Bick et al.

BMC Pregnancy and Childbirth 2010, 10:10

http://www.biomedcentral.com/1471-2393/10/10

STUDY PROTOCOL Open

Access

PErineal Assessment and Repair Longitudinal

Study (PEARLS): protocol for a matched pair
cluster trial
1* 2,3 4 5 6 3,7
Debra E Bick , Christine Kettle , Sue Macdonald , Peter W Thomas , Robert K Hills , Khaled MK Ismail

Abstract
Background: The Perineal Assessment and Repair Longitudinal Study (PEARLS) is a national clinical quality
improvement initiative designed to improve the assessment and management of perineal trauma. Perineal trauma
affects around 85% of women who have a vaginal birth in the UK each year and millions more world-wide.
Continuous suturing techniques compared with traditional interrupted methods are more effective in reducing
pain and postnatal morbidity, however they are not widely used by clinicians despite recommendations of
evidence based national clinical guidelines. Perineal suturing skills and postnatal management of trauma remain
highly variable within and between maternity units in the UK as well as worldwide. Implementation of a
standardised training package to support effective perineal management practices could reduce perineal pain and
other related postnatal morbidity for a substantial number of women.
Methods/Design: PEARLS is a matched pair cluster trial, which is being conducted in maternity units across the
UK. Units within a matched pair will be randomised to implement the study intervention either early or late in the
study period. The intervention will include the cascading of a multi-professional training package to enhance
midwifery and obstetric skills in the assessment, repair and postnatal management of perineal trauma. Women
who have had an episiotomy or second degree perineal tear will be eligible for recruitment. Prior to developing
the intervention and deciding on study outcomes, a Delphi survey and a consensus conference were held to
identify what women, who previously suffered perineal trauma during childbirth, considered to be important
outcomes for them. Findings from this preliminary work (which will be reported elsewhere) and other outcomes
including women’s experiences of perineal pain and pain on activity, breastfeeding uptake and duration and
psychological well-being as assessed using the Edinburgh Postnatal Depression Scale (EPDS) will be assessed at 10
days and three months post-birth.
Discussion: Implementation of evidence-based perineal assessment and management practices, could lead to
significantly improved physical and psychological health outcomes for women in the UK and world-wide.
Trial registration: PEARLS is registered with the Current Controlled Trials Registry (no: ISRCTN28960026). NIHR
UKCRN portfolio no: 4785.

Background family. Around 85% of women who have a vaginal deliv-

Persistent perineal pain is one of the most commonly
experienced health problems associated with birth [1,2].
It is a symptom highly related to perineal trauma and can
impact on a woman’s physical and psychological well-
being as well as her relationship with her baby and
* Correspondence: debra.bick@kcl.ac.uk
1
King’s College London, Florence Nightingale School of Nursing and
Midwifery, James Clerk Maxwell Building, 57 Waterloo Road, London, UK
ery will sustain perineal trauma, which occurs either
spontaneously or as a consequence of an episiotomy, and
three-quarters of women will require suturing to facilitate
healing of the disrupted tissue [3]. Studies investigating
maternal morbidity have reported that for some women,
perineal pain persists well beyond the postnatal period
[1,2]. In the UK childbirth related perineal trauma is sub-
divided into the following four types according to the tis-
sues and structures involved (table 1). Third and fourth

© 2010 Bick et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons
Attribution License (http://creativecommons .org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
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Table 1 Classification of perineal trauma

