Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000994381
Ethics application status
Approved
Date submitted
30/06/2017
Date registered
10/07/2017
Date last updated
19/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the usability of a new U-shaped measuring tool for episiotomy: a mixed methods study
Scientific title
Evaluating ease of use and acceptability of a perineal measuring device (Episiometer) in ensuring correct angle and length of mediolateral episiotomy: a mixed methods study
Secondary ID [1] 292314 0
Nil known
Universal Trial Number (UTN)
U1111-1198-5330
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Episiotomy 303854 0
Labour 303855 0
Condition category
Condition code
Reproductive Health and Childbirth 303216 303216 0 0
Childbirth and postnatal care
Surgery 303273 303273 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once the decision to proceed to episiotomy is made, standard practice is for the attending clinician (doctor or midwife) to perform an episiotomy with no formal measuring tool.

The proposed intervention is use of the 'Episiometer' prototype, which is a U-shaped, thin, transparent template made of vellum paper which is intended to be placed on the perineum and guide the correct angle and length of a mediolateral episiotomy. The template will have measurements on it, marking the angle of 0-60 degrees from the mid-line (the midline being that between the posterior fourchette of the vagina and the anus), and indicating the appropriate angle range between 45 and 60 degrees with a 'green' segment, and the length measurement of 4cm + on the 60 degree line. When applied to the perineum, the episiotomy can be performed and the clinician can cut through the Episiometer as they cut through the perineum given the very thin nature of the paper.

The Episiometer would only be used if the clinical decision is made to proceed to episiotomy for delivery of the baby. It does not affect the decision to proceed to episiotomy, which is a clinical decision.

The aim of the study is to:
- Assess feedback from clinicians (doctors and midwives) about perceived ease of use, whether use of the device was burdensome (practicality/time) and opinions on feasibility of the tool.
- Evaluate clinicians' opinions about advantages/disadvantages of the device
- Evaluate the indications for episiotomy in Townsville Hospital
- Assess patients' attitudes surrounding episiotomy and use of Episiometer

Given the primary aim for this study is to gather feedback from clinicians, there will be multiple information sessions held to inform them about the Episiometer and how it is used. The attendance at these information sessions will be voluntary, and they will be undertaken in morning, afternoon and evening sessions such that all staff should be available to come to at least one session. Four information sessions will be run within two weeks after receiving approval, in order to educate the clinicians about the trial and the opportunity to be involved should they wish to be. There will then be one information session every week - alternating between targeting doctors and midwives given their different meeting times. During this information session, there will be an informative slideshow, handouts (flow-charts illustrating how the study will run) as well as an opportunity to practice using the Episiometer on mannequins. The information sessions will run for approximately 30 minutes and clinicians will be able to stay afterwards to practice using the Episiometer if they wish. Dr. Harsha Ananthram and Brittany Van Der Lugt will be running these information sessions. Dr. Harsha Ananthram is a consultant obstetrician and gynaecologist at the Townsville Hospital, he has trained for several years in Townsville and is well known by all of the doctors and midwives. Brittany Van Der Lugt is the fifth year medical student (at James Cook University) who will assist in running these sessions, such as informing the clinicians on which forms should be filled in, discussing where to put the forms (i.e consent forms) when completing them. She is an honours research student who has played a significant part in designing the study.
There will also be an instruction sheet on how to use the Episiometer that will be available for clinicians to read at any point in time, should they not be able to attend the information sessions but still want to be involved in the study/trial the Episiometer.
In the recruitment of patients on whom the Episiometer will be used, we have a thorough information sheet about the Episiometer and the study, as well as contact details available should they have any questions. Due to many of the clinicians also being educated about the trial and the Episiometer, they will also be able to provide answers to any initial questions that the patients will have.

The clinicians who will use the Episiometer will include midwives who have performed episiotomies in the past, as well as resident doctors practicing in obstetrics, obstetrics registrars and consultants in obstetrics and gynaecology. Performing an episiotomy at the Townsville Hospital is a procedure that is usually undertaken by the most skilled person available, and if not, a junior member of staff (such as a junior midwife or junior doctor) is normally closely supervised by a senior member of staff. This is a principle that would continue throughout the trial, and if a junior member of staff does not feel comfortable performing a standard episiotomy, they will not be asked to perform an episiotomy using the Episiometer. However, doctors that will be performing the 6-8 week follow-up in the gynaecology clinic will not need to be proficient in performing episiotomies, and it is only required that they understand how to perform an appropriate intimate genital examination to inspect for any complications of the episiotomy that was performed.

The mode of delivery will be the application of the Episiometer to the perineum in each individual woman. This will occur individually, not in groups. Each clinician that uses the Episiometer, as well as the assisting doctor or midwife, will be asked to fill out a Clinician survey to provide feedback on the device.

- The Episiometer will be used on 50-100 women, depending on the number of clinicians who use the Episiometer - as we require at least 30 who have positive opinions on the device and at least 30 who have negative opinions on the device such that the results are statistically significant. The Episiometer trial will likely be running over 18 months, with the aim to compete data collection by September 2018.

