Impact of a Mobile Application for Tracking Nausea and Vomiting During Pregnancy (NVP) on NVP Symptoms, Quality of Life, and Decisional Conflict Regarding NVP Treatments: MinSafeStart Randomized Controlled Trial

BACKGROUND: Pregnant women are active users of mobile apps for health purposes. These apps may improve self-management of health-related conditions. Up to 70% of pregnant women experience nausea and vomiting (NVP). Even mild NVP can significantly reduce quality of life (QoL), and it can become an economic burden for both the woman and society. NVP often occurs before the first maternal care visit; therefore, apps can potentially play an important role in empowering pregnant women to recognize, manage, and seek appropriate treatment for NVP, when required. OBJECTIVE: This study investigated whether the MinSafeStart (MSS) mobile app could impact NVP-related symptoms, QoL, and decisional conflict regarding NVP treatment. METHODS: This randomized controlled trial enrolled 268 pregnant women with NVP in Norway from 2019 to 2020. The intervention group had access to the MSS app, which could be used to track NVP symptoms and access tailored advice. NVP severity was rated with the Pregnancy Unique Quantification of Emesis (PUQE) score. The control group followed standard maternal care. We collected data on maternal baseline characteristics, NVP severity, QoL, and decisional conflict using 2 sets of online questionnaires. One set of questionnaires was completed at enrollment, and the other was completed after 2 weeks. We performed linear regression analyses to explore whether the use of the MSS app was associated with NVP severity, QoL, or decisional conflict. RESULTS: Among the 268 women enrolled in the study, 192 (86.5%) completed the baseline questionnaires and were randomized to either the intervention (n=89) or control group (n=103). In the intervention group, 88 women downloaded the app, and 468 logs were recorded. In both groups, women were enrolled at a median of 8 gestational weeks. At baseline, the average PUQE scores were 4.9 and 4.7; the average QoL scores were 146 and 149; and the average DCS scores were 40 and 43 in the intervention and control groups, respectively. The app had no impact on NVP severity (aβ 0.6, 95% Cl −0.1 to 1.2), QoL (aβ −5.3, 95% Cl −12.5 to 1.9), or decisional conflict regarding NVP treatment (aβ −1.1, 95% Cl −6.2 to 4.2), compared with standard care. CONCLUSIONS: Tracking NVP symptoms with the MSS app was not associated with improvements in NVP symptoms, QoL, or decisional conflict after 2 weeks, compared with standard care. Future studies should include a process evaluation to improve our understanding of how pregnant women use the app and how to optimize its utility within maternity care. Specifically, studies should focus on how digital tools might facilitate counseling and communication between pregnant women and health care providers regarding NVP management during pregnancy. TRIAL REGISTRATION: ClinicalTrails.gov (NCT04719286): https://www.clinicaltrials.gov/ct2/show/NCT04719286