First degree: Injury to skin only
Second degree: Injury to the perineum involving perineal muscles but not involving the anal sphincter
Third degree: Injury to the perineum involving the anal sphincter complex;
3a < 50% of external anal sphincter (EAS) thickness torn;
3b > 50% of EAS thickness torn;
3c Internal anal sphincter (IAS) torn
Fourth degree: Injury to perineum involving the anal sphincter complex (EAS and/or IAS) and anal epithelium
RCOG Green Top Guideline 23. Methods and Materials Used in Perineal Repair. Kettle C, O’Brien PMS.
Bick et al. BMC Pregnancy and Childbirth 2010, 10:10 Page 3 of 8
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degree tears represent the the continuous and some of whom may not perineal anatomy [10].
most severe forms of interrupted techniques have received adequate Only 20% of the trainees
perineal trauma, with a for episiotomy and basic or updated training and 48%
reported incidence of 0.5% second degree perineal [10]. An audit of of midwives reported
to 3% [4], how- ever, the repair and reported a knowledge of perineal their training to have
actual incidence may be significant improvement anatomy, classification of been of a
higher as some tears may in peri- neal pain with trauma and satisfaction ‘good standard’. Many
be missed or the continuous with training in perineal responses relating to
misdiagnosed. Most technique [7]. More management, which was questions on anatomy and
childbirth related perineal recently, members of our undertaken by Sultan et al perineal repair were
trauma fall into the collaborative team (CK, (75 midwives and 75 incorrectly answered, for
second-degree or KMKI and RKH) trainee doctors) reported example, most classified a
episiotomy category. conducted a Cochrane that a large proportion of partial or complete tear of
review of seven RCTs and the participating the EAS as ‘second
S reported that the use of clinicians had a poor degree’. The anatomy of
u continuous suturing understanding of the perineum and pelvic
t techni- ques for all layers floor and training in
u suturing is included within
was associated with less
r the pre-registration
i short-term pain
compared to the midwifery education
n
traditional interrupted programme, sup- ported
g
method [8]. The RCOG by practical experience in
Greentop and NICE the clinical area. How-
m
e intrapartum guide- lines ever, the time and focus
t recommend that the allocated to this area of
h continuous suturing learning is variable
o between individual units
techni- que and Vicryl
d and some midwives will
s Rapide suture material
should be used for repair not undertake perineal
a
n of episiotomy and second suturing until after
d degree tears [5,9]. qualifying when practical
training usually takes
m T place in the work- place.
a r Moreover, there is little
t a information to inform the
e i content and delivery of
r n training in perineal
i i management and repair,
a n
l which may only be
g
s undertaken at the instiga-
There are considerable tion of the individual
i
variations in suture s clinician.
materials and techniques s
used for repairing u P
perineal trauma in e o
s s
current clinical practice,
Identification, correct t
despite guidelines and n
classification and the
evidence to support best a
technique used to repair
practice [5-9]. A t
perineal injury are a
Cochrane systematic
procedures that require l
review based on eight
knowledge and skills to
randomised controlled
ensure that the tissues c
trials (RCTs) showed
involved are correctly a
that the use of
aligned to facilitate r
absorbable synthetic e
healing and minimise
material is associated In addition to gaps in
postpartum morbidity. In
with less perineal pain immediate care,
the UK, the assessment
and less requirement for subsequent post- partum
and repair of trauma
analgesia [6]. A large management is unlikely to
following vaginal
RCT involving be based on robust
delivery are mainly
1542 women compared evidence or the degree
undertaken by midwives,
 Bick et al. BMC Pregnancy and Childbirth 2010, 10:10 Page 4 of 8
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trauma sustained. term maternal morbidity,
Despite pain being including perineal pain,
experienced by and improve women’s
hundreds of thousands experiences of maternity
of women in the UK, and care relating to the
many more worldwide management of perineal
and the availability of trauma.
evidence-based guidance
for postnatal
management [3,11-13],
the identification and
manage- ment of longer-
term perineal morbidity
such as pain, dyspareunia,
wound infection and
haematoma, has not been
a high priority in practice
or research.

