Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000168651
Ethics application status
Approved
Date submitted
4/02/2023
Date registered
17/02/2023
Date last updated
17/02/2023
Date data sharing statement initially provided
17/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing an operative vaginal birth safety bundle
Scientific title
Implementing routine intrapartum ultrasound, structured time out and safety checklist for operative vaginal births: A mixed-methods prospective cohort study
Secondary ID [1] 307325 0
Nil known
Universal Trial Number (UTN)
U1111-1279-1225
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Operative vaginal birth 326612 0
Condition category
Condition code
Reproductive Health and Childbirth 323855 323855 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 325266 0
Diagnosis / Prognosis
Comparator / control treatment
A historical control group of all women delivering via OVB or second stage caesarean section in the 18months preceding the initial pilot at Monash Health (1/5/2020 to 31/10/2021)
Control group
Historical

Outcomes
Primary outcome [1] 331671 0
Composite neonatal morbidity and mortality:
- Apgar <7 at five minutes
- Need for intubation and/or cardiac compressions
- Cord lactate >8mmol/L
- Hypoxic-ischaemic encephalopathy
- Need for therapeutic hypothermia
- Neonatal intensive care admission
- Fetal trauma (including subgaleal and intracranial haemorrhage, cephalo-haematoma, facial nerve injury, fracture)
- Perinatal mortality

Data will be obtained from medical records
Timepoint [1] 331671 0
At discharge of neonate from hospital
Secondary outcome [1] 410705 0
Composite maternal morbidity and mortality:
- Postpartum haemorrhage >1500ml
- Need for blood transfusion
- Anal sphincter injury
- Visceral injury
- Caesarean hysterectomy
- Maternal ICU admission
- Maternal mortality

Data will be obtained from medical records
Timepoint [1] 410705 0
At time of discharge of mother from hospital
Secondary outcome [2] 410706 0
Apgar <7 at five minutes
Timepoint [2] 410706 0
At time of delivery, from medical records
Secondary outcome [3] 410707 0
Need for intubation
Timepoint [3] 410707 0
At time of discharge of neonate, from medical records
Secondary outcome [4] 410708 0
Cord lactate >8mmol/L
Timepoint [4] 410708 0
At delivery, from medical records
Secondary outcome [5] 410709 0
Hypoxic-ischaemic encephalopathy
Timepoint [5] 410709 0
At time of discharge of neonate, from medical records
Secondary outcome [6] 410710 0
Need for therapeutic hypothermia
Timepoint [6] 410710 0
At time of discharge of neonate, from medical records
Secondary outcome [7] 418389 0
Fetal trauma (including subgaleal and intracranial haemorrhage, cephalo-haematoma, facial nerve injury, fracture)
Timepoint [7] 418389 0
At time of discharge of neonate, from medical records
Secondary outcome [8] 418390 0
Perinatal mortality
Timepoint [8] 418390 0
At time of discharge of neonate, from medical records
Secondary outcome [9] 418391 0
Shoulder dystocia
Timepoint [9] 418391 0
At time of delivery, from medical records
Secondary outcome [10] 418392 0
Inaccurate fetal head position
Timepoint [10] 418392 0
At time of delivery, from medical records
Secondary outcome [11] 418393 0
Unsuccessful OVB attempt
Timepoint [11] 418393 0
At time of delivery, from medical records
Secondary outcome [12] 418394 0
Mode of delivery
Timepoint [12] 418394 0
At time of delivery, from medical records
Secondary outcome [13] 418395 0
Postpartum haemorrhage >1500ml
Timepoint [13] 418395 0
At time of discharge of mother, from medical records
Secondary outcome [14] 418396 0
Need for blood transfusion
Timepoint [14] 418396 0
At time of discharge of mother, from medical records
Secondary outcome [15] 418397 0
Anal sphincter injury
Timepoint [15] 418397 0
At time of delivery, from medical records
Secondary outcome [16] 418398 0
Visceral injury
Timepoint [16] 418398 0
At time of discharge of mother, from medical records
Secondary outcome [17] 418399 0
Caesarean hysterectomy
Timepoint [17] 418399 0
At time of discharge of mother, from medical records
Secondary outcome [18] 418400 0
Maternal ICU admission
Timepoint [18] 418400 0
At time of discharge of mother, from medical records
Secondary outcome [19] 418401 0
Maternal mortality
Timepoint [19] 418401 0
At time of discharge of mother, from medical records
Secondary outcome [20] 418402 0
maternity care provider perception of uptake of the bundle - from content and thematic analysis of surveys and semi structured, one-on-one interviews (either face-to-face or online with a member of the research team) of maternity care providers
Timepoint [20] 418402 0
Surveys will be given to participants at PROMPT training (annual simulation training required by all maternity staff) for the 12 months following bundle implementation.
Semi structured interviews will be performed on a representative sample of junior and senior maternity care providers during the 18 month post implementation period
Secondary outcome [21] 418403 0
maternity care provider perception of the influence of the bundle on clinical practice - from content and thematic analysis of surveys and semi structured, one-on-one interviews (either face-to-face or online with a member of the research team) of maternity care providers
Timepoint [21] 418403 0
Surveys will be given to participants at PROMPT training (annual simulation training required by all maternity staff) for the 12 months following bundle implementation
Semi structured interviews will be performed on a representative sample of junior and senior maternity care providers during the 18 month post implementation period
Secondary outcome [22] 418658 0
Need for cardiac compressions
Timepoint [22] 418658 0
At time of neonatal delivery, from medical records
Secondary outcome [23] 418660 0
Neonatal intensive care admission, from medical records
Timepoint [23] 418660 0
At time of discharge from hospital

