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

NCT04719286 | Completed

• 1 other identifier: MinSafeStart
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperemesis Gravidarum; Emesis; Emesis Pregnancy

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (13)

• Change in quality of life

  between baseline (Q1) and 2 weeks from baseline (Q2)

• Change in quality of life

  between baseline (Q1) and 4 weeks from baseline (Q3)

• Change in quality of life

  between baseline (Q1) and 6 weeks from baseline (Q4)

• Decisional Conflict

  between baseline (Q1) and 2 weeks from baseline (Q2)

• Decisional Conflict

  between baseline (Q1) and 4 weeks from baseline (Q3)

Study Arms (2)

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.

Device: MinSafeStart app

Control group

NO INTERVENTION

Standard care.

Interventions

MinSafeStart app 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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women currently experiencing all degrees of NVP
• Owners of a smartphone (iOS or Android) with phone lock
• Speak and understand Norwegian

Sponsors & Collaborators

• Hedvig Marie Egeland Nordeng: lead

Study Sites (1)

Department of Pharmacy, University of Oslo

Oslo, 0371, Norway

Location

Related Publications (1)

• 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.

  PMID: 35787487 DERIVED

MeSH Terms

Conditions

Hyperemesis Gravidarum; Vomiting

Condition Hierarchy (Ancestors)

Morning Sickness; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Henrik Schultz, MSc

  Department of Pharmacy, University of Oslo

  STUDY CHAIR

• Hedvig Nordeng

  Department of Pharmacy, University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 22, 2021
• Study Start: September 2, 2019
• Primary Completion: July 1, 2020
• Study Completion: May 16, 2022
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)