the university of hong kong - school of nursingnursing.hku.hk/dissert/uploads/kwok lai ming.pdf ·...

The University of Hong Kong

Li Ka Shing Faculty of Medicine

School of Nursing

Master of nursing

Year 2

Final

Dissertation

Name: Kwok Lai Ming Student ID: 2005603730

Supervisor: Dr Janet Wong Submission Date: 15 th August, 2013

P.1

Abstract of thesis entitled

An evidence-based guideline of using perineal massage

in the second stage of labor for reducing perineal trauma

Submitted by

Kwok Lai Ming

For the degree of Master of Nursing

at The University of Hong Kong

in July 2014

Perineal trauma is commonly experienced by women during birth especially for

those who has their first time delivery. It can be either resulted from spontaneous laceration or

episiotomy.

Apart from restricting the use of episiotomy, perineal massage in second stage of

labour has shown to be a protective technique to perineum. Massaging and stretching the

perineum in a sweeping motion helps to promote vasodilation, elasticity and relaxation of

perineal tissue and thus prevents tearing and need for episiotomy.

The dissertation aims to evaluate the current evidences on the effectiveness of

perineal massage in the second stage of labour for reducing perineal trauma and to develop an

P.2

evidence-based guideline for midwives to perform perineal massage during labour in addition

to assess its implementation potential and to design implementation plan and evaluation plan

for its application in a local public hospital in Hong Kong.

A systematic search of literature identified 7 eligible articles on perineal massage

during second stage of labour and quality assessment of the studies was performed by using

the Scottish Intercollegiate Guidelines Network (SIGN) checklists. Evidences were

synthesized and summarized in the table of evidence and three recommendations were made.

First, perineal massage during second stage decreased the rate of episiotomies and increase

chance of intact perineum. Second, perineal massage was initiated when the cervix 10cm

dilated. Third, the duration of perineal massage would be more beneficial if carried out more

than 10 minutes.

An evidence-based guideline for performing perineal massage during labour was

then developed. A pilot plan was established by assessing its transferability, feasibility and

cost-benefit ratio of the innovation. An evaluation plan was developed to assess the

acceptance of the innovation and the effectiveness of the innovation in achieving the expected

outcomes on women and midwives.

Sincerely hope that the innovation can be implement in Hong Kong to reduce the

perineal trauma in women by midwives and to keep the episiotomy rate below 30% as

recommended by Argentine Episiotomy Trial Collaborative Group.

P.3

An evidence-based guideline of using perineal massage

in the second stage of labor for reducing perineal trauma

By

Kwok Lai Ming

BNurs (HKU), RN(HK), RM(HK)

A dissertation submitted in partial fulfillment of the requirements for

the degree of Master of Nursing

at The University of Hong Kong.

July 2014

P.4

Declaration

I declare that this thesis represents my own work, except where due acknowledgement is

made, and that it has not been previously included in a thesis, dissertation or report submitted

to this University or to any other institution for a degree, diploma or other qualifications.

________________________________________

KWOK LAI MING

P.5

Acknowledgement

I would like to express my grateful thank and sincere appreciation to my supervisor,

Dr Janet Wong for her encouragement and guidance throughout the program. During the past

year, she has provided me inspirational advices and insightful comments when I am

bewildering. This dissertation would not be accomplished smoothly and successfully without

her support and enlightenment.

I would also like to heartily thank Dr. William Li for his patience, understanding

and encouragement when there was an incident in the beginning of the dissertation. He was

very caring and encouraging when I am in complete perplexity. Without his support, this

dissertation would not be possible.

Besides, I am also greatly thankful to my dearest friends when I am in frustration

between work and study. Thanks for being there for supporting and listening. Last but not

least, a biggest thank to my boyfriend Man Ho Lei for his understanding, supporting and

incentivizing throughout the program without which I would not have been able to complete

my dissertation. I am blessed to have you all in my life.

P.6

Table of Contents Abstract ...................................................................................................................................... 1

Declaration ................................................................................................................................. 4

Acknowledgement ...................................................................................................................... 5

Table of Contents ....................................................................................................................... 6

Chapter 1: Introduction ........................................................ 8

1.1 Background ....................................................................................................................... 8

1.2 Affirming the need ............................................................................................................ 9

1.3 Objectives and Significance ........................................................................................... 12

Chapter 2: Search and Appraisal Strategies ................... 14

2.1 Identification of studies .................................................................................................. 14

2.12 Data extraction

2.13 Appraisal straegies

2.2 Results ............................................................................................................................ 21

2.3 Summary and Synthesis .................................................................................................. 23

Chapter 3: Implementation potential ............................... 25

3.1 Target setting .................................................................................................................. 26

3.2 Target audience ............................................................................................................... 26

3.3 Transferability of the findings ........................................................................................ 27

3.4 Feasibility ....................................................................................................................... 29

3.5 Cost-benefit ratio of the innovation ................................................................................ 33

P.7

Chapter 4: Developing evidence-based practice guideline…35

4.1 Evidenced-based practice guidelines .............................................................................. 35

4.2 Guideline title ................................................................................................................. 35

4.3 Aim of guidelines ........................................................................................................... 35

4.4 Objectives of the guideline ............................................................................................. 35

4.5 Target group.................................................................................................................... 36

4.6 Major outcomes .............................................................................................................. 36

4.7 Recommendations........................................................................................................... 36

Chapter 5: Implementation plan ...................................... 38

5.1 Introduction..................................................................................................................... 38

5.2 Communication plan with the stakeholders .................................................................... 39

5.3 Initiating the change ....................................................................................................... 39

5.4 Integrate and maintain the change in practice ................................................................ 40

5.5 Pilot study plan ............................................................................................................... 42

Chapter 6: Evaluation plan ............................................... 44

6.1 Introduction..................................................................................................................... 44

6.2 Intervention outcomes .................................................................................................... 44

6.3 Process evaluation .......................................................................................................... 45

6.4 Nature and number of women involved ......................................................................... 45

6.5 Consideration to determine the effectiveness of the innovation ..................................... 46

6.6 Dissemination of results ................................................................................................. 47

6.7 Anticipated limitations of the evaluation ........................................................................ 47

Chapter 7: Conclusion ....................................................... 48

Tables ............................................................................................................................... 49

Appendices ....................................................................................................................... 50

Reference ............................................................................................................................ 75

P.8

Chapter 1: Introduction

1.1 Background

Perineal trauma is any damage in the genital area during childbirth, results from

spontaneous laceration or episiotomy. It classified into different degree according to the

Royal College of Obstetricians and Gynaecologists (Table 1). Episiotomy, which is a standard

obstetrics procedure since 19th

century, is equivalent to a second degree laceration. It was

performed to shorten second stage of delivery and people believe it can protect perineum from

extensive trauma. However, more research found that it does more harm than benefit.

Asian ethnicity is thought to be an independent risk factor for third and fourth

degree perineal tears during delivery because of shortness and tenacity of the perineum

(Goldberg, Hyslop, Tolosa, & Sultana, 2003; Lam, Wong, & Pun, 2006). Therefore Chinese

women, especially primiparous, were more likely to undergo episiotomy at delivery in Hong

Kong (Lam et al., 2006). However, recent studies have shown that the perineal length of

Chinese women is not shorter than other races and it is not a predictive factor for perineal

tears (Lai, Cheung, Lao, Lau, & Leung, 2009; Tsai et al., 2012; Wheeler, Davis, Fry, Brodie,

& Homer, 2012). Hence, episiotomy should carry out only when necessary and primiparous

women can have chance of retaining an intact perineum. Other studies also demonstrated that

routine use of episiotomy is ineffective in protecting the perineum and even increase risk of

third or fourth degree tear (Hartmann et al., 2005; Lappen Justin R & Gossett Dana R, 2010;

P.9

Shahraki, Aram, Pourkabirian, Khodaee, & Choupannejad, 2011). Perineal trauma can causes

long term problem such as urinary and fecal incontinence, dyspareunia (Hartmann et al., 2005;

Shahraki et al., 2011). It affects the quality of life and their ability to cope with the daily tasks

of motherhood.

Apart from restricting the use of episiotomy, perineal massage in second stage of

labour has shown to be a protective technique to perineum (Geranmayeh et al., 2012; Huang,

Li, & Ye, 2012; Karacam, Ekmen, & Calisir, 2012; Stamp, Kruzins, & Crowther, 2001; Wang

& Zhang, 2010). Massaging and stretching the perineum in a sweeping motion is done by

midwife with 2 fingers inserted inside the vagina and stopped if it was unpleasant to woman

(Stamp et al., 2001). It helps to promote vasodilation, elasticity and relaxation of perineal

tissue and thus prevents tearing and need for episiotomy (Avery & Van Arsdale, 1987).

1.2 Affirming the need

In 2012, the episiotomy rate was 97% in primiparous and 49% in mulitiparous in a

Hong Kong pubic hospital while it was 44% in primiparous and 6% in mulitiparous in other

hospital (Queen Mary Hospital, 2012a). The huge discrepancy in the episiotomy rate implied

that routine episiotomy is still routinely performed in some hospital. The overall episiotomy

rate in Hong Kong is still higher than that suggested by Argentine Episiotomy Trial

Collaborative Group (1993) and it reported that episiotomy rates above 30% cannot be

justified (Argentine Episiotomy Trial Collaborative Group, 1993).

