Clinical trial NCT04719286: MinSafeStart - Decision Aid Tool for Better Treatment of Nausea and Vomiting During Pregnancy
Official title: MinSafeStart - New Decision Aid Tool to Empower Women and Promote Better Treatment of Nausea and Vomiting During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperemesis Gravidarum
Emesis
Emesis Pregnancy
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 217
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Nausea and vomiting in pregnancy (NVP) is affecting up to 70% of pregnant women. Studies have also shown that NVP may have a profound impact on pregnant women's wellbeing and that even mild NVP symptoms have been shown to significantly reduce pregnant women's quality of life. However, NVP symptoms often occur during the first period of pregnancy where antenatal care not yet have been established.

The objective of this project is to evaluate whether the "MinSafeStart" mobile application (app) can empower pregnant women to better self-manage NVP and hence improve their quality of life.

Detailed description: Nausea and vomiting in pregnancy (NVP) is one of the most common pregnancy-related ailments, affecting up to 70% of pregnant women. The causes of NVP are unclear but it has been described as multifactorial and complex. Studies investigating NVP and the use of antiemetics states that early recognition and treatment of the condition is important in order to prevent further deterioration. In contrary to this recommendation, many healthcare providers and pregnant women themselves are reluctant to use antiemetics due to the fear of teratogenicity. Studies have also shown that NVP may have a profound impact on pregnant women's wellbeing and that even mild NVP symptoms have been shown to significantly reduce pregnant women's quality of life. As NVP symptoms often occur during the first period of pregnancy where antenatal care not yet have been established, it is important to empower women to optimally self-manage their care to ensure maternal and fetal health.

The objective of this project is to evaluate whether the "MinSafeStart" mobile application (app) can empower pregnant women to better self-manage NVP and hence improve their quality of life.

The "MinSafeStart" app is a patient-centered app for women with NVP. The app was developed by us, in corporation with a team consisting of interaction designers, programmers, and researchers from the University Center for Information Technology (USIT) at the University of Oslo. The app utilizes the Pregnancy-Unique-Quantification-of-Emesis-24 (PUQE-24) scale to categorize the women's NVP severity (e.g. mild, moderate, or severe) on a daily basis, and visualizes the fluctuations over time in a graph. Each woman will have their own personal graph based on the information they put in. They will also be able to see how their symptoms are compared to an average graph. The women will get treatment advice based on their PUQE-24 scale, e.g. dietary and lifestyle advice for mild symptoms and referral to see the doctor for moderate and severe symptoms.

All pregnant women over 18 years experiencing NVP, and owners of a smartphone (iOS or Android) are eligible for inclusion. Participants will be randomized to either the intervention group (opportunity to use the app) or the control group (standard care).

Data will be collected by four questionnaires (from both groups) and through the MinSafeStart app (intervention group only). All questionnaires will be distributed to the participants by email. The first questionnaire (Q1) at enrollment (baseline) and questionnaire Q2, Q3, and Q4 at follow up, 2, 4, and 6 weeks after randomization respectively.

Data about the participants will, in addition, be collected from four national registries; The Norwegian Patient Registry, The Norwegian Prescription Database, The Medical Birth Registry of Norway, and the Municipality Patient and User Registry. These data will be linked to the self-reported data (by the unique identification number of every citizen in Norway) collected during the intervention study.

Eligibility criteria: Inclusion Criteria:

* Pregnant women currently experiencing all degrees of NVP
* Owners of a smartphone (iOS or Android) with phone lock
* Speak and understand Norwegian

Exclusion Criteria:

-

Primary outcomes:
measure: Nausea and vomiting
timeFrame: between baseline (Q1) and 2 weeks from baseline (Q2)
measure: Nausea and vomiting
timeFrame: between baseline (Q1) and 4 weeks from baseline (Q3)
measure: Nausea and vomiting
timeFrame: between baseline (Q1) and 6 weeks from baseline (Q4)
Secondary outcomes:
measure: Change in quality of life
timeFrame: between baseline (Q1) and 2 weeks from baseline (Q2)
measure: Change in quality of life
timeFrame: between baseline (Q1) and 4 weeks from baseline (Q3)
measure: Change in quality of life
timeFrame: between baseline (Q1) and 6 weeks from baseline (Q4)
measure: Decisional Conflict
timeFrame: between baseline (Q1) and 2 weeks from baseline (Q2)
measure: Decisional Conflict
timeFrame: between baseline (Q1) and 4 weeks from baseline (Q3)
measure: Decisional Conflict
timeFrame: between baseline (Q1) and 6 weeks from baseline (Q4)
measure: Knowledge
timeFrame: Up to 40 weeks. Measured at four time points. Baseline (Q1), 2 (Q2), 4 (Q3), and 6 (Q4) weeks from baseline.
measure: Sick leave rates
timeFrame: Up to 40 weeks. Measured at four time points. Baseline (Q1), 2 (Q2), 4 (Q3), and 6 (Q4) weeks from baseline.
measure: Sick leave duration
timeFrame: Up to 40 weeks
measure: Hospitalization duration
timeFrame: Up to 40 weeks. Measured at four time points. Baseline (Q1), 2 (Q2), 4 (Q3), and 6 (Q4) weeks from baseline.
measure: Hospitalization duration
timeFrame: up to 40 weeks
measure: Beliefs About Medication
timeFrame: Up to 40 weeks. Measured at four time points. Baseline (Q1), 2 (Q2), 4 (Q3), and 6 (Q4) weeks from baseline.
measure: Risk evaluation
timeFrame: Up to 40 weeks. Measured at four time points. Baseline (Q1), 2 (Q2), 4 (Q3), and 6 (Q4) weeks from baseline.
Other outcomes:
Locations:
city: OSlo
country: Norway
facility: Department of Pharmacy, University of Oslo
Study officials:
affiliation: Department of Pharmacy, University of Oslo
name: Henrik Schultz, MSc
role: STUDY_CHAIR
affiliation: Department of Pharmacy, University of Oslo
name: Hedvig Nordeng
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ngo E, Truong MB, Wright D, Nordeng H. 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. JMIR Mhealth Uhealth. 2022 Jul 5;10(7):e36226. doi: 10.2196/36226.