The inclusion of pregnant women in research during disease outbreaks globally: A scoping review.
Haley Kartchner Williams, Maria Docal, Angela Chang Chiu and 2 others
PMID 40667949WHAT IT FOUND
Pregnant women were systematically excluded from most clinical trials during recent outbreaks, with exclusion rates between 52% and 97.8%.
This lack of data forces clinicians to prescribe off-label without evidence of safety or efficacy for mothers and babies.
Key findings
01Across multiple studies reviewing clinical trial registries during outbreaks, pregnant women were excluded from 52% to 97.8% of trials.
02Automatic exclusion of pregnant women denies them potential benefits and raises ethical concerns about justice and autonomy, leading to calls for presumptive inclusion.
03Information on pregnancy status and outcomes is often not routinely collected, creating significant gaps in safety and efficacy data for this population.
STILL TO COME
How it was doneWhat they foundWhat it means for RNs
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What it does not show
Most evidence came from high-income countries, limiting generalizability to low- and middle-income settings where outbreak impacts may be different. The levels of evidence in the reviewed studies were relatively low, with no experimental or quasi-experimental studies identified. Many articles focused on single disease outbreaks in specific geographical regions, which may not apply to all future pandemics. The review excluded HIV/AIDS literature, which is a major area of pregnancy research, potentially missing broader context on inclusion criteria.
Declared interests
The review received no external funding. No other conflicts of interest were reported in the provided text.
The easy way to misread this
Do not interpret the call for presumptive inclusion as a recommendation to ignore safety risks. The review states that inclusion requires clear justification and safety monitoring, and that exclusion is appropriate when data shows risks likely exceed benefits. It highlights the lack of evidence, not the absence of risk.