Archives of Gynecology and Obstetrics

https://doi.org/10.1007/s00404-020-05585-4

IMAGES IN OBSTETRICS AND GYNECOLOGY

Prevalence of levator ani avulsion in a multicenter study (PAMELA

study)
Jordi Cassadó1 · Marta Simó2 · Nuria Rodríguez3 · Oriol Porta2 · Eva Huguet1 · Irene Mora4 · Marta Girvent5 ·
Rebeca Fernández6 · Ignasi Gich7

Received: 20 December 2019 / Accepted: 5 May 2020

© Springer-Verlag GmbH Germany, part of Springer Nature 2020

Abstract
Purpose The objective is to determine the prevalence of levator ani muscle (LAM) avulsion using four-dimensional ultra-
sound in primiparous women after vaginal delivery and according to delivery mode.
Methods This prospective, multicenter study included 322 women evaluated at 6–12 months postpartum by four-dimensional
transperineal ultrasound to identify levator ani muscle avulsion. The researcher who performed the ultrasound was blinded to
all clinical data. Meaningful data about the birth were also recorded: mode of delivery, mother’s age and body mass index,
duration of second stage, episiotomy, perineal tearing, anesthesia, assistant, head circumference and fetal weight.
Results 303 volumes were valid for evaluation. The overall prevalence of levator ani muscle avulsion was 18.8% (95% CI
14.4–23.2%). In our multivariate analysis, only mode of delivery reached statistical significance as a risk factor for leva-
tor ani muscle avulsion (p < 0.001). The prevalence according to the different modes of delivery was 7.8% in spontaneous
delivery, 28.8% in vacuum-assisted and 51.1% in forceps-assisted delivery. Compared with spontaneous delivery, the OR for
LAM avulsion was 12.31 with forceps (CI 95% 5.65–26.80) and 4.78 with vacuum-assisted delivery (CI 95% 2.15–10.63).
Conclusions Levator ani avulsion during vaginal delivery in primiparous women occurs in nearly one in every five deliveries.
Delivery mode is a significant and modifiable intrapartum risk factor for this lesion. The incidence is lower in spontaneous
delivery and significantly increases when an instrument is used to assist delivery, especially forceps.

Keywords Levator ani muscle avulsion · Delivery mode · Pelvic floor ultrasound · Childbirth · Forceps · Vacuum extractor

Introduction
* Jordi Cassadó Pelvic floor dysfunction is a very prevalent disease in the
jcassado@gmail.com
female population (25%) [1]. Vaginal delivery is one of the
1
Obstetrics and Gynecology Department, Hospital most important predisposing factors for pelvic floor dys-
Universitari Mútua de Terrassa, Plaça Dr. Robert, 4, function, especially pelvic organ prolapse (POP) [2]. Some
08221 Terrassa, Spain studies suggest that levator ani muscle (LAM) injury could
2
Obstetrics and Gynecology Department, Hospital explain, in a large number of cases, the relationship between
Universitari de la Santa Creu i Sant Pau, Barcelona, Spain vaginal delivery and the occurrence of POP many years later
3
Obstetrics and Gynecology Department, Hospital [3, 4]. In vaginal delivery, the puborectal-pubovisceral fas-
Universitari de la Vall d’Hebrón, Barcelona, Spain cicle of the LAM must be distended considerably to allow
4
Obstetrics and Gynecology Department, Consorci Sanitari passage of the fetal head [4]. It has been estimated that this
d’Igualada, Igualada, Spain distension can increase the length of its fibers between 25
5
Obstetrics and Gynecology Department, Hospital General de and 245% [5]. Such a substantial distension can damage
Granollers, Granollers, Spain or rupture this muscular fascicle, either by detaching its
6
Obstetrics and Gynecology Department, Hospital insertion from the pubic bone (termed “avulsion”) [6] or by
Universitari Dexeus, Barcelona, Spain hyperdistention of the muscular fibers (termed “ballooning”)
7
Sant Pau Biomedical Research Institute (IIB Sant Pau) [7]. Muscle avulsion is a permanent injury that is associated
and CIBER Epidemiology and Public Health (CIBERESP),
Barcelona, Spain