R
a
t
i
o
n
a
l
e

f
o
r

P
E
A
R
L
S
For the above reasons and
in the absence of a
standar- dised approach
or formally recognised
training pro- gramme for
perineal management,
our collaborative team
felt that there was an
urgent need to focus on
the training needs of
individual clinician as
the unskilled operator,
even when using the best
materials and techni- ques,
could contribute
significantly to the
extent of maternal
morbidity. The main
aim of this trial is to
evaluate if enhanced
clinician training in
perineal assess- ment and
management can reduce
immediate and longer-
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Bick et al. BMC Pregnancy and Childbirth 2010, 10:10 Page 6 of 8
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M midwifery clinical training n Unit randomisation
e and management in t and collection of
s baseline data
t relation to childbirth-
/ Once pairs of units have
h related perineal trauma E
o was also conducted. The been identified, third
l
d aim of the survey was to i party randomisation will
s assess the level of imple- g be carried out at Cardiff
/ mentation of national i University; the statistician
D guidelines and reasons, if b (RKH) will be blind to
e i information that could
any, for lack of l
s implementation prior to identify t he study unit.
i
i introducing any quality Following a baseline
t
g improvement y audit, one maternity unit
n intervention. The from each matched pair
S information generated c will commence early
t r implementation of the
from the survey will be a
u i intervention. The use of
d reference point to
t a deferred training arm
y demonstrate the potential
e will allow primary study
impact of the trial on the r
level of knowledge and outcomes to be assessed
d i
e clinical practice within a
between units in the
s maternity units in the All women who sustain a pair at a second period
i UK. Results of the Delphi, second degree perineal of data collection and
g consensus conference and assess- ment of the s
tear or episiotomy in a
n ustainability of a ny
national midwifery survey participating unit during
The study is a multi- improvements in those
will be published the study per- iod will
centre, matched pair units randomised to early
elsewhere. be eligible. Women will
cluster rando- mised trial. intervention. (see Fig- ure
not be eligible for
Matching criteria include 1).
S recruitment if:
unit size as deter- mined e All women booked for
by the total number of t delivery in participating
• under 16 years of
births per annum, type of t units will receive written
age
unit (ie obstetric led or i information about the
n • non-English
birth centre) and the study during the antenatal
g speaking
qualifica- tions of the period, at approximately
The trial will be • have suffered
facilitators, information pregnancy loss 36 weeks gesta- tion.
on which were obtained undertaken within a wide
Following the birth, all
from study sites on range of mater- nity units.
All births during a pre- eligible women will be
recruitment to the study. Units will be analysed in
specified period will offered information about
To ensure generalisability matched pairs. An open
contribute to analyses. the study and given time
of the study findings, we invitation will be sent by
to read the leaflet prior to
will aim to recruit units of the study team to Heads
being invited to take
varying size, organisational of Midwifery in maternity
part. Informed consent
struc- ture and units across the UK
will be obtained either on
population exploring their intention
the Labour Ward, or prior
demographics. A to participate. Detailed
to discharge home.
minimum of 20 units (10 information about the trial
Women who decide to
pairs) will be recruited. will be sent to units that
participate will receive a
Prior to commencing the show an initial intention to
study pack to take home,
trial a Delphi survey and participate. Matching
containing a covering
con- sensus conference criteria parameters will
letter, a 10-12 day
were undertaken at two be col- lected from each of
questionnaire and a pre-
sites not parti- cipating in the participating units.
paid reply envelope. A
the main trial. The aim letter will also be sent to
of this preliminary work P
the GPs informing them
a
was to generate a list of of the study. Women
r
outcomes considered to t who return the 10-12 day
be important by women i questionnaire will receive
who had recently c a second questionnaire
experienced peri- neal i and return envelope at
trauma (≤ 6 months). A p three months
national survey of current a
 Bick et al. BMC Pregnancy and Childbirth 2010, 10:10 Page 7 of 8
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postpartum. training intervention

I
n
t
e
r
v
e
n
t
i
o
n
The intervention that is
being tested in the trial
is a multi-professional
training package to
enhance the assessment
and management of
perineal trauma by mid-
wives and obstetricians.
The training package will
com- prise of:

▪ Reading material
for independent study
and self directed
learning
▪ Copies of the
RCOG and postnatal
perineal care
guidelines and perineal
pain relief protocol
[5,12,13]
▪ A formal workshop
which will provide
information on the
principles of
recognition and
management of
perineal trauma,
surgical skills and
simulated hands- on
experience for the
second degree &
episiotomy repair
▪ An interactive
CD-ROM to help
participants refresh
core information, and
maintain competency
▪ An Objective
Structured
Assessment of
Training (OSAT)
proforma which will
form part of the parti-
cipants initial and
ongoing assessment
process, to be
completed within 3
months of the
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Figure 1 Plan of investigation for matched pairs of units.

