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OASI Care Bundle Project: FAQs

Frequently asked questions about the OASI Care Bundle Project

About the care bundle

Elements of the care bundle

Hands on and Manual Perineal Protection

Modes of delivery

Episiotomies

Diagnosis and per rectum examinations

Women and the care bundle

Evaluation of the care bundle

 

About the care bundle

What is a care bundle?

The US Institute for Healthcare Improvement (IHI) originally developed care bundles to describe a collection of interventions needed to effectively and safely care for patients. They define a care bundle as a small set of evidence-based interventions for a defined patient segment or population and care setting that, when implemented together, will result in significantly better outcomes than when implemented individually. 

What does the care bundle consist of? 

The elements of the bundle include speaking with the woman about her risk and Obstetric Anal Sphincter Injury (OASI) and communicating with her during the birth to enable a slow controlled birth of the baby, performing an episiotomy (a cut in the perineum to assist birth and prevent tears) when required, using the hands to enable perineal protection at the time of birth and a thorough examination after birth to detect tears, not all of which will be immediately obvious.

The introduction of the care bundle follows training using a specially developed manual, videos and simulations. Professionals from the participating units will receive training from the project team. They in turn will provide training for all midwives and obstetricians in the participating units.

How was the OASI care bundle developed and who was involved in its development?

A systematic review of intrapartum interventions used to reduce the rate of OASI was conducted. This process involved the extraction of data from randomised controlled trials (RCTs) using comprehensive search strategies within EMBASE, Ovid MEDLINE, the Cochrane Library, the Maternity and Infant Care database and CINAHL. Following this, a review of the non-RCT literature was conducted identifying studies that considered the effect of various interventions on OASI rates. The results from these reviews were presented to the OASI Care Bundle project team of clinical experts for consideration in the final care bundle.

The final interventions selected for inclusion within the pilot OASI Care Bundle were based on the expert consensus of obstetricians and midwives in the OASI Care Bundle project team. In addition to the quality of evidence, other factors such as feasibility and patient acceptability facilitated the selection process.

How does the OASI Care Bundle differ from other projects such as the PEACHES Care Bundle?

The OASI Care Bundle is a Quality Improvement Project that is being implemented nationally in 16 sites across England, Scotland and Wales. The project will be evaluated through qualitative and quantitative data in terms of its implementation outcomes as well as the primary outcome, OASI rates. The OASI Care Bundle was developed by the RCM and the RCOG through a systematic review of intrapartum interventions, the results from which were presented to a panel of clinical experts for consideration in the final list of care bundle interventions. The final interventions selected for inclusion within the care bundle were based on expert consensus using this information. In addition to the high quality of evidence, other factors such as feasibility and acceptability to women facilitated the selection process.

The four interventions selected need to be implemented consistently together to enable significantly better outcomes. The care bundle is supported by a multi-disciplinary skills development module and an awareness campaign targeting clinicians and expectant mothers.

Has the care bundle been piloted? 

The care bundle and skills development module have been piloted in 2 units. This was to determine if using a care bundle for this aspect of labour care was feasible and acceptable to women and maternity professionals. The learning from the pilot study informed the design of the Health Foundation funded project that began in May 2016.

What are the project team's thoughts on the recently updated Cochrane review – Aaseheim et al.'s 'Perineal techniques during the second stage of labour for reducing perineal trauma'?

The updated review contains 22 trials (randomised and quasi-randomised controlled trials) which includes 12 new trials and 2 previously excluded trials. Included trials have various primary outcomes including: Perineal trauma requiring suturing, frequency of perineal trauma, perineal pain, need for episiotomy and severity of perineal trauma.

In terms of hands on vs. hands off/poised there were 2 new studies included in the review: Foroughipour (2011) and Rezaei (2014). Both of which reported that perineal trauma was slightly reduced in the ‘hands off’ group. However, Cochrane has graded this evidence as low quality as the treatment effect is not clear and there was substantial heterogeneity. It is noted that it is very hard to ensure that practitioners fully comply with ‘hands off’ as they are able to use their clinical judgement and intervene when they feel it necessary. Additionally, as found in the 2011 review, the authors note that the terms ‘hands on’, ‘hands off’ and ‘perineal support’ all mean very different things in all the included studies. Similarly, that ‘hands on’ techniques are poorly described.

