Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07114471

Addressing Pregnant Women's First Trimester Worries and Information Needs With mHealth Solutions

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pregnancy Trimester, First Antenatal Care Anxiety Anxiety Disorders Behavior Health Knowledge, Attitudes, Practice Mental Disorders Mobile Application Patient Education as Topic Worries mHealth Application

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Pregnant women

Inclusion criteria

  • To ensure that participants have the first trimester of pregnancy fresh in their minds the sample will include women that are currently pregnant or have had a child within the last 2 years
  • Living in the UK
  • Over the age of 18
  • Able to give informed consent Exclusion criteria
  • Evidence of/diagnosis of cognitive impairment

Healthcare professionals

Inclusion criteria

  • Belonging to one of the following professional groups i.e. healthcare professionals involved in the care of pregnant women
  • Doctor in obstetrics and gynaecology
  • Midwives
  • Nurses (within the field of obstetrics and gynaecology),
  • Sonographers that scan pregnant women
  • General practitioners
  • Psychologists (that work with pregnant women)
  • Physiotherapists (that work with pregnant women)
  • Living in the UK
  • Over the age of 18
  • Able to give informed consent Exclusion criteria
  • Evidence of/diagnosis of cognitive impairment

Digital Health Experts

Inclusion criteria

  • Professionals with at least 3 year's experience in digital health, health informatics or mobile health application development
  • Based in the United Kingdom Exclusion criteria
  • Evidence of/diagnosis of cognitive impairment

Treatment and study plan

Primary outcomes

  1. Levels of Self-Reported Anxiety in the First Trimester (Quantitative Survey Data)

    Time frame: Day 1

    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).

  2. Themes of Anxiety During the First Trimester (Qualitative Survey Data)

    Time frame: Day 1

    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.

  3. Themes of Anxiety During the First Trimester (Interview Data)

    Time frame: Day 1

    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.

  4. Information Needs During the First Trimester (Survey responses)

    Time frame: Day 1

    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.

  5. Information Needs During the First Trimester (Interview Data)

    Time frame: Day 1

    Interview responses regarding informational gaps will be analysed thematically using NVivo. Outcomes reported as a list of core unmet information needs.

Secondary outcomes

  1. mHealth Applications Perspectives and Feature Preferences from a Healthcare Professional Perspective (Qualitative survey data)

    Time frame: Day 1

    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

  2. mHealth Application Content Preferences and Perceived Gaps from a Healthcare Professional perspective (Quantitative Survey Data)

    Time frame: Day 1

    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.

  3. Key Themes from Healthcare Professionals on Design, Implementation, and AI Use in Pregnancy mHealth Tools (Interview Data)

    Time frame: Day 1

    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.

  4. mHealth Applications Perspectives and Feature Preferences from a Digital Health Expert Perspective (Quantitative survey data)

    Time frame: Day 1

    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.

  5. Feature Preferences and Content Gaps in current mHealth tools from a Digital Health expert perspective (Qualititative survey data)

    Time frame: Day 1

    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.

  6. Key Themes from Digital Health Experts on App Design, Implementation, and AI Use in Pregnancy mHealth Applications (Interview Data)

    Time frame: Day 1

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Gorgievska, MBBS BSc MRCOG

CONTACT

[email protected]

00442037334385

Sponsors and collaborators

Lead sponsor

Bournemouth University

Other

Collaborators

  • Chelsea and Westminster NHS Foundation Trust
  • Kendall Healthcare Group, Ltd.

Registry information

Official study title

Exploring the Anxieties and Health Information Needs of Women in the First Trimester to Inform mHealth Solutions for Antenatal Care

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 11, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.