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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorThe Royal Wolverhampton Hospitals NHS Trust

About this trial

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?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Midwifery lead and consultant lead patient older than 18 years.

Consented to participation after an informed choice.

Disqualifiers

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)

Trial population

Pregnant women during labour

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: iCount Device1 intervention
Group B: User Feedback Survey0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
12 months
2

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

Time frame
12 months
3

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
4

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

Time frame
12 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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