Status:
NOT_YET_RECRUITING
Feasibility Study to Evaluate the Role of a Novel Device in Childbirth
Lead Sponsor:
The Royal Wolverhampton Hospitals NHS Trust
Conditions:
Surgical Item, Retained
Childbirth
Eligibility:
FEMALE
18+ years
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 ...
Eligibility Criteria
Inclusion
- Midwifery lead and consultant lead patient older than 18 years.
- Consented to participation after an informed choice.
Exclusion
- • 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05373342
Start Date
December 1 2025
End Date
February 1 2026
Last Update
November 17 2025
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