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Interventions to reduce complications after shoulder

dystocia: a systematic review and
Bayesian meta-analysis
Stephen M. Wagner, MD; Cynthia S. Bell, PhD; Megha Gupta, MD, MSc; Hector Mendez-
Figueroa, MD; Lara Ouellette, MLS; Sean C. Blackwell, MD; Suneet P. Chauhan, MD, Hon DSc

OBJECTIVE: This study aimed to evaluate the outcomes associated with the implementation of simulation exercises to reduce the sequela of shoulder
dystocia.
DATA SOURCES: Electronic databases (Ovid MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature database, and Scopus)
were initially queried in June 2020 and updated in November 2020. The following 3 concepts were introduced and refined using the controlled vocabulary
of the database: vaginal birth, shoulder dystocia, and simulation training. There were no limitations to the year of publication as part of the search strategy.
STUDY ELIGIBILITY CRITERIA: We included all studies that reported on the frequency of shoulder dystocia and the associated complications before
and after the implementation of interventional exercises to improve outcomes.
METHODS: Two authors independently assessed the abstracts and full-text articles of all studies for eligibility and evaluated the quality of the included
studies using the Newcastle-Ottawa Scale. Any inconsistencies related to study evaluation or data extraction were resolved by a third author. The
coprimary outcomes of this systematic review and meta-analysis were neonatal brachial plexus palsy diagnosed following deliveries complicated by
shoulder dystocia and persistence of brachial palsy at 12 months or later. The secondary outcomes were the frequency of shoulder dystocia and cesarean
delivery. Study effects were combined using a Bayesian meta-analysis and were reported as risk ratios and 95% credible intervals (Crs).
RESULTS: Of the 372 articles reviewed, 16 publications, which included 428,552 deliveries with 217,713 (50.8%) deliveries during the pre-intervention
and 210,839 (49.2%) deliveries during the postinterventional period, were included in the meta-analysis. The incidence of neonatal brachial plexus palsy
after shoulder dystocia decreased from 12.1% to 5.7% (risk ratio, 0.37; 95% Cr, 0.26e0.57; probability of reduction 100%).
The overall proportion of neonatal brachial plexus palsy decreased, but with less precision, from 0.3% to 0.1% (risk ratio, 0.53; 95% Cr, 0.21e1.26;
probability of reduction 94%). Two studies followed newborns with brachial plexus palsy for at least 12 months. One study that reported on persistent
neonatal brachial plexus palsy at 12 months among 1148 shoulder dystocia cases noted a reduction in persistent neonatal brachial plexus palsy from
1.9% to 0.2% of shoulder dystocia cases (risk ratio, 0.13; 95% confidence interval, 0.04e0 .49). In contrast, the study that reported on persistent neonatal
brachial plexus palsy at 12 months for all deliveries noted that it did not change significantly, namely from 0.3 to 0.2 per 1000 births (risk ratio, 0.77; 95%
confidence interval, 0.31e1.90). Following the implementation of shoulder dystocia interventional exercises, the diagnosis of shoulder dystocia increased
significantly from 1.2% to 1.7% of vaginal deliveries (risk ratio, 1.39; 95% Cr, 1.19e1.65; probability of increase 100%). Compared with the
preimplementation period, the cesarean delivery rate increased postimplementation from 21.2% to 25.9% (risk ratio, 1.22; 95% Cr, 0.93e1.59; probability
of increase 93%). We created an online tool (https://ccrebm-bell.shinyapps.io/sdmeta/) that permits calculation of the absolute risk reduction and absolute
risk increase attributable to the intervention vis-a-vis the incidence of shoulder dystocia, neonatal brachial plexus palsy, and cesarean deliveries.

CONCLUSION: Introduction of shoulder dystocia interventional exercises decreased the rate of neonatal brachial plexus palsy per shoulder dystocia
case; the data on persistence of neonatal brachial plexus palsy beyond 12 months is limited and contradictory. Implementation of the interventions was
associated with an increase in the diagnosis of shoulder dystocia and rate of cesarean deliveries.

Key words: cesarean delivery, clavicular fracture, neonatal brachial plexus palsy, simulation exercise, third- or fourth-degree laceration

From the Department of Obstetrics and Gynecology, Alpert Medical School, Brown University, Providence, RI (Dr Wagner); Department of Pediatrics,
Center for Clinical Research & Evidence-Based Medicine, McGovern Medical School at The University of Texas Health Science Center at Houston
(UTHealth), Houston, TX (Dr Bell); Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale School of Medicine, Yale University, New
Haven, CT (Dr Gupta); Department of Obstetrics, Gynecology and Reproductive Sciences, McGovern Medical School at UTHealth, Houston, TX (Drs
Mendez-Figueroa, Blackwell, and Chauhan); and the Texas Medical Center Library, Houston, TX (Ms Ouellette).
Received March 13, 2021; revised May 5, 2021; accepted May 12, 2021.
The authors report no conflict of interest.
Corresponding author: Suneet P. Chauhan, MD, Hon DSc. Suneet.P.Chauhan@uth.tmc.edu
0002-9378/$36.00 ª 2021 Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.ajog.2021.05.008

