Addressing Pregnant Women's First Trimester Worries and Information Needs With mHealth Solutions
- Conditions
- Pregnancy Trimester, FirstAnxietyWorriesHealth Knowledge, Attitudes, PracticemHealth ApplicationMobile ApplicationAntenatal CarePatient Education as Topic
- Registration Number
- NCT07114471
- Lead Sponsor
- Bournemouth University
- Brief Summary
The first 12 weeks of pregnancy, known as the first trimester, can be one of the most worrying times for women. (Where this lay summary refers to women, it should be taken to include people who do not identify as women but who have the capacity to become pregnant). Many experience nausea, bleeding, or anxiety about whether the pregnancy is progressing normally. Despite this, most women do not see a midwife or doctor until around 10 weeks into the pregnancy. This leaves a gap where they may have important questions but little professional support. As a result, many turn to mobile phone applications or the internet to find answers - but the quality of information online is mixed, and it can be confusing or even unsafe.
This research aims to understand what support women really need in early pregnancy, what concerns they have, and whether a mobile health application (mHealth app) could help fill this gap in current pregnancy care in a safe and personalised way. The study will also ask healthcare professionals and digital health experts what such an application should include, and how it can be made accessible, and easy to understand for all women - including those with different levels of health knowledge and digital skills.
To carry out the research, we will use a combination of online surveys and interviews. Women who are currently pregnant or have had a baby in the last two years will be invited to take part, along with healthcare professionals such as midwives and doctors, and experts in digital health. The survey will ask about their experiences in early pregnancy, how they have used digital tools or apps, and whether they felt their questions were answered before their first NHS appointment. The interview stage will allow participants to talk in more depth about what support they wanted and what would have helped them most. All participants will receive information about support services because we realise that discussing unmet information needs or worries in early pregnancy may be upsetting for some women.
The views collected will inform the design of a new mobile application to support women during early pregnancy. The application will use artificial intelligence (AI) to personalise information based on each woman's needs and background, and to explain things clearly and simply. The content and design of the application will be reviewed by doctors and digital health specialists to make sure it is safe, accurate, and easy to use.
Public and patient involvement is central to this project. A diverse group of women and representatives from grassroots organisations will be invited to shape the questions we ask, review the design of the application, and help us make it inclusive for people from different backgrounds.
This research will help us create a practical, trustworthy, and inclusive tool to support women during one of the most vulnerable times in pregnancy when women don't usually see a doctor. If successful, it could be used widely across the NHS to help reduce anxiety, improve understanding, and ensure women get the right support earlier in their pregnancy with the long-term aim of improving outcomes for women, babies, and families across the UK.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1450
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Levels of Self-Reported Anxiety in the First Trimester (Quantitative Survey Data) At a single time point, upon completion of the participant's survey Measured using a single-item 5-point Likert scale (1 = not anxious at all, 5 = extremely anxious). Outcomes will be reported as the proportion of participants selecting each response category (1 through 5).
Themes of Anxiety During the First Trimester (Qualitative Survey Data) At a single time point, upon completion of the participant's survey Free-text responses in the survey describing anxieties/worries will be coded and analysed thematically using NVivo. Outcomes will be reported as a list of key themes.
Themes of Anxiety During the First Trimester (Interview Data) At a single time point, during the participant's interview following survey completion Semi-structured interview transcripts will be thematically analysed in NVivo to identify common sources of anxiety in the first trimester. Outcome reported as major and minor themes.
Information Needs During the First Trimester (Survey responses) At a single time point, upon completion of the participant's survey Measured by 8 multiple-choice and Likert-scale survey items assessing participants' perceived gaps in information during the first trimester, preferred information sources, and level of trust in sources they currently use. Outcomes will be reported as the proportion of participants selecting each response option, with summary statistics for each category.
Information Needs During the First Trimester (Interview Data) At a single time point, during the participant's interview following survey completion Interview responses regarding informational gaps will be analysed thematically using NVivo. Outcomes reported as a list of core unmet information needs.
- Secondary Outcome Measures
Name Time Method mHealth Applications Perspectives and Feature Preferences from a Healthcare Professional Perspective (Qualitative survey data) At a single time point upon completion of the participant's survey Survey responses from healthcare professionals will include Likert-scale and multiple-choice items on the use and perceived value of mobile health tools in early pregnancy. Likert items use a 5-point scale (1 = strongly disagree, 5 = strongly agree). Outcomes will be reported as the proportion of participants selecting each response option, and the mean and standard deviation for each Likert item
mHealth Application Content Preferences and Perceived Gaps from a Healthcare Professional perspective (Quantitative Survey Data) At a single time point upon completion of the participant's survey Survey responses from healthcare professionals will include open-ended questions regarding ideal application content for the first trimester of pregnancy and perceived gaps in current digital health resources. Free-text responses will be thematically analysed.
Key Themes from Healthcare Professionals on Design, Implementation, and AI Use in Pregnancy mHealth Tools (Interview Data) At a single time point, during the participant's interview following survey completion Semi-structured interviews with healthcare professionals will explore three domains: 1) desired features and functions of a first trimester pregnancy app, 2) perceived clinical, ethical, technical, and organisational barriers and facilitators to its implementation, and 3) attitudes toward the integration of artificial intelligence (AI) into digital health tools for early pregnancy support. Interview transcripts will be analysed thematically using NVivo.
mHealth Applications Perspectives and Feature Preferences from a Digital Health Expert Perspective (Quantitative survey data) At a single time point, upon completion of the participant's survey Survey responses from digital health experts will include Likert-scale and multiple-choice items on the design, usage, and perceived utility of digital tools in pregnancy. Likert items will use a 5-point scale (1 = strongly disagree, 5 = strongly agree).Outcomes will be reported as the proportion of participants selecting each response option and mean and standard deviation for each Likert item.
Feature Preferences and Content Gaps in current mHealth tools from a Digital Health expert perspective (Qualititative survey data) At a single time point, upon completion of the participant's survey Survey responses from digital health experts will include open-ended questions about ideal features, perceived gaps in current tools, and suggestions for app content. Free-text responses will be thematically using NVivo. Outcomes will be reported as a list of key themes.
Key Themes from Digital Health Experts on App Design, Implementation, and AI Use in Pregnancy mHealth Applications (Interview Data) At a single time point, during the participant's interview Semi-structured interviews with digital health experts will explore three key areas: 1) desired design and content features for a first trimester pregnancy app, 2) perceived logistical, technical, or policy-related barriers and facilitators to implementation, and 3) attitudes toward the integration of artificial intelligence (AI) in digital pregnancy tools. Interview transcripts will be thematically analysed using NVivo. Outcomes will be reported as a list of key themes