13
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with increased risk of POP in the anterior and central com-
partments [8].
Three-dimensional ultrasound is a very useful tool for
the anatomical evaluation of LAM defects. Detection of this
type of injury is important since it carries a risk of develop-
ing POP in the future. Although LAM avulsion is not the
only predisposing factor of POP, its prevalence in patients
with POP is high enough to be relevant. Assessment of LAM
morphology requires imaging techniques. Three and four-
dimensional (3D/4D) ultrasound (US) provides access to the
axial plane of the levator, which was previously only pos-
sible with magnetic resonance imaging (MRI). At present,
the reproducibility and low cost of ultrasound [9] make it a
valuable, objective tool for assessment of levator injuries.
Published studies report a variable prevalence of LAM
avulsion in vaginal delivery, ranging from 14 to 36% [6,
10–13]. Nonetheless, there are few multicenter studies about
this topic, and multicenter studies provide more real and
extrapolable data to the rest of population. To find data with
a multicenter study, we conducted this work.
Several delivery-related factors are associated with LAM
damage during vaginal delivery in primiparous women:
maternal age, newborn weight and head circumference,
prolonged second stage, anal sphincter tear and the use of
vacuum or forceps [14–17]. Among all of them, operative
vaginal delivery, especially the use of forceps, is a signifi-
cant risk factor for LAM avulsion [18]. This has been cor-
roborated by a recently published meta-analysis [19].
Here, we present the results of the multicenter study prev-
alence of the levator ani avulsion (PAMELA by its Catalan
acronym). Our main objective was to determine the preva-
lence of LAM avulsion, as diagnosed by 3–4D transperineal
ultrasound in our cohort of primiparous women with vaginal
delivery. Our secondary aim was to analyze the prevalence
of LAM avulsion in the different modes of vaginal delivery
in our cohort.
Materials and methods
The PAMELA study is a prospective, multicenter observa-
tional study. We followed up a cohort of 322 primiparous
women with vaginal delivery evaluated at 6–12 months
postpartum by three and four-dimensional transperineal
ultrasound to identify levator ani muscle avulsion from
six hospitals in Catalonia: Hospital de la Santa Creu i Sant
Pau, Hospital Mútua de Terassa, Hospital Vall d’Hebron,
Hospital d’Igualada, Hospital General de Granollers and
Hospital Dexeus. The delivery was managed according to
the standard clinical practice at each hospital. We analyzed
some delivery-related risk factors, the prevalence of avulsion
overall and according to the mode of delivery.
Inclusion criteria:
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Archives of Gynecology and Obstetrics
• Women aged 18 or older.
• No previous vaginal delivery.
• No other pregnancy or delivery during the study period.
• Vaginal delivery between 37–42 weeks of a single fetus
in cephalic presentation at the obstetrics departments of
the participating study centers.
• No history of pelvic floor surgery or pelvic trauma that
could distort the pelvic floor muscular anatomy.
The recruitment period was 24 months (June 2016–June
2018).
Women who met the inclusion criteria were informed
about the project during their admission in the labour ward
for delivery by the medical staff (specialist or medical resi-
dent). The standard practice at the sites is that most deliv-
eries are performed by a physician resident, midwife or
resident midwife, always supervised by a present specialist
that intervenes if there is a difficult delivery. Delivery mode
was decided according to the usual clinical practice at each
center. The indications of operative vaginal delivery were
fetal distress or second stage arrest (suspecting dispropor-
tion or malposition of the fetal head), in third-fourth Hodge
plane. The instruments used in the delivery were Kielland
fórceps, Naegele fórceps, Thierry spatula (spatulas are two
symmetric, independent, non-articulated, thin and solid
non-fenestrated levers that they were categorized separately
because they work different than fórceps do) and vacuum
(Medela silicone cup). When episiotomy was indicated, it
was made mediolateral and in 60°.
Patients who agreed to participate in the study were
scheduled a single medical visit between 6 and 12 months
post-partum. Those who attended the visit were recruited