In terms of warm compresses, 4 studies are included. Use of warm compresses were found to have a reduction in the average number of OASI and this is graded as moderate quality. The control group for warm compresses for one study was hands off, or no warm compresses, so different to disentangle what effect ‘no hands on’ may have.

All in all, the update review states that ‘the overall conclusions have not changed’ and that further research is needed to evaluate perineal techniques. The need to collect information on women’s views is also highlighted – our project looks to address both of these.

Are breech births eligible for use of the OASI Care Bundle?

Vaginal breech births are not eligible for the Care Bundle and should be delivered in accordance to the RCOG guidelines.

Read "Management of Breech Presentation" (Green-top Guideline No. 20b)

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Elements of the care bundle

Why do I have to ensure that all four components of the care bundle have been used for it to be compliant?

A care bundle is a small set of evidence-based interventions that, when implemented together, will result in better outcomes than when implemented individually. It is therefore important that all four elements are used consistently for all eligible births.

Can warm compresses still be used?

Warm compresses were identified in the systematic review which was carried out when developing the care bundle. Due to the quality of the evidence, there was much discussion around including warm compresses; however, due to the wide variation in practice (whether the compress is held continuously, what is used for the compress, the temperature, and when it is re-heated) it was decided that the clinical practicalities of ensuring standardisation made it unfeasible to include as a component of the care bundle. We also realised that many units were unable to ensure that warm packs could be heated to the required temperature due to constraints on access to reliable sources of heat.  However, in units where they are available, we still recommend that warm compresses should be offered to women during the second stage of labour, if this is acceptable to the woman.

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Hands on and Manual Perineal Protection

My normal practice is to be hands poised, why should I change my practice?

Evidence from Scandinavia has shown that using manual perineal protection can reduce the incidence of OASI. This, in combination with the other elements of the care bundle, has been shown to reduce the rates of OASI. If a woman chooses not to have manual perineal protection, her choice should be respected but the birth will not be compliant with the care bundle.

My normal practice is ‘hands on’. What is different about Manual Perineal Protection (MPP) and do I still need to seek training?

For this project, we are teaching an evidence-based technique, the Finnish Grip. We ask that this technique is consistently used in those units participating in the OASI Care Bundle project. If your practice is already ‘hands on’, you will still need to seek training in the care bundle to ensure that your technique is consistent with that being taught.

Why should I use Manual Perineal Protection when the HOOP trial showed that hands on showed no improvement for perineal outcomes?

The findings of the HOOP trial have often been interpreted as suggesting that the ‘hands on’ approach, adopted by many midwives, was inconsequential in preventing perineal trauma. The HOOP trial studied the effect of hands on or poised at delivery on perineal pain, rather than perineal trauma. It is therefore not a reliable source of evidence by which to base decisions to practice hands on or hands poised in relation to reducing incidence of, and severity of, perineal tears.

I don’t feel comfortable performing MPP when a women is on all fours/standing. Should I ensure that she moves position?

A woman should be able to mobilise freely during the birth so that she is as comfortable as possible. The care bundle includes training in MPP with the woman in different positions.

If the students I mentor are taught ‘hands off’ at university, what should I do?

For the participating sites, the aim is for all Midwives and Obstetricians to be trained and use the ‘Finnish Grip’ MPP technique. If a student has not been taught to practice ‘hands on’ in this particular way, they should be advised to seek out a local Champion for training. The local Champion will explain the rationale and evidence for the use of the technique. The student will be asked to practice the technique consistently during their time in the unit.

Will using the Manual Perineal Protection technique create discomfort in my hands and wrists?

When done correctly, the Manual Perineal Protection technique should not cause any discomfort. The technique is only used for a short period, during the delivery of the baby. If you do find that you are experiencing discomfort, ask a colleague or one of your local champions to observe your next delivery and see how your technique or positioning might be able to be adjusted. 

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Modes of delivery

Is the care bundle tailored according to mode of delivery, i.e. unassisted and assisted?

The care bundle is focused on all vaginal births in order to reduce the incidence of OASI among all women. The same interventions apply to all women who give birth vaginally, but the technique for manual perineal protection will differ depending on whether the birth is unassisted or assisted, and depending on the birth position of the women.

Furthermore, an episiotomy (at 60 degrees at crowning) will only be performed when indicated. (The project excludes the management and prevention of OASI resulting from gynaecological/urological procedures. It also excluded considerations on repair techniques and related co-morbidities).

