NCT05373342

Feasibility Study to Evaluate the Role of a Novel Device in Childbirth

Feasibility Study to Evaluate the Role of a Novel Device in the Prevention of Retained Items In Childbirth Environment- Clinical Usability Pilot Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: The Royal Wolverhampton Hospitals NHS Trust · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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. 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?

Conditions

• Surgical Item, Retained
• Childbirth

Interventions

Type	Name	Description
DEVICE	iCount system assembled with swabs	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.

Timeline

• Start date: 2026-09-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2022-05-13
• Last updated: 2026-04-09