Bick et al. BMC Pregnancy and Childbirth 2010, 10:10 Page 9 of 8
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▪ A leaflet for all obstetricians) who have
women who sustain undergone intensive
sutured peri- neal training in perineal
trauma to promote assessment and
self-management of management provided by
their perineal trauma, the trial team, and will
and their general health be responsible for
and well- being, and cascading the training
advice on who to package within their units
contact if they have (with support from the
any concerns project team). To ensure
optimal recruitment of
The intervention will women from each study
take place during a three site, the project manager
month period and will be will maintain regular
delivered by local clinical contact with the local
facilitators. These will be clinical facilita- tors (at
clinicians from the unit one to two weekly
(midwives or intervals) who will also
have responsibility for
overseeing recruitment
at each site,
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following training in management will be as second degree perineal Following completion
research procedures from per local protocol. tear, will be invited to of this stage of the study,
the study team. complete questionnaires the local training
Delivering the D at 10-12 days (Survey facilitators in units
intervention using local a 1A) and three months randomised to later
facilitators will accrue t (Survey 1B) postpartum intervention will be trained
a to moni- tor immediate
several benefits: to deliver the intervention
and longer-term impact in their individual units.
C on health and other
• It will ensure that L
o outcomes.
the intervention could a
l
be deliv- ered by a Audit and t
l
surveys e
well trained clinician, e
following r
not necessarily pre- c
t early
viously an expert in intervention
i i
the field Following n
o
• It will increase the implementation of the t
n
sense of local intervention in the units e
B
ownership of the a allocated to the early r
intervention within the s v
intervention group, a e
participating units e second prospective clinical
l n
• It will facilitate the audit (Audit 2) will be
i t
use of Objective undertaken in both i
Structured n
e groups over a period o
A n
of around two months.
s
s a Women who give birth
u during the same time p
e e
s d period, who have an
i r
s episiotomy or sustain a i
m t second degree peri- neal o
e tear, will be invited to d
n a complete questionnaires Implementation of the
t n
at intervention will
o d
10-12 days (Survey 2A) commence in those units
f and three months
s randomised to receive
T (Survey 2B)
u later intervention,
r p
ai r delivered by local training
v o facilitators with help and
n s
i e sup- port from the
y t
n central project team.
s p
g a The intervention will be
( Baseline data will be
r delivered over a three
O collected from each pair of
t month period.
S units by undertaking a
u Audit and
A prospective clinical audit surveys
m
T (Audit 1) over a period . following
) of around one month late
Data from Audit 2 and
• It will minimise (although the precise intervention
Surveys 2A-B will be
potential confounding length of time may be Following
compared to data from
of an influ- ential shorter, depending on the implementation of the
the previous audits and
facilitator in that their size of the units intervention in units
surveys (1A-B) within
level of experience recruited). allocated to group B, a
individual units to assess
will be one of the The aim of the first third prospective clinical
the impact that the inter-
criteria for matching audit (Audit 1) is to audit (Audit 3) will be
vention had in those units
units assess prac- tice prior to carried out in both groups
that receive the
any intervention, against over a per- iod of two
intervention, compared
Facilitators will quality standards for months. Women who
with those who had not
receive their training perineal management give birth during the
so far received it. These
immediately prior to the [5,12,13]. Women who same time period, who
data will inform the
implementation of the give birth during the same have an episiotomy or
primary and secondary
intervention in their unit. time period, who have an sustain a second degree
trial outcomes.
All other aspects of episiot- omy or sustain a perineal tear, will be
 Bick et al. BMC Pregnancy and Childbirth 2010, 10:10 Page 12 of
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invited to complete improvements in an
questionnaires at 10-12 maternal health p ag
days (Survey 3A) and following o e
m
three months (Survey 3B) implementation of the s
en
postpartum. Data from intervention. t
t
Audit 3 and Surveys 3A- P an
B will be compared to r b d
data from the pre- vious i i va
m r li
audits and surveys within
a t da
individual units to assess r h ti
the impact and y on
sustainability of the
• severity of perineal Audit data for evaluation
implementation of the S pain of the training package
intervention. t
• need for suture will be managed and
u
removal validated locally, before
O d
y • use of pain relief being sent to the
u
t duirng the previous 24
c O hours
o u • uptake and duration
m t of exclusive
e c breastfeeding
o • perineal wound
m m infection
e e
a • Experience of perineal T
s pain on daily activity at h
u 10 - r
r 12 days post birth. e
e S e
s e
P c
r m
o o
i n
m n
d
a t
a
r r h
y y s