The Episiometer will be used at The Townsville Hospital (a regional hospital in North Queensland) in the Birth Suite. The Episiometer will only be used for women who already require an episiotomy.
The intervention will not be personalised or titrated for each patient - the same Episiometer design will be used for every patient.
Intervention adherence or fidelity will not be assessed.
Intervention code [1] 298485 0
Treatment: Devices
Comparator / control treatment
No control group in the initial feasibility study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302592 0
Assess feedback from clinicians (defined as ‘doctors and midwives’) about:
1. Perceived ease of use
Timepoint [1] 302592 0
After a minimum of 60 clinicians have used the device (must have at least 30 clinicians who have negative views and 30 who have positive views for statistical significance) when performing a minimum of 60 episiotomies.
There will be a question on the Clinician Feedback Survey (using a Likert scale) which asks the clinician about ease of use.
Primary outcome [2] 302655 0
2. Whether use of the device was burdensome (i.e. practicality, time etc.) and advantages/disadvantages of using the device (composite primary outcome)
Timepoint [2] 302655 0
After a minimum of 60 clinicians have used the device (must have at least 30 clinicians who have negative views and 30 who have positive views for statistical significance) when performing a minimum of 60 episiotomies.

Practicality/time - questions about whether they believe it would be practical for a younger member of staff to use if they are still learning to get an accurate angle/length of episiotomy?
Time - did it take longer/same/less time than normal to perform an episiotomy using the Episiometer?
Advantages/disadvantages - open ended questions, as well as a question of 'was the delivery/birth complex?' and finding a correlation between complexity/difficulty of birth and negative/positive opinion of the clinician toward the device.
Primary outcome [3] 302656 0
3. Opinions on feasibility of the tool (accuracy for performing mediolateral episiotomy)
Timepoint [3] 302656 0
After a minimum of 60 clinicians have used the device (must have at least 30 clinicians who have negative views and 30 who have positive views for statistical significance) when performing a minimum of 60 episiotomies.
- Questions (Likert scales) asking how accurate they think the device is.
Secondary outcome [1] 336458 0
1. Assess patients’ attitudes surrounding episiotomy and use of the Episiometer (composite outcome)
Timepoint [1] 336458 0
After the device has been used on at least 50, (50-100) patients - as approved by HREC
- On Patient Immediately Postpartum survey and 6-8 week surveys asking their opinions on episiotomy (using Likert scales) and their opinion toward the device, as well as open ended questions asking about experiences with possible previous episiotomies,
Secondary outcome [2] 336459 0
2. Patients reporting complications experienced following episiotomy at a 6-8 week follow-up (after use of the Episiometer)
Timepoint [2] 336459 0
After the device has been used on at least 50, (50-100) patients - as approved by HREC.
Patients will be able to choose from a set list of possible complications on the 6-8 week postpartum follow-up survey. There will be a box that they can tick if they have not experienced any of those listed, labelled 'Other', which they can tick, and can write this complication in dedicated open comments section.
Secondary outcome [3] 336683 0
3. Understanding current methods used at the Townsville Hospital (and in any clinical setting where the clinician has previously worked) to teach staff how to perform an episiotomy.
Timepoint [3] 336683 0
A minimum of 60 clinicians who have used the device or assisted on an episiotomy where the Episiometer was used (must have at least 30 clinicians who have negative views and 30 who have positive views for statistical significance) are required to fill out the Clinician Surveys. There is an open comments section asking about current methods used to teach staff how to perform an episiotomy.
The information gathered from these surveys will be collated, and an interview question grid will be constructed. This question will be included, in order to find out other methods used to train midwives and doctors when learning how to perform an episiotomy. On the survey, clinicians are asked whether they would mind being part of the interview process and to write their contact details on the form. From these clinicians, we will create a randomly stratified sample, where each role (midwife or doctor) and each range of experience is represented in the interview sample as in the total population of clinicians who used the Episiometer. The interview answers will then by analysed using thematic analysis.
Secondary outcome [4] 336684 0
4. Comparing patient's opinions of the device with birth outcomes
Timepoint [4] 336684 0
After the device has been used on at least 50, (50-100) patients - as approved by HREC.
The patient's opinions are first assessed within 48 hours post-episiotomy, and then again at a 6-8 week follow-up appointment.
Investigators will access the patient's medical file (accessing only the very necessary entries) and assessing the birth outcomes (was there additional tearing associated with episiotomy, was there excessive bleeding caused by the episiotomy, significant pain associated with the episiotomy etc.) in comparison to how the patient viewed how the episiotomy was performed and their opinion of the device. The patient's opinions will be gathered through both Likert scales and open ended questions asking about the device.
Secondary outcome [5] 352064 0
Compare the incidence of patient outcomes and complications with the Episiometer compared to patient outcomes for episiotomy without the Episometer during the same time period at The Townsville Hospital.
Timepoint [5] 352064 0
After we have compared all patients at TTH who received an episiotomy during the same study period time as the study sample utilising the Episiometer - as approved by PHA/HREC/SSA.

