Arch Gynecol Obstet
DOI 10.1007/s00404-016-4101-2
MATERNAL-FETAL MEDICINE
Single-knot versus multiple-knot technique of perineal repair:
a randomised controlled trial
Dan O. Selo-Ojeme1 • Chukwunwendu Anthony Okonkwo2 • Chukwuemeka Atuanya2
Kingsley Ndukwu2
Received: 19 January 2016 / Accepted: 8 April 2016
Ó Springer-Verlag Berlin Heidelberg 2016
Abstract
Purpose An important factor influencing the outcome of
perineal repair is the repair technique. This study was done
to determine if there is a difference in post perineal repair
pain scores following the use of the standard multiple-knot
technique (MKT) of perineal repair and a single-knot
technique (SKT).
Methods We randomised 260 women who sustained a
second-degree perineal tear at the University of Benin
Teaching Hospital, Benin City, Nigeria and had perineal
repair using either a SKT or a MKT between 1 July 2014
and 28 February 2015. Primary outcome measure was pain
assessed with a numerical rating scale (0 = no pain,
10 = worst imaginable pain) on day two, day 10 and at
3 months. Secondary outcome measures were pain scores
during basic activities of daily living, analgesia use, dys-
pareunia and patient satisfaction.
Results Mean pain scores were significantly lower in the
SKT group on day two (2.8 versus 5.6; P \ 0.001) and day
10 (1.8 versus 3.3; P \ 0.001). Significantly fewer women
in the SKT group reported pain on day two (90/126,
71.4 % versus 122/128, 95.3 %; Relative Risk [RR] 0.6,
95 % Confidence Interval [CI] 0.6–0.8; P \ 0.001), and
day 10 (69/126, 54.8 % versus 107/128, 83.6 %; RR 0.7,
95 % CI 0.5–0.7; P \ 0.001)]. Women in the SKT group
were more likely to be satisfied with outcome of repair at
& Dan O. Selo-Ojeme
Dseloojeme@aol.com
1 National Institute for Health and Clinical Excellence
Women & Children’s Division, Royal Free London NHS
Foundation Trust, Barnet and Chase Farm Hospitals,
Wellhouse Lane, Barnet E5 3DJ, UK
2
Department of Obstetrics and Gynaecology, University of
Benin Teaching Hospital, Benin City, Edo State, Nigeria
•
three months (RR 1.4, 95 % CI 1.2–1.5; P \ 0.001). No
difference in pain scores and dyspareunia at 3 months.
Conclusions SKT of perineal repair is associated with
significantly less pain in the first 10 days postdelivery and
a higher patient satisfaction rate at 3 months.
Keywords Episiotomy
Perineal repair technique

Vaginal trauma
Perineal suture
Obstetric perineal
trauma
Numerical rating scale
Introduction
In the United Kingdom, perineal laceration remains the most
common complication during childbirth [1]. It is estimated
to affect about 350,000 women annually with 70 % needing
repair [2]. Pain can occur after the repair, which is also the
most common complaint after vaginal delivery [3, 4]. Post-
repair perineal pain is a health and social concern. For
example, perineal pain significantly affects a new mother’s
quality of life by causing distress and interfering with some
of her basic activities of daily living (BADL), such as sitting,
walking, passing urine and bowel movements [3, 5, 6]. Also,
a review of the claims data of the National Health Service
Litigation Authority between 1 April 2000 and 31 March
2010 showed that 205 of the 441 legal claims related to
perineal trauma included first- or second-degree tears or
episiotomies [7]. This amounted to about £8.7 million.
It is for reasons such as these that the Royal College of
Obstetricians and Gynaecologists (RCOG) and the
(NICE) produced evidence-based guidelines on the man-
agement of birth-related perineal trauma [8, 9]. Unfortu-
nately, adherence to these guidelines has not resulted in the
expected reduction of reported post-repair perineal pain
123

