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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]

Nil known

Universal Trial Number (UTN)

U1111-1198-5330

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Episiotomy

Labour

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Surgery

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]

Treatment: Devices

Comparator / control treatment

No control group in the initial feasibility study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Assess feedback from clinicians (defined as ‘doctors and midwives’) about:
1. Perceived ease of use

Timepoint [1]

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]

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]

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]

3. Opinions on feasibility of the tool (accuracy for performing mediolateral episiotomy)

Timepoint [3]

Secondary outcome [1]

1. Assess patients’ attitudes surrounding episiotomy and use of the Episiometer (composite outcome)

Timepoint [1]

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]

2. Patients reporting complications experienced following episiotomy at a 6-8 week follow-up (after use of the Episiometer)

Timepoint [2]

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]

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]

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]

4. Comparing patient's opinions of the device with birth outcomes

Timepoint [4]

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]

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]

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]

The Townsville Hospital - Douglas

Recruitment postcode(s) [1]

4814 - Douglas

Funding & Sponsors

Funding source category [1]

University

Name [1]

James Cook University

Address [1]

The Townsville Hospital - Obstetrics and Gynaecology Department
100 Angus Smith Drive,
Douglas, QLD, 4814

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Townsville HHS Human Research Ethics Committee

Ethics committee address [1]

Postal: 
Research Support Unit
IMB 52, PO Box 670
Townsville QLD, Australia 4810
Office: 
JCU Clinical School
1st Floor 
The Townsville Hospital
100 Angus Smith Drive,
Douglas, QLD, Australia, 4814

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/03/2017

Approval date [1]

12/06/2017

Ethics approval number [1]

HREC Reference number: HREC/17/QTHS/37

Summary

Brief summary

Episiotomy is the most common obstetric operation, which consists of a surgically placed incision on the perineum and posterior vaginal wall. The operation is usually performed at the height of contraction when the birth is imminent or in attempt to shorten the second stage of labour for a foetal indication such as foetal distress, or a maternal indication, such as previous or underlying cardiac disease or potential obstetric anal sphincter inujuries.
Midline episiotomy (where an incision is made from the posterior vagina in a vertical line toward the anus) is a known risk factor for obstetric anal sphincter injuries, leading obstetricians and midwives to prefer the use of mediolateral episiotomy (incision at 30-60 degrees).

There has been found to be remarkable variation in the techniques and indications for episiotomy amongst midwives and obstetricians which may alter the consequences of a mediolateral episiotomy. While the technique of performing a mediolateral episiotomy is generally understood by accouchers, there are currently no standard guidelines or measurement tools to guide obstetricians and midwives in the length and angle of their incision.

To standardised length and angle of episiotomy, Professor Rane developed a prototypal tool, called the 'Episiometer'. The Episiometer is made of transparent paper, the device is then sterilised, and is applied to the perineum to assist the clinician in measuring the angle of the episiotomy incision, given the clinical decision is made to proceed to episiotomy.

This feasibility pilot study aims to find whether the Episiometer is a helpful tool for accouchers performing episiotomy and acceptable for women having an episiotomy performed.

Primary objectives/outcomes:
Assess feedback from clinicians (defined as ‘doctors and midwives’) about:
1.Perceived ease of use
2.Whether use of the device was burdensome (i.e. practicality, time etc.)
3. Opinions on feasibility of the tool (accuracy for performing mediolateral episiotomy)
4. Indication for performing episiotomy at the Townsville Hospital
5. Evaluate clinicians’ opinions about advantages/disadvantages of the device

Secondary objectives/outcomes: 
1.	Assess patients’ attitudes surrounding episiotomy and use of the Episiometer
2.	Patients reporting complications experienced following episiotomy at a 6-8 week follow-up (after use of the Episiometer)
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.
4.	Comparing patient's opinions of the device with birth outcomes
Research questions: 
-Is the Episiometer is easy to use OR does it interfere with standard of practice?
-Do clinicians find the visual guidance that the Episiometer provides to be helpful and beneficial?
-What are the advantages/disadvantages/limitations of having a visual device such as this one? 
-Can the Episiometer be used in everyday practice?

Trial website

Trial website: 
http://www.researchweb.org/info/index.php/jcu/document/208851

Trial related presentations / publications

None yet

Public notes

Contacts

Principal investigator

Name

Prof Ajay Rane

Address

Obstetrics and Gynaecology Department, The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, Aus 4814

Country

Australia

Phone

+61 7 4781 4111

Fax

ajay.rane@jcu.edu.au

Contact person for public queries

Name

Brittany Van Der Lugt

Address

James Cook University, Clinical School
The Townsville Hospital
100 Angus Smith Drive,
Douglas, QLD, 4814

Country

Australia

Phone

+61427019182

Fax

brittany.vanderlugt@my.jcu.edu.au

Contact person for scientific queries

Name

Brittany Van Der Lugt

Address

James Cook University, Clinical School
The Townsville Hospital
100 Angus Smith Drive,
Douglas, QLD, 4814

Country

Australia

Phone

+61427019182

Fax

brittany.vanderlugt@my.jcu.edu.au

No information has been provided regarding IPD availability

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No Supporting Document Provided

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