Eligibility
Key inclusion criteria
PATIENTS - PREGNANT WOMEN FOR PLANNED VAGINAL DELIVERY:
The inclusion criteria for this study includes all women presenting for antenatal care at The Townsville Hospital who are expected to deliver at The Townsville Hospital. We would aim to introduce women to this project if they are at 28 weeks gestation or beyond.
The women need to be able to give valid informed consent to participate.

Participants must be 18 years or older to be able to give consent.

Women whose primary language is not English are likely to be coincidentally recruited, but women who do not have sufficient English language skills to understand the study's aims, risks and benefits, will not be able to give valid consent.

Women who clinicians believe to be unable to consent (i.e mentally incapable) can still participate, as we have produced a patient carer information and consent form which can be filled in on their behalf.

CLINICIANS:
Clinical staff at the Townsville Hospital - working in either the antenatal cliic or the birth suite.
These include doctors (obstetricians, registrars, medical residents) and midwives - all individuals at the TTH who are qualified to perform an episiotomy.
These are the clinicians who will be performing the episiotomy and using the Episiometer itself.
Due to this being a new device, we wish to interview a number of these health professionals on their opinions about the Episiometer, whether the felt it was accurate, improvements, and how it may have complemented their own methods for ensuring an accurate angle and length for performing a mediolateral episiotomy.

Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
PATIENTS:
l Children and/or young people (ie. <18 years)
2 People with an intellectual or mental impairment, where judgement of the participant's mental capacity is made by the clinician WHO DO NOT HAVE A GUARDIAN/CARER (as there is also a Patient Guardian/carer information sheet conveying the same information as the Patient Information Sheet, but in a way that would allow a guardian/carer to consent for the participant - using the same normal consent form).
3. Patients who do not speak English and are unable to give consent.

CLINICIANS:
1. Doctors or midwives who have not performed an episiotomy before or do not feel comfortable performing an episiotomy.




Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not a randomised controlled trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis
QUANTITATIVE ANALYSIS - analysis of data collected through surveys from both clinicians and patients
1. Univariate analysis to describe participant demographics and responses (frequency analysis, mean & standard deviation)
2. Bivariate tests to determine factors associated with stakeholders having a positive/negative attitude to using the Episiometer (via chi-square tests, t-tests or Mann-Whitney tests, as appropriate)
3. Binary logistic regression to determine independent predictors of stakeholders having a positive/negative attitude to using Episiometer.

QUALITATIVE ANALYSIS for the data collected through the interviews with clinicians
NVIVO
Thematic analysis with conceptual analysis is widely used and is the process of identifying implicit and explicit terms within the text (Thomas 2010)

Free text in the comments section of the surveys will be thematically analysed and aid in the development of the interview questions


Unable to calculate sample size - descriptive study
Sample size for clinicians determined by WHO suggestion/literature - 30 in each group ( at least 30 who have negative opinions about the Episiometer, at least 30 who have positive opinions)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/07/2017
Actual
1/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2018
Actual
Sample size
Target
120
Accrual to date
100
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8458 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 16540 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 296856 0
University
Name [1] 296856 0
James Cook University
Country [1] 296856 0
Australia
Primary sponsor type
Individual
Name
Professor Ajay Rane
Address
Mater Pelvic Health Education and Research Unit
The Mater Hospital
21-37 Fulham Rd, Pimlico QLD, Australia 4812
Country
Australia
Secondary sponsor category [1] 295862 0
None
Name [1] 295862 0
Address [1] 295862 0
Country [1] 295862 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298084 0
Townsville HHS Human Research Ethics Committee
Ethics committee address [1] 298084 0
Ethics committee country [1] 298084 0
Australia
Date submitted for ethics approval [1] 298084 0
20/03/2017
Approval date [1] 298084 0
12/06/2017
Ethics approval number [1] 298084 0
HREC Reference number: HREC/17/QTHS/37

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

Contacts
Principal investigator
Name 75942 0
Prof Ajay Rane
Address 75942 0
Obstetrics and Gynaecology Department, The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, Aus 4814
Country 75942 0
Australia
Phone 75942 0
+61 7 4781 4111
Fax 75942 0
Email 75942 0
[email protected]
Contact person for public queries
Name 75943 0
Brittany Van Der Lugt
Address 75943 0
James Cook University, Clinical School
The Townsville Hospital
100 Angus Smith Drive,
Douglas, QLD, 4814
Country 75943 0
Australia
Phone 75943 0
+61427019182
Fax 75943 0
Email 75943 0
[email protected]
Contact person for scientific queries
Name 75944 0
Brittany Van Der Lugt
Address 75944 0
James Cook University, Clinical School
The Townsville Hospital
100 Angus Smith Drive,
Douglas, QLD, 4814
Country 75944 0
Australia
Phone 75944 0
+61427019182
Fax 75944 0
Email 75944 0
[email protected]

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