Surgical Item, RetainedPRINCENCT05373342
Feasibility Study to Evaluate the Role of a Novel Device in Childbirth
An observational study of Surgical Item, Retained and Childbirth, run by The Royal Wolverhampton Hospitals NHS Trust.
Trial summary
Accidentally retained surgical items or swabs are well-recognised errors that result in adverse consequences for patients. This error is one of the commonest "Never Events" - patient safety incidents that are considered preventable. Although uncommon, these incidents can have devastating consequences. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Item, Retained, Childbirth
- What is being tested?
- iCount system assembled with swabs
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women during labour
Who may be able to join
- Midwifery lead and consultant lead patient older than 18 years.
- Consented to participation after an informed choice.
Who cannot join
- Under 18 years of age
- Antenatal (before labour):
- Patients who have a high risk of expected/unexpected maternal, fetal or neonatal deterioration such that during birth, the focus of attention would be towards safe patient care and observation required for using the swab-counter device system would not be possible such as :
- Patients who are seriously unwell and require high dependency care.
- Maternal cardiac conditions
- Severe pre-eclampsia
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- Fetal anomalies where neonatal deterioration is expected (These will be relatively rare conditions where the doctor/midwife would decide to not recruit the patient)
- Intrapartum and postpartum factors:
- Patient having an emergency Caesarean section instead of a vaginal birth due to maternal or fetal indication.
- Eclampsia (seizure/fitting in labour or after delivery)
- Maternal cardiac conditions requiring high dependency care
- Severe sepsis requiring high dependency care
- Fetal anomalies where neonatal deterioration is expected
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility Study to Evaluate the Role of a Novel Device in the Prevention of Retained Items In Childbirth Environment- Clinical Usability Pilot Study
Accidentally retained surgical items or swabs are well-recognised errors that result in adverse consequences for patients. This error is one of the commonest "Never Events" - patient safety incidents that are considered preventable. Although uncommon, these incidents can have devastating consequences. Retained surgical items have 70% re-interventions, reaching 80% morbidity and 35% mortality.
Swabs or sponges are like small towels that soak up blood and body fluids so that the surgeon can visualise the operating area effectively. Swabs are used in all areas of surgery which include operations on the tummy, chest, limbs. They are also used in the vagina during childbirth, to assess for tears and to minimise blood oozing from the vagina.
Read more
The common risk factors for this error are out of hours surgical or childbirth procedures, multiple handovers in the care of the patient, raised BMI (Body Mass Index) and unplanned change to the operative intervention.
As the name suggests, a 'never event' should never happen in the first place. Never. Unfortunately, this is not the case. Incidents involving surgical swabs being left behind, particularly during a caesarean section or a perineal repair following a vaginal birth, are still happening despite over 100 years of institutional awareness of the problem and tentative solutions being implemented in clinical practice.
never-event incidents involving retained surgical swabs are a widespread problem affecting healthcare systems worldwide. It is therefore reasonable to ask the question: why are surgical swabs being left behind and what can be done to prevent this from happening?
- Conditions
- Surgical Item, Retained, Childbirth
- Being tested
- iCount system assembled with swabs
- Medical subject headings
- Foreign Bodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCount system assembled with swabsDevice
Designed as single use. Intended purpose - To be used to count swabs and tampons after childbirth in an objective manner. This is intended to be used in women during and after childbirth.