[10] and this has perhaps prompted a recently proposed
search for alternative techniques of repair of episiotomies
or second-degree perineal tears [11].
The main factors that influence the outcome of a perineal
repair are the type of suture material used, repair technique
and operator skill [9]. Rapidly absorbable synthetic poly-
glactin 910 suture material (vicryl rapide) is recommended
and is widely-used for perineal repairs [12]. Nevertheless,
this material’s expected benefits are completely nullified by
inadequate perineal suturing techniques. The technique of
repair, which hinges on the skill of the operator, is critical to
the outcome of a perineal repair.
Several techniques of perineal repair have been descri-
bed [9, 10, 13, 14]. All share the primary goal of reducing
post-repair perineal pain. In addition to a starting or
anchoring knot at the apex, all the techniques involve the
placement of an end or terminal knot, as well as an addi-
tional knot(s), such as the ‘crown stitch’. Unfortunately,
physiological oedema creates tissue constriction between
knots, which generates pain. We hypothesised that a start
and end knot, as well as the number of knots involved in
perineal repair influences the likelihood of significant post-
repair perineal pain. There is a lack of studies comparing
perineal repair techniques that involve a single knot with
those involving multiple knots.
The aim of this randomised controlled trial was to test
the hypothesis that there is no difference in the mean pain
scores of women whose second-degree perineal tear is
repaired using a continuous single-knot technique (SKT)
and those repaired by the standard continuous multiple-
knot technique (MKT)
Materials and methods
Study design
This was a randomised controlled trial conducted at the
University of Benin Teaching Hospital, Benin City, Nige-
ria, a tertiary referral facility in southern Nigeria that serves
a population of about three million people.
Before the start of the study, one of the lead authors
(CAO) held training programmes on the continuous SKT of
repair for all the doctors and midwives involved in the
study. This was complemented by an audit and feedback
for each individual clinician. They all had over 5 years’
experience in perineal repairs and their competency with
the new technique was certified by CAO.
Trial registration and approval
The procedures used in this study are in accordance with
the Declaration of Helsinki regarding human
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Arch Gynecol Obstet
experimentation guidelines. The study was approved by the
Ethics Committee of the University of Benin Teaching
Hospital. The study was registered with the Pan African
Clinical Trials Registry with the identifier number
PACTR201405000819843 (www.pactr.org). The study
protocol was explained to all participants and informed
written consent was obtained from them before entering the
study.
Participants, inclusion and exclusion criteria
The study sample consisted of women who sustained a
second-degree perineal tear at delivery between 1 July
2014 and 28 February 2015. From May 2014, the study was
discussed in detail during the routine antenatal clinic visit
of all women who were 34 weeks pregnant. Their decision
of whether to participate was documented in their mater-
nity notes. Interested participants were given information
leaflets about the study. They were made aware of the data
collection procedure either face to face or via telephone
contact by research assistants.
When a woman was admitted to the delivery suite and it
was confirmed she was interested in the study, preliminary
verbal consent to participate was obtained. After delivery,
if all the study criteria were met, written consent was
obtained before treatment allocation. The participants were
reassured that they were free to withdraw from the study at
any time during the follow-up period, irrespective of their
allocation. Inclusion criteria were spontaneous vaginal
delivery, gestational age of 37 weeks or more, episiotomy
or second-degree perineal tear and perineal repair per-
formed by one of the trained clinicians. Exclusion criteria
were decision not to participate, instrumental vaginal
delivery, extensive perineal trauma, massive obstetric
haemorrhage, delivery of a stillborn baby or baby with
severe congenital anomalies, past history of perineal injury
or surgery, haematological disorder, infection with human
immunodeficiency virus or hepatitis B virus, sickle cell
disease and severe perineal warts.
Randomisation schedule and allocation
Randomisation to MKT or SKT took place on the labour
ward. The allocation sequence was computer generated and
allocation concealment was achieved by placing the allo-
cation in serially numbered opaque sealed envelopes. The
envelopes were held in a secure box on the labour ward.
The serially numbered envelopes were opened in sequence
by the duty labour ward coordinator only after a partici-
pant’s details were written on it. The coordinator then
proceeded to record the randomisation in a specific trial
register.
Arch Gynecol Obstet

