Factors influencing the recruitment of lactating women in a clinical trial involving direct oral anticoagulants: a qualitative study

Background Robust human data on medication use during lactation is scarce. With increasing medication use in postpartum women, it is important to conduct clinical lactation studies measuring the excretion of drugs in human milk and generate evidence. We plan to conduct a clinical lactation study, involving the direct oral anticoagulants (DOACs). Objective This study aimed to identify factors influencing lactating women's clinical trial participation and to improve the design of a proposed DOACs clinical lactation study. Setting Lactating women in London, UK. Methods Three focus groups were conducted in lactating women with differing experiences of being prescribed anticoagulants during puerperium. Main outcome measures Thematic framework approach was used to analyse and identify key themes, using NVivo version 11. Results Eight breastfeeding mothers participated. Women's decision-making on clinical trial participation was largely influenced by the lactation stage and previous breastfeeding experience. The concern of harm to their infant caused by the test medication or interruption of lactation were the predominant barriers to potential participation. Around 6 months following the birth of their infant and second-time mothers appeared to be more amenable to clinical trial participation. The provision of home visits for the execution of the study was highly recommended. Conclusion Our findings suggest that lactating women would participate in a clinical trial during the breastfeeding period, if the timing is right and if the woman is an experienced mother. Home visits will be provided in our proposed DOACs clinical lactation study.