The IRIS clinic: A Protocol for a mixed-methods study evaluating the management of Hyperemesis Gravidarum

Background: Hyperemesis Gravidarum (HG) is a severe form of nausea and vomiting in pregnancy that affects 0.3-3% of women and has profound nutritional, physical and psychological consequences. Research is lacking regarding the most effective management of the condition. In response to patient feedback, a multidisciplinary HG day-case service (IRIS Clinic) was launched in 2020 at The National Maternity Hospital, Ireland. The clinic provides routine, day-case care in a comfortable space with pre-booked appointments. The MDT involves midwives, dietitians, perinatal mental health, obstetrics and pharmacy, and the nature of the clinic enables peer-topeer support. As this clinic is the first of its kind in Ireland, we aim to assess its effectiveness and feasibility, and suggest recommendations for improvement. Methods: This is a sequential, mixed-methods study that commenced in August 2021. The prospective arm of the study is ongoing and involves enrolling women (n = 50) who are attending the IRIS clinic. Data are collected on first admission (pre-intervention) and approximately 8 weeks' later (post-intervention) relating to symptoms of HG, well-being, food tolerances, quality of life and nutritional intake. Qualitative, semi-structured interviews will be conducted to evaluate women's experiences of attending the clinic. The retrospective arm of the study will be a chart review (n = 200) of women diagnosed with HG to describe assessments, treatments and pregnancy and birth outcomes. Conclusion: The IRIS clinic has the potential to improve pregnancy outcomes and nutritional status among women with HG. If found to be effective and feasible, the model for this clinic could be replicated elsewhere.