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Implementing an operative vaginal birth safety bundle

Implementing routine intrapartum ultrasound, structured time out and safety checklist for operative vaginal births: A mixed-methods prospective cohort study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12623000168651
Enrollment
1888
Registered
2023-02-17
Start date
2023-02-24
Completion date
Unknown
Last updated
2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a mixed methods prospective cohort study aiming to assess the impact of introducing a safety bundle for all operative vaginal birth (OVB) at Monash Health. This will include up-skilling obstetric staff in the use of intrapartum ultrasound, which they will be encouraged to use routinely prior to OVB. Additionally, we will introduce a routine team time out and procedural checklist to be performed at all OVB. We hypothesize that this bundle will reduce composite maternal and neonatal morbidity and mortality for women where OVB is considered during their clinical care. Secondarily we will assess uptake of all aspects of the bundle, rates of incorrect determination of fetal head position, unsuccessful instrumental birth attempts, mode of delivery and healthcare worker uptake and experience of the bundle. Our primary outcome is composite neonatal morbidity and mortality, which we will compare the 18months following safety bundle intervention to a historical cohort 18months preceding role out of the safety bundle.

Interventions

Operative vaginal birth (OVB) safety bundle comprising of: 1. Up-skilling obstetric staff in the use of ultrasound for fetal head position 2. Introduction of routine dedicated OVB time out and procedural checklist An OVB safety bundle was implemented at Monash Health with the pilot beginning in November 2021, followed by a transitional phase, including up-skilling of obstetric staff in the use of ultrasound for fetal head position as well as routine time out and safety checklist for all OVB. Th

Operative vaginal birth (OVB) safety bundle comprising of: 1. Up-skilling obstetric staff in the use of ultrasound for fetal head position 2. Introduction of routine dedicated OVB time out and procedural checklist An OVB safety bundle was implemented at Monash Health with the pilot beginning in November 2021, followed by a transitional phase, including up-skilling of obstetric staff in the use of ultrasound for fetal head position as well as routine time out and safety checklist for all OVB. The bundle is currently being endorsed by Safer Care Victoria (SCV). Following final implementation (expected end of February), the bundle will be recommended to be used as routine care for all OVB and we aim to prospectively evaluate the impact of this bundle on neonatal and maternal morbidity. Prospective data collection will continue from final bundle implementation (End of February 2023) for 18 months (ie until September 2024). Details of the bundle are as follows: 1. Up-skilling obstetric staff in the use of ultrasound for fetal head position - A mixture of didactic and practical workshops designed to up-skill junior and senior obstetric medical staff in the use of intrapartum ultrasound to determine fetal position in the second stage. This is expected to include 1-2 hour sessions, with 4-5 occurring over a 6 month period. These sessions are run by obstetric ultrasound specialists and/or obstetric sonographers - Learning resources will be made available to all obstetric medical staff. These have been designed specifically for the bundle under the guidance of an obstetric ultrasound specialist. - Staff will be encouraged to develop these skills under appropriate supervision in the labour ward - Obstetric staff will then be encouraged to use ultrasound to confirm fetal head position prior to all OVB if deemed safe to do so - Portable ultrasound machines, probes, gel and cleaning equipment will be well stocked in birth suites and theatre to facilitate use - Whether or not ultrasound was used prior to operative vaginal birth or decision to proceed wth second stage caesarean section will be documented in the electronic medical records (EMR) and the birthing outcome system (BOS). 2. Introduction of routine dedicated OVB Time Out and procedural checklist - A multidisciplinary team involving senior obstetric, midwifery, paediatric and anaeathetic staff will use existing international instrumental birth guidelines to formulate a dedicated OVB Time Out and safety checklist - The Time Out involves asking the team to pause briefly before proceeding with an OVB to verbalise outloud the Background (brief history of the patient), Intervention (planned intervention and back up plan), Risks and Requirements (any specific risks or requirement for this delivery), Teams (who is present and who is available), Help (Who is available and what the plan is if issues arise). This should be brief and should not take more than a couple of minutes - The procedural checklist involves following a prompted form and verbalising the steps of the procedure as they occur to maintain situational awareness, team communication and awareness of safety guidelines. This form should be used during the OVB. - This form will be piloted at Monash Health birthing suites where feedback from staff will be used to optimise usability and effectiveness - Policy at Monash Health will include performing the Time Out and safety checklist at all OVB where safe to do so. Annual simulation training through Practical Obstetric Multi-Professional Training (PROMPT) will be utilised to role play the use of the Time Out/Checklist to allow staff to become more familiar with the form(s) and to identify any areas for improvement. The use of the Time Out/checklist will be documented on EMR and BOS for all women undergoing OVB or second stage caesarean section Survey's to assess pre-existing use of ultrasound for this purpose, uptake and barriers to use of all aspects of the form and impact on clinical care will be performed throughout the learning curve to address any issues that arise. Surveys take approximately 5-10minutes to complete and will be administered to staff when they complete their PROMPT training throughout the 18 month period following the final implementation of the bundle.

Sponsors

Monash Health
Lead SponsorHospital

Eligibility

Sex/Gender
All
Healthy volunteers
No

Inclusion criteria

The study will assess maternal and neonatal outcomes for all women of term gestation with cephalic presentation having an OVB or second stage caesarean section at three Monash health maternity centres. The following cohort of patients will be included: Inclusion criteria - Term gestation - Cephalic presentation - Spontaneous, induced or augmented labour - In the second stage undergoing attempted OVB or second stage caesarean section - Women delivering in the 18 months after completion of the pilot and transition phase, following final bundle implementation (prospective cohort - March 2023 to September 2024) and those delivering in the 18months preceding the pilot (historical control cohort - 1/5/2020 to 31/10/2021).

Exclusion criteria

Exclusion criteria - Women less than 37 weeks gestation - Non-cephalic presentation - Cervix not fully dilated - Contraindication to vaginal birth or OVB for any reason - Multifetal pregnancy - Women delivery via: •Normal vaginal birth •Breech vaginal birth - including forceps for aftercoming head •Planned elective caesarean section pre-labour •Caesarean section in the first stage of labour

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026