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

Hyperemesis Gravidarum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04719286
• Other study ID #: MinSafeStart
• Status: Completed
• Phase: N/A
• 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
• 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:

-

Related Conditions & MeSH terms

• Emesis
• Emesis Pregnancy
• Hyperemesis Gravidarum
• Vomiting

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.