In a groundbreaking advancement poised to transform our understanding of medication safety during breastfeeding, researchers at Uppsala University, Sweden, are pioneering innovative clinical trials to establish rigorous scientific standards for studying drug transfer through human breast milk. This effort addresses critical gaps in knowledge that have long challenged healthcare providers and new mothers alike, who must balance the necessity of pharmacological treatments during pregnancy and lactation with the wellbeing of their infants.
Despite the widespread use of medications among pregnant and breastfeeding women—approximately 70 percent are prescribed various drugs during these periods—there remains a glaring lack of robust data informing their safety. The urgency of this issue is compounded by the fact that 95 percent of medicines on the market lack adequate safety information concerning their use while breastfeeding. This insufficiency leaves both clinicians and mothers navigating a murky landscape fraught with ethical dilemmas and health risks. Women are often advised either to discontinue essential drugs or to abstain from breastfeeding, both decisions imposing potential harm.
Traditional approaches to studying medication excretion in breast milk have relied heavily on animal data and limited human studies measuring the concentration of drugs in breast milk alone. Pharmacokinetic and pharmacodynamic (PB/PK) modeling have been applied to infer infant exposure, yet these models are often based on outdated techniques and small sample sizes, leading to significant uncertainty. The pressing need for methodological refinement and comprehensive data has propelled a new era of research centered on direct measurement and analysis of drug levels in both maternal milk and infant plasma.
The latest protocol published in BMJ Open outlines a meticulously designed multicenter, low-intervention clinical trial focusing on quantifying prednisolone concentrations in human breast milk and in the plasma of breastfed infants. Prednisolone, a corticosteroid widely prescribed for chronic inflammatory conditions such as Rheumatoid Arthritis, serves as a pertinent model drug in this context due to its prevalent use among women of childbearing age and the need for long-term therapeutic regimens during lactation.
What sets this research apart is its dual-sampling approach: simultaneously collecting biological specimens from mothers and their breastfed infants. This method enables precise mapping of the pharmacokinetic profile of prednisolone, shedding light on the extent of drug transfer through lactation and its bioavailability in infants. Such data are invaluable for accurately assessing potential risks and for refining clinical recommendations, thus directly impacting patient care and informing regulatory guidelines.
Additionally, the trial incorporates robust biobanking practices, storing collected samples for future research initiatives. This prospective framework not only safeguards against data attrition but also anticipates advances in analytical methodologies and emerging research questions. By securing informed consent for unspecified future studies, this protocol exemplifies ethical foresight, promoting longitudinal investigations into the long-term effects of medicinal excretion into breast milk.
The research protocol has been developed under the auspices of ConcePTION, a comprehensive European collaborative infrastructure dedicated to generating trustworthy information on medication safety during pregnancy and breastfeeding. Integration into this consortium facilitates standardized protocols, promotes data sharing, and fosters multinational cooperation, thereby amplifying the impact and reach of the findings.
Recruitment for the study is undertaken via a network of clinical centers across Sweden, ensuring a diverse and representative participant cohort. Moreover, samples are preserved within a coordinated breast milk biobank system managed by the BBMRI-ERIC, the European Research Infrastructure Consortium. This strategic alignment with established biobanking frameworks ensures optimal specimen quality, accessibility for secondary analyses, and adherence to rigorous ethical and legal standards.
From an ethical vantage point, the research addresses the pivotal dilemma faced by women who must decide between discontinuing vital treatment or forgoing breastfeeding benefits due to the uncertainty of drug safety data. Breastfeeding is unequivocally associated with numerous health advantages for both mother and child; therefore, elucidating the actual exposure and risk posed by essential medications is critical to empowering informed choices.
The inclusion of metformin—a cornerstone medication for type 2 Diabetes—in the scope of these studies further broadens the clinical relevance of this research. As metabolic disorders become increasingly prevalent globally, understanding the lactational pharmacokinetics of drugs like metformin holds promise for enhancing care protocols for an expanding patient population.
Advanced analytical techniques applied to the biobanked samples promise unprecedented accuracy in quantifying drug levels, encompassing aspects such as metabolism, clearance rates, and dose-response relationships. Such precision will refine models predicting infant exposure and facilitate tailoring maternal treatment plans to maximize therapeutic benefit while minimizing risk.
The trial’s randomized controlled design underlines its methodological rigor, offering robust evidence that can shift clinical practice paradigms concerning medication use in breastfeeding women. The prospective collection and analysis of matched mother-infant samples symbolize a paradigm shift from indirect estimations to direct, evidence-based assessments.
This pioneering initiative not only fills a critical knowledge void but also sets a new benchmark for future lactation research. By combining ethical sensitivity, technical innovation, and collaborative infrastructure, the study charts a course toward safer maternal pharmacotherapy and improved infant health outcomes, embodying the intersection of biomedical ethics and cutting-edge clinical science.
Subject of Research: People
Article Title: Determination of prednisolone concentration in human breast milk and plasma of breastfed infants: study protocol of a Swedish multicentre low-intervention clinical trial
News Publication Date: 22-May-2025
Web References: http://dx.doi.org/10.1136/bmjopen-2024-097898
Image Credits: Mikael Wallerstedt
Keywords: breastfeeding, prednisolone, pharmacokinetics, breast milk, infant plasma, lactation studies, medication safety, biomedical ethics, clinical trial, biobanking, ConcePTION, Uppsala University