consecutively and written informed consent was obtained.
Afterwards, a clinical examination and a 3D/4D transper-
ineal ultrasound to assess the LAM morphology were per-
formed. Delivery data were taken from the data records of
each hospital [age, body mass index (BMI)], duration of
second stage, fetal position at delivery, episiotomy, mode of
vaginal delivery, baby’s head circumference, fetal weight,
assistant, type of anesthesia and high degree perineal tear-
ing: Obstetric Anal Sphincter Injury (OASI) according to
Sultan’s classification [20]. The researcher who performed
the ultrasound was blind to the clinical data and was differ-
ent from those who obtained the delivery data. Data were
stored in a common, anonymized and centralized database
in the Hospital de la Santa Creu i Sant Pau.
The study was reviewed and approved by the ethics com-
mittee of the Hospital de la Santa Creu i Sant Pau, Reference
PAMELA PV 15/197 OBS.
To assess the integrity of the LAM puborectal-pubo-
visceral fascicle, we used the ultrasound device available
at each center capable of 3D/4D ultrasound scanning and
analysis of tomographic cuts. The ultrasound devices used
Archives of Gynecology and Obstetrics
were Voluson E8 GE, Voluson E6 GE and Toshiba Aplio
300, all with their corresponding tomographic data analysis
software. Ultrasound was performed transperineally, cover-
ing the probe with a sheath and placing it directly on the
perineum. Avulsion was determined according to the cri-
teria described by Dietz, that is, the presence of a defect
or discontinuity in the muscular insertion on all three cen-
tral slices of the eight obtained in Tomographic Ultrasound
Imaging (TUI) mode. The cuts were evaluated at intervals of
2.5 mm from the plane of minimal hiatal dimensions, bilat-
erally [21]. If a defect was not present on all three images,
the scan was considered normal or indicative of no LAM
avulsion (Figs. 1 and 2). We mainly used the qualitative
evaluation system even though in case of doubtful diagnoses
of avulsion we used the levator-urethra gap measurement
(more than 25 mm). That is because the measurement of
levator-urethra gap is reproducible and strongly associated
with levator avulsion trauma diagnosed on vaginal palpation
[22]. Before starting patient enrolment, all the researchers
undertook a training program led by the most experienced
researcher to ensure that US assessments adhered to quality
standards and they performed at least ten exams to achieve a
right learning curve [23]. When the researchers started per-
forming the explorations, the teacher validated their ten first
explorations and all the researchers passed the validation.
Sample size was calculated based on our main objective
of determining the prevalence of LAM after vaginal birth,
which was estimated to occur in 20% of vaginal deliver-
ies according to previously published data [13, 24]. The
Fig. 1  Tomographic ultrasound imatge (TUI) showing the normal appearance of the puborectalis component of levator ani muscle (LAM). No
muscle defects is observed
required precision was set at 5% for calculation of the 95%
confidence interval (95% CI). Taking this into account, the
initial estimated number of patients required was 360. Six
hospitals in Catalonia participated in the study. Categorical
variables were reported as number of cases and percentage;
quantitative variables were reported as the arithmetic mean
and standard deviation (SD). To determine the relationship
of all variables with LAM avulsion, bivariate analysis was
performed, using contingency tables and Chi-square or
Fisher exact test, as appropriate, for categorical variables,
and independent t-test for quantitative variables. Multivari-
ate analysis (binary logistic regression) was also carried out
to expand the available information. All variables with a
tendency to significance in the bivariate approach (p ≤ 0.10)
were included in the analysis. In all cases, the level of signif-
icance used was the usual 5% (α = 0.05, bilateral approxima-
tion). The statistical package IBM SPSS Statistics (V21.0)
was used for the analysis.
Results
7048 primipara vaginal deliveries during study period in 6
participating centres (PAMELA group) were enrolled, 766
agreed to participate, 322 attended follow-up and 19 vol-
umes were not suitable for analysis. The total number of
patients finally included was 303 women (recruitment flow
chart in Table 1).
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 Archives of Gynecology and Obstetrics