a S p
n t o
d u s
d t
s y
e b
c O i
o u r
n t t
d c h
a o
r m
y • Edinburgh Postnatal
e
s
Depression Scale
(EPDS [14])
o 1
u score of ≥ 13
0
t • timing of resumption
c of intercourse
-
o • satisfaction with the
m perineal repair.
e 1 • duration of exclusive
Previous studies of 2 breastfeeding
maternal morbidity have
identifed several outcomes d D
associated with perineal a at
trauma, some of which y a
s m
will be used to measure
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PEARLS Central Office. respond to the reminder 12 days 75% of women D
Survey participants will be they will be deemed to have any pain whilst a
iden- tified and consented have withdrawn. In walking or sitting in the t
past a
locally and the 10-12 day addition, participants
question- naire and may withdraw at any 24 hours, that the ICC is
0.013, a 1% significance a
prepaid envelope will be time by contacting the
n
given by ward staff prior PEARLS Central Office. level, and a cluster size of
a
to the woman’s discharge Reasons for withdrawal 40. With 16 clusters (8 l
from the postnatal ward. will be sought in this pairs) this would give the y
The three month instance, but women study 95% power to detect s
questionnaire will be will not be required to a 20% reduction in i
sent directly from the give details if they choose primary outcome from s
PEARLS Central Office, not to. 75% to 55% (as seen in the The analysis of this trial
to women who con- trial by Kettle et al 2002 will be by ‘intention to
sented and responded S [7]) or alternatively a treat’, in that we will
at 10-12 days. All t small-to-moder- ate attempt to include all
completed questionnaires a difference of one third of a clusters in the analysis
t standard deviation on con- regardless of
will be returned to the
i tinuous scales, such as implementation of the
PEARLS Central Office, s
where data forms and VAS scores for pain). intervention, and attempt
t
electronic files will be This calculation assumes to get completed
i
securely stored (in c 0 correlation between questionnaires returned
locked filing cabinets or a paired clusters. Assuming from all women recruited
relational databases on l a response rate of 60%, in each cluster. A 5% 2-
password-protected implies recruiting 67 sided signifi- cance level
computers). Data will be i women in each cluster. will be used. Analysis of
s Having additional the primary and sec-
entered using form
s ondary outcomes,
based entry systems, to clusters will help to
u following the early
ensure data quality. e preserve sample size
Automated data checking s should clusters withdraw intervention (i.e in phase
will be used to identify S from the study. 2), will be by means of the
outliers and improbable a matched-pair random
data, and if data quality m effects model [15] and
appears to be poor as a p analysed using a multi-level
l model framework [16]
result of automated
e with MLWin software
procedures, site data
verification may be [17]. In this way the
s paired cluster design is
considered in a subset of i
centres. taken into account.
z
W e Results will be presented
i In a clustered design, due graphically as Forest plots
t consideration needs to be to show the variation of
h effect size between cluster
made of the fact that there
d pairs. This frame- work
r are certain factors
pertaining to the cluster permits extending the
a
(maternity unit), as well as analyses to include
w
a to the individual, which individual level and
l can affect outcome paired-cluster level (such
Only those women who measures, and hence the as cluster size, and
sign a consent form and sample size depends not baseline compliance with
return the questionnaire only on the size of RCOG guidelines)
at 10-12 days will be difference one wishes to variables as covariates.
sent the three month detect, but also the intra- Multilevel models will
questionnaire. Non- cluster correlation be used to assess
respondents will be coefficient (ICC) [15]. whether the effect of the
deemed to have Typically such values are intervention persists by
withdrawn. Where small, and it is very looking in addition at the
women respond at 10- unlikely that the ICC will data following the second
12 days but not at three exceed 0.05. The sample period of intervention.
months, a reminder will size cal- culation for the The proportion of
be issued. If they fail to trial assumes that at 10 - eligible women who
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completed questionnaires requirements for research
will be calculated for each govern- ance. The
