Abstract

Abstract Background Managing inflammatory bowel disease (IBD) during pregnancy is challenging as pregnancy-related symptoms may overlap with symptoms of active IBD. Fecal calprotectin (FCP) is an optimal non-invasive measure of assessing disease activity during pregnancy. However, regular FCP during pregnancy may be impractical due to collection techniques. Rather, a home point-of care rapid lateral assay FCP test such as IBDoc® and a self-reported clinical disease activity program (IBD Dashboard) may be beneficial in routine monitoring of IBD activity during pregnancy. Aims To assess whether tight control of objective IBD disease activity using a point-of-care FCP (IBDoc®) monitoring is concordant with self-reported clinical symptoms (IBD Dashboard) in pregnant women with IBD. Methods Pregnant patients, aged ≥18 years, with IBD (Crohn’s Disease (CD) or Ulcerative colitis (UC)), in the 1st trimester (<13 weeks) with a singleton pregnancy were identified and enrolled. Patients were required to have access to a smartphone and internet to use the IBDoc® and IBD Dashboard. Patients completed a IBDoc® FCP and IBD Dashboard assessment at three study time points, 1) screening/baseline in 1st trimester, 2) 2nd trimester (14 to 18 weeks), and 3) 3rd trimester (28 to 32 weeks). Clinical disease activity was assessed by the modified HBI (Harvey Bradshaw Index) for CD and partial Mayo Index (pMayo) for UC. Elevated FCP (≥250 µg/g), mHBI ≥5 or pMayo ≥2 triggered an intervention to investigate or optimize therapy if required. A 5-point Likert scale questionnaire assessed patient satisfaction and feasibility of the IBDoc® and IBD Dashboard. Median values with interquartile ranges (IQR) were calculated for all continuous variables using SPSS. Results 29 patients (17 CD, 12 UC) were included. Median mHBI and pMayo were 2.0 (IQR 2.0) and 0.5 (IQR 1.25) respectively. A total of 17.6% (3/17) of CD patients, and 25.0% (3/12) of UC patients had active clinical disease. Median IBDoc® FCP was 73 µg/g (IQR 343) in the CD group and 267 µg/g (IQR 677) in the UC group. At baseline, disease activity was categorized into four groups: 1) clinical remission (CR) and normal FCP (n=16, no treatment Δ, 100% stayed in CR); 2) clinical disease and elevated FCP (n=5, treatment Δ in all five patients, 80% stayed in CR, 20% had a clinical flare); 3) clinical remission and elevated FCP (n=5, treatment Δ in three patients, 100% stayed in CR); 4) clinical disease and normal FCP (n=1, no treatment Δ, 100% stayed in CR). Median IBDoc® and IBD Dashboard feasibility scores were 5.0 (IQR 1.0). Conclusions A combination of both clinical scores and objective disease markers may better predict disease relapse compared to either clinical scores or objective markers in isolation. A home point-of-care FCP test is feasible among pregnant patients with IBD. Funding Agencies None

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