Click Supplemental Materials under article title in Contents at

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Systematic Review ajog.org

and reported according to the Preferred

AJOG at a Glance
Reporting Items for Systematic Reviews
Why was this study conducted? and Meta-Analyses criteria.19 A
This study aimed to determine if the rate of complications associated with shoulder comprehensive literature search was
dystocia is lowered after the implementation of simulation exercises. conducted by a trained Medical Librarian
(LO) to locate material on the effect of
Key findings interventional exercises on the clinical
Compared with the preintervention period, implementation of simulation ex-ercises outcomes of vaginal births complicated by
to reduce the morbidity associated with shoulder dystocia was shown to reduce the shoulder dystocia. Using Ovid MEDLINE
rate of neonatal brachial plexus palsy subsequent to shoulder dystocia in conjunction (MEDLINE on OvidSP), a systematic
with an increase in the rate of cesarean delivery and diagnosis of shoulder dystocia. search string of relevant terms was
In 2 studies, the persistence of neonatal brachial palsy at 12 months was reported constructed. The complete search strategy
with contradicting conclusions. was then given to the primary investigator
for approval before translation to the
What does this add to what is known?
following 3 additional databases: Embase,
This systematic review and meta-analysis indicate that although interventional the Cu-mulative Index to Nursing and
exercises decrease the rate of brachial palsy subsequent to shoulder dystocia, this
Allied Health Literature, and Scopus. The
decrease occurs concurrent with an increase in cesarean delivery rates and may not
final searches were all run on the same
influence the rate of persistent brachial plexus at 12 months. day—November 25, 2020—in each
database for consistency and continuity.

Introduction reduction in the frequency of NBPP after Details about the search strategy and data
Shoulder dystocia occurs in about 1% to the implementation of training.12,13 A extraction are available in the Appendix.
3% of all deliveries and, by definition, universal recommendation for simulated
requires additional maneuvers other than training, however, is problematic for at
gentle traction to effectuate birth. least 4 reasons. First, some reports Study Selection
Deliveries complicated by shoulder suggest that the rate of brachial plexus We included randomized and non-
dystocia are associated with maternal (eg, palsy does not change or may paradoxi- randomized studies published in English
obstetrical anal sphincter injuries) and cally increase after training.14e16 Second, that reported on the outcomes of brachial
neonatal complications (eg, frac-ture).1 the decrease in the likelihood of palsy at plexus injury after the implementation of
Among the various complications linked the time of shoulder dystocia may be shoulder dystocia inter-ventional exercises
to shoulder dystocia, neonatal brachial caused by an increased rate of cesarean in labor and delivery units. We excluded
plexus palsy (NBPP), defined as weakness delivery or a tendency to overdiagnose studies that did not examine the rates of
or paralysis of the upper ex-tremity, is shoulder dystocia. Third, about 40% of neonatal brachial plexus injury after the
associated with long-term sequelae like palsy cases is not associated with shoul- implementation of interventional exercises
contractures and sub-luxations, need for der dystocia and a smaller proportion is to reduce sequelae of shoulder dystocia
microreconstruction and muscle transfers diagnosed subsequent to cesarean or those that did not assess the outcomes
with residual muscle imbalance, and delivery.2,17,18 Fourth , in the absence of a shoulder dystocia simulation program.
glenohumeral abnormalities.2e7 In of a systematic review and meta-analysis,
addition, children with NBPP are at risk the unintended consequences of in- Data from each included study were
for obesity and for developing psychological interventions are insufficiently explored. extracted into a custom data collection
and behavioral problems.8,9 To reduce The coprimary outcomes of this sys- form by 2 authors (SPC and SMW) to
the risk of thematic review and meta-analysis were a ensure accuracy. Two authors (SMW and
NBPP, 3 national guidelines on shoulder diagnosis of NBPP following deliveries MG) independently assessed the eligibility
dystocia recommend interventional complicated by shoulder dystocia and of all studies and evaluated the quality of
exercises (ie, con-variably didactics, persistence of brachial palsy at 12 months the included studies using the Newcastle-
of
sisting communication skills, or later. The secondary out-comes were Ottawa Scale (NOS) (supplement for
simulation exer-cises with mannequins, the impact of the intervention on the details are given in Supplemental Table
reviewing the maneuvers to use, debriefing, frequency of shoulder dystocia and 1).20 Given the pre- post design of
and documentation) for all staff in the cesarean delivery. studies included in the final analysis, we
labor and delivery unit because it improves used the NOS, a con-tent validation tool
communication skills and reduces the Sources designed specifically for the evaluation of
incidence of NBPP associated with This systematic review and meta-analysis nonrandomized trials, to assess bias in
were registered in the International each study. Any inconsistencies related to
shoulder dystocia.1,10,11 Some reports Prospective Register of Systematic data extraction or study evaluation were
on the topic of simulated exercise suggest a Reviews database (CRD42020166467) resolved by a