P.10

Reducing episiotomy rate can increase the chance of retaining an intact perineum

and decrease the chance of having sever perineal trauma. A hospital in Hong Kong with

restrictive episiotomy policy adopted, the episiotomy rate drop dramatically from 43% to 26%

in 2010 and 2012 respectively (Queen Mary Hospital, 2012a) (Table 2). The drop in

episiotomy brought a rise in incidence of intact perineum and a reduced in incidence of third

degree tear. During 2010 and 2012 respectively, the percentage of women having intact

perineum in normal vaginal delivery increased from 17% to 21%, first degree tear was 30% to

45 %, second degree tear was 18% to 33%, third degree tear was decreased from 0.2% to

0.07% respectively and no women having fourth degree of tear (Queen Mary Hospital, 2012b)

(Table 2). Other study demonstrated same results. A study in Finland from 2004 to 2011,

when episiotomy rate drop from 56.7% to 45.5%, incidence of third and fourth degree tear

decreased in women without episiotomy while increased in women with episiotomy

(Raisanen et al., 2013).

Episiotomy causes both short and long term problem to women after childbirth. Short

term problems include perineal pain, increased blood loss, increased need for suturing and

prolonged recovery time after delivery (Shahraki et al., 2011). Study showed that women who

received episiotomy has significantly longer perineal pain (Sule & Shittu, 2003). Long term

problems include urinary and fecal incontinence, dyspareunia (Hartmann et al., 2005;

Shahraki et al., 2011). Women who have episiotomy show a delay in resume sexual life

P.11

(McDonald & Brown, 2013). It also caused complications such as wound infection,

hematoma, cellulite, abscess, rectovaginal fistula and necrotizing fasciitis and increase the

risk of serious tearing into the anal sphincter (Carroli & Mignini, 2012; Shahraki et al., 2011).

Furthermore, women who had episiotomy in their first delivery would increase the risk for the

need of episiotomy in subsequent delivery and higher risk of perineal tears (Lurie, Kedar,

Boaz, Golan, & Sadan, 2013). Besides, episiotomy didn’t show any improvement in neonatal

outcome and it delayed mother- infant bonding, skin to skin contact and thus affect mother to

breastfeed her baby. (Karaçam & Eroğlu, 2003).

P.12

1.3 Objectives and Significance

The objectives of this proposed study are as follow:

1. To gather evidence-based journal in using perineal massage in the second stage of

labour for reducing perineal trauma in primiparous women.

2. To evaluate the effectiveness of the perineal massage in the second stage of labour.

3. To assess the implementation potential of guideline for using perineal massage in the

second stage of labour.

4. To set up an evidence-based guideline for using perineal massage in the second stage

of labour

Significance

Decreasing perineal trauma can benefit both the mother, midwives and the

department. Firstly, perineal pain was significantly shorten for 4.4 days in women

without episiotomies and it also significantly associated with reduced use of analgesic for

3.6 days (Sule & Shittu, 2003). Therefore mother can mobilize better and to get out of

bed to care their baby without difficulties (East, Sherburn, Nagle, Said, & Forster, 2012).

Besides, reducing perineal trauma can save lots of costs for suturing materials and time

for suturing by midwife. It also minimized the complication and the need of further

follow up of the perineal wound. The cost saved can use for training and development of

P.13

the department. Moreover, the time saved for suturing by midwives can be fully utilized

in initiating skin to skin contact between mother to their newborn soon after delivery as

recommended by World Health Organization (1998). This helps to establish the bonding

between mother and newborn and promote the success of breastfeeding (Karaçam &

Eroğlu, 2003; World Health Organization, 1998). For all of the above, it is essential as a

midwife to develop measure in decreasing perineal trauma as well as the rate of

episiotomy (Dannecker et al., 2004). In order to gather evidence-based practice for

answer, a clinical question was formulated according to the PICO format (Melnyk, 2011).

It defined as: Does perineal massage carried out by midwives in second stage of labour

reduce perineal trauma in primiparous women?

Patient population: Primiparous women

Intervention: Perineal massage in second stage of labour

Comparison: Routine care

Outcome: Reducing perineal trauma

P.14

Chapter 2: Search and Appraisal Strategies

2.1 Identification of studies

Electronic data base PubMed and China Journal Net were used for identification of

studies from 1980 to 1st June 2013.

Inclusion Criteria and Exclusion Criteria

Studies were included with if published in either English or Chinese; studies with

women having uncomplicated pregnancies and give birth vaginally; studies with

intervention about perineal massage performed by midwives during second stage of labour;

studies with perineal outcomes in terms of intact perineum, perineal tear or episiotomy.

Studies with perineal massage done in antenatal period and studies with only brief

report were excluded.

Keywords

Four groups of keywords “Perineal” or “perineum”; “massage”; “Episiotomy” or

“episiotomies”; “trauma” or “laceration” or “tear” were used together for identifying

relevant journals in PubMed and “会阴按摩” was used for identifying relevant journals in

China Journal Net. After screening by title and abstract and applying the inclusion and

exclusion criteria, a total of 7 eligible articles were identified. The searching processes of

P.15

electronic databases were summarized as follow:

2.12 Data extraction

Data of selected studies were summarized in Table of Evidence in Appendix 1

including the Bibliographic citation, study type, patient characteristics, intervention,

comparison, length of follow up, outcome measures and effect size.

2.13 Appraisal strategies

The Scottish Intercollegiate Guidelines Network (SIGN) checklists were adopted

for the quality assessment of the 7 studies which will rate according to the level of evidence in

appendix 2 and 3 (Scottish Intercollegiate Guidelines Network, 2012). The checklists were

P.16

attached to appendix 4 and it included the assessment of internal validity and overall

assessments of the study.

Internal validity

All 7 studies identified were Randomized controlled trial (RCT) and had addressed

appropriate and clearly-focused question. They also include proper outcome measure in table

format to evaluate the effectiveness of perineal massage in the second stage of labour.

All studies had stated that they had randomized the subject to control group or

perineal massage group but only 3 studies clearly descripted how randomization take place by

using sequentially numbered sealed envelopes (Albers, Sedler, Bedrick, Teaf, & Peralta, 2005;

Stamp et al., 2001) and lottery system (Karacam et al., 2012). In study of Albers et al.(2005),

the allocation sequence was generated by a computer program randomly and put in sealed

envelopes by the database manager and opened by a midwife when vaginal birth was

expecting. In study of Stamp et al (2001), the randomization schedule was prepared by

research assistant and placed in sealed envelopes then opened by attending midwife when the

women admitted. In study of Karacam et al (2012), a lottery system will determine the

allocation and printed on a label. When the women’s cervix was 8cm dilated, she will assign

to the destined group.

Due to the nature of the intervention, it was not possible to blind both the midwives

P.17

and women as the midwife will perform the perineal massage and the women can feel it.

There were 4 studies (Albers et al., 2005; Geranmayeh et al., 2012; Karacam et al.,

2012; Stamp et al., 2001) mentioned about the dropout rate and 2 studies (Albers et al., 2005;

Stamp et al., 2001) using the intention to treat analysis. In study of Geranmayeh et al (2012),

there was 18% of participants drop out because of meeting the exclusion criteria but replaced

with other participants before study end. In study of Karacam et al (2012), the dropout rate

increased throughout the 1 year follow up from 2% on the first day postpartum to 18% during

the third week postpartum and to 31% during the first year postpartum. However study didn’t

mention the reason for dropout. Unlike study of Stamp et al (2001), reasons were clearly

stated such as woman changed mind, rapid progress and midwife forgot and intent-to-treat

analysis had used. In this study, the dropout rate was 18% during 3 days postpartum, slightly

decreased to 11% during 10 days postpartum and increased to 30% during 3 month

postpartum. In study of Albers et al (2005), there was 27% participant dropout before entering

the study because of some maternal medical problem, changed mind or missed. After the

intervention, there was 19.6% dropout in the intervention group while there was 19.5%

dropout in control group.

The perineal massage group and the control group were not significantly different in

7 studies and the only different between groups was the intervention given. Thus the two

groups were comparable.

P.18

There were 3 studies mentioned about the sample size and statistical power of study.

In study of Karacam et al (2012) used a sample size of 199 women in each intervention and

control group to detect 10% episiotomy difference by 80% power at 5% level of statistical

significance. In study of Stamp et al (2001) used a sample size of 1340 women to detect 23%

more of chances having a intact perineum for women who receive perineal massage during

second stage of labour by 80% power at 5% level of statistical significance. In study of Albers

et al (2005) used a sample size of 800 women to detect 10% increase in the rate of intact

perineum by 80% power at 5% level of statistical significance.

