Researchers create a new gold standard for human lactation studies

Women who choose to stop treatment during pregnancy and lactation endanger their health and should weigh their desire to have children and breastfeed against at risk that we know very little. In two ongoing clinical trials, researchers create a new model for human lactation studies that include sampling breast milk and plasma by both mothers and lactating infants.

Lack of scientific evidence is a moral problem for women and doctors, as about 70 % of women should use medicines at some point during their pregnancy. In many cases, women are recommended to avoid breastfeeding or stop using their medicines. However, breastfeeding has benefits for both the mother and the child. ”

Mats G. Hansson, Higher Professor of Biomedical Ethics, University of Uppsala Center for Research Ethics & Bioethics, Head of Two Continuing Clinical Tests

95 % of all drugs have not been well studied well enough to include safety about pregnancy and lactation. The current standard for lactation studies uses animal data and drug concentrations in breast milk, using PB/PK to assess how much a particular substance transfers to the baby. The studies are old and based on data from very few people, with old methods of analysis.

Bmj open He just published a protocol for a new golden model for clinical lactation studies, examining the concentration of prednisolone in mother’s milk and creature from both the mother and the infant. Prednisolone is prescribed for various conditions, including rheumatoid arthritis, a chronic and debilitating condition that requires long -term treatment.

The samples are analyzed and analyzed in relation to the pharmacokinetic properties of the drugs and the transfer from breast milk to infants in the plasma. The present studies focus on prednisolone, used in the treatment of rheumatoid arthritis and metformin, used in the treatment of type 2 diabetes. By gaining and acquiring informed consent for future but indefinable research, the protocol opens.

Women are hired through a network of clinical centers in Sweden and the samples are stored for future research on a network of breast milk manufactured by the BBMRIIR. According to Mats G. Hansson, this ensures that the study is part of a larger European infrastructure, enabling future research.

The protocol that has just been published was developed in the context of the large European arrest of a framework of cooperation and describes the way sample analyzes and analyzes.