Prevention of Retained Items iN Childbirth Environment and Surgical Sites
PRINCESS
1 other identifier
observational
30
0 countries
N/A
Brief Summary
To evaluate the user confidence in the confirmation of correct counts using a novel device and to assess clinical usability of the device during surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2026
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2024
CompletedFirst Posted
Study publicly available on registry
August 26, 2024
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
Study Completion
Last participant's last visit for all outcomes
June 1, 2027
January 15, 2026
January 1, 2026
1 year
August 20, 2024
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Understanding user experience/usability factors
User responses on Likert scale for the various usability factors such as user confidence in the accuracy of counts, functional aspects and ease of use collected with an online software-assisted survey.
12 months
How the device sits within the current system
The purpose is to obtain user centred narratives and a rich qualitative data. Semi-structured interviews of staff will be conducted via a virtual platform or in a safe face-to-face manner. These will be recorded with a dictaphone recording device or Microsoft teams auto-transcription
12 months
Study Arms (2)
iCount Device
A novel external device which can count the swabs and surgical tampons used during childbirth in an objective and validated manner.
User Feedback Survey
Anonymised feedback data will be collected from 20 staff users about the user experience and usability of the device. This will be conducted with an online survey questionnaire designed with advice from ergonomics experts after an extensive literature review of human factors-ergonomics principles and MHRA guidance about conducting medical device usability 5 staff users will be randomly selected from the consent forms to have semi-structured interviews developed in accordance with qualitative research methodology for medical device usability testing and user experience.
Interventions
Designed as single use. Intended purpose - To be used to count swabs and tampons after surgery in an objective manner. This is intended to be used in patients during and just after surgery. This is a device accessory.
Eligibility Criteria
The participants will be pregnant women during labour. Staff who work in the operating theatres and are involved in performing swab and instrument counts. Consented to participation after an informed choice.
You may qualify if:
- Patients due to undergo surgery at the chosen NHS Trust.
- Patients 18 years or older and consented to participation after an informed choice.
You may not qualify if:
- Under 18 years of age
- Emergency surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Royal Wolverhampton Hospitals NHS Trustlead
- Innovate UKcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aditi Desai
The Royal Wolverhampton NHS Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2024
First Posted
August 26, 2024
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
January 15, 2026
Record last verified: 2026-01