Overall assessment of the study

According to the SIGN checklists in appendix 2, there were 2 studies graded as high

quality evidence (Albers et al., 2005; Stamp et al., 2001), 2 studies (Geranmayeh et al., 2012;

Karacam et al., 2012) of medium-quality evidence and 3 studies (Huang et al., 2012; Li,

Wang, Yu, & Li, 2010; Wang & Zhang, 2010) of low-quality evidence.

High-quality evidence

With reference to the SIGN checklist in appendix 2, most of the criteria were met in

the study of Albers et al (2005) and Stamp et al (2001). They rated 1++ as there will be a very

low risk of bias. Both studies randomized the subject with detailed description. Due to the

P.19

nature of the intervention, concealment and binding may not possible to carry out in the

studies. However both researchers had calculated the sample size to ensure adequate sample

size to yield significant result. Moreover, they also used intension-to-treat analysis during data

analysis. The perineal outcome is based on midwives clinical judgment. There may be risk of

selection bias, reporting bias during the data collection as different midwives may have

different clinical judgment. In the study of Albers et al (2005), meeting with the midwives

was held bimonthly starting from3 month before the study begin till 1 year after the study.

Therefore consent process, technique on perineal massage, assessment on perineum trauma

and data collecting process can be standardized. In the study of Stamp et al (2001), regular

staff development session was held for midwives to prepare them for perineal massage. This

measure can reduced the reporting bias and increase the validity of the study.

Medium-quality evidence

With reference to the SIGN checklist in appendix 2, the study of Geranmayeh et al

(2012) and Karacam et al (2012) rated 1+ as only part of the criteria were met. Some efforts

were made to randomize the subject. In the study of Karacam et al (2012), lottery system was

used to determine the allocation by a label with “massage” and “control” placed at the top of

consent form without any protection. Sample size of 398 women was calculated to ensure

adequate sample to yield desired results. In order to have a more accurate data collection, the

P.20

whole study was conducted by 3 investigators, 2 nurses and 1 midwife to ensure the accuracy

and consistency of the data collection. In the study of Geranmayeh et al (2012), no description

on how the randomization carried out. To control the consistency of intervention, all

deliveries were conducted by a midwife.

Low-quality evidence

There were 3 studies (Huang et al., 2012; Li et al., 2010; Wang & Zhang, 2010)

rated 1- as there was a high chance of bias according to the checklist of SIGN. They both

didn’t descript the process of randomization, no calculation on sample size, no any effort in

controlling the confounding factors.

P.21

2.2 Results

Studies characteristics

All 7 studies identified were RCT with 4 studies in English (Albers et al., 2005;

Geranmayeh et al., 2012; Karacam et al., 2012; Stamp et al., 2001) and 3 studies in Chinese

(Huang et al., 2012; Li et al., 2010; Wang & Zhang, 2010). Those 4 studies in English were

conducted in New Mexico, USA (Albers et al., 2005), Tehran, Iran (Geranmayeh et al., 2012),

Turkey(Karacam et al., 2012) and Australia (Stamp et al., 2001) while those 3 studies in

Chinese were conducted in Guangdong Dongguan (Huang et al., 2012), Beijing (Wang &

Zhang, 2010) and Chongqing (Li et al., 2010) of China.

Subject characteristics

The selected studies includes total of 3165 women with sample size range from 90

to 1340. 5 studies (Geranmayeh et al., 2012; Huang et al., 2012; Karacam et al., 2012; Li et al.,

2010; Wang & Zhang, 2010) were mainly focused on primiparous and 2 studies (Albers et al.,

2005; Stamp et al., 2001) were focused on both primiparous and multiparous. All women in

the studies were healthy with all normal parameters throughout pregnancy and underwent

vaginal delivery. The gestational age in most of the studies was term while only one study

(Stamp et al., 2001) included gestational age of 36 weeks.

P.22

Intervention

All perineal massage was performed by midwife during labour in all the studies.

Most studies started the perineal massage when the cervix was fully dilated while only one

stated that perineal massage can be started when the cervix was 8cm dilated in primiparous

and 5cm in multiparous (Stamp et al., 2001).

Outcome measures

All studies include perineal outcome in term of intact perineum, tear and episiotomy.

4 studies (Geranmayeh et al., 2012; Huang et al., 2012; Li et al., 2010; Wang & Zhang, 2010)

has shown that perineal massage in second stage of labour significantly promote the integrity

of perineum while 1 studies (Albers et al., 2005) showed there was an improvement in

perineum integrity but not statistically significant. 2 studies (Karacam et al., 2012; Stamp et

al., 2001) showed that there is no such effect.

There were 4 studies (Geranmayeh et al., 2012; Huang et al., 2012; Karacam et al.,

2012; Li et al., 2010) showed that perineal massage can decrease the rate of episiotomy.

P.23

2.3 Summary and Synthesis

The timing of performing perineal massage was difference in primiparous and

multiparous. In the study of Albers et al. (2005), Geranmay et al. (2012), Karacam et al.

(2012), Huang et al. (2012), Li et al. (2010), Wang & Zhang (2010), midwives perform

perineal massage when cervix was fully dilated. Nonetheless, in study of Stamp et al. (2001),

perineal massage was initiated when the cervix was ≥8cm dilated in primiparous and ≥ 5 cm

dilated in multiparous. However, the study of Stamp et al found there was no improvement on

perineum integrity but there was a protective effect for third and fourth degree tears by

performing perineal massage. By considering the actual clinical situation and lack of

manpower in labor ward, the most appropriate time for midwife to perform perineal massage

was when the cervix was fully dilated, as the midwife would gown up and standby for the

delivery.

For the duration of the perineal massage, it was very much depend on the decision

of mother. If the mother felt discomfort, perineal massage was discontinued. However, only in

Karacam et al. (2012) study mentioned that if there was no declined of perineal massage in

the intervention group, it will continue for at least 10 minutes, during uterine contractions and

until the baby’s head was out.

Regarding the kind of lubricant used, there was only 1 study using Vaseline as

lubricant (Geranmayeh et al., 2012) while the others used water soluble lubricant. The use of

P.24

different lubricant may be the choice of women and should avoid to those with allergy.

However water soluble lubricant is more preferable as it is already available in labour ward

and ready to use.

2.31 Recommendations

1. Perineal massage during second stage promotes perineal integrity and decreases trauma to

perineum as perineal massage decreased the rate of episiotomies and increase chance of intact

perineum (Geranmayeh et al., 2012; Huang et al., 2012; Karacam et al., 2012; Li et al., 2010;

Wang & Zhang, 2010)

2. Perineal massage was initiated when the cervix was 10cm dilated (Albers et al., 2005;

Geranmayeh et al., 2012; Huang et al., 2012; Karacam et al., 2012; Li et al., 2010; Wang &

Zhang, 2010).

3. The duration of perineal massage would be according to the comfort of women but it may

be more beneficial if carried out more than 10minutes as perineal massage promote

vasodilatation and increased blood supply, tissue stretching or extensibility, muscle relaxation

(Karacam et al., 2012).

P.25

Chapter 3: Implementation Potential

Perineal trauma was commonly experienced by women during child birth. It can be

either a natural tearing or an episiotomy which is a surgical incision to facilitate delivery.

Being a midwife in Hong Kong, we would like to promote natural birth as far as possible.

Apart from restrictive use of episiotomy, by performing perineum massage during second

stage of labour can reduce perineal trauma was supported and discussed in previous chapter

(Geranmayeh et al., 2012; Huang et al., 2012; Karacam et al., 2012; Stamp et al., 2001; Wang

& Zhang, 2010). It seems that the implementation of a perineal massage guideline in local

hospital will be helpful in reducing perineal trauma. In view of its transferability to local

hospital, an assessment of its implementation potential would be discussed in the following

chapter. This included the assessment of transferability, feasibility and the cost-benefit ratio

of the proposed innovation. Subsequently, an evidence-based guideline of using perineal

massage in the second stage of labor for reducing perineal trauma will be developed.

P.26

3.1 Target Setting

The proposed perineal intervention is implemented at the Obstetric Units in Hong

Kong hospital. Most of the women in Hong Kong had their deliveries in the labour ward of a

hospital.

3.2 Target Audience

The proposed target audience includes nulliparous women with an uncomplicated

pregnancy, singleton in cephalic presentation with a gestational age more than 37 weeks and

less than 42weeks and didn’t take any antenatal interventions to prevent perineal trauma.

Exclusion criteria included multiple pregnancy, prematurity, polyhydramnios,

occipitoposterior position, fetal distress during labour and instrumental assisted delivery.

Women who undergo caesarean section, previous caesarean section, visible perineal scar,

vaginal infection are also excluded and standard care was provided. Women can withdraw at

any time from the innovation if they feel discomfort.

P.27

3.3 Transferability of the Findings

Similarity of Proposed Setting and Target Population to those in studies

The settings of the research studies were in hospital. As the labour ward setting of

the hospital in Hong Kong are similar to those in the reviewed studies, so if perineal massage

is implemented in Hong Kong, it is transferable.

The target population in the studies is also similar to those in proposed innovation.

