Pre-eclampsia prevention resource acceptability and feasibility study
Not Applicable
- Conditions
- Improving adherence to aspirin treatment to prevent pre-eclampsiaPregnancy and Childbirth
- Registration Number
- ISRCTN13284374
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 70
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
Contraindications to aspirin use in pregnancy as described in the national Patient Group Directive (PGS) for supply of aspirin in pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the feasibility of delivery of the intervention programme and to evaluate delivery, receipt, and alternation to the programmes via process evaluation<br><br>Fidelity of intervention delivery <br><br>Barriers to implementation of the intervention <br><br>Alternations <br><br>Accessibility of the materials (physical and cognitive) <br><br>Acceptability of the materials (cultural and emotional) <br><br>Acceptability of intervention delivery schedule <br><br>Engagement with the intervention <br><br>Usefulness of the content <br><br>Accessibility of medicine and it’s storage at home <br><br>Ethicality (potential for negative effects) <br><br>Engagement of partners/supporters in the intervention.
- Secondary Outcome Measures
Name Time Method Feasibility of recruitment and data collection for future evaluative trial. <br><br>Feasibility of recruitment and data collection for future evaluation trial: <br>Proportion of eligible patients <br>Recruitment rate <br>Retention rate <br>Adherence rate <br>Rate of completion of questionnaires <br>Feasibility of collection of clinical outcomes <br>Feasibility of collection of health economic outcomes <br>Feasibility of using existent questionnaires to elicit change in key targeted domains: knowledge, necessity, and concerns. <br>Address uncertainties identified through public consultations: <br>Acceptability of use of the NHS app and adherence to data sharing with NHS. <br>Involvement and interaction with wider family/friends using intervention materials. <br>Risk perception of vaginal bleeding and significance of bleeding for parents. <br>Significance of potential for stopping aspirin early considering bleeding risk.