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third author (HMF). The following variables were
extracted from each article: study design, type of
publication, year of publication, study completion
year, study country, time periods of cohort
assessment, number of deliveries, number of
cesarean deliveries, incidence of shoulder
dystocia, incidence of NBPP among shoulder
dystocia cases, incidence of NBPP among all
deliveries, incidence of persistent NBPP at 12
months among shoulder dystocia cases, rates of
third- or fourth-degree lacera-tions, and incidence
of neonatal fracture
counts.
The coprimary outcomes were NBPP
diagnosed in (1) deliveries complicated by
shoulder dystocia, (2) in all deliveries during the
study period, and (3) NBPP persistence at 12
months or later. The secondary outcomes were
the frequency of shoulder dystocia and cesarean
de-livery. The incidence of third- or fourth-
degree perineal lacerations and neonatal
fractures of the clavicle or humerus was also
evaluated. A requirement for inclusion in the
meta-analysis was the reporting of outcomes
from labor and delivery units unexposed and
exposed to a shoulder dystocia interventional
exercise.
Bayesian meta-analyses were independently
performed (CSB) for primary and secondary
outcomes when more than 1 study was available.
A Bayesian meta-analysis has multiple benefits
over traditional, frequentist meta-analyses
including the ability to incorporate pre-vious,
external evidence, to provide complete
information about the distribution of credible
parameter values, and to calculate the certainty
of the increase or decrease in the outcomes,
which aids in interpreting the risk and benefit of
in-interventions.33 Furthermore, the frequentist
random-effects meta-analysis model as-sumes
that the between-study variance, s2
, has a fixed value, whereas the Bayesian
approach uses a distribution to represent the
uncertainty of s2 . Thus, a Bayesian meta-
analysis more accurately describes between-
study heterogeneity, particularly when only a few
important studies are available.34,35 The study
effects were
combined with Bayesian multilevel models
and reported
as risk ratios (RRs) and 95% credible intervals
(Crs).36 To represent the un-known utility of the
simulation training intervention, we used neutral,
weakly informative priors centered at an RR¼1
to estimate the intervention effect (log scale
mwNormal [ 0, 4]) and s2 (s2 whalf-Normal
[scale¼0.5]). For studies with no observed
outcomes in 1 arm, a continuity correction of 0.5
was added to all 22 cells to allow computation.
To evaluate the influence of studies with
potentially high bias, a sensitivity analysis was
undertaken, restricting study inclusion to studies
with a good or fair bias rating according to the
NOS. Heterogeneity of the effects was assessed
using s2 and I2 based on the posterior distribution
of s2 significant heterogeneity of the effects
across studies was defined as median
. Evidence of
2
Yo
>50%. Two possible sources of heterogeneity,
namely study location (United States vs
noneUnited States) and type of simulation
training (NOELLE or PROMPT vs others), were
examined by a stratified meta-analysis.
Frequentist RRs with 95% confidence intervals
(CIs) were reported for out-comes described in
only 1 study (eg, persistent NBPP). Publication
bias was assessed with funnel plots of the RRs
by standard error for each outcome.
To place the harms and benefits in context,
we created an online tool to calculate the
absolute risk reduction (ARR) and absolute risk
increase (ARI) attributable to the intervention in
terms of the incidence of should dystocia, NBPP,
and cesarean deliveries ( https :// ccrebm-
bell.shinyapps.io/sdmeta/). The ARR for NBPP
and ARI for shoulder dystocia and cesarean
delivery were calculated by multiplying the total
number of deliveries by the baseline prevalence
and absolute value of 1 minus the RR for each
outcome, followed by rounding it to whole, integer
values.37 This calculation was applied to the
posterior RR values to determine the dis-tribution
and 95% Cr of the ARI and ARR for each
outcome. Posterior prob-ability of reduction or
increase represents the percentage of an ARR
of <0 or ARI of >0, respectively, from these
posterior distributions. The online tool
MONTH 2021 American Journal of Obstetrics & Gynecology 3
Systematic Review
for the calculation of ARRs and ARIs allows for
the adjustment of the total delivery number,
baseline prevalence, and a reduction or increase
in the thresholds to assess potential intervention
effects for a variety of labor and delivery unit
settings and caseloads. All analyzes were
completed using R version 3.6.1 with additional
“bayesmeta” and “shiny” packages.36,38e40
Results
Of the 1298 articles identified, 751 nonduplicated
articles were screened and 379 of these were
excluded. A total of 372 full-text articles were
evaluated of which 16 met the inclusion criteria
(Figure 1); 14 of these were peer-reviewed
publications and 2 were
abstracts.12,13,15,16,21e32 The 16 included
studies encompassed 428,552 deliveries, with
217,713 (50.8%) deliveries in labor and delivery
units not exposed to inter-ventional exercises
and 210,839 (49.2%) deliveries in units exposed
to exercises.
NOS bias assessment categorized 10 studies as
of poor quality,12,21,24e31 2 as of fair
quality,13,15 and 3 as of good quality
(Supplemental Table 1).22,23,32 The study by
Fransen et al16 was a ran-domized clinical trial
and was, therefore, not assessed using the NOS.
Funnel plots did not indicate evidence of
publication bias (Supplemental Figures 1e6).
Of the 16 studies that met the inclusion
criteria in the qualitative analysis, 15 studies
compared pre- and post-intervention cohorts in
a retrospective design12,13,15,21e32 and only
1 was a
cluster-randomized control trials
(Supplemental Table 2).16 Considering the
nature of the intervention, it was not possible to
blind the assessor to the outcomes. Although 9
(56.3%) of the studies were conducted in the
United States,12,13,21,22,31,32,25e27 the
remainder were done in other
countries.15,16,23,24,26,29,30 Shoulder dystocia
was identified either by International Classification
of Diseases (ICD)-9 or ICD-10 codes (6
studies),13,21,22,27,30,32 medical record review
(4 studies),15,23e25 or the identi-fication method
was not disclosed (6 studies).12,16,26,28,29,31
The interventional exercises varied among the
trials
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Two studies followed newborns with brachial

