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PregnancyEMBRACE-BLOOMNCT07623096

EMBRACE- BLOOM - Building Literacy and Outcomes Through Observation and Monitoring: Information Needs and Wearable Data in Pregnancy Couples

An observational study of Pregnancy, run by King's College London at 1 site in United Kingdom.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this observational study (a single-site, prospective longitudinal cohort study) is to understand how the health information needs and information-seeking behaviours of pregnant women and their partners change over time, and to identify the factors linked to unmet information needs, in pregnant women aged… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
Questionnaires
How many people
1,000 participants
Where
1 siteUnited Kingdom
Study dates
Jun 2026to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Participants will be recruited from pregnant women aged 18 or over attending a routine first-trimester ultrasound appointment at the Harris Birthright Research Centre for Fetal Medicine, King's College Hospital, London, who are UK residents, able to give informed consent, able to read and understand English sufficiently to complete the study questionnaires, and have access to a compatible smartphone. Each pregnant participant may optionally nominate one partner - any individual identified as providing partner support, regardless of gender or relationship status - who meets the same age, residency, consent, language, and smartphone criteria. This is a demographically diverse urban NHS population.

Who may be able to join

  • Pregnant participants
  • Aged 18 years or over;
  • Attending a routine first-trimester ultrasound appointment at the study site;
  • Resident in the UK;
  • Able to provide informed and documented consent;
  • Able to read and understand English sufficiently to complete study questionnaires delivered via the study mobile application;
Show all 14Show fewer
  • Have access to a compatible smartphone.
  • Partners
  • Aged 18 years or over;
  • Nominated by a participating pregnant participant;
  • Resident in the UK;
  • Able to provide informed and documented consent;
  • Able to read and understand English sufficiently to complete study questionnaires delivered via the study mobile application;
  • Have access to a compatible smartphone.

Who cannot join

  • Pregnant participants and partners:
  • Under 18 years of age;
  • Not resident in the UK;
  • Unable to provide informed consent;
  • No access to a compatible smartphone.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site
  • King's College Hospital

    London

    Argyro Syngelaki, +44 020 3299 7164, argyro.syngelaki@kcl.ac.uk

Other trials in United Kingdom

About this study

The goal of this observational study (a single-site, prospective longitudinal cohort study) is to understand how the health information needs and information-seeking behaviours of pregnant women and their partners change over time, and to identify the factors linked to unmet information needs, in pregnant women aged 18 or over attending routine first-trimester care in the UK, together with one optional nominated partner (also aged 18 or over), followed from early pregnancy (11-13 weeks' gestation) to around 6-8 weeks postpartum. The main questions it aims to answer are:

How do health information needs and information-seeking behaviours evolve across pregnancy and the postpartum period for women and their partners (measured as longitudinal change in the Information Mismatch Index)? What barriers, facilitators, and sociodemographic factors are associated with unmet information needs, and how do the needs of women and their partners align or diverge?

Read more

This study has no comparison group or intervention; it is non-interventional and does not involve randomisation, treatment allocation, or any change to clinical care. Instead of comparing arms, researchers will examine how needs change over time and will explore differences between women and partners, and associations with health literacy, wellbeing, and optional passive digital data.

Participants will:

Complete short app-delivered questionnaires at four milestone timepoints (around 11-13 weeks, 20-22 weeks, 35-36 weeks' gestation, and 6-8 weeks postpartum), each taking no longer than about 20 minutes and covering information needs, information-seeking behaviour, trust, health and digital literacy, mental health, quality of life, social support, and relationship satisfaction.

Optionally complete brief biweekly check-in surveys between milestones (about 2-3 minutes each) on recent information needs.

Optionally consent to electronic health record linkage and to sharing passive smartphone- and wearable-derived health metrics (e.g. steps, sleep, heart rate) via their own devices.

