BACKGROUND
Pregnant women are active users of mobile applications (app) 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 the 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 mobile application (MSS app) could impact NVP-related symptoms, QoL, and decisional conflicts regarding NVP treatment.
METHODS
This randomized controlled trial enrolled 222 pregnant women with NVP in Norway from 2019-2020. 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 conflicts with two sets of online questionnaires. One set of questionnaires was completed at enrollment, and the other was completed after two weeks. We performed linear regression analyses to explore whether the use of the MSS app was associated with NVP severity, QoL, or decisional conflicts.
RESULTS
Among the 222 women enrolled in the study, 192 (86.5%) completed the baseline questionnaires and were randomized to either the intervention (n=89) or the 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 decisional conflict 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, 1.2), QoL (aβ: -5.3; 95% Cl: -12.5, 1.9), or decisional conflicts regarding NVP treatment (aβ: -1.1, 95% Cl -6.2, 4.2), compared to standard care.
CONCLUSIONS
Tracking NVP symptoms with the MSS app was not associated with improvements in NVP symptoms, QoL, or decisional conflicts after two weeks, compared to 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.
CLINICALTRIAL
This trial was registered at ClinicalTrails.gov (identifier: NCT04719286, registration date: January 22, 2021).
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