FIGURE 1
plexus palsy for at least 12 months. One study
PRISMA flow diagram
that reported on persistent NBPP at 12 months
among 1148 shoulder dystocia cases noted a
Records identified through database Additional records identified
reduction from 1.9% to 0.2% in persistent NBPP
searching through other sources
(n=1298) (n=0) among shoulder dystocia cases (RR, 0.13; 95%
CI, 0.04e0.49).23 In In contrast, the study that
cn
tfie
tIid o a

reported on persistent NBPP at 12 months for

all deliveries noted that it did not change
Records aer duplicates removed
(n=751) significantly following intervention from 0.3 to 0.2
per 1000 births (RR, 0.77; 95% CI, 0.31e1.90).15
There was evidence that the proportion of
Records screened Records excluded cesarean deliveries increased from 21.2% to
nn
Screie g

(n=751) (n=379)
25.9% following the
introduction of shoulder dystocia simulation
(RR, 1.22; 95% Cr, 0.93e1.59; probability of
Full-text arcs excluded, with increase 93%)
Full-text arcles assessed for reasons
eligibility (n=356)
illiitE
by
g

(n=372) SD Simulaon with no BPI=116

Not assessment of SD Sim=240

(Figure 5) in 8 studies with 311,886

Studies included in
deliveries.13,15,21e23,25,27,30 However, there
quantave synthesis (meta- was extremely high heterogeneity among studies
analysis)
ludIendc

(n=16) evaluating cesarean de-liveries both in US and

PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses; SD, shoulder dystocia.
Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.
with 8 of the 16 reporting the use of either the
PROMPT or NOELLE high-fidelity
trainers.21e26,28,32 All studies had
multidisciplinary attendance for the exercises.
There was diverse simulation leadership among
the trials. How NBPP or shoulder dystocia was
defined and the indication for cesarean delivery
are described in Supplementary Table 3.
Following the implementation of interventional
exercises for the management of the shoulder
dystocia, the rate of diagnosis of shoulder
dystocia increased from 1.2% to 1.7% for vaginal
deliveries (RR, 1.39; 95% Cr, 1.19e1.65;
probability of increase 100%) in 12 studies with
235,342 deliveries (Figure 2).12,13,22e25,27e32
There was significant heterogeneity among the
study effects for the outcome of shoulder
dystocia (I2 ¼68%), primarily among US-
based studies.12,13,22,25,27,31,32 The
increased diagnosis of shoulder dystocia
postintervention was more pronounced in the
studies using NOELLE or PROMPT simulators
compared with other training methods
(Supplemental Figure 7).
The proportion of NBPP per shoulder dystocia
cases fell from 12.1% to 5.7% (RR, 0.37; 95%
Cr, 0.26e0.57; probability of reduction 100%)
( Figure 3) in 10 studies with 3121 cases of
shoulder
dystocia.12,13,23,24,27e29,31,32 The reduction
in the incidence of NBPP per shoulder dystocia
case was similar among studies that did and did
not use NOELLE or PROMPT training
(Supplemental Figure 8). The overall incidence
of NBPP among all deliveries, regardless of route
of delivery, was reduced (RR, 0.53; 95% Cr,
0.21e1.26; probability of reduction 94%) (Figure
4), but with high variability in findings among the
only 3 studies with 124,522 deliveries.13,15,27
There was high heterogeneity among these
studies (I2 ¼78%) with 2 smaller, US-based
studies showing a dramatic (w70%) decrease in
NBPP incidence postintervention,13,27 but 1
large study showing no difference.15 None of
the studies that assessed the overall incidence
of NBPP reported the use of NOELLE or
PROMPT training (Supplemental Figure 9).
non-US studies
(I2 ¼99%), which decreased the precision of
the RR. High heterogeneity between studies
remained after stratifi-cation by NOELLE or
PROMPT training (Supplemental Figure 10).
The majority of studies showed increases in
cesarean delivery rates after the intervention but
2 sizable yet poor quality studies showed
decreases in the rate of cesarean deliveries.25,30
The proportion of clavicle or humerus fractures
(RR, 0.56; 95%
Cr, 0.27e1 .18; probability of reduction 94%)
in 6 studies with 2275 cases of shoulder dystocia
showed some evidence of reduction following
the implementation of a shoulder dystocia
simulation exercise (Supplemental Figure
11).23,24,28,29,30,32 Furthermore , there was
less evidence of a change in the incidence of
obstetrical anal sphincter injuries (RR, 0.79;
95% Cr, 0.49e1.29; probability of reduction 84%)
in 4 studies with 1071 cases of shoulder dystocia
reported, irrespective of the de-livery
(Supplemental Figure 12).12,28,30,32 Among
vaginal de-liveries, the evidence for reduction in
obstetrical anal sphincter injuries post-
intervention wasroute
similar (RR, 0.73; 95% Cr,
0.39e1.42; probability of reduction 88%) in 2
studies with 36,078 vaginal

