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

Overview

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.

Full Title of Study: “MinSafeStart – New Decision Aid Tool to Empower Women and Promote Better Treatment of Nausea and Vomiting During Pregnancy”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Other
  • Masking: None (Open Label)
• Study Primary Completion Date: July 1, 2020

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.

Interventions

• Device: MinSafeStart app
  • 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.

Arms, Groups and Cohorts

• Experimental: Intervention group
  • 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.
• No Intervention: Control group
  • Standard care.

Clinical Trial Outcome Measures

Primary Measures

• Nausea and vomiting
  • Time Frame: between baseline (Q1) and 2 weeks from baseline (Q2)
  • 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
• Nausea and vomiting
  • Time Frame: between baseline (Q1) and 4 weeks from baseline (Q3)
  • 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
• Nausea and vomiting
  • Time Frame: between baseline (Q1) and 6 weeks from baseline (Q4)
  • 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

Secondary Measures

• Change in quality of life
  • Time Frame: between baseline (Q1) and 2 weeks from baseline (Q2)
  • 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
• Change in quality of life
  • Time Frame: between baseline (Q1) and 4 weeks from baseline (Q3)
  • 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
• Change in quality of life
  • Time Frame: between baseline (Q1) and 6 weeks from baseline (Q4)
  • 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
• Decisional Conflict
  • Time Frame: between baseline (Q1) and 2 weeks from baseline (Q2)
  • Decisional Conflict measured by Decisional Conflict Scale (DCS) questionnaire. Score ranges from 0 (no decisional conflict) to 100 (extreme high decisional conflict)
• Decisional Conflict
  • Time Frame: between baseline (Q1) and 4 weeks from baseline (Q3)
  • Decisional Conflict measured by Decisional Conflict Scale (DCS) questionnaire. Score ranges from 0 (no decisional conflict) to 100 (extreme high decisional conflict)
• Decisional Conflict
  • Time Frame: between baseline (Q1) and 6 weeks from baseline (Q4)
  • Decisional Conflict measured by Decisional Conflict Scale (DCS) questionnaire. Score ranges from 0 (no decisional conflict) to 100 (extreme high decisional conflict)
• Knowledge
  • Time Frame: Up to 40 weeks. Measured at four time points. Baseline (Q1), 2 (Q2), 4 (Q3), and 6 (Q4) weeks from baseline.
  • 10 statements about nausea and vomiting, measured by numbers of correct answers (agree/unsure/disagree). 80% correct considered as sufficient high knowledge
• Sick leave rates
  • Time Frame: Up to 40 weeks. Measured at four time points. Baseline (Q1), 2 (Q2), 4 (Q3), and 6 (Q4) weeks from baseline.
  • Self-reported sick leave rate in percentage
• Sick leave duration
  • Time Frame: Up to 40 weeks
  • Self-reported sick leave duration in weeks among those with sick leave
• Hospitalization duration
  • Time Frame: Up to 40 weeks. Measured at four time points. Baseline (Q1), 2 (Q2), 4 (Q3), and 6 (Q4) weeks from baseline.
  • Self-reported hospitalization duration in days
• Hospitalization duration
  • Time Frame: up to 40 weeks
  • As reported in the Norwegian Patient Registry in days among those with hospitalization
• Beliefs About Medication
  • Time Frame: Up to 40 weeks. Measured at four time points. Baseline (Q1), 2 (Q2), 4 (Q3), and 6 (Q4) weeks from baseline.
  • 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”
• Risk evaluation
  • Time Frame: Up to 40 weeks. Measured at four time points. Baseline (Q1), 2 (Q2), 4 (Q3), and 6 (Q4) weeks from baseline.
  • 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

Participating in This Clinical Trial

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:

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Gender Eligibility: Female

Pregnant women

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Hedvig Marie Egeland Nordeng
• Provider of Information About this Clinical Study
  • Sponsor-Investigator: Hedvig Marie Egeland Nordeng, Professor – University of Oslo
• Overall Official(s)
  • Henrik Schultz, MSc, Study Chair, Department of Pharmacy, University of Oslo
  • Hedvig Nordeng, Principal Investigator, Department of Pharmacy, University of Oslo