In Hong Kong, women with healthy pregnancy and would like to have normal vaginal

delivery in hospital will be included (Albers et al., 2005; Geranmayeh et al., 2012; Huang et

al., 2012; Karacam et al., 2012; Li et al., 2010; Stamp et al., 2001; Wang & Zhang, 2010).

Philosophy of Care

According to guideline for specialty nursing service from Hospital Authority Head

Office (2012), “Midwifery is holistic by nature addressing the physiological, psychological,

cultural and spiritual needs of a woman and her family by promoting and protecting the safety

and health of the mother and her infant.” The care provided should be “evidence-based and

effective in enhancing the well-being of the woman.” Moreover, the care should “reviewed

periodically to suit contemporary practice.”

P.28

During the labour process, midwives should “minimize technological interventions”, and

promote “natural childbirth as far as possible”.

The proposed innovation is an evidence-based intervention to preserve the integrity

of the perineum, decrease the over-use of episiotomy and thus enhancing the birth experience

of mother as it can shorten the birth process, decrease postpartum pain (Karaçam & Eroğlu,

2003; Sule & Shittu, 2003). Besides, the proposed innovation didn’t do any harm to the

mother and it is a safe practice (Stamp et al., 2001). Therefore, it has potential to meet the

philosophy of care of Hospital Authority.

With the same aim to promote normal birth as far as possible, there is a high

possibility that the obstetric units in HA hospital will approve the implementation of the

proposed innovation and to include it as a part of the standard care.

Clients Benefit from Innovation

Between 1 January and 31 December 2012, there were 27691 normal vaginal

delivery with episiotomy rate of 76.3% in primiparous and 33% in multiparous respectively at

HA hospital (Queen Mary Hospital, 2012a). If the innovation can be carried out in HA

hospital, there would be lots of pregnant women benefit from it.

P.29

3.4 Feasibility

In well-controlled research environment, the intervention was well applied.

However, when it comes to the ward situation, many factors need to be considered to ensure

its implementation. They are discussed as follow:

Motivational Readiness for Change

Midwifes could always practice autonomously as they do what are best for the

client based on evidence-based practice. Avoiding perineal damage is a matter of pride for

midwives and the proposed innovation can be a feasible change to promote perineal integrity.

Moreover, they are also free to terminate it anytime if they perceived the condition is no

longer suitable to carry out the intervention.

Measuring tools

The progress of the delivery and the perineum outcome are well documented in the

partogram in all hospital. However the delivery position for mother adopted during delivery

was not included and this may also affect the perineal outcome. It is suggested to include in

the partogram and this may need to approval from the COS. The format and design of the

partogram can keep unchanged but just add an extra column for document position of the

mother during delivery. This can be done by using a chop. When the old version of partogram

P.30

is finished, then updated version can be used.

Availability of Staff

In labour ward, one midwife is responsible to take care of 1 to 2 clients. Therefore

nursing care can be provided more intensively. During labour, a midwife will be responsible

for delivery and performing perineal massage while she is waiting the baby’s head crowned or

while the mother is pushing. The innovation may not cause any extra workload to midwife but

to provide an extra aid for them to help with the mother during the delivery.

Availability of Resources

Perineal massage will use KY jelly as lubricant which was already available in

labour ward and it is not expensive.

There were 6 antenatal classes held by midwife for women who are going to deliver

in designated hospital every month. We can add some slides about perineal massage and

introduce to mother during the talk. Therefore the mother can understand more about perineal

massage and how could it be help.

P.31

Require Skills and Training

Perineal massage was not included in the midwifery training. Extra training to

midwife is needed. Workshop with dumpy can be held so the midwife can practice the skill

needed. Sharing session can be held and senior midwife can share their experience, so that

midwife can further updated their knowledge and get prepare

Anticipate Resistance

Perineal massage may be more beneficial if carried out more than 10mins (Karacam

et al., 2012). However, if the labour progress was too rapid or there was presence of fetal

distress in the second stage of labour. This may not be feasible. Moreover, if the mother didn’t

feel comfort and accept the feeling of massaging and stretching the perineum, the midwife

cannot continue the perineal massage. Therefore, well explanation to mother is needed and

gain a consent from mother before performing perineal massage by midwife. Perineal

massage can also be introduced in the antenatal talk, so the mother can have some basic

knowledge what going on during her childbirth.

Midwives may not perceive to have confident in performing perineal massage.

Midwives will be instructed with video-training session and instructional pamphlet.

Midwives can first practice with a dumpy with being an observer and then practice under

guidance. Suggestion was given to improve in the next practice by NO or APN.

P.32

Evaluation

Group interview can be carried out with midwives after implementation of the

innovation for 1 month, 3 months and 6 months. Their feeling on performing perineal

massage and difficulties they encounter can be addressed. Regular staff meeting can be

carried out to midwives to share the difficulties they encounter, and suggest ways to improve.

Measurements of key outcomes will include the compliance of midwife to perform

perineal massage, the rate of episiotomy, perineal tears and women’s postpartum pain level

and their satisfaction during the labour process.

P.33

3.5 Cost-benefit Ratio of the Innovation

Potential risk of carry out the innovation

Perineal massage didn’t cause any harm to women but only if it was not done

appropriately (Stamp et al., 2001). Adequate training and guidance for midwives will provide

and regular staff meeting will held for them to raise out their concern.

Potential benefit in carry out the innovation & risks of Maintaining Current Practice

The proposed innovation can benefit the mother, midwives and the department.

Firstly, it protects the women from short term or long term problem of episiotomy like urinary

and fecal incontinence, dyspareunia and perineal pain (Hartmann et al., 2005; Shahraki et al.,

2011). Minimize perineal discomfort can also help to establish the bonding between mother

and newborn as soon as possible after delivery and promote early skin to skin contact

(Karaçam & Eroğlu, 2003). Moreover, less perineal trauma saves the time of midwives for

suturing. They can have more time in helping mother start breastfeeding her baby in labor

ward. Furthermore, less perineal trauma saves the suturing material and gauze. It also

minimized the complication and the need of further follow up the perineal wound. A study by

Borghi et al. has shown that there can be a potential reduction of $17- $29 HKD for each low

risk vaginal delivery if restrictive episiotomy policy was adopted (Borghi et al., 2002). Last

year, there were 27691 normal vaginal deliveries, by estimation there would be around

P.34

$1,943,015 HKD can be saved (Appendix 5). The cost saved can use for the staff

development and training in the department.

Conclusions

Sincerely hope that the innovation can be implement in Hong Kong to reduce the

perineal trauma by midwife and to keep the episiotomy rate below 30% as recommended by

Argentine Episiotomy Trial Collaborative Group (1993).

P.35

Chapter 4: Developing Evidence-Based Practice Guideline

4.1 Evidenced-based Practice Guideline

Upon affirming the implementation potential of perineal massage in Hong Kong

public hospital, an evidenced-based practice guidelines is developed. They are discussed as

follow.

4.2 Guideline Title

The guideline title is “A clinical guideline on antenatal perineal massage for

nulliparous women to reduce perineal trauma”

4.3 Aim of Guidelines

The aim of the guideline is to provide information for midwives in performing

perineal massage in the second stage of labour to reduce perineal trauma.

4.4 Objectives of the Guideline

- To equip midwives with knowledge in performing perineal massage.

- To reduce the rate of perineal tear and episiotomy for nulliparous women by performing

perineal massage in the second stage of labour.

- To increase the acceptance of perineal massage by women in the second stage of labour.

P.36

4.5 Target Group

The target group is nulliparous women with an uncomplicated pregnancy, single

fetus in cephalic presentation with a gestational age more than 37 weeks and less than

42weeks and didn’t take any antenatal interventions to prevent perineal trauma and who plan

to deliver vaginally in a Hong Kong public hospital.

4.6 Major Outcomes

The major outcomes are rate of perineal tear and episiotomy, compliance of perineal

massage by midwives and acceptance of perineal massage by women.

4.7 Recommendations

The studies used in this guideline were graded rate according to the level of

evidence and the recommendations formulated based on grades of Scottish Intercollegiate

Guidelines Network (2012).

1. Perineal massage during second stage promotes perineal integrity and decreases

trauma to perineum.

Grade A. Perineal massage decreased the rate of episiotomies and increase chance of

intact perineum (Geranmayeh et al., 2012; Huang et al., 2012; Karacam et al., 2012; Li et

al., 2010; Wang & Zhang, 2010)

P.37

2. Perineal massage was initiated when the cervix is 10cm dilated. It can also initiated

when the cervix is ≥8cm dilated in primiparous and ≥ 5 cm dilated in multiparous.

Grade A. In the study of Albers et al. (2005), Geranmay et al. (2012), Karacam et al.

(2012), Huang et al. (2012), Li et al. (2010), Wang & Zhang (2010), midwives perform

perineal massage when cervix was fully dilated. Nonetheless, in study of Stamp et al.

(2001), perineal massage can be initiated when the cervix was ≥8cm dilated in

primiparous and ≥ 5 cm dilated in multiparous.

3. The duration of perineal massage would be more beneficial if carried out more than

10mins

Grade A. Perineal massage promote vasodilatation and increased blood supply, tissue

stretching or extensibility, muscle relaxation (Karacam et al., 2012).

