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Pre-eclampsia prevention resource acceptability and feasibility study

Pre-eclampsia prevention resource acceptability and feasibility study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13284374
Enrollment
70
Registered
2024-08-19
Start date
2024-10-31
Completion date
Unknown
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improving adherence to aspirin treatment to prevent pre-eclampsia Pregnancy and Childbirth

Interventions

Previous interventions as of 08/10/2024: This study involves a behavioural change intervention generally consisting of: 1. Pre-eclampsia resources (delivered as a hard copy, web content and bite-siz
an active offer of support during regular appointments with healthcare professionals, supply of aspirin at the point of contact to ensure access to medicine. Previous interventions: This study invol

Sponsors

Newcastle upon Tyne Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Women at increased risk of PE as per NICE recommendation 2. Aged 18 years old and over 3. Able to provide informed consent 4. Able to understand written English and complete the questionnaires

Exclusion criteria

Exclusion criteria: Contraindications to aspirin use in pregnancy as described in the national Patient Group Directive (PGS) for supply of aspirin in pregnancy

Design outcomes

Primary

MeasureTime frame
To assess the feasibility of delivery of the intervention programme and to evaluate delivery, receipt, and alternation to the programmes via process evaluation Fidelity of intervention delivery Barriers to implementation of the intervention Alternations Accessibility of the materials (physical and cognitive) Acceptability of the materials (cultural and emotional) Acceptability of intervention delivery schedule Engagement with the intervention Usefulness of the content Accessibility of medicine and it’s storage at home Ethicality (potential for negative effects) Engagement of partners/supporters in the intervention.

Secondary

MeasureTime frame
Feasibility of recruitment and data collection for future evaluative trial. Feasibility of recruitment and data collection for future evaluation trial: Proportion of eligible patients Recruitment rate Retention rate Adherence rate Rate of completion of questionnaires Feasibility of collection of clinical outcomes Feasibility of collection of health economic outcomes Feasibility of using existent questionnaires to elicit change in key targeted domains: knowledge, necessity, and concerns. Address uncertainties identified through public consultations: Acceptability of use of the NHS app and adherence to data sharing with NHS. Involvement and interaction with wider family/friends using intervention materials. Risk perception of vaginal bleeding and significance of bleeding for parents. Significance of potential for stopping aspirin early considering bleeding risk.

Countries

England, United Kingdom

Contacts

Public ContactRaisa Vinogradov
raya.vinogradov@ncl.ac.uk+44 (0)191 2820540

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026