Treatment schedules

Women randomised to the standard MKT technique had

their second-degree perineal tears repaired in accor-
dance with the NICE guidelines [14]. Women ran-
domised to SKT had their second-degree tears repaired
using the procedure used in a perineal repair teaching
workshop since 2001 [15] and detailed in 2008 [16].
The main difference in the techniques was that there
was only the starting knot at the apex of the trauma in
the SKT. The repair was continued as a continuous non-
locking repair of the vaginal wall and perineal muscles
with sub-cuticular repair to the skin. Finally, the suture
exited through the muscle tissue 2 cm lateral to the
incision and cut flush to the skin without any other knot
(Figs. 1, 2, 3). In all cases, repair was carried out using
polyglactin 910 (2-0 vicryl rapide, Ethicon Ltd, Edin-
burgh, UK). The women were unaware of which tech-
nique was used. Fig. 2 Repair of the perineal muscles. The direction of the needle is
diagonal and bites are taken to pair each part of the separated edge to
Data collection its counterpart

A pilot trial questionnaire was peer reviewed by other

researchers in the specialty for content validity [17] and
modified thereafter. On day two, day 10 and 3 months post-
delivery, the participants were asked to score any perineal
pain using an 11-point numerical pain rating scale (NRS-
11) with a score of ‘0’ equal to ‘no pain’, and a score of
‘10’ equal to ‘worst imaginable pain’ [18–20]. They also

Fig. 3 Repair of perineal skin—the continuous subcuticular tech-

nique. The exit point of the needle must correspond to the entry point
in the opposite edge to prevent puckering

scored any pain associated with some BADL, such as sit-

Fig. 1 Repair of vaginal wall. The starting knot is above the apex.
The continuous non-locking suture apposes the vaginal wall and
rectovaginal fascia. The posterior hymen, fourchette and posterior
commissure is reconstructed
ting, walking, passing urine and bowel movements. Addi-
tionally, the questionnaire addressed the presence of
perineal scar pain during sexual activity at 3 months
postpartum. The collected data was entered on to a com-
puter database by an assistant and crosschecked by another
assistant.

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 Arch Gynecol Obstet

Outcomes scores between the groups at 10 days, at an alpha level of 5

The primary outcome was perineal pain as measured on
days two and 10 post-delivery. Secondary outcomes were
pain scores during BADL, use of analgesia, need for suture
removal, wound breakdown, dyspareunia and patient sat-
isfaction with the cosmetic appearance.
Sample size calculation
Based on a review of the published literature [4, 21], we
calculated that to detect a 15 % difference in reported pain
and 80 % power, 120 women were needed in each arm of
the study giving a total sample size of 240 patients. To
allow for 15 % attrition, we enrolled 280 patients.
Data analyses
The trial was analysed and reported according to CON-
SORT requirements [22]. All statistical analyses were
undertaken on an intention-to-treat basis using Stata sta-
tistical software version 7 (Stata Corp., College Station,
TX). Dichotomous outcomes were compared using v2 or

Enrolment Assessed for Eligibility (n=280)

Excluded (n=4)

Declined to parcipate (n=4)

Not meeng criteria (n=3)

Randomised (n=269)

Allocaon

Allocated to SKT group (n=134) Allocated to MKT group (n=135)

Received allocated intervenon (n=134) Received allocated intervenon (n=135)

Follow -up

Lost to follow up (n=8, lost contact) Lost to follow up (n=7, lost contact)

Analysis

Analysed (n=126) Analysed (n=128)

Excluded from analysis (n=0) Excluded from analysis (n=0)

Fig. 4 CONSORT 2010 flow diagram of trial

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Arch Gynecol Obstet

Table 1 Comparison of
SKT (n = 126) MKT (n = 128) OR (95 % CI) P value
baseline characteristics of
women in the SKT and MKT Age (years) 30.7 ± 4.4 29.4 ± 4.9 0.3
groups
BMI 28.0 ± 1.9 31.0 ± 2.1 0.6
Parity 0.2
Nullipara 63 (50) 67(52.3)
Multipara 63(50) 61(47.7)
Gestation (weeks) 39.1 ± 1.5 38.8 ± 1.6 0.6
Type of injury 0.8
Episiotomy 103 981.7) 111 (86.7)
2nd degree tear 23 (18.3) 17 (13.3)
Previous repair 36 (28.60 33 (25.8) 0.26
Breakdown of repair 4 (3.2) 5 (3.9) 0.39
Additional use of analgesia 2 (1.6) 8 (6.3) 0.06
Use of C2 suture packets 4(3.1) 42 (38.2) 0.03 (5.1–43.2) \0.001
Values presented as mean (SD)