| Study group | Role | What they receive |
|---|---|---|
| iCount Device | A novel external device which can count the swabs and surgical tampons used during childbirth in an objective and validated manner. Receives: Device: iCount system assembled with swabs | |
| User Feedback Survey | Feedback will be taken from 20 users including midwives/ doctors. Users will be emailed an online survey or given the same survey as a printout to complete. All 20 users will also then also be approached to have a semi-structured interview. 10 of the users who first express interest will be interviewed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of device count accuracy (conspicuity of spotting a missing swab) measured via staff questionnaire feedback
Measured: 12 months
User experience about general look and feel and user satisfaction (overall perception) measured via staff questionnaire feedback
Measured: 12 months
User perception about the confidence about the accuracy of the count with use of the device and thoughts about intention to use, if available (functionality) measured via staff questionnaire feedback
Measured: 12 months
User perception about the ease of learning of how to use the device measured via staff questionnaire feedback
Measured: 12 months
User perception of how device works within current system measured via staff questionnaire feedback
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Item, RetainedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aditi Desai, Principal investigator, The Royal Wolverhampton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373342
- Sponsor's protocol ID
- 2021SUR119
- Acronym
- PRINCE
- Status last verified
- Apr 2026
- First submitted
- 3 May 2022
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Evaluate the Role of a Novel Device in the Prevention of Retained Items In Childbirth Environment- Clinical Usability Pilot Study
- ClinicalTrials.gov ID
- NCT05373342
- Acronym / sponsor ID
- PRINCE / 2021SUR119
- Conditions
- Surgical Item, Retained, Childbirth
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Accidentally retained surgical items or swabs are well-recognised errors that result in adverse consequences for patients. This error is one of the commonest "Never Events" - patient safety incidents that are considered preventable. Although uncommon, these incidents can have devastating consequences. Retained surgical items have 70% re-interventions, reaching 80% morbidity and 35% mortality.
Swabs or sponges are like small towels that soak up blood and body fluids so that the surgeon can visualise the operating area effectively. Swabs are used in all areas of surgery which include operations on the tummy, chest, limbs. They are also used in the vagina during childbirth, to assess for tears and to minimise blood oozing from the vagina.
The common risk factors for this error are out of hours surgical or childbirth procedures, multiple handovers in the care of the patient, raised BMI (Body Mass Index) and unplanned change to the operative intervention.
As the name suggests, a 'never event' should never happen in the first place. Never. Unfortunately, this is not the case. Incidents involving surgical swabs being left behind, particularly during a caesarean section or a perineal repair following a vaginal birth, are still happening despite over 100 years of institutional awareness of the problem and tentative solutions being implemented in clinical practice.
never-event incidents involving retained surgical swabs are a widespread problem affecting healthcare systems worldwide. It is therefore reasonable to ask the question: why are surgical swabs being left behind and what can be done to prevent this from happening?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iCount Device | – | Device: iCount system assembled with swabsA novel external device which can count the swabs and surgical tampons used during childbirth in an objective and validated manner. |
| User Feedback Survey | – | –Feedback will be taken from 20 users including midwives/ doctors. Users will be emailed an online survey or given the same survey as a printout to complete. All 20 users will also then also be approached to have a semi-structured interview. 10 of the users who first express interest will be interviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women during labour
Key inclusion criteria (2 listed)
- Midwifery lead and consultant lead patient older than 18 years.
- Consented to participation after an informed choice.
Key exclusion criteria (13 listed)
- Under 18 years of age
- Patients who have a high risk of expected/unexpected maternal, fetal or neonatal deterioration such that during birth, the focus of attention would be towards safe patient care and observation required for using the swab-counter device system would not be possible such as :
- Patients who are seriously unwell and require high dependency care.
- Maternal cardiac conditions
- Severe pre-eclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCount system assembled with swabsDesigned as single use. Intended purpose - To be used to count swabs and tampons after childbirth in an objective manner. This is intended to be used in women during and after childbirth. | Device | iCount Device |
Primary outcome
Rate of device count accuracy (conspicuity of spotting a missing swab) measured via staff questionnaire feedback
Time frame: 12 months
User experience about general look and feel and user satisfaction (overall perception) measured via staff questionnaire feedback
Time frame: 12 months
User perception about the confidence about the accuracy of the count with use of the device and thoughts about intention to use, if available (functionality) measured via staff questionnaire feedback
Time frame: 12 months
User perception about the ease of learning of how to use the device measured via staff questionnaire feedback
Time frame: 12 months
User perception of how device works within current system measured via staff questionnaire feedback
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aditi Desai principal investigator
The Royal Wolverhampton NHS Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Item, Retained and Childbirth, run by The Royal Wolverhampton Hospitals NHS Trust.
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 2 inclusion and 13 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 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Aditi Desai (01902695166, aditidesai@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of device count accuracy (conspicuity of spotting a missing swab) measured via staff questionnaire feedback (time frame: 12 months). The study lists 5 primary outcomes in all. 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 9 Apr 2026.