Fig. 2  Tomographic ultrasound image (TUI) showing a unilateral avulsion (right side) of the LAM. A muscle defect is seen in the three central
images (arrows)

Table 1  Flow chart of

recruitment of PAMELA study 7048 primipara vaginal deliveries during
study period in 6 participating centres
(PAMELA group)

6262 declined to participate

766 agreed to participate

444 did not attend follow-up visit

322 attended follow-up

19 volumes not suitable for analysis

303 volumes analyzed

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Archives of Gynecology and Obstetrics

The mean age of the study population was
32.3 years ± 5.31 SD. The mean BMI was 24.77 kg/m2 ± 4.7
SD. Regarding quantitative variables, the mean fetal weight
was 3194.67 g ± 419.98 SD, the mean head circumference
was 340.66 mm ± 31.14 SD and the mean duration of the
second stage was 83.98 min ± 61.36 SD. The instrumenta-
tion rate in our study was 37.6%. No forceps deliveries fol-
lowed by malfunctioned vacuum were reported.
The overall prevalence of LAM avulsion in our popula-
tion of primiparous women as diagnosed by 3D/4D trans-
perineal ultrasound was 18.8% (Table 2).
The prevalence of LAM avulsion according to mode of
delivery is shown in Table 2. There were statistically signifi-
cant (p < 0.001) differences according to the different modes
of delivery. The lowest prevalence of LAM avulsion was
in spontaneous delivery 7.8%, followed by Thierry spatula-
assisted 25.0%; vacuum-assisted 28.8% and forceps-assisted
51.1%.
The results of the bivariate analysis of the factors associ-
ated with LAM avulsion are shown in Table 2. The variables
that showed statistically significant results were episiotomy,
mode of delivery and fetal weight.
Multivariate analysis of variables reaching or with a
tendency toward statistical significance showed that the
only independent variable with a statistically significant
association with LAM avulsion was the mode of delivery.
Thus, taking spontaneous delivery as a reference, the risk
of LAM avulsion for the different instrumental deliver-
ies was as follows: vacuum increased the risk of avulsion
4.78-fold (CI 2.153–10.631); Thierry spatulas 3.93-fold (CI
0.961–16.094), and forceps 12.31-fold (CI 5.657–26.800)
(Table 3).
Discussion
In our study, levator ani avulsion during vaginal delivery in
primiparous women occurred in nearly 20% of deliveries.
This rate decreased with spontaneous delivery and signifi-
cantly increased in instrumental deliveries, especially those
with forceps. The prevalence of avulsion in vaginal delivery
described in the literature varies highly, since the manage-
ment of the childbearing process also varies worldwide. Our
rate of 18.8% avulsion in vaginal delivery is similar to that
described by others, such as Handa 10–30% [25], Caudwell-
Hall et al. at 16% [12], Skek et al. at 14% [10] or Van Delft
at 21% [26]. The instrumentation rate in our study (37.5%)
was similar to the average instrumentation rate among all
primiparous with vaginal delivery at the six participating
centers (34.7%) during the study period.
When we analyzed the data on the variables associated
with LAM injury, delivery mode was the only independ-
ent risk factor for avulsion. Therefore, according to our
results, instrumental delivery is one of the most important

Table 2  Results of the bivariate Variable Measure Normal N = 246 Avulsion N = 57 p value
analysis of risk factors for
levator ani muscle avulsion Age mean (SD) Years 32.1 (5.4) 33.0 (5.3) p = 0.247
BMI mean (SD) Kg/m2 24.9 (4.9) 24.2 (3.9) p = 0.311
Duration of second stage mean (SD) Minutes 79.8 (60) 92.6 (57.2) p = 0.148
Expulsive fetal position mean (SD) Anterior 241 (98) 53 (93) p = 0.068
Occiput posterior 5 (2) 4 (7)
Episiotomy N (%) No 113 (46) 16 (28.1) p = 0.017
Yes 133 (54) 41 (71.9)
Delivery mode N (%) Spontaneous 177 (72) 15 (26.3) p < 0.001
Vacuum 37 (15) 15 (26.3)
Spatula 9 (3.7) 3 (5.3)
Forceps 23 (9.3) 25 (42.1)
Head circumference mean (SD) Mm 338.5 (32.1) 347.8 (35) p = 0.065
Fetal weight mean (SD) Grams 3125.3 (417.5) 3331.5 (433.6) p = 0.004
Assistant N (%) Midwife resident 36 (14.7) 5 (8.8) p = 0.244
Midwife 37 (15) 5 (8.8)
Medical Resident 124 (50) 30 (54.4)
Specialist 50 (20.3) 16 (28)
Anesthesia N (%) No 8 (3.3) 2 (3.5) p = 0.310
Local 7 (2.8) 1 (1.8)
Epidural 232 (93.9) 53 (94.7)
OASI N (%) Yes 8 (3.3) 4 (7) p = 0.245
No 239 (96.7) 52 (93)

