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

NCT ID: NCT04719286

Last Updated: 2023-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-02
• Study Completion Date: 2022-05-16

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MinSafeStart app

Intervention Type: DEVICE

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.

Control group

Standard care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hedvig Marie Egeland Nordeng

OTHER

Sponsor Role: lead

Responsible Party

Hedvig Marie Egeland Nordeng

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Henrik Schultz, MSc

Role: STUDY_CHAIR

Department of Pharmacy, University of Oslo

Hedvig Nordeng

Role: PRINCIPAL_INVESTIGATOR

Department of Pharmacy, University of Oslo

Locations

Department of Pharmacy, University of Oslo

Oslo, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 35787487 (View on PubMed)

Other Identifiers

MinSafeStart

Identifier Type: -

Identifier Source: org_study_id