Exploring the Anxieties and Health Information Needs of Women in the First Trimester to Inform mHealth Solutions for Antenatal Care
Trial ID: NCT07114471
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2025-09
Completion date: 2027-10
Sponsor: Bournemouth University
Collaborators: Chelsea and Westminster NHS Foundation Trust; Kendall Healthcare Group, Ltd.
Conditions: Pregnancy Trimester, First; Anxiety; Worries; Health Knowledge, Attitudes, Practice; mHealth Application; Mobile Application; Antenatal Care; Patient Education as Topic
Enrollment: 1450
Age range: 18 Years - None
Sex: ALL

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.

Eligibility criteria:
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

Outcomes:
Levels of Self-Reported Anxiety in the First Trimester (Quantitative Survey Data); Themes of Anxiety During the First Trimester (Qualitative Survey Data); Themes of Anxiety During the First Trimester (Interview Data); Information Needs During the First Trimester (Survey responses); Information Needs During the First Trimester (Interview Data)