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FIGURE 2
Incidence of SD among all deliveries during pre- and postintervention
Cr, credible interval; SD, shoulder dystocia.
Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.
deliveries with heterogeneous effects (I2 ¼85%)
(Supplemental Figure 13).24,30
Comment
Principal findings of the study Our
systematic review and meta-analysis of
intervention studies indicate that the risk for
NBPP following shoulder dystocia decreased by
63% post-intervention compared with the pre-
intervention period.
However,
concurrent with the decrease in the risk for NBPP
per shoulder dystocia case, the frequency of
documented shoulder dystocia cases increased
by 39%
alongside a 22% increase in the rate of cesarean
delivery, albeit with significant heterogeneity in
the findings across studies. The overall rate of
NBPP, however, showed a more attenuated
decrease of 47% after the implementation of
interventions among only 3 studies with high
13,15,27
variability, and the authors of the 2
studies that followed the newborns to assess
whether the brachial palsy that persisted for
more than a year reached different
conclusions.15,23 The Bayesian meta-analysis
technique used in this study
allows a more accurate estimation of between-
study
MONTH 2021 American Journal of Obstetrics & Gynecology 5
Systematic Review
heterogeneity and aids in interpreting the certainty
of effects (probability of increase or decrease in
outcomes). The summarized effects show high
certainty of a decrease in NBPP per shoulder
dystocia case after the implementation of
interventional exercises (>90% sure of a decrease
in NBPP per shoulder dystocia case of at least
50% from
baseline).12,13,23,24,27e32 These benefits
should be viewed along with the potential
increase in risks. The meta-analyses also show
high certainty of a simultaneous increase in the
rate of cesarean deliveries after the implementation
of
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FIGURE 3
Proportion of NBPP per shoulder dystocia case during pre- and postintervention
Cr, credible interval; NBPP, neonatal brachial plexus palsy.
Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.
simulation training (>90% sure of some increase
from baseline).13,15,21e23,25,27,30 We do,
however, acknowledge that temporal trends
and changes in clinical practice patterns may
have contributed to the increase in the
postintervention cesarean delivery rate.
As an example of the implications of these
findings, consider the impact of simulation
training exercises in a labor and delivery unit
with 1500 deliveries annually. Among 1500
deliveries, identification of shoulder dystocia
increases from 18 cases at baseline to 25 cases,
with a high certainty of increase (probability of
increase 100%). Most units this size
6 American Journal of Obstetrics & Gynecology MONTH 2021
would then see an approximate reduction of 1
NBPP per shoulder dystocia case (from an
average of 2 at baseline) and a reduction of 2
NBPP cases overall (from an average of 4 at
baseline). Thus, there is a high certainty that at
least 1 case of NBPP per shoulder dystocia
cases or 1 NBPP case overall will be prevented
(probability of decrease of 100% and 94%,
respectively). However, the same unit will also
see an increase of 69 ce-sarean deliveries
(baseline 318 to 387 after) on average. Although
there is some variability in the number of
additional cesarean deliveries, there is high
certainty that there will be some increase
ajog.org
(more than 0) in cesarean delivery rates (93%
probability of increase). The implications for
units of varied sizes and baseline prevalence
can be estimated with the online calculator tool
( https://ccrebm-bell.shinyapps.io/sdmeta/).
Results
To contextualize the results, several shortcomings
of the studies included in the analysis should be
acknowledged.
First, by utilizing the NOS, most of the studies
were categorized as of poor quality because of
a lack of matching individuals pre- and
postexposure and a lack of statistical adjustment
for possible
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ajog.org Systematic Review

FIGURE 4
Proportion of overall NBPP among all deliveries during pre- and postintervention

Cr, credible interval; NBPP, neonatal brachial plexus palsy.

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.

confounders.20 A sensitivity meta- occurs without shoulder dystocia or interventional exercises for shoulder
analysis, however, of only studies with subsequent to cesarean delivery2,17,18 dystocia included in this systematic re-
fair or good bias ratings showed similar and yet most reports did not provide the view and meta-analysis reveal improved
effects for shoulder dystocia, NBPP (per overall rate of palsy at maternal complications.12,13,15,16,21e32
shoulder dystocia case and overall), delivery.12,16,21e26,28e32Fifth, the Seventh, using Kirkpatrick's framework
and cesarean deliveries as was seen in sequelae of NBPP occurs when the for multiprofessional training, pur-ported
the main analysis (Supplemental Figures neurological deficit persists beyond the benefits of interventions should be
14e17). Second, there was high first year of life and yet most reports did evaluated in the following 4 categories:
heterogeneity in the results among not follow the newborns beyond learners' reaction, knowledge, behavioral
studies, particularly for the outcomes of discharge.12,13,16,21,22,24e32 The 2 change, and improvement in outcomes.41
cesarean deliveries and NBPP incidence studies that did follow newborns up to Most reports do not provide data for all
among all deliveries. Subgroup analysis 12 months had divergent results.15,23 the categories. For example, it is
stratified by study location and use of Fifth, as acknowledged by Crofts et uncertain if the learned practice
NOELLE or PROMPT training did not al23, an increased rate of cesarean de- persisted and if there was an overall
explain this variation; However, we did livery could contribute to the noted improvement in the outcomes of the
employ random effects models to decrease in NBPP and yet most reports maternal-neonatal death. Although the
account for the distribution of the effects did not provide data on the rate and decrease in NBPP is a desirable goal, it
across studies. Third, the definition of indications for a cesarean delivery. should be reported in context with other
shoulder dystocia was not provided in Sixth, shoulder dystocia is associated potential adverse outcomes, especially
most publications,12,16,21,22,25,26,28e31with an increased maternal complication considering the increased cesarean
and the diagnostic criteria for NBPP rate such as postpartum hemorrhage delivery rate associated with the
was often not described.12,15,16,21e32 and third- or fourth-degree lacerations.1 implementation of interventional
Fourth, it is recognized that NBPP None of the studies reporting on exercises.42 Eighth, in 2017, the Standards for

