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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04719286
Other study ID # MinSafeStart
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2, 2019
Est. completion date May 16, 2022

Study information

Verified date November 2023
Source University of Oslo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 217
Est. completion date May 16, 2022
Est. primary completion date July 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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: -

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Norway Department of Pharmacy, University of Oslo OSlo

Sponsors (1)

Lead Sponsor Collaborator
Hedvig Marie Egeland Nordeng

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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.
Secondary 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.
Secondary Sick leave duration Self-reported sick leave duration in weeks among those with sick leave Up to 40 weeks
Secondary 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.
Secondary Hospitalization duration As reported in the Norwegian Patient Registry in days among those with hospitalization up to 40 weeks
Secondary 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.
Secondary 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.
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