P.38

Chapter 5: Implementation Plan

5.1 Introduction

After assessing implementation potential and developing evidence-based practice

(EBP) guideline in previous chapter, carrying out perineal massage in the second stage of

labour in Hong Kong public hospital is considered as transferable and feasible. In order to

carry out the innovation, a communication plan, pilot test and the evaluation plan will be

discussed in this chapter.

5.2 Communication plan with the stakeholders

A workflow of the innovation will be attached in the appendix 5.

Identification of stakeholders:

Before carrying out the innovation, approval needs to be made with the stakeholders

who may affect the implementation. They included the Chief of Service (COS), Departmental

Operation Manager (DOM), obstetricians, ward manager (WM), advanced practice nurses

(APN), nursing officers (NO), midwives, pregnant women who plan to have their delivery in

public hospital and their partner.

The process of communicating

After communicating with NO, APN and WM and have a general agreement, a

formal meeting with DOM and COS will be arranged and a proposal of the innovation will be

P.39

present to them includes the needs of changing, the significant, potential benefits, risk and

cost of the innovation.

After gaining support from DOM and COS, a comprehensive presentation about the

innovation is held to other stakeholder like the Obstetricians, WM, APN, and NO.

The presentation also includes the objective, reviewed evidence, implementation procedures,

logistic arrangement of the innovation and the roles of the stakeholder play in the project.

They are free to raise out questions after the presentation to clarify the doubt and vagueness.

5.3 Initiating the Change

Forming committee team

After the presentation, a group of committee form a team called “perineal massage

team” (PMT). They include obstetrician, WM, NO and APN. The proposed guideline and the

implementation plan will be reviewed and a tentative timeline will be developed. The team

will meet monthly and to evaluate the innovation and make necessary amendment throughout

the project.

P.40

5.4 Integrate and Maintain the Change in Practice

Perineal massage training

The committee team will sent e-mails to all midwives in the department and post

poster to antenatal, labour and postnatal ward. Five training workshops will be held five

months before the launch of pilot study. All midwives are welcome to attend but it is highly

recommended to those who currently work in labour ward. Each 3-hours workshop includes a

PowerPoint lecture which shows the current evidences, benefits, risks and skills in performing

perineal massage. It then follows by an interactive dummy demonstration session and each

midwife needs to return demonstrate the skill they have learnt in the workshop. Evaluation

form (Appendix 7) will be given to each midwives after the workshop and collect their

suggestion for improvement.

Several copies of the lecture notes and PowerPoint will be kept in each ward and all

midwives are welcome to read through. A video with clear steps and procedures will be

produced and kept in each ward’s desktop and welcome all midwives to review when

necessary.

P.41

Antenatal talk

Several antenatal talks are held each month by midwives. Extra slides about

perineal massage will be included in the lecture. Evaluation form (Appendix 7) will be given

at the end of the talk and collect the viewpoint of pregnant women toward perineal massage.

Individual coaching in performing perineal massage

The first five cases of the midwife in performing perineal massage are coached by

APN or NO. Evaluation form (Appendix 9) will be completed by the midwife about their

feeling toward perineal massage.

Meeting with midwives:

Two meeting will be held with midwives 2 weeks after and at the end of the pilot

study to gather the feedback about the workflow in the antenatal, labour and postnatal ward.

Committee evaluation meeting

Before the launch of the pilot study, the committee team will meet biweekly to

gather the information and difficulties they encounter and to amend the guideline and protocol

whenever necessary.

P.42

5.5 Pilot Study Plan

A one-month pilot test will be conducted to determine the inadequacies in the

innovation planning and make it smoother when we actually launch the innovation. The

results and evaluation of the pilot study is useful to assess the acceptability, feasibility and

transferability of the innovation to both pregnant women and midwives.

Recruitment of eligible women

Cases will be recruited when the pregnant women have the antenatal checkup in the

hospital. An information sheet and consent will be given to the women. When we obtain the

consent, a label written with “PM group” will be put on the patient folder to indicate it is a

recruit case of perineal massage. A pink card will be clipped on the antenatal follow up card

and given to the women. They are reminded to show the pink card and inform the midwives

when they admitted to the hospital. Then midwife will inform the staff in labour ward.

Inclusion Criteria for the Pilot Study

The sample size of the pilot study is 30 pregnant women with 15 women in the

control group and 15 women in experimental group. The women who sent to labour ward

with “PM group” label on the folder will be randomized by a midwife using a sealed envelope.

The inclusion criteria are: (1) primiparous women aged 18 to 35, (2) with pregnancy of 37

to 42 weeks gestation of singleton, and (3) going to delivery vaginally with cephalic

P.43

presentation. The following women who meet the criteria will be excluded: (1) have any form

of perineal preparation during pregnancy, (2) Having infection/ inflammation in genital tract

during pregnancy, and (3) Anatomical abnormality in the genital tract or pelvic that may

hinder normal vaginal birth.

Evaluation

After receiving perineal massage, women will receive a questionnaire (Appendix 10)

to determine their feeling and their acceptance toward perineal massage. The sustainability of

perineal massage also very depends on the wiliness of midwife in performing perineal

massage. A questionnaire (appendix 9) will be used to determine the midwives’ views when

they performing perineal massage. The result collected will combine with the suggestions

received from the meeting with midwives to determine the difficulties they encounter and to

list out the barriers that hinder them in performing perineal massage. A data collection form

(Appendix 11) will be filled up by midwife to collect the outcome of the perineal massage.

Data will be analysis and a formal report on the pilot study will be written and submitted to

the DOM and COS. An evaluation presentation will be held after the pilot study and to review

the result to all midwives in the department.

P.44

Chapter 6: Evaluation Plan

6.1 Introduction

Evaluation is critical to assess the effectiveness of the innovation and to detect the

barriers or complications arise during the process. In the following, we will evaluate and

measure the outcome of client, midwives.

6.2 Intervention Outcomes

Client outcome:

The primary outcomes of the innovation are the rate of intact/nick perineum,

episiotomy, first degree tear, secondary degree tear, third degree tear and forth degree tear.

The data will be collected using data collection from (appendix 11). The data can be analyzed

by comparing the data in 2010 to 2012 in Hong Kong public hospital(Queen Mary Hospital,

2012a, 2012b) (Table 2). The secondary outcome is the satisfaction level of the women

toward perineum massage. The data is collected by a questionnaire (appendix 10).

Midwives outcome:

The perineal massage is mainly carried out by midwives. Their acceptance and

sustainability toward perineal massage is crucial to the successes of the innovation. A

P.45

questionnaire (appendix 9) is adopted to evaluate the midwives’ views after they have

performed perineal massage.

6.3 Process Evaluation

Measures need to be taken to ensure the innovation carry out smoothly. To evaluate

the progress of the innovation and to identify the barrier we have encounter. Two

questionnaires (appendix 9, 10) are adopted to evaluate the acceptance of perineal massage by

midwife and women. The meeting with midwife can also identify the risk and barrier they

encounter.

6.4 Nature and number of women involved

Eligibility Criteria:

The eligibility criteria of the pregnant women are: (1) primiparous aged 18 to 35, (2)

with 37 to 42 weeks gestation of singleton, and (3) delivered vaginally with cephalic

presentation during the study period.

Sample Size Calculation:

Using the sample size calculator of Rasoft (2004), the number of pregnant women

to be involved in the evaluation plan is 105 with 80% power at the 5% level of statistical

significance with 20% of attribution.

P.46

6.5 Considerations to Determine the Effectiveness of the Innovation

Client outcome:

It is expected to have a decrease in the rate of episiotomy and an increase in the rate

of intact/nick perineum, first degree tear and secondary degree tear. But no change in the rate

of third degree tears and forth degree tears. The innovation will be considered successful if

there is a decreased of 10% in the rate of episiotomy and a 10% increase in the rate of

intact/nick perineum.

The secondary outcome is the satisfaction level of the women toward perineum

massage. If we could consider the innovation is effective if there is at least 80% of women

accept and satisfy to perform perineal massage during labour.

Midwives outcome:

The innovation is also considered to be effective if more than 80% of midwives feel

confident in performing perineal massage.

P.47

6.6 Dissemination of Results

After the data analysis, results will be published through a project presentation

dinner. COS, DOM, Obstetrician, WM, APN, NO are invited and all midwives are welcome

to join. We will also invite the PMT committee to share their feeling when they organize and

carry out the innovation.

6.7 Anticipated Limitations of the Evaluation

As the innovation is mainly focus on primiparous women with low risk pregnancy,

the result may not able to generalize to all pregnant women and cannot apply to multiparous

or women with complication during pregnancy.

P.48

Chapter 7: Conclusion

This dissertation aims to develop an evidence-based guideline for midwives to

perform perineal massage during second stage of labour. After apprising best available

evidences, performing perineal massage during second stage of labour by midwives has been

demonstrated to be a safe and effective practice in promote perineal integrity and decrease

perineal trauma when compared with standard care.