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Episiotomies

I do not really ever do episiotomies, why do I need further training?

We are asking that all Midwives and Obstetricians within participating units are trained in all elements of the care bundle to ensure that they are confident and skilled in the techniques. We appreciate that some Midwives rarely perform episiotomies, but it is important that they should feel comfortable performing one should the situation arise. For this care bundle, we ask that clinicians perform an episiotomy when there is fetal distress and the birth needs to be expedited and also when it is thought that a severe tear is imminent, as well as for all forceps deliveries.

Why have you chosen to teach episiotomies at a 60 degree angle at crowning?

The aim is for the sutured episiotomy to be at 45 degrees from the midline after delivery. For this to happen the incision needs to be made at an angle of 60 degrees from the midline at the point of crowning of the head. Research has shown that using mediolateral episiotomy when required, at an angle of 60 degrees from the midline at crowning, significantly reduces the change of anal sphincter injury. There is evidence that when the episiotomy is performed at 45 degrees at crowning it measures at 22.5 degrees after delivery.

Are Episcissors-60 part of the project?

No, Episcissors-60 are not part of the project, but for those units who do use them they may help with episiotomies being performed consistently at 60 degrees at crowning and clinicians may find them easier to use than normal scissors.

I am concerned that the OASI Care Bundle will greatly increase our episiotomy rate in our hospital

We will be monitoring each hospital’s episiotomy rates on a weekly basis throughout the implementation phase to ensure that these rates do not increase unnecessarily. Episiotomies should never be a ‘routine’ intervention to reduce the risk of OASI and should only be carried out after clinical assessment of the fetal and maternal risks. The indication for an episiotomy should be recorded in the woman’s notes.

When indicated, a mediolateral episiotomy should be performed at a 60-degree angle to the midline at crowning. There is little evidence to support the routine use of episiotomy for an unassisted birth; however, there is some evidence that episiotomy reduces the risk of OASI during instrumental delivery. In the context of this care bundle, episiotomy is indicated in cases of fetal distress, delayed second stage of labour, instrumental delivery, and in cases when a severe perineal tear is judged to be imminent – feel digitally for remaining space/stretch and observe whether blood flow to the perineum appears significantly reduced. 

An episiotomy should be used for all term forceps and ventouse/kiwi births in nulliparous women. In multiparous women, an episiotomy should also be used for all term forceps births, but may be omitted with a ventouse birth after considering and discussing the woman’s risk of sustaining an OASI.

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Diagnosis and per rectum examinations

How do I perform a per rectum check?

Obtain informed consent to perform the examination. With good communication, including an explanation of the importance of the need to perform a per rectum examination, most women will consent to you performing the examination. Make sure you document in the notes that you have performed a PR check before and after repair of perineal trauma (in the presence of such an injury). Make sure there is good lighting and good access and the woman has adequate pain relief. Insert the lubricated index figure into the anal canal to the 2nd joint. Feel anteriorly above the sphincter (the sphincter complex is only 2.5cms long) and ensure there is no damage to the rectal mucosa. At this point just above the sphincter the normal anatomy will feel quite thin. Withdraw the index finger slowly whilst placing the thumb in the vagina, and systematically palpate the anal sphincter using a pin rolling motion starting at 9 o’clock and palpating along the sphincter until the 3 o’clock position. Swab the area and look carefully and feel for any damage. If you are not sure what you are feeling ask another clinician to check.

Why should you perform a per rectum check on woman, even when the perineum appears intact?

Anal sphincter injury after vaginal delivery is not always immediately obvious and can occur even in presence of an intact perineum. Therefore, it is recommended that to ensure an OASI is not missed, all women who give birth vaginally should have a per rectum examination after a vaginal birth to ensure the integrity of the anal sphincter muscles. This also ensures that all tears, including those above the sphincter and involving the rectal mucosa, are diagnosed. When a woman suffers a third degree or fourth degree tear the clinician at delivery is not usually at fault. However, failure to diagnose a third or fourth degree tear is regarded as negligent. Damage to the anal sphincter must be ruled out for every woman who has a vaginal birth. Failure to do this is the leading cause of negligence claims amongst women who present with ‘missed’ third or fourth degree tears. Compensation for women varies according to their symptoms, but recent cases show that it is approximately £200,000.

Why have you asked us to perform a per rectum examination on every woman after a vaginal birth?