clus- ter and the PEARLS Central Office
intervention groups will help Principal
compared. Investigators obtain local
R&D approval. The local
Ethical Prin- cipal Investigator
consideration will be responsible for
s and Safety liaison with the local Trust
Committee
management team
The protocol has been regarding locality issues,
approved by the Thames and must obtain the
Valley ethics committee. necessary signatures
The conduct of the from their Trust. Once
trial will be according to local R&D approval have
the principles of MRC been granted and
Guidelines for Good evidence provided to the
Clinical Practice in PEARLS Central Office,
Clinical Trials (1998) the
[18] and the appropriate
NHS Research Governance
Frameworks. All
participating units will be
required to sign an
Investiga- tor’s Agreement,
detailing their
commitment to accrual,
compliance, Good
Clinical Practice,
confidentiality and
publication. Deviations
from the agreement will
be mon- itored and the
Project Steering
Committee will decide
whether any action needs
to be taken, e.g.
withdrawal of funding,
suspension of centre.
Site Specific R&D
approval is required for
each parti- cipating unit,
whereby the NHS Trust
Research and
Development (R&D)
Office will assess “locality
issues” relating to the
local population,
investigators, facilities
and resources. In order to
comply with current
arrange- ments, an
employee of each unit
(this could be the
appointed local training
facilitator) would have to
assume responsibility as
the local ‘Principal
Investigator’, assisting the
project team with
procedures to obtain
local R&D approval
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8
local Principal Investigator management of women, University School of Medicine,
n 7
Heath Park, Cardiff, UK. Institute
will receive a folder the TSC can then decide t
of Science and Technology, in
contain- ing all the whether to close or s
Medicine, Keele University
This study is
necessary materials to modify any part of the funded by a grant
Medical School, Keele,
Staffordshire, UK.
allow the trial to com- study. Unless this happens, from The Health
mence in their unit. how- ever the central Foundation.
Authors’ contributions
It is unlikely that the project team, the steering A DB and CK conceived the original
study, and DB, CK, SM, RKH, KI and
introduction of a training committee, the u
PT contributed to the study design.
t
pack- age in perineal investigators and all of h All authors edited the manuscript
care will cause any the central o and read and approved the final
r manuscript.
adverse reactions administrative staff
amongst women. (except the statisticians Competing interests
d
However, any serious who supply the e
Financial competing interests
The Keele and Staffs Episiotomy
unexpected adverse confidential analyses) will t Trainer was developed by Limbs
events (SAEs) believed remain unaware of the a and Things in collaboration with
i
to be due to perineal interim results. l
CK and KI through the Office of
Research and Enterprise, Keele
suturing will be reported s
University and the University
1
to the study office as C King’s College London,
Hospital of North Staffordshire R&D
Florence Nightingale
soon as possible. This o School of Nursing and
Department. CK and KI receive a
small royalty fee, paid via Keele
should be followed n Midwifery, James Clerk Maxwell University, from the sales of the
within 7 days by a c Building, 57 Waterloo Road,
trainer for their contribution. Other
London, UK.
completed SAE form. l 2
Faculty of Health,
members of the PEARLS study
group declare they have no
Events that might u Staffordshire University,
financial or non- financial
reasonably be expected to s Blackheath Lane, Stafford, UK.
3 competing interests.
University Hospital of North
occur in women following i Staffordshire, Maternity Centre,
o Received: 28 September 2009
childbirth do not need to Stoke on Trent, Staffordshire, UK.
Accepted: 25 February 2010
be reported. For the n 4
Royal College of Midwives, 15 Published: 25 February 2010
s Mansfield Street, London,
purposes of this study, 5
UK. Dorset Research and
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Pre-publication history
The pre-publication history for this paper can be accessed here:http://www.
biomedcentral.com/1471-2393/10/10/prepub

doi:10.1186/1471-2393-10-10
Cite this article as: Bick et al.: PErineal Assessment and Repair
Longitudinal Study (PEARLS): protocol for a matched pair cluster trial.
BMC Pregnancy and Childbirth 2010 10:10.

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