Eligibility
Key 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).
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
This is a mixed methods prospective cohort study with a historical control cohort.

Our power calculation is based on a retrospective review of births at Monash Health, which demonstrated that 727 women delivered via OVB or second stage caesarean section over a 6 month period with the above defined primary outcome (composite neonatal morbidity and mortality) occurring in 16% of these deliveries. Accordingly, we estimate that data for 1888 women will be required to achieve 80% power to determine a 20% difference in the primary outcome of composite neonatal morbidity and mortality from 16% to 12.8%. Therefore, we estimate data collection to take approximately 16 months.

Data will be tested for normality and the cohorts’ maternal and neonatal baseline characteristics will be compared using a chi-squared or Fisher’s Exact test for categorical data, and independent t-tests or Wilcoxon rank sums tests for continuous data depending on normality. An interrupted time series analysis with the use of autoregressive integrated moving average (ARIMA) models will be used to compare outcomes in the 18 months following final policy implementation (prospective cohort) to the 18 months preceding the policy pilot (historical control cohort), with a washout period to allow for the bundle pilot and transition phase. An interrupted time series analysis is used to account for underlying trends over time, changes in baseline characteristics and seasonality. We have allowed additional recruitment time to allow for possible fluctuations in rates of OVB and second stage caesarean sections, as well as fluctuations in perinatal outcomes. Descriptive data of the two cohorts and healthcare staff uptake of the safety bundle will also be reported.

Qualitative data will be sought from maternity staff surveys and semi-structured interviews designed with evaluation approach based on the Kirkpatrick framework which uses 4 levels of evaluating policy implementation, including 1 – Reaction, 2a – Modification of attitudes and perceptions, 2b – Acquisition of knowledge and/or skills, 3 – Behaviour change, 4a – Changes in organisational practice, 4b – Benefits to patients/healthcare workers. Survey data will be analysed using content analysis. Transcribed audio recordings of semi-structured interviews will undergo qualitative thematic analysis to identify key themes relating to bundle uptake and clinical impact.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/02/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1888
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22529 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 22530 0
Dandenong Hospital- Monash Health - Dandenong
Recruitment hospital [3] 22531 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 37768 0
3168 - Clayton
Recruitment postcode(s) [2] 37769 0
3175 - Dandenong
Recruitment postcode(s) [3] 37770 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 311617 0
University
Name [1] 311617 0
Australian Government Research Training Program (RTP) Scholarship, Monash University
Country [1] 311617 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
Monash Medical Centre, 246 Clayton Rd, Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 313051 0
University
Name [1] 313051 0
Monash University
Address [1] 313051 0
Wellington Rd, Clayton VIC 3800
Country [1] 313051 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311058 0
The Monash Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 311058 0
Ethics committee country [1] 311058 0
Australia
Date submitted for ethics approval [1] 311058 0
19/05/2021
Approval date [1] 311058 0
23/05/2021
Ethics approval number [1] 311058 0
ERM Reference No. 76336; HREC Reference Number: QA/76336/MonH-2021-265279(v1); Our Local HREC Reference No. RES-21-0000-332Q – 76336

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119850 0
Dr Sasha Skinner
Address 119850 0
Monash Medical Centre, 246 Clayton Rd, Clayton VIC 3168
Country 119850 0
Australia
Phone 119850 0
+61403189828
Fax 119850 0
Email 119850 0
[email protected]
Contact person for public queries
Name 119851 0
Sasha Skinner
Address 119851 0
Monash Medical Centre, 246 Clayton Rd, Clayton VIC 3168
Country 119851 0
Australia
Phone 119851 0
+613 95946666
Fax 119851 0
Email 119851 0
[email protected]
Contact person for scientific queries
Name 119852 0
Sasha Skinner
Address 119852 0
Monash Medical Centre, 246 Clayton Rd, Clayton VIC 3168
Country 119852 0
Australia
Phone 119852 0
+613 95946666
Fax 119852 0
Email 119852 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a quality improvement study


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18241Study protocol  [email protected]



Results publications and other study-related documents

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