MinSafeStart - Decision Aid Tool for Better Treatment of Nausea and Vomiting During Pregnancy

Study Overview
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Brief Summary
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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
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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.

Official Title
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MinSafeStart - New Decision Aid Tool to Empower Women and Promote Better Treatment of Nausea and Vomiting During Pregnancy

Conditions
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Hyperemesis Gravidarum, Emesis, Emesis Pregnancy

Intervention / Treatment
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* Device: MinSafeStart app


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The intervention is the use of the MinSafeStart mobile application. 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. | Device: MinSafeStart app<br>* The intervention is the opportunity of using the MinSafeStart app. Women can register their NVP severity in the app by answering a few questions daily. Based on this, they will get tailored advice on NVP, and get alert when they should see a doctor.<br>|
| No Intervention: Control group<br>Standard care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea and vomiting | Nausea and vomiting measured by Pregnancy-Unique-Quantification-of-Emesis-24 (PUQE-24) scale. Units of measure: 0-15 where higher score indicates more severe NVP. Categorization: 0-15, mild: ≤6 points, moderate: 7-12 points, severe: ≥13-15 points | between baseline (Q1) and 2 weeks from baseline (Q2) | 
| Nausea and vomiting | Nausea and vomiting measured by Pregnancy-Unique-Quantification-of-Emesis-24 (PUQE-24) scale. Units of measure: 0-15 where higher score indicates more severe NVP. Categorization: 0-15, mild: ≤6 points, moderate: 7-12 points, severe: ≥13-15 points | between baseline (Q1) and 4 weeks from baseline (Q3) | 
| Nausea and vomiting | Nausea and vomiting measured by Pregnancy-Unique-Quantification-of-Emesis-24 (PUQE-24) scale. Units of measure: 0-15 where higher score indicates more severe NVP. Categorization: 0-15, mild: ≤6 points, moderate: 7-12 points, severe: ≥13-15 points | between baseline (Q1) and 6 weeks from baseline (Q4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | Quality of life measured by the Health-Related of Quality of Life for Nausea and Vomiting during Pregnancy (NVPQOL). Score ranges from 30 to 210 points where lower scores indicate better quality of life | between baseline (Q1) and 2 weeks from baseline (Q2) | 
| Change in quality of life | Quality of life measured by the Health-Related of Quality of Life for Nausea and Vomiting during Pregnancy (NVPQOL). Score ranges from 30 to 210 points where lower scores indicate better quality of life | between baseline (Q1) and 4 weeks from baseline (Q3) | 
| Change in quality of life | Quality of life measured by the Health-Related of Quality of Life for Nausea and Vomiting during Pregnancy (NVPQOL). Score ranges from 30 to 210 points where lower scores indicate better quality of life | between baseline (Q1) and 6 weeks from baseline (Q4) | 
| Decisional Conflict | Decisional Conflict measured by Decisional Conflict Scale (DCS) questionnaire. Score ranges from 0 (no decisional conflict) to 100 (extreme high decisional conflict) | between baseline (Q1) and 2 weeks from baseline (Q2) | 
| Decisional Conflict | Decisional Conflict measured by Decisional Conflict Scale (DCS) questionnaire. Score ranges from 0 (no decisional conflict) to 100 (extreme high decisional conflict) | between baseline (Q1) and 4 weeks from baseline (Q3) | 
| Decisional Conflict | Decisional Conflict measured by Decisional Conflict Scale (DCS) questionnaire. Score ranges from 0 (no decisional conflict) to 100 (extreme high decisional conflict) | between baseline (Q1) and 6 weeks from baseline (Q4) | 
| Knowledge | 10 statements about nausea and vomiting, measured by numbers of correct answers (agree/unsure/disagree). 80% correct considered as sufficient high knowledge | Up to 40 weeks. Measured at four time points. Baseline (Q1), 2 (Q2), 4 (Q3), and 6 (Q4) weeks from baseline. | 
| Sick leave rates | Self-reported sick leave rate in percentage | Up to 40 weeks. Measured at four time points. Baseline (Q1), 2 (Q2), 4 (Q3), and 6 (Q4) weeks from baseline. | 
| Sick leave duration | Self-reported sick leave duration in weeks among those with sick leave | Up to 40 weeks | 
| Hospitalization duration | Self-reported hospitalization duration in days | Up to 40 weeks. Measured at four time points. Baseline (Q1), 2 (Q2), 4 (Q3), and 6 (Q4) weeks from baseline. | 
| Hospitalization duration | As reported in the Norwegian Patient Registry in days among those with hospitalization | up to 40 weeks | 
| Beliefs About Medication | Beliefs About Medication were measured by Pregnant women's Beliefs About Medications - twelve Pregnancy-Specific Statements. Rated in strongly agree, agree, uncertain, disagree, and strongly disagree | Up to 40 weeks. Measured at four time points. Baseline (Q1), 2 (Q2), 4 (Q3), and 6 (Q4) weeks from baseline. | 
| Risk evaluation | Risk evaluation were measured by the risk evaluation scale containing 17 substances (egg, cheese, ginger, cranberry, folic acid/folate, smoking cigarettes, alcohol, X-ray, drugs for acid reflux, paracetamol, ibuprofen, antibiotics, meclizine, metoclopramide, ondansetron, thalidomide, swine flu vaccine). Women categorize the substances on a scale from 0 (not harmful) and 10 (very harmful) about how harmful they think these funds are during pregnancy | Up to 40 weeks. Measured at four time points. Baseline (Q1), 2 (Q2), 4 (Q3), and 6 (Q4) weeks from baseline. |