An observational study in Surgical Item, Retained and Childbirth, sponsored by The Royal Wolverhampton Hospitals NHS Trust. Not yet recruiting. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by The Royal Wolverhampton Hospitals NHS Trust · Observational
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?
29 studies on the registry are indexed under Foreign Bodies; 8 are open to participants now.
This study's planned enrollment of 70 is below the median of 100 across 19 observational studies indexed under Foreign Bodies.
Browse Foreign Bodies studies →The Royal Wolverhampton Hospitals NHS Trust is the lead sponsor of 51 studies on the registry; 16 are open to participants now.
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Pregnant women during labour
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Antenatal (before labour):
Intrapartum and postpartum factors:
A novel external device which can count the swabs and surgical tampons used during childbirth in an objective and validated manner.
Device: iCount system assembled with swabs
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.
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.
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
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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The Royal Wolverhampton Hospitals NHS Trust