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

Launched by THE ROYAL WOLVERHAMPTON HOSPITALS NHS TRUST · May 12, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new device designed to help prevent a serious problem that can occur during childbirth: the accidental leaving behind of surgical items, like swabs, inside a patient's body. This issue, known as a "never event," can lead to significant complications and even life-threatening situations for patients. The trial aims to see if this device can help healthcare providers keep track of swabs used during childbirth, which is particularly important during procedures like Cesarean sections or repairs after vaginal births.

To participate in this study, women aged 18 and older who are receiving care from midwives or consultants and are willing to consent to the trial may be eligible. However, those with certain medical conditions or who are experiencing emergencies during childbirth may not be included. Participants can expect to use the new device during their delivery, and the study will help researchers determine if it effectively reduces the risk of surgical items being left behind. This trial is an important step in improving patient safety during childbirth and ensuring better outcomes for mothers and babies.

Gender

FEMALE

Eligibility criteria

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