Hyperemesis GravidarumNCT04719286
MinSafeStart - Decision Aid Tool for Better Treatment of Nausea and Vomiting During Pregnancy
A study testing MinSafeStart app in people with Hyperemesis Gravidarum and Emesis, run by Hedvig Marie Egeland Nordeng at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hyperemesis Gravidarum, Emesis, Emesis Pregnancy
- What is being tested?
- MinSafeStart app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteNorway
- Study dates
- 2 Sep 2019to 16 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women currently experiencing all degrees of NVP
- Owners of a smartphone (iOS or Android) with phone lock
- Speak and understand Norwegian
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MinSafeStart - New Decision Aid Tool to Empower Women and Promote Better Treatment of Nausea and Vomiting During Pregnancy
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.
Read the 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.
- Conditions
- Hyperemesis Gravidarum, Emesis, Emesis Pregnancy
- Being tested
- MinSafeStart app
- Medical subject headings
- Hyperemesis Gravidarum, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinSafeStart appDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Device: MinSafeStart app |
| Control group | No intervention | Standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: between baseline (Q1) and 6 weeks from baseline (Q4)
Secondary outcomes (13)
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 40 weeks
Hospitalization duration
Self-reported hospitalization duration in days
Measured: 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
Measured: 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"
Measured: 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
Measured: Up to 40 weeks. Measured at four time points. Baseline (Q1), 2 (Q2), 4 (Q3), and 6 (Q4) weeks from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start2 Sep 2019
- Primary completion1 Jul 2020
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyperemesis GravidarumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hedvig Marie Egeland Nordeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hedvig Marie Egeland Nordeng, University of Oslo
- Investigators
- Henrik Schultz, MSc, Study chair, Department of Pharmacy, University of OsloHedvig Nordeng, Principal investigator, Department of Pharmacy, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719286
- Sponsor's protocol ID
- MinSafeStart
- Status last verified
- Nov 2023
- First submitted
- 11 Jan 2021
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available because of data protection regulation.
Publications
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.
PubMed 35787487
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MinSafeStart - New Decision Aid Tool to Empower Women and Promote Better Treatment of Nausea and Vomiting During Pregnancy
- ClinicalTrials.gov ID
- NCT04719286
- Acronym / sponsor ID
- MinSafeStart
- Conditions
- Hyperemesis Gravidarum, Emesis, Emesis Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Hedvig Marie Egeland NordengUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: MinSafeStart appThe 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. |
| Control group | No intervention | –Standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women currently experiencing all degrees of NVP
- Owners of a smartphone (iOS or Android) with phone lock
- Speak and understand Norwegian
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinSafeStart appThe 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. | Device | Intervention group |
Primary outcome
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
13 secondary outcomes
Change in quality of life
Time frame: between baseline (Q1) and 2 weeks from baseline (Q2)
Change in quality of life
Time frame: between baseline (Q1) and 4 weeks from baseline (Q3)
Change in quality of life
Time frame: between baseline (Q1) and 6 weeks from baseline (Q4)
Decisional Conflict
Time frame: between baseline (Q1) and 2 weeks from baseline (Q2)
Decisional Conflict
Time frame: between baseline (Q1) and 4 weeks from baseline (Q3)
Decisional Conflict
Time frame: between baseline (Q1) and 6 weeks from baseline (Q4)
Knowledge
Time frame: Up to 40 weeks. Measured at four time points. Baseline (Q1), 2 (Q2), 4 (Q3), and 6 (Q4) weeks from baseline.
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.
Sick leave duration
Time frame: Up to 40 weeks
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.
Hospitalization duration
Time frame: up to 40 weeks
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 35787487Ngo 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available because of data protection regulation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Schultz, MSc study chair
Department of Pharmacy, University of Oslo
Hedvig Nordeng principal investigator
Department of Pharmacy, University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MinSafeStart app in people with Hyperemesis Gravidarum and Emesis, run by Hedvig Marie Egeland Nordeng at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nausea and vomiting (time frame: between baseline (Q1) and 2 weeks from baseline (Q2)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04719286, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.