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FIGURE 5
Proportion of cesarean deliveries during pre- and postintervention
Cr, credible interval.
Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.
Reporting Implementation Studies (StaRI)
guidelines were published owing to a multitude
of concerns with reports on implementation
trials.43 Because
most of the studies included in the analysis were
published before the StaRI guidelines,
compliance of these studies with the guidelines
is unlikely.
Clinical implications A
corollary of studies' shortcomings is whether
currently there is sufficient ev-idence for national
guidelines to recommend simulation exercise to
all providers involved with delivery.1,10,11 We
opine that, at present, there is insufficient
evidence to support a recommendation for all.
Aside from the
8 American Journal of Obstetrics & Gynecology MONTH 2021
poor quality of the underlying reports,12,21,24e31
there is a concern for
the notable variations in shoulder dystocia
simulation exercises, including who the instructor
is and whether a mannequin is used, the
frequency at which the ex-ercise is conducted,
and whether attention-dance is mandatory or
not. The current interventions assume that once
shoulder dystocia is diagnosed and the
recommended ancillary maneuvers are utilized,1
persistent NBPP is preventable.
The multifactorial nature of palsy that persists
may preclude prevention with current
interventions.44 Delay in the infant's management
of brachial plexus may contribute to the residual
deformity and is beyond the scope of clinicians
ajog.org
involved in the delivery process.45 Finally, it
needs to be recognized that the combined
economic and human cost may impede the
widespread utilization of simulation exercise.11
Currently, for example, there are up-wards of
3200 labor and delivery units in the United
States staffed with 350,000 nurses; there are
11,000 certified nurse-midwives and 33,000
physicians who participate in the delivery of
more than 3.7 million births annually.46e50
Simulation exercises for all could strain
resources.
Strengths and limitations
The strength of our analysis is that this study is
a systematic review or meta-
Machine Translated by Google
ajog.org
analysis on the impact of simulation exercises
on NBPP. A MEDLINE search (with terms
“shoulder dystocia,” “neonatal brachial plexus
palsy,” “simulation,” “exercise,” “systematic
review,” and “meta-analysis”) indicates that
although there are previous meta-analyses on
simulation exercises, none examined the impact
on NBPP.51,52 Our analysis provides stratified
data for studies conducted in the United States
and those conducted in other countries.
The largest study contributed 41% to the meta-
analyzed effect of the overall NBPP rate among
all deliveries.15 The funnel plot indicates that
there was no apparent publication bias for any of
the assessed outcomes. An increased rate of
cesarean delivery after implementing the
simulation exercises, irrespective of whether
the study was conducted in the United States or
another country, is of concern, which is not
recognized in the national guidelines
recommending the intervention. Admittedly,
there are multiple reasons for the increase in the
rate of cesarean deliveries.53e58 From the
analysis, however, we cannot establish a causal
relationship between the inter-vention and the
change in the route of delivery.42 The limitation
of the analysis should be acknowledged. Almost
all the studies included in the analysis were
conducted
in developed countries. Therefore, the effect
of the application of simulation exercises in
developing countries is uncertain. We did not
include the potential cost-effectiveness of
simulation training. van de Ven et al59 have
reported on the cost-effectiveness of simulation
training done not only to reduce the adverse
outcomes of shoulder dystocia but also that of
the sequelae of postpartum hemorrhage,
eclampsia, and neonatal hypoxia. The analysis
was based on clinical practice and cost of care
in the Netherlands and may not be applicable to
the United States.59 Some of our findings are
contradicted by the only cluster-randomized trial
done on the topic. The cluster-randomized trial
by Fransen et al16 reported that the rate of
NBPP after shoulder dystocia did not decrease
significantly after the introduction of simulation
exercises, but that the rate of
fracture did. Both of these findings are in contrast
to our results. In most studies, however, how
NBPP was diagnosed was not described and the
follow-up of the newborns varied. Using the NOS,
the majority of included pre-post studies were
considered as being of poor quality.12,21,24e31
Conclusions
We noted that implementation of shoul-der
dystocia simulation exercises decreased the rate
of NBPP following shoulder dystocia but it was
associated with an increase in shoulder dystocia
di-agnoses and does not impact the overall rate
of brachial plexus injury. Reports addressing the
persistence of NBPP—a major sequela of
shoulder dystocia—are lacking and the potentially
associated in-crease in cesarean delivery rates
is con-cerning. The current data, which
demonstrate mixed clinical outcomes following
introduction of shoulder dystocia simulation,
indicate the need for a reassessment of the
recommendations calling for the universal
implementation of shoulder dystocia interventional
exer-cises. The uncertainties surrounding the
nature of the interventional exercises and the
necessary audience, the potential un-intended
consequences, the questionable improvement in
the long-term sequelae of shoulder dystocia
along with resource utilization and cost-
effectiveness together construct a compelling
reason to under-take an adequately powered
trial that in-corporates long-term follow-ups. -
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Appendix
Supplemental content search
strategy Using Ovid MEDLINE
(MEDLINE on OvidSP) as the
primary database, 3 concepts were
introduced, including vaginal birth,
shoulder dystocia, and simulation
training. Each concept was refined
using both the controlled vo-cabulary
of the database and keywords from
natural language. Multiple MeSH
(Medical Subject Headings) terms
were identified for each concept in
Ovid MEDLINE. Keyword were
added to each concept, in addition
to numerous synonyms. Keywords
were searched using the title,
abstract, and keyword fields within
the MEDLINE Ovid database. When
the concepts were thoroughly
developed, they were added together
to create 1 encom-passing search
string. The initial search strategy
was finalized the week of May 20,
2019 and re-run on November 25,
2020. No limits were used due to the low search result numbers.
Search strategy designed on MED-LINE
(Ovid Platform):
pregnancy/ or exp pregnancy outcome/ or
Pregnancy Complications/
(pregnan* and (outcome* or birth* or delivery*
or complication*)).ti,ab,kw. delivery, obstetric/
or extraction, obstetrical/ or vaginal birth after
cesarean/ exp Labor, Obstetric/ ((vagina* or
natural* or
obstetric*) adj3 (birth* or
childbirth* or “child-birth*” or delivery* or
labor * or labor*)).ti,ab,kw. exp Obstetrics/
obstetric*.ti,ab,kw. or/1-7 Dystocia/ exp Birth
Injuries/ “birth
injur*”.ti,ab,kw.
((“brachial plexus*” or
shoulder*)
adj3 (injur* or palsy*
or stretch* or
dystocia*)).ti,ab,kw.
(“Neonatal Brachial Plexus Palsy” or paraly*
or parali*).ti,ab,kw. or/9-13
exp High Fidelity Simulation Training/ or exp
Patient Simulation/ or exp Computer
Simulation/ or exp Simulation Training/
(simulat* or “virtual
realit*” or VR or haptic* or “augment* realit*”
or 3D or “3-D” or “three dimension*”).ti,ab,kw.
models, anatomic/ or exp manikins/
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(manikin* or mannequin*).ti,ab,kw. (model*
adj3 (human* or female* or woman* or
women*)).ti,ab,kw. exp Inservice
Training/ ((staff* or team*
or physician* or doctor* or nurs* or resident*)
and train*).ti,ab,kw. exp Patient Care Team/
((“patient care*” or
healthcare* or “health-care*”
or “medical care*”) and team*).ti,ab,kw. or/
15-23 8 and 14 and 24
The results were then uploaded to the
EndNote citation manager for automatic and
manual de-duplication.
The de-duplication process was completed
between June 3, 2019, and June 4, 2019. The
final number of re-sults from all 4 databases for
review came to 655. Once the de-duplication
process was carried out and the search
strategies recorded , a com-pressed Endnote
library was delivered to the group, along with
the search strategies for each database, the de-
duplication numbers, the search methodology,
in addition to a PRISMA flowchart and checklist.
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SUPPLEMENTAL FIGURE 1
Publication bias for shoulder dystocia

