSTRACT

INTRODUCTION:

Data 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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Vaccines / Developing Countries Type of study: Experimental Studies / Observational study / Prognostic study / Qualitative research / Randomized controlled trials / Reviews / Systematic review/Meta Analysis Topics: Vaccines Limits: Female / Humans / Pregnancy Language: English Journal: BMJ Open Year: 2023 Document Type: Article Affiliation country: Bmjopen-2022-070543

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Vaccines / Developing Countries Type of study: Experimental Studies / Observational study / Prognostic study / Qualitative research / Randomized controlled trials / Reviews / Systematic review/Meta Analysis Topics: Vaccines Limits: Female / Humans / Pregnancy Language: English Journal: BMJ Open Year: 2023 Document Type: Article Affiliation country: Bmjopen-2022-070543