Fisher’s exact test, with calculation of relative risk (RR) Table 2 Comparison of reported pain scores between both groups on
day 2, day 10 and 3 months
and 95 % confidence interval (CI). Student’s t test and
Mann–Whitney U test was used to compare normally dis- SKT (n = 126) MKT (n = 128) P value
tributed continuous data and skewed data, respectively.
Day 2 2.8 (1.4) 5.6 (2.3) \0.001
P \ 0.05 was considered significant.
Day 10 1.8 (1.1) 3.3 (1.7) \0.001
3 months 0.6 (1.4) 0.4 (0.9) 0.69

Results Values presented as mean (SD)

Figure 4 shows the trial flow chart. The baseline data of the Table 3 Comparison of reported pain scores BADL in both groups
participants is shown in Table 1. There was no significant on days and day 10
difference in the mean maternal age (30.7 versus SKT MKT P value
29.4 years, P = 0.3), gestational age at delivery (39.1 (n = 126) (n = 128)
versus 38.8 weeks, P = 0.6), body mass index (28.0 versus
Day 2
31.0 kg/m2, P = 0.6), parity (P = 0.8) and type of perineal
Pain at rest 2.5 (1.5) 3.7 (2.1) 0.02
trauma (P = 0.7) between the two groups. Compared to
the MKT group, patients in the SKT group were 15 times Pain when walking 2.2 (1.2) 4.2 (2.1) \0.001
less likely to use over two packets of suture material (Odds Pain in a sitting 2.2 (1.4) 3.3 (1.8) \0.001
position
Ratio 0.03, 95 % CI 5.1–43.2; P \ 0.001).
Pain during defecation 1.9 (1.5) 3.6 (1.7) 0.001
As demonstrated in Table 2, women in the SKT group
Pain during urination 1.1 (1.0) 1.9 (1.7) 0.05
reported a significantly lower mean pain score on day two
Day 10
(2.8 versus 5.6; P \ 0.001) and day 10 (1.8 versus 3.3;
Repose 0.82 (1.1) 1.1 (1.5) 0.3
P \ 0.001) compared to the MKT group. Similarly, they
Walk 0.6 (0.9) 1.6 (1.4) 0.005
reported significantly lower pain scores in the various
Sit 0.6 (0.8) 1.0 (1.3) 0.145
activities of daily living as shown in Table 3.
Table 4 shows that compared to the MKT group, the risk Stool 0.2 (0.6) 0.9 (0.2) 0.01
of reporting perineal pain was reduced in the SKT group by Urinate 0.07 (0.2) 0.5 (0.9) 0.01
40 % on day two (71.4 % [90/126] versus 95.3 % [122/ Values presented as mean (SD)
128]; RR 0.6, 95 % CI 0.6–0.8; P \ 0.001), and by 30 %
on day 10 (54.8 % [69/126] versus 83.6 % [107/128]; RR
0.7, 95 % CI 0.5–0.7; P \ 0.001). Women in the SKT CI 1.2–1.5; P \ 0.001). There was no difference in pain
group were one and half times more likely to be satisfied scores (P = 0.74) and dyspareunia (P = 0.62) at
with the outcome of the repair at 3 months (RR 1.4, 95 % 3 months.