By assessing the transferability, feasibility and cost-benefit ratio of the innovation,

the implementation of perineal massage during second stage of labour in local hospital setting

is feasible. The development of an evidence-based guideline for midwives help to

standardized the procedure in performing perineal massage. In addition, conducting a

one-month pilot study plan and forming a committee team help to initiate the changes and

ensure the sustainability and effectiveness of performing perineal massage by midwives. By

proposing the innovation, it is sincerely hoped that the perineal trauma in women is reduced

by midwives in Hong Kong and the overall episiotomy rate in Hong Kong will be further

decreased and below 30% as recommended by Argentine Episiotomy Trial Collaborative

Group (1993).

P.49

Table 1.

Classification of perineal trauma by Royal College of Obstetricians and Gynaecologists

(2007).

Table 2.

Episiotomy rate and perineal tear rate in 2010 and 2012 respectively in a Hong Kong

Public hospital.

2010 2012

Episiotomy rate 43% 26%

Intact perineum 17% 21%

First degree tear 30% 45 %

Second degree tear 18% 33%

Third degree tear 0.2% 0.07%

Classification of perineal trauma

First degree Injury to perineal skin only.

Second degree Injury to perineum involving perineal muscles

but not involving the anal sphincter.

Third degree Injury to perineum involving the anal sphincter complex:

3a: Less than 50% of external anal sphincter( EAS) thickness torn.

3b: More than 50% of EAS thickness torn.

3c: Both EAS and internal anal sphincter (IAS) torn.

Fourth degree Injury to perineum involving the anal sphincter complex

(EAS and IAS) and anal epithelium.

P.50

Appendix 1 Table of Evidence

Albers, L. L., Sedler, K. D., Bedrick, E. J., Teaf, D., & Peralta, P. (2005). Midwifery care measures in the second stage of labor and reduction of genital tract trauma at

birth: a randomized trial. [Comparative Study

Randomized Controlled Trial

Research Support, N I H , Extramural

Research Support, U S Gov't, P H S]. J Midwifery Womens Health, 50(5), 365-372.

Geranmayeh, M., Rezaei Habibabadi, Z., Fallahkish, B., Farahani, M. A., Khakbazan, Z., & Mehran, A. (2012). Reducing perineal trauma through perineal massage

with vaseline in second stage of labor. Archives of Gynecology and Obstetrics, 285(1), 77-81.

Bibliograp

hic citation

Study type

No of

patients

Patient characteristics Intervention Comparison Length of

follow up

Outcome measures Effect size

(Albers,

Sedler,

Bedrick,

Teaf, &

Peralta,

2005)

RCT 808 - women who were 18

or older, healthy

- expecting a vaginal

birth

Perineal

massage

group

(n =404)

Hands off

(n= 404)

After delivery

and postpartum

office visit

1. Intact perineum

2. Perineal trauma:

i. First degree tear

ii. Secondary degree tear

iii. Third degree tear

iv. Episiotomy

1. +1%

2.

i. +0.6%

ii. -0.2%

iii.+0.5%

iv: +1.2%

Level of evidence:

1++

(Geranmay

eh et al.,

2012)

RCT

90

- primiparous

- 18- 30 years of age

- 38–42 weeks gestation

- vaginal delivery with

anterior cephalic

presentation

perineal

massage with

Vaseline

(n=45)

receiving

routine care

(n=45)

Just after

delivery

1. Intact perineum

2. Perineal trauma:



iii. Episiotomy

3. the length of the

second stage of labor

(mins)

1. +23%

(p=0.004)

2. (p=<0.001)

i. +11%

ii. +8%

iii. -43%

3. -9

(p=0.038)

Level of evidence:

1+

General comments: There was no 3 and 4 degree of tear

P.51

Bibliograp

hic citation

Study type

No of

patients


follow up


(Karacam,

Ekmen, &

Calisir,

2012)

RCT

396

- primiparous

- 18–35 years of age


perineal

Massage

(n = 198)

control

groups

(n = 198)

1 year

postpartum

1. Intact perineum

2. Perineal trauma:



iii. Episiotomy

1. 0%

p=1.00

2.

i. +14%

ii. +1.1%

iii.-8.6%

(p=0.042, OR=0.71

with 95%CI)

Level of evidence:

1+


(Stamp,

Kruzins, &

Crowther,

2001)

RCT

1340

- women who at 36 weeks

gestation, expecting

normal birth of a

singleton

massage

group (n

=708)

control

groups

(n = 632)

3 month

postpartum

1. Intact perineum

2. Perineal trauma:



iii. Third degree tear

iv. Episiotomy

1. +1% (p=0.76)

2.

i. +0.5% (p=0.88)

ii. +0.9%(p=0.76)

iii.-2% (p=0.04)

iv: +0.02% (p=0.43)

Level of evidence:

1++

General comments:

P.52

Bibliograp

hic citation

Study type

No of

patients


follow up


(Huang, Li,

& Ye, 2012)

RCT

110

- primiparous

- 19- 35 years of age


- Low risk normal vaginal

delivery

perineal

massage

(n=55)

receiving

routine care

(n=55)

Just after

delivery

1. Intact perineum

2. Perineal trauma:



iii. Episiotomy

3. the length of the

second stage of labor

(mins)

1. +7%

(p<0.05)

2. (p=<0.05)

i. +20%

ii. -11%

iii. -16%

3. -20

Level of evidence:

1-


(Li et al.,

2010)

RCT

244

- primiparous


- Full term

- Confident to have natural

birth

perineal

Massage

(n = 122)

control

groups

(n = 122)

Just after

delivery

1. Intact perineum

2. Perineal trauma:



iii. Episiotomy

3.the length of the second

stage of labor (mins)

1. +12.3%

(p<0.05)

2. (p<0.05)

i. +12.3%

ii. -6.6%

iii.-15.6%

3. -39

Level of evidence:

1-


(Wang &

Zhang,

2010)

RCT

177

- primiparous



- Cephalic presentation

- singleton

perineal

Massage

(n = 93)

control

groups

(n = 84)

Just after

delivery

1. Intact perineum

2. Perineal trauma:



1. +1.1%

(p<0.05)

2. (p<0.05)

i. +39.8%

ii. -40.9%

Level of evidence:

1-


P.53

Appendix 2: Levels of Evidence (Scottish Intercollegiate Guidelines Network,2012)

Appendix 3: Grades Of Recommendation

1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias

1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias

1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias

2++

High quality systematic reviews of case control or cohort or studies

High quality case control or cohort studies with a very low risk of confounding or bias and a high

probability that the relationship is causal

2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate

probability that the relationship is causal

2- Case control or cohort studies with a high risk of confounding or bias and a significant risk that the

relationship is not causal

3 Non-analytic studies, e.g. case reports, case series

4 Expert opinion

A At least one meta-analysis, systematic review, or RCT rated as 1++,

and directly applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly applicable to

the target population, and demonstrating overall consistency of results

B A body of evidence including studies rated as 2++, directly applicable to the target

population, and demonstrating overall consistency of results;

or

Extrapolated evidence from studies rated as 1++ or 1+

C A body of evidence including studies rated as 2+,

directly applicable to the target population and demonstrating overall consistency of

results;

or

Extrapolated evidence from studies rated as 2++

D

Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

P.54

Appendix 4: Methodology Checklist for randomized Controlled Trials by Scottish

Intercollegiate Guidelines Network (SIGN) 2012

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Albers, L. L., Sedler, K. D., Bedrick, E. J., Teaf, D., & Peralta, P. (2005). Midwifery care measures in the second

stage of labor and reduction of genital tract trauma at birth: a randomized trial. J Midwifery Womens

Health, 50(5), 365-372.

Guideline topic: Key Question No: Reviewer:

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated

higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention

Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

Section 1: Internal validity

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised. Yes

Can’t say

No

1.3 An adequate concealment method is used.

Yes

Can’t say

No

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

Yes

Can’t say

No

P.55

1.5 The treatment and control groups are similar at the start of the trial. Yes

Can’t say □

No

1.6 The only difference between groups is the treatment under

investigation.

Yes

Can’t say

No

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.

Yes

Can’t say

No

1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study

dropped out before the study was completed?

18%. Of the 2535 potentially eligible women approached, 1670 consented and only 1211 were

randomised because of medical problem (337), changed mind (5), missed (113), other (4).

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).

Yes

Can’t say

No

Does not apply

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.

Yes

Can’t say

No

Does not apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++) Acceptable (+)

Unacceptable – reject 0

2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the

statistical power of the study, are you certain that the overall effect is due to the study

intervention?

To test the primary hypothesis that women who receive perineal massage in the second stage of

labour will have a 1% increase in the likelihood of an intact perineum compared with control. This

required a sample size of 1200 women (P < 0.05, 80% power).

Random assignment was done by computer generated sequentially numbered, sealed, opaque

envelopes in balanced block of 12 which prepared by a database management not involved in care of

the women.

2.3 Are the results of this study directly applicable to

the patient group targeted by this guideline?