SD, shoulder dystocia.

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.

10.e2 American Journal of Obstetrics & Gynecology MONTH 2021

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SUPPLEMENTAL FIGURE 2
Publication bias for NBPP per shoulder dystocia

NBPP, neonatal brachial plexus palsy.

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.

MONTH 2021 American Journal of Obstetrics & Gynecology 10.e3

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SUPPLEMENTAL FIGURE 3
Publication bias for overall NBPP with all deliveries

NBPP, neonatal brachial plexus palsy.

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.

10.e4 American Journal of Obstetrics & Gynecology MONTH 2021

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SUPPLEMENTAL FIGURE 4
Publication bias for cesarean delivery

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.

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SUPPLEMENTAL FIGURE 5
Publication bias for clavicle or humerus fractures per shoulder dystocia

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.

10.e6 American Journal of Obstetrics & Gynecology MONTH 2021

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SUPPLEMENTAL FIGURE 6
Publication bias for third-fourth degree lacerations per shoulder dystocia

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.

MONTH 2021 American Journal of Obstetrics & Gynecology 10.e7

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SUPPLEMENTAL FIGURE 7
Documentation of shoulder dystocia stratified by use of NOELLE or PROMPT simulators

Cr, credible interval.

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.

10.e8 American Journal of Obstetrics & Gynecology MONTH 2021

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SUPPLEMENTAL FIGURE 8
NBPP per shoulder dystocia case stratified by use of NOELLE or PROMPT simulators

Cr, credible interval; NBPP, neonatal brachial plexus palsy.

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.

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SUPPLEMENTAL FIGURE 9
Overall rate of NBPP stratified by use of NOELLE or PROMPT simulators

Cr, credible interval; NBPP, neonatal brachial plexus palsy.