Per rectum examinations are the only way to confirm whether a woman has not suffered a third or fourth degree tear and accurately classify the tear. Through the OASI Care Bundle, we hope to ensure that no third or fourth degree tears, including button hole tears, are left undetected and ask that every woman who has given birth vaginally is examined. Participating units will be trained in performing per rectum examinations to ensure that these are carried out in a consistent manner and with a high level of knowledge of the anatomy involved.

Will we see more labial and urethral tears as a result of implementing the care bundle?

It may be that an increase is seen in these types of tear once the majority of the unit are using the care bundle interventions. As part of the evaluation we will look at all types of tears that are sustained during vaginal births and these results will be available mid-2018. Although ideally all tears would be avoided, anterior tears are usually more straightforward to repair than a third or fourth degree tear and do not have severe long term effects on the woman.

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Women and the care bundle

How do I know if the woman has been informed about the care bundle?

We are asking that all women are informed about their risks of perineal trauma and the OASI care bundle at their 32-36 week ante-natal appointment when speaking about her birth plan. This discussion should be documented in her notes. If possible, the care bundle should be discussed again when she is in labour. If the woman is not spoken to about her risks and the project, her birth is not compliant with the care bundle.

Do women need to give consent to receive the care bundle?

One of the four interventions of the care bundle includes communicating to women about their risks of OASI and about the care bundle. When they are discussing their birth plan at 32-36 weeks, the use of the care bundle in the unit should be discussed and, if this does not conflict with her birth plan and she does not object to any elements of it, it should be used. It is important to communicate with women throughout their birth experience so that they can make informed decisions. The care bundle uses evidence-based techniques and therefore should not pose any adverse risks to women.

Does the woman need to be semi-recumbent on the bed to have the care bundle?

No, manual perineal protection can be used in whatever position a woman chooses to be in. The only women not eligible for the care bundle are those who choose to give birth in a very upright position (where it is impossible to give MPP) or give birth in water. It is important that the woman feels free to mobilise during her labour. Should the clinician feel that a woman is particularly at risk of severe perineal trauma, they may wish to suggest some positions above others that allow a good visualisation of their perineum and a slow and controlled birth. The MPP is only given at crowning, so all the benefits of mobilising and staying upright in the second stage of labour still apply.

Will the project restrict women’s choices, discourage water births or birth positions where perineal protection cannot be used?

A key element of the project involves encouraging clinicians to listen to the woman’s choice for position of birth. At the same time it is important that all clinicians keep the woman informed of risks related to her birth.

The project is not intending to prescribe a woman’s position for birth or restrict her movement. The aim is to evaluate how perineal trauma can be avoided. Clinicians can use the evidence to support and advise women about their choice of birth position. The care bundle interventions can be used with women in most positions. Ultimately, the choice is always the woman’s, armed with the best available information.

Is there lay representation on the project?

The care bundle was developed with an expert clinical team and a workshop was held with the RCOG Women’s Network who were consulted on the project. As a result of the workshop, we were able to ensure that the resource for women for the OASI Care Bundle was clear, concise and relevant to women. We also have two lay members who are part of our Advisory Group who are able to feed back about all developments in the project.

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Evaluation of the care bundle

How will we know if the implementation of the care bundle works?

The care bundle has been piloted in two units. Now, with funding from the Health Foundation, we are scaling up the programme to a further 16 sites and will be working closely with them to evaluate the feasibility, acceptability and effectiveness of the OASI Care Bundle quality improvement programme at each of the maternity units.

Will the care bundle change midwifery practice in Great Britain?

The different interventions within the care bundle are all practices which clinicians will already use in their day to day practice that, when implemented together, will result in significantly better outcomes than when implemented individually. The next stage of the programme is to ‘scale up’ to a further 16 sites in the England, Wales and Scotland. Through working with these maternity units, we want to evaluate the care bundle’s efficacy as well as look at the feasibility and acceptability of the programme. The sites that we are working with have agreed to implement the care bundle. Following which, we will evaluate whether or not the care bundle can be implemented nationally.

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Are breech births eligible for use of the OASI Care Bundle?

Vaginal breech births are not eligible for the Care Bundle and should be delivered in accordance to the RCOG guidelines. https://www.rcog.org.uk/globalassets/documents/guidelines/gtg-no-20b-breech-presentation.pdf    

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