Yes

2.4 Notes. Because of the nature of the intervention it was not possible to mask the treatment allocation.

P.56

S I G N



Geranmayeh, M., Rezaei Habibabadi, Z., Fallahkish, B., Farahani, M. A., Khakbazan, Z., & Mehran, A. (2012). Reducing

perineal trauma through perineal massage with vaseline in second stage of labor. Archives of Gynecology and

Obstetrics, 285(1), 77-81.






higher than 1+







Yes

Can’t say

No


Can’t say

No


Yes

Can’t say

No


allocation.

Yes

Can’t say

No


Can’t say □

No

P.57


investigation.

Yes

Can’t say

No


way.

Yes

Can’t say

No

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was

completed?

Nil.



Yes

Can’t say

No

Does not apply



Yes

Can’t say

No

Does not apply



Code as follows:



2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, is you certain that

the overall effect is due to the study

intervention?

/



Yes

2.4 Notes.

P.58

S I G N



Karacam, Z., Ekmen, H., & Calisir, H. (2012). The use of perineal massage in the second stage of labor and follow-up of

postpartum perineal outcomes. Health Care Women Int, 33(8), 697-718.




design algorithm available from SIGN and make sure you have the correct checklist.





Yes

Can’t say

No


Can’t say

No


Yes

Can’t say

No


allocation.

Yes

Can’t say

No


Can’t say □

No


investigation.

Yes

Can’t say

No


way.

Yes

Can’t say

No

1.8 What percentage of the individuals or clusters recruited into each Nil.

P.59

treatment arm of the study dropped out before the study was

completed?

Initially recruited 404 ->396 left

∵Missing data and thus

excluded



Yes

Can’t say

No

Does not apply



Yes

Can’t say

No

Does not apply



Code as follows:





intervention?

Yes. A power analysis indicated that a sample size of 199 women per group would give 80% power to

detect the difference of 10% episiotomies between groups, with an α = 0.05.

The study was conducted by three investigators. Data were collected via Data collection forms and

were developed by the study investigators based on literature reports. The forms were reviewed by five

specialists, and revisions were made according to their recommendations. Besides, the forms were

piloted on 20 gravidas to improve both understandability and applicability. The perineal massage was

done by a midwife and was also standardized in the pilot study.



Yes.

2.4 Notes.

1.2: The lottery system was used to determine whether the participants are control group or

intervention group. Although subject was randomly assigned, however it is done by the midwife, one of

the researchers without binding. “Two different versions of the informed consent form were attached to

the top of the case report forms. Before the study was initiated, the case report forms were arranged

one on top of the other and labeled with “massage” or “control” groups.”

P.60

S I G N



Stamp, G., Kruzins, G., & Crowther, C. (2001). Perineal massage in labour and prevention of perineal trauma:

randomised controlled trial. Bmj, 322(7297), 1277-1280.






higher than 1+







Yes

Can’t say

No


Can’t say

No


Yes

Can’t say

No


allocation.

Yes

Can’t say

No


Can’t say □

No


investigation.

Yes

Can’t say

No

P.61


way.

Yes

Can’t say

No



25%. Of the 3050 potentially eligible women approached, 2291 consented and only 1340 were

randomised because of caesarean section (217), instrumental birth (105), no reason given (168),

woman changed her mind (112), rapid progress (121), the midwife forgot (77), the midwife

was too busy (80), and various other reasons (71).



Yes

Can’t say

No

Does not apply



Yes

Can’t say

No

Does not apply



Code as follows:





intervention?

To test the primary hypothesis that women who receive perineal massage in the second stage of

labour will have a 23% increase in the likelihood of an intact perineum compared with control. This

required a sample size of 1340 women (P < 0.05, 80% power).

Random assignment was done by sequentially numbered envelopes in batches of 100 which

prepared by a research assistant not involved in care of the women.



Yes


P.62

S I G N



Wang, H., & Zhang, Y. (2010). Effect of massage on perineal body in degrading the severity of perineal tear.

Modern Clinical Nursing, 9(9), 17-19.






higher than 1+







Yes

Can’t say

No


Can’t say

No


Yes

Can’t say

No


allocation.

Yes

Can’t say

No


Can’t say □

No


investigation.

Yes

Can’t say

No

P.63


way.

Yes

Can’t say

No



Nil



Yes

Can’t say

No

Does not apply



Yes

Can’t say

No

Does not apply



Code as follows:





intervention?

/



Yes


P.64

S I G N



Li, C., Wang, P., Yu, Y. H., & Li, S. C. (2010). 第二產程中行會陰體按摩的可行性分析. Journal of Nurses

Training, 25(23), 2192-2193.






higher than 1+







Yes

Can’t say

No


Can’t say

No


Yes

Can’t say

No


allocation.

Yes

Can’t say

No


Can’t say □

No


investigation.

Yes

Can’t say

No

P.65


way.

Yes

Can’t say

No



nil



Yes

Can’t say

No

Does not apply



Yes

Can’t say

No

Does not apply



Code as follows:





intervention?

/



Yes


P.66

S I G N



Huang, J., Li, Q., & Ye, Q. (2012). Effect of perineal massage on natural childbirth. Modern Clinical Nursing,

11(6), 26-27.






higher than 1+







Yes

Can’t say

No


Can’t say

No


Yes

Can’t say

No


allocation.

Yes

Can’t say

No


Can’t say □

No


investigation.

Yes

Can’t say

No

P.67


way.

Yes

Can’t say

No



Nil



Yes

Can’t say

No

Does not apply



Yes

Can’t say

No

Does not apply



Code as follows:





intervention?

/



Yes


P.68

Appendix 5

Extra Material cost of implementing perineal massage for 1 year

Items Expenses (HK$)

Staff training for 2hours 60 staffs x $177 x 2= $21240

Teaching materials for staff

- pamphlet and video

- Perineum model x1

- Evaluation form

$300

$1045

$

Printed material for client

- Information sheet + evaluation form

$0.5 x 27000

= $2700

Total: $25285

Estimated Saving of implementing perineal massage for 1 year

Items Expenses (HK$)

Time for suturing a wound by midwife $88.5 x 16200 = $1433700

Suturing material $30/pack x 16200= $486000

Analgesic saved

Panadol 1g QID for 3 days

$1.8 x 27000 = $48600

Total: $1968300

Saving from implementing perineal massage = $1968300 - $25285 = $1943015

Note 1: Assumed hourly rate of $177 for midwives. (MPS point 20: $31200) (Hospital Authority,

2013)

Note 2: Assumed there will be around 27000 normal vaginal deliveries.

Note 3: Assumed 2/3 of the women (16200) would have perineal trauma that require suturing.

Note 4: Assumed suturing time for each delivery ~30mins.

P.69

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21

Evaluation

Pilot study implementation

Innovation introduce to woman

Trainning to midwives

Presentation to stakeholder

Communication to thestakeholder

Develop evaluation plan

Develop implementation plan

Develop evidence-based guidline

Assessment of implementionpotential

Synthesis of data

Searching of evidence

Month

Duration (Month)

Appendix 6

Project timeline

P.70

Appendix 7

Staff Evaluation Questionnaire about the Perineal massage workshop

Questions

( Please tick the appropriate answer)

Strongly

Agree

Agree

Disagree

Strongly

Disagree

1. The workshop is properly arranged

2. The program is good in time

management

3. The speaker is well prepared.

4. The program can strengthen my

professional knowledge and

understand the benefit in

performing perineal massage

during labour.

5. After the workshop, I understand

the steps and procedure in

performing perineal massage.

6. After the workshop, I am confident

in performing perineal massage

7. The strength of the workshop:

8. The weakness of the workshop:

9. Suggestions to improve the workshop:

P.71

Appendix 8

Client Evaluation Questionnaire about the antenatal talk

Questions


Strongly

Agree

Agree

Disagree

Strongly

Disagree

1. The talk is properly arranged

2. The talk is good in time

management

3. The speaker is well prepared.

4. The talk helps me understand the

benefit in performing perineal

massage during labour.

5. After the workshop, I am willing to

try perineal massage during labour

done by midwife.

6. After the workshop, I believe

performing perineal massage can

help to preserve the integrity of the

perineum.

7. The strength of the workshop:

8. The weakness of the workshop:

9. Suggestions to improve the workshop:

P.72

Appendix 9

Staff Evaluation Questionnaire

about performing Perineal massage during labour

Questions


Strongly

Agree

Agree

Disagree

Strongly

Disagree

1. I enjoy performing perineal

massage to women.

2. I believe perineal massage is useful

in preserve the integrity of

perineum.

3. I feel confident in performing

perineal massage.

4. Performing perineal massage add

extra workload to me

5. The guidelines of perineal massage

are clear and easy to follow.

6. I would recommend my colleague

to perform perineal massage.

7. Your feeling in performing perineal massage:

8. Difficulties encounter during performing perineal massage:

9. Suggestion to the workflow of the project:

P.73

Appendix 10

Client Evaluation Questionnaire

about receiving Perineal massage during labour

Questions


Strongly

Agree

Agree

Disagree

Strongly

Disagree

1. I understand what perineal massage

is before I go into labour room.

2. I was well informed when the

midwife is going to perform

perineal massage.