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Table 3  Prevalence of levator ani muscle avulsion by mode of delivery and multivariate analysis
Variables Normal N (%) Avulsion N (%)
Delivery mode Spontaneous 177 (92.2) 15 (7.8)
Vacuum 37 (71.2) 15 (28.8)
Spatula 9 (75) 3 (25)
Forceps 23 (48.9) 24 (51.1)
Total 246 (81.2) 57 (18.8)
Fetal weight 3125.3 (417.5)b 3331.5 (433.6)b
Episiotomy 133 (76.4) 41 (23.6)
a
Spontaneous delivery reference group
b
Mean—grams (SD)
risk factors for LAM avulsion. Many of our findings are
similar to those of other studies in the literature regarding
the role of instrumentation in LAM avulsion. Although the
low incidence of Thierry spatula use means that our results
for this instrument should be interpreted cautiously, the rest
of the instruments in our series had avulsion rates very simi-
lar to those described in the literature. Spontaneous deliv-
ery had the least risk of avulsion (7.8%). In the literature,
this percentage is variable (6–13.3%) and our results are
included in this range [13, 27]. The way of diagnose LAM
avulsion, the population studied, etc., may be responsible
for this variation.
Our results for vacuum (28.8%) and forceps (51.1%) are
similar to those found by other groups [17]. The risk with
forceps was triple that with vacuum, as reported by other
authors. Dietz et al., in a review article [18], described the
risk of LAM avulsion (OR) comparing forceps-assisted
and spontaneous delivery as ranging between 2.45 and 32
depending on the results of the various studies included.
In a recent meta-analysis, the OR of avulsion with forceps
relative to spontaneous delivery was estimated at 6.94 (CI
4.93–9.78) [19]. We did not include the indication of for-
ceps delivery because according to Kearney et al. women
delivered by forceps have a higher rate of levator ani injury
independently of indication (forceps for fetal distress or for
second stage arrest) [27].
Regarding episiotomy, although episiotomy appeared as
a significant variable in the bivariate analysis, it lost signifi-
cance in the multivariate analysis. This is in line with the
findings of other authors such as Speksnijder et al. who did
not find differences in avulsion rate between groups with and
without episiotomy (26.7% with and 22.8% without) [28] or
Cassadó et al. (10.9% vs. 15.1%) [29], although both studies
included spontaneous deliveries only. Other authors such
as Kearney et al. found an OR of 3.1 (95% CI 1.4–7.2) for
the risk of LAM injury with episiotomy [30]. However, this
difference could also be due to differences in the diagnostic
criteria for avulsion used with MRI. The fact that episiotomy
was not a significant variable in our study, which includes a
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Archives of Gynecology and Obstetrics
Total p Coef p OR 95% CI
192 < 0.001 1a
52 0.407 < 0.001 4.784 2.153–10.631
12 0.719 0.057 3.933 0.961–6.094
47 0.397 < 0.001 12.313 5.657–26.800
303
303 0.001 0.068 1.001 1.000–1.002
174 − 0.234 0.557 0.791 0.362–1.730
high percentage of instrumental deliveries (37.58%) makes
us question its role as a risk factor for LAM avulsion, some-
thing which warrants further discussion.
Regarding the duration of the second stage of labor, our
study did not show significant differences between women
with or without LAM avulsion, unlike Caudwell-Hall et al.
[17], who found differences in the duration of second stage
in a postpartum retrospective study of 844 women. We found
neither fetal weight nor posterior position to be risk factors
for LAM avulsion in our population.
It is difficult to control and then to find references in the
literature about the "art" or ability for instrumentation in
vaginal delivery. Sainz et al. did not find statistically sig-
nificant reduction in the LAM avulsion rate with disengage-
ment of the forceps (Kielland) branches before delivery of
the fetal head as compared to the performance of forceps
without disengagement [31]. García Mejido et al. did not
observe differences on the LAM avulsion rate between rota-
tional and non-rotational forceps [32]. In view of the results
of this multicenter study involving different obstetric teams
and equipment in each center, which yielded similar results
overall and for each center, we conclude that the technical
proficiency in instrumentation may have little influence on
the incidence of LAM injury [19]. Nevertheless, more stud-
ies are needed to establish whether some technical aspects
exist that may influence the results and complications of
vaginal delivery.
Prospective multicenter studies that assess LAM avulsion
