| dc.description.abstract |
Introduction Pharmacovigilance (PV), or the ongoing safety monitoring after a medication has been licensed, plays a crucial
role in pregnancy, as clinical trials often exclude pregnant people. It is important to understand how pregnancy PV projects
operate in low- and middle-income countries (LMICs), where there is a disproportionate lack of PV data yet a high burden
of adverse pregnancy outcomes. We conducted a scoping review to assess how exposures and outcomes were measured in
recently published pregnancy PV projects in LMICs.
Methods We utilized a search string, secondary review, and team knowledge to review publications focusing on therapeutic
or vaccine exposures among pregnant people in LMICs. We screened abstracts for relevance before conducting a full text
review, and documented measurements of exposures and outcomes (categorized as maternal, birth, or neonatal/infant) among
other factors, including study topic, setting, and design, comparator groups, and funding sources.
Results We identified 31 PV publications spanning at least 24 LMICs, all focusing on therapeutics or vaccines for infectious
diseases, including HIV (n = 17), tuberculosis (TB; n = 9), malaria (n = 7), pertussis, tetanus, and diphtheria (n = 1), and
influenza (n = 3). As for outcomes, n = 15, n = 31, and n = 20 of the publications covered maternal, birth, and neonatal/infant
outcomes, respectively. Among HIV-specific publications, the primary exposure-outcome relationship of focus was exposure to
maternal antiretroviral therapy and adverse outcomes. For TB-specific publications, the main exposures of interest were second-
line drug-resistant TB and isoniazid-based prevention therapeutics for pregnant people living with HIV. For malaria-specific
publications, the primary exposure-outcome relationship of interest was antimalarial medication exposure during pregnancy and
adverse outcomes. Among vaccine-focused publications, the exposure was assessed during a specific time during pregnancy,
with an overall interest in vaccine safety and/or efficacy. The study settings were frequently from Africa, designs varied from
cohort or cross-sectional studies to clinical trials, and funding sources were largely from high-income countries.
Conclusion The published pregnancy PV projects were largely centered in Africa and concerned with infectious diseases. This may
reflect the disease burden in LMICs but also funding priorities from high-income countries. As the prevalence of non-communicable
diseases increases in LMICs, PV projects will have to broaden their scope. Birth and neonatal/infant outcomes were most reported,
with fewer reporting on maternal outcomes and none on longer-term child outcomes; additionally, heterogeneity existed in definitions
and ascertainment of specific measures. Notably, almost all projects covered a single therapeutic exposure, missing an opportunity to
leverage their projects to cover additional exposures, add scientific rigor, create uniformity across health services, and bolster exist-
ing health systems. For many publications, the timing of exposure, specifically by trimester, was crucial to maternal and neonatal
safety. While currently published pregnancy PV literature offer insights into the PV landscape in LMICs, further work is needed
to standardize definitions and measurements, integrate PV projects across health services, and establish longer-term monitoring. |
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