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

Study acronym: PRINCE
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Start date: Mar 2026 to Sep 2026
    • Primary and study completion pushed from Mar 2027 to Sep 2027
    v10
  2. Notable Primary and study completion dates: Feb 2026 to Mar 2027
    • Start date: Dec 2025 to Mar 2026
    v9
  3. Notable Start date: Oct 2025 to Dec 2025
    • Primary and study completion dates: Dec 2025 to Feb 2026
    v8
  4. Notable Start date: Jun 2025 to Oct 2025
    • Primary and study completion dates: Oct 2025 to Dec 2025
    v7
  5. Notable Primary and study completion dates: Dec 1, 2024 to Oct 2025
    • Start date: Dec 1, 2024 to Jun 2025
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Start date: Jun 1, 2024 to Dec 1, 2024v5
  2. Notable Start date: Feb 1, 2023 to Jun 1, 2024
    • Primary and study completion dates: Jul 1, 2024 to Dec 1, 2024
    v4
  3. Notable Primary and study completion dates: Jul 1, 2023 to Jul 1, 2024
    • Start date: Oct 1, 2022 to Feb 1, 2023
    v3
  4. Notable Start date: Jul 1, 2022 to Oct 1, 2022v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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?
Trial Details
NCT Number NCT05373342
Lead Sponsor The Royal Wolverhampton Hospitals NHS Trust
Conditions
(from sponsor)
Surgical Item, Retained, Childbirth
Related terms Foreign Bodies
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov