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

Abstract

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.

Improving Racial and Ethnic Equity in Clinical Trials Enrolling Pregnant and Lactating Individuals

“…54 Similarly, lactating women are willing to participate when considerations are made for safety and timing. 55 With this willingness to participate, racial and ethnic marginalized groups can be included in trials through targeted efforts to overcome barriers to enrollment and retention.…”

“…56,63 To address these barriers, it is important to facilitate meaningful discussions regarding the history of unethical research practices, the current regulatory policies, and the importance of informed consent. 55,56 This allows participants to actively participate in their own medical decisions alongside research staff and providers. 56,57 These conversations can be uncomfortable, but transparency and allowing populations to openly discuss their concerns can help build trust.…”

“…Regarding obstetric research, studies show that pregnant women are willing to participate in research, 53 and that a pregnant woman's willingness to participate is not associated with race 54 . Similarly, lactating women are willing to participate when considerations are made for safety and timing 55 . With this willingness to participate, racial and ethnic marginalized groups can be included in trials through targeted efforts to overcome barriers to enrollment and retention.…”

“…Among Black individuals, one study cited that the main concerns include harmful side effects of the study, a belief that research is only benefiting White individuals, and the overall ethics of the research process 56,63 . To address these barriers, it is important to facilitate meaningful discussions regarding the history of unethical research practices, the current regulatory policies, and the importance of informed consent 55,56 . This allows participants to actively participate in their own medical decisions alongside research staff and providers 56,57 .…”

Pregnancy-Associated Venous Thromboembolism: Insights from GARFIELD-VTE

“… 16 17 Although DOAC dose detection in breast milk was low, the safety for breastfeeding infants has not been adequately determined, largely due to lack of trial participation. 18 How widely these principles are applied in the global management of PA-VTE remains uncertain. The purpose of this analysis was to use data from the Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE to compare patient characteristics and trends in diagnosis and therapy among women with PA-VTE versus nonpregnancy associated VTE (NPA-VTE).…”