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

NCT05373342 | Not Yet Recruiting

• 1 other identifier: 2021SUR119
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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

Childbirth; Surgical Item, Retained

Outcome Measures

Primary Outcomes (5)

• Rate of device count accuracy (conspicuity of spotting a missing swab) measured via staff questionnaire feedback

  12 months

• User experience about general look and feel and user satisfaction (overall perception) measured via staff questionnaire feedback

  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

  12 months

• User perception about the ease of learning of how to use the device measured via staff questionnaire feedback

  12 months

• User perception of how device works within current system measured via staff questionnaire feedback

  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.

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.

Interventions

iCount system assembled with swabs DEVICE

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.

iCount Device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women during labour

You may qualify if:

• Midwifery lead and consultant lead patient older than 18 years.
• Consented to participation after an informed choice.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead

MeSH Terms

Conditions

Foreign Bodies

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Aditi Desai

  The Royal Wolverhampton NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aditi Desai

CONTACT

01902695166; aditidesai@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 13, 2022
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04