3. My feeling is considered when the

midwife is performing perineal

massage.

4. I do not think perineal massage is

useful during labour.

5. I will not recommend perineal

massage to my friend who going to

have vaginal delivery.

6. Your feeling in receiving perineal massage:

7. Things you don’t like when receiving perineal massage:

8. Suggestion to improve:

P.74

Appendix 11

Data collection form for perineal massage during labour

Gum label:

Date of delivery: ______________

Duration in 2nd stage of labour: _______ Maturity: ________weeks

Birth weight: _________kg AS 1mins ______5 mins ______

Position at birth: OA/ OP/ OT/ Brow/ Face/ others: ________________

Birthing position: ______________________________

Modes of Delivery:

Normal spontaneous delivery Forceps delivery Vacuum extraction

Others: __________________ Caesarean section, indication: ________________________

Duration of perineal massage:

<5mins 5-10mins >10mins

Perineum status:

Intact/ nick 1st degree 2

nd degree 3

rd degree 4

th degree Episiotomy

Remarks:

Name of woman: ____________________

Age of woman: ________________

H.N. number: ____________________

P.75

Reference

Albers, L. L., Sedler, K. D., Bedrick, E. J., Teaf, D., & Peralta, P. (2005). Midwifery care

measures in the second stage of labor and reduction of genital tract trauma at birth: a

randomized trial. J Midwifery Womens Health, 50(5), 365-372.

Argentine Episiotomy Trial Collaborative Group. (1993). Routine vs selective episiotomy: a

randomised controlled trial. Lancet, 342(8886-8887), 1517-1518.

Avery, M. D., & Van Arsdale, L. (1987). Perineal massage Effect on the incidence of

episiotomy and laceration in a nulliparous population. Journal of Nurse-Midwifery,

32(3), 181-184. doi: http://dx.doi.org/10.1016/0091-2182(87)90095-4

Borghi, J., Fox-Rushby, J., Bergel, E., Abalos, E., Hutton, G., & Carroli, G. (2002). The

cost-effectiveness of routine versus restrictive episiotomy in Argentina. American

Journal of Obstetrics and Gynecology, 186(2), 221-228.

Carroli, G., & Mignini, L. (2012). Episiotomy for vaginal birth. The Cochrane Collaboration

Library(11).

Dannecker, C., Hillemanns, P., Strauss, A., Hasbargen, U., Hepp, H., & Anthuber, C. (2004).

Episiotomy and perineal tears presumed to be imminent: randomized controlled trial.

Acta Obstetricia et Gynecologica Scandinavica, 83, 364-368.

East, C. E., Sherburn, M., Nagle, C., Said, J., & Forster, D. (2012). Perineal pain following

childbirth: Prevalence, effects on postnatal recovery and analgesia usage. Midwifery,

28(1), 93-97.

Geranmayeh, M., Rezaei Habibabadi, Z., Fallahkish, B., Farahani, M. A., Khakbazan, Z., &

Mehran, A. (2012). Reducing perineal trauma through perineal massage with vaseline

in second stage of labor. Archives of Gynecology and Obstetrics, 285(1), 77-81.

Goldberg, J., Hyslop, T., Tolosa, J. E., & Sultana, C. (2003). Racial differences in severe

perineal lacerations after vaginal delivery. American Journal of Obstetrics and

Gynecology, 188(4), 1063-1067.

Hartmann, K., Viswanathan, M., Palmieri, R., Gartlehner, G., Thorp, J., & Lohr, K. N. (2005).

Outcomes of Routine Episiotomy: A Systematic Review. The Journal of the American

Medical Association, 293(17), 2141-2148.

Hospital Authority. (2013). HA Management Pay Scale. Retrieved 1 June, 2014, from

http://www.nurse.org.hk/pdf/cent/c04011337.pdf

Hospital Authority Head Office. (2012). Guidelines For Specialty Nursing Services -

Midwifery Care.

Huang, J., Li, Q., & Ye, Q. (2012). Effect of perineal massage on natural childbirth. Modern

Clinical Nursing, 11(6), 26-27.

Karaçam, Z., & Eroğlu, K. (2003). Effects of episiotomy on bonding and mothers’ health.

Journal of Advanced Nursing, 43(4), 384-394.

http://dx.doi.org/10.1016/0091-2182(87)90095-4

http://www.nurse.org.hk/pdf/cent/c04011337.pdf

P.76

Karacam, Z., Ekmen, H., & Calisir, H. (2012). The use of perineal massage in the second

stage of labor and follow-up of postpartum perineal outcomes. Health Care Women Int,

33(8), 697-718.

Lai, C. Y., Cheung, H. W., Lao, T. H. T., Lau, T. K., & Leung, T. Y. (2009). Is the policy of

restrictive episiotomy generalisable? A prospective observational study. Journal of

Maternal-Fetal & Neonatal Medicine, 22(12), 1116-1121.

Lam, K. W., Wong, H. S., & Pun, T. C. (2006). The practice of episiotomy in public hospitals

in Hong Kong. Hong Kong Medical Journal 12(2), 94-98.

Lappen Justin R, & Gossett Dana R. (2010). Changes in episiotomy practice: evidence-based

medicine in action. Expert Review of Obsterics & Gynecology, 5(3), 301-309.

Li, C., Wang, P., Yu, Y. H., & Li, S. C. (2010). 第二產程中行會陰體按摩的可行性分析.

Journal of Nurses Training, 25(23), 2192-2193.

Lurie, S., Kedar, D., Boaz, M., Golan, A., & Sadan, O. (2013). Need for episiotomy in a

subsequent delivery following previous delivery with episiotomy. [Clinical Trial].

Archives of Gynecology and Obstetrics, 287(2), 201-204.

McDonald, E. A., & Brown, S. J. (2013). Does method of birth make a difference to when

women resume sex after childbirth? [Multicenter Study

Research Support, Non-U S Gov't]. Bjog, 120(7), 823-830.

Melnyk, B. M. (2011). Evidence-based practice in nursing & healthcare : a guide to best

practice (2nd ed. ed.). Philadelphia :: Wolters Kluwer/Lippincott Williams & Wilkins.

Queen Mary Hospital. (2012a). Episiotomy statistics among pubic hospitals in Hong Kong.

Unpublished Audit data. Department of Obstetrics and Gynecology.

Queen Mary Hospital. (2012b). Tear rate with no episiotomy. Unpublished Audit data.

Department of Obstetrics and Gynecology.

Raisanen, S., Cartwright, R., Gissler, M., Kramer, M. R., Laine, K., Jouhki, M. R., &

Heinonen, S. (2013). Changing associations of episiotomy and anal sphincter injury

across risk strata: results of a population-based register study in Finland 2004-2011.

British Medical Journal Open, 3(8), e003216.

Raosoft. (2004). Sample size calculator Retrieved May 30, 2014, from

http://www.raosoft.com/samplesize.html

Royal College of Obstetricians and Gynaecologists. (2007). The Management Of Third- And

Fourth-Degree Perineal Tears. Green-top Guideline No. 29. Retrieved June 18, 2013,

from http://www.rcog.org.uk/files/rcog-corp/GTG2911022011.pdf

Shahraki, A. D., Aram, S., Pourkabirian, S., Khodaee, S., & Choupannejad, S. (2011). A

comparison between early maternal and neonatal complications of restrictive

episiotomy and routine episiotomy in primiparous vaginal delivery. Journal of

Research in Medical Sciences, 16(12), 1583-1589.

Stamp, G., Kruzins, G., & Crowther, C. (2001). Perineal massage in labour and prevention of

http://www.raosoft.com/samplesize.html

http://www.rcog.org.uk/files/rcog-corp/GTG2911022011.pdf

P.77

perineal trauma: randomised controlled trial. British Medical Journal, 322(7297),

1277-1280.

Sule, S. T., & Shittu, S. O. (2003). Puerperal complications of episiotomies at Ahmadu Bello

University Teaching Hospital, Zaria, Nigeria. East Afr Med J, 80(7), 351-356.

Tsai, P. J., Oyama, I. A., Hiraoka, M., Minaglia, S., Thomas, J., & Kaneshiro, B. (2012).

Perineal body length among different racial groups in the first stage of labor. Female

Pelvic Medicine & Reconstructive Surgery, 18(3), 165-167.

Wang, H., & Zhang, Y. (2010). Effect of massage on perineal body in degrading the severity

of perineal tear. Modern Clinical Nursing, 9(9), 17-19.

Wheeler, J., Davis, D., Fry, M., Brodie, P., & Homer, C. S. E. (2012). Is Asian ethnicity an

independent risk factor for severe perineal trauma in childbirth? A systematic review

of the literature. Women and Birth, 25(3), 107-113.

World Health Organization. (1998). Evidence for the Ten Steps to Successful Breastfeeding.

Retrieved June 16, 2013, from

http://whqlibdoc.who.int/publications/2004/9241591544_eng.pdf

http://whqlibdoc.who.int/publications/2004/9241591544_eng.pdf

the university of hong kong - school of nursingnursing.hku.hk/dissert/uploads/kwok lai ming.pdf ·...

Documents