123

Table 4 Comparison of the
proportion of women that report
any pain on day 2, day 10, Pain on day 2
3 months; dyspareunia at
3 months and satisfaction at Pain on day 10
3 months Have pain at 3 months
Dyspareunia at 3 months
Satisfied
Values presented as n(%)
Discussion
The repair of perineal trauma sustained during childbirth is
part of the immediate postpartum care of the parturient.
Perineal pain following repair of birth-related perineal
injury can be quite distressing for the new mother and
adversely affects her capacity to carry out the necessary
activities related to motherhood [7] and BADL, thereby
delaying her post-natal recovery [23]. This is particularly
important in the immediate post-natal period when it is
necessary to quickly establish bonding with the new baby.
Therefore, identification of strategies to minimise pain and
discomfort during this period is important.
This study showed that, compared to the use of the
standard MKT of repair, SKT perineal repair was associ-
ated with significantly lower reported mean pain scores on
days two and 10. Pain scores were also lower during the
various BADL. This can be explained by the fact that the
physiological reaction to tissue trauma includes oedema
formation which can, in the presence of restricting multiple
knots, result in tissue constriction with consequent ische-
mia and pain. It is therefore not surprising that postpartum
perineal pain is still a common complaint, even when there
is seemingly satisfactory compliance with current routine
maternity care guidelines for perineal repair [24]. Whether
it is better to completely avoid episiotomy during childbirth
has been considered [25, 26].
When there is a birth-related perineal trauma, it is
essential to have a repair technique associated with mini-
mal pain. That is why researchers have for 70 years been
actively seeking new and better ways of performing per-
ineal repairs. Some of these studies investigated whether it
is best to leave the perineal trauma completely unsutured
[27, 28], or to suture only the perineal muscles and leave
the perineal skin unsutured [29–31]. Results have largely
been inconclusive. Other studies examined the different
aspects involved in perineal repair, including whether it
was best to use a synthetic suture material or catgut [12,
32–36]. The technique of suturing has also been exten-
sively investigated; some studies suggested that the use of a
continuous non-locking suturing technique for repair of the
vagina, perineal muscles and skin was associated with less
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Arch Gynecol Obstet
SKT (n = 126) MKT (n = 128) RR (95 % CI) P value
90 (71.4) 122 (95.3) 0.6 (0.6–0.8) \0.001
69 (54.8) 107 (83.6) 0.7 (0.5–0.7) \0.001
16 (12.7) 18 (14.0) 0.9 (0.4–1.6) 0.74
6 (4.7) 7 (5.5) 0.7 (0.2–2.6) 0.62
121 (96.0) 88 (68.7) 1.4 (1.2-1.5 \0.001
perineal pain when compared to the use of the interrupted
method of repair [14, 21, 37, 38]. In 2012, a Cochrane
Systematic review [14] concluded that the continuous non-
locking suturing technique was associated with less pain on
days two and 10 post-delivery. While birth-related perineal
trauma cannot be completely prevented, our study shows
that compared to the current technique, the SKT is asso-
ciated with less perineal pain.
Although there was no difference in the reported pain
scores and dyspareunia at 3 months, women in the SKT
group were more likely to be satisfied with the outcome of
their repair at that time. Patient-reported satisfaction is
subjective and it may well be that the degree of satisfaction
is related to the rapidity of resolution of post-repair pain in
the immediate postpartum period.
The percentage of participants reporting post-repair
perineal pain in this study is higher than reported elsewhere
[4]. This may be due to racial differences in the perception
of pain as the rate in this study is similar those reported by
previous authors at this centre [39].
Strengths of the study include good patient recruitment,
good adherence to the study protocol and relatively small
loss during follow-up. In addition, the analysis was on an
intention-to-treat basis. The main limitation is that pain
perception is mostly subjective and was reported using the
NRS. However, for general purposes the NRS has good
sensitivity [40] and is to a large extent very practical, easy
to understand and does not need dexterity, paper or pen.
The NRS and the VAS have been shown to give almost
identical values in the same patient [19].
As we strive to provide better care to the parturient, the
introduction of perineal repair techniques associated with
least pain morbidity, such as the SKT, for those that need
repair must be welcomed.
Compliance with ethical standards
Funding No funding was obtained by any of the authors for this
study.
Conflict of interest Selo-Ojeme: declares that he has no conflict of
interest; Okonkwo: declares that he has no conflict of interest; Atu-
anya: declares that he has no conflict of interest; Ndukwu: declares
that he has no conflict of interest.
Arch Gynecol Obstet
Ethical approval All procedures performed in studies involving
human participants were in accordance with the ethical standards of
the institutional and/or national research committee and with the 1964
Helsinki declaration and its later amendments or comparable ethical
standards.
Informed consent Informed consent was obtained from all indi-
vidual participants included in the study.
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