after delivery with ultrasound are usually performed in a
single center. Our PAMELA study is a multicenter obser-
vational prospective study that evaluates the overall rate
of levator ani muscle avulsion in primipara women. One
strength of our study is being multicenter since it includes
centers with their own idiosyncratic childbirth management
and thus, reflects diverse practices, therefore being repre-
sentative of day-to-day clinical practice in our setting.
The number of women included, 303, was lower than
initially calculated due to difficulties in recruitment. This
number was calculated with an estimated incidence of
Archives of Gynecology and Obstetrics
LAM avulsion of 20%. As the prevalence in our popula-
tion was lower (18.8%), we recalculated the number of
patients needed while maintaining the same accuracy of
5%. This gave a sample size of 280. We therefore trust
that our sample of 303 women is sufficient for our objec-
tives. Because of the difficulties in the recruitment and to
assess that there was no selection bias we have analyzed
the instrumentation rate in the population of primipara
women that gave birth in the participant centers during
the study period to ensure that there are no differences
with that of our sample. Then, we can say that our cohort
represents the population of primipara women of the six
participant centres. The rate of instrumentation was 37.6%
in PAMELA study and 34.7% in the population of vaginal
deliveries in primipara women attended in the participant
centres during the study period. However, the real total
rate is lower since we have not included the patients with
caesarean section. Therefore, the risk of under-represen-
tation of women delivering spontaneously that might have
led to a selection bias seems to have been controlled.
The major strength of our study is its prospective, mul-
ticenter design that reflects the usual clinical practice in
our setting. Also, we consider the quantification of risk
associated with each instrument as compared to spontane-
ous delivery to be of great interest. Several studies com-
pare forceps with vacuum but few offer comparative data
of all types of vaginal deliveries and instruments [33]. Our
work not only quantifies the risk of each instrument but
also compares them with each other, taking spontaneous
delivery—the least invasive—as a reference. We believe
that this provides important information that can help
guide physicians’ decision making at the time of deliv-
ery. So according our results, if normal vaginal delivery
is not possible, and operative vaginal delivery is indicated,
vacuum is less dangerous for levator ani than forceps.
One of the limitations of our study is the high number
of women who had to be recruited to achieve the esti-
mated sample size, given the low rate of attendance at
the first study visit. This may be because, in a complex
moment like a baby’s first months of life, many women are
not motivated to participate in or complete a study, espe-
cially in the absence of symptoms. Also, in our country,
4 months after delivery, women usually return to work.
This might have led to a selection bias that has to be con-
sidered when interpreting the results, because women
who had symptoms related to their delivery probably
were more motivated to attend the visit. Another limitation
could be that our numbers may be too low to determine
whether some obstetrical characteristics may be a risk
factor for avulsion. For example, only nine participants
had an expulsive fetal position of occiput posterior. We
evaluated the rate of avulsion according to certain factors
usually considered important in the delivery process but
probably there may be other factors that may have been
underestimated.
To conclude, in our study, levator ani avulsion during
vaginal delivery in primiparous women occurs in nearly one
in every five deliveries. Delivery mode is a significant and
modifiable risk factor for LAM avulsion to occur in vaginal
delivery in the population studied. The rate of LAM avulsion
is lower with spontaneous delivery (less than one in every
ten women) and significantly increases when an instrument
is used to assist delivery, especially forceps. Thus, instru-
mentation of vaginal delivery, especially with forceps,
entails a greater risk of LAM avulsion.
Author contributions JC and MS project development, data collection,
manuscript writing and editing. NR, OP, EH, IM, MG and RF data
collection. IG statistical analysis.
Compliance with ethical standards
Conflict of interest The authors declare that they have no conflict of
interest.
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