Read the detailed description

Why this study is being done Pregnant women and their partners need reliable health information throughout pregnancy and the period after birth, covering topics such as nutrition, screening tests, medications, labour, newborn care, and maternal physical and mental recovery. Many now use digital sources to find this information. However, the large volume of available material varies in quality and reliability, and it can be difficult to identify sources that are trustworthy, relevant, and accurate. This may contribute to information overload, anxiety, and reliance on advice that does not reflect an individual's circumstances.

Most existing research on pregnancy information needs is cross-sectional, examines a single time point, and includes only the pregnant person rather than their partner. As a result, there is limited longitudinal evidence on how these needs change over time or how they differ between the child bearing person and their partner. This study aims to address this gap and provide evidence to inform the design of maternity information resources.

What the study is EMBRACE-BLOOM is a prospective, non-interventional observational cohort study. It does not test a drug, device, or treatment and does not alter participants' clinical care. The study follows expectant parents through pregnancy and the early postpartum period to document how their health information needs and information-seeking behaviours change over time. It is one independently governed and approved component of the wider EMBRACE programme at King's College London, which aims to improve maternal and infant health through high-quality data and AI-supported approaches.

The study includes both pregnant participants and, optionally, one nominated partner per participant. This design allows comparison of information needs between women and their partners, including where these needs align, where they differ, and how each changes over the course of pregnancy and after birth.

What participation involves Participants are recruited at a routine first-trimester ultrasound appointment and followed remotely through a study smartphone application, without additional study visits. App-delivered questionnaires are completed at four milestone timepoints from early pregnancy to approximately 6-8 weeks postpartum, with optional brief check-in surveys offered between milestones. The questionnaires use validated instruments to assess information needs and information-seeking behaviour, as well as health and digital literacy, mental health, quality of life, social support, and relationship satisfaction.

With separate explicit consent, participants may also choose to contribute electronic health record data relating to their pregnancy and delivery, and passively collected health metrics from their own smartphone or wearable device, such as step count, sleep, and heart rate. These optional data streams allow exploratory analysis of associations between objective health metrics and self-reported information needs and wellbeing. All optional components are opt-in, and participants may withdraw from the study or any individual component at any time without any effect on their clinical care.

Intended outcomes The study will produce longitudinal evidence on when and why parents seek health information, how the needs of women and their partners compare, and how factors such as health literacy and sociodemographic circumstances are associated with access to information. The findings are intended to inform the development of more effective, inclusive, and literacy-appropriate maternity information resources, including evidence on user preferences to guide the design of digital and AI-supported information tools.

Conditions
Pregnancy
Being tested
Questionnaires

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnairesOther

    Participants complete validated app-delivered questionnaires at four timepoints across pregnancy and postpartum, assessing information needs, wellbeing, and related measures. No intervention administered.

Study groups in NCT07623096
Study groupRoleWhat they receive
Pregnant participantsNot described
Receives: Other: Questionnaires
Partners of pregnant participantsNot described
Receives: Other: Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Longitudinal change in the Information Mismatch Index (IMI)

    The Information Mismatch Index (IMI) measures the gap between participants' health information needs and the information they are able to access and use during pregnancy and the postpartum period. It is derived from self-reported, app-delivered questionnaire items, with higher scores indicating greater unmet information need. The outcome is the change in IMI score across the four milestone timepoints.

    Measured: Measured at four timepoints from early pregnancy to postpartum: 11+0-13+6 weeks' gestation (T1), 20+0-22+6 weeks (T2), 35+0-36+6 weeks (T3), and 6-8 weeks postpartum (T4).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07623096
Sponsor's protocol ID
370088
Acronym
EMBRACE-BLOOM
Status last verified
May 2026
First submitted
28 May 2026
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy, run by King's College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Longitudinal change in the Information Mismatch Index (IMI) (time frame: Measured at four timepoints from early pregnancy to postpartum: 11+0-13+6 weeks' gestation (T1), 20+0-22+6 weeks (T2), 35+0-36+6 weeks (T3), and 6-8 weeks postpartum (T4).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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