Effects of a pre-conception care program for women diagnosed with inflammatory bowel disease: A mixed-methods study including a randomized controlled trial

Abstract Background: The purpose of this study was to conduct a pre-conception care education program for women of childbearing age with inflammatory bowel disease (IBD) in Korea and verify its effects on pregnancy knowledge and anxiety, as well as on self-efficacy related to IBD management. Methods: This was a convergent mixed-methods study, which integrated a randomized controlled trial and interviews. In the quantitative phase, 35 women (17 in the intervention group and 18 in the control group) participated. Those in the intervention group attended a pre-conception care program that included small-group sessions and individual tele-coaching across foursessions. The quantitative research analysis used the generalized estimation equation method to compare changes between the two groups. In the qualitative phase, focus group interviews and tele-coaching were conducted for participants in the intervention group. The qualitative data were analyzed using deductive content analysis. Results: After the program ended, significant differences were observed between the intervention and control groups for pregnancy knowledge, pregnancy anxiety, and self-efficacy related to IBD management. As a result of qualitative data analysis, the themes derived were “improving IBD awareness related to pregnancy and childbirth,” “relieving anxiety about pregnancy and actively accepting pregnancy,” and “improving confidence in IBD management and awareness related to planned pregnancy.” Conclusions: It is meaningful that this was the first study to develop a pre-conception care program for women diagnosed with IBD and confirm its effectiveness. The program improved pregnancy-related knowledge, enhanced self-efficacy related to disease management, andreduced anxiety in women with IBD. This program is expected to be suitable for patient counseling and education in clinical practice. Trial registration: This study was registered on the Korea Clinical Trial Registration (KCT0008022). Retrospectivelyregistered 20/12/2022.