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.

10.e10 American Journal of Obstetrics & Gynecology MONTH 2021

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SUPPLEMENTAL FIGURE 10
Cesarean delivery rate by use of NOELLE or PROMPT simulators

Cr, credible interval.

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.

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SUPPLEMENTAL FIGURE 11
Clavicle or humerus fracture for shoulder dystocia

Cr, credible interval; NA, not available.

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.

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SUPPLEMENTAL FIGURE 12
Third- or fourth-degree lacerations per shoulder dystocia

Cr, credible interval.

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.

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SUPPLEMENTAL FIGURE 13
Third- or fourth-degree lacerations with vaginal deliveries

Cr, credible interval.

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.

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SUPPLEMENTAL FIGURE 14
Shoulder dystocia rate stratified by studies with Newcastle-Ottawa Scale ratings of fair or good bias

Cr, credible interval.

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.

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SUPPLEMENTAL FIGURE 15
NBPP per shoulder dystocia case stratified by studies with Newcastle-Ottawa Scale ratings of fair or good bias

CI, confidence interval; NBPP, neonatal brachial plexus palsy.

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.

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SUPPLEMENTAL FIGURE 16
Overall rate of NBPP stratified by studies with Newcastle-Ottawa Scale ratings of fair or good bias

Cr, credible interval; NA, not available; NPBB, neonatal brachial plexus palsy.

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.

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SUPPLEMENTAL FIGURE 17
Overall rate of cesarean delivery stratified by studies with Newcastle-Ottawa Scale ratings of fair or good bias

Cr, credible interval.

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.

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SUPPLEMENTAL TABLE 1
Newcastle-Ottawa Scale for assessing the quality of nonrandomized studies in a meta-analysis
Selection Comparability Outcome
Author, year (maximum 4) (maximum 3) (maximum 4)

Reisner and Landers,21 2010 3 0 3

Grobman et al,12 2011 3 0 3

Inglis et al,13 2011 3 2 3

Walsh et al,15 2011 2 1 3

Nguyen et al,22 2011 3 1 3

Croft et al,23 2016 3 1 3

van de Ven et al,24 2016 3 0 3

Weiner et al,25 2016 3 0 3

Sienas et al,26 2017 3 0 2

Gurewitsch et al,27 2017 3 0 3

Kumar et al,28 2018 3 0 3

Alsafi et al,29 2018 3 0 2

Dahlberg et al,30 2018 3 0 3

Seligman et al,31 2019 2 0 2

Kim et al,32 2019 3 2 3

The thresholds for converting the Newcastle-Ottawa scales to AHRQ standards (good, fair, and poor) are as follows:

Good quality: 3 or 4 stars in selection domain AND 1 or 2 stars in comparability domain AND 2 or 3 stars in outcome or exposure domain.

Fair quality: 2 stars in selection domain AND 1 or 2 stars in comparability domain AND 2 or 3 stars in outcome or exposure domain.

Poor quality: 0 or 1 star in selection domain OR 0 stars in comparability domain OR 0 or 1 stars in outcome or exposure domain.

Fransen et al16 was a randomized clinical trial and was, therefore, not assessed using Newcastle-Ottawa scales.

AHRQ, Agency for Health Research and Quality.

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SUPPLEMENTAL TABLE 2
Study characteristics
Abstract or Published or Study period and Training by, attended by, and
Authors article presented country RCT duration of training Key components of training mandatory
Reisner and Landers21 Article 2010 United States No 2000 e2007 Interdisciplinary crisis - N.M.
36 mo before simulation - NM if mandatory
12th intervention NOELLE simulation
36 mo after Structured debriefings
Grobman et al12 Article 2011 United States No 2006 e2007 Low-fidelity multidisciplinary - N.M.
6 mo before training - N.M.
6th intervention w Didactic portion, repeated - NM if mandatory
6 mo later simulation, debrief
intervention Team-level response to SD
No focus on manual skills to
resolve SD
Announce SD
Summon additional help
Establish roles for clinicians
Documentation

Inglis et al13 Article 2011 United States No 2003 e2009 Hands off—no hands and no - MFM, CNM, RN
36 mo before traction - Attending, residents, CNM,
2nd intervention Assess position of the anterior R.N.

36 mo after shoulder - Mandatory

Pushing when shoulder is
oblique or posterior arm is
delivered
Calm approach to emergency
Documentation

Walsh et al15 Article 2011 Ireland No 1994 e1998 Call for help - Senior obstetrical atten-dants,
2004 e2008 McRoberts and suprapubic midwifery tutors
promoted as first line - Obstetric residents and
Internal maneuvers second midwives
line

Nguyen et al22 Article 2011 United States No 2007 e2009 TeamSTEPPS model - Attending, obstetricians,
18 mo before Didactic training house staff, L&D nurses
11 mo after NOELLE simulation

croft Article 2016 United Kingdom No 1996 e2012 PROMPT birth trainer - Obstetricians, CNM
et al23 36 mo before Don't pull hard; do not pull - Obstetricians, CNM
24 mo gap w quickly; do not pull down - Mandatory
72 mo after Documentation
(2001 e2004;
2009 e2012)

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Study characteristics (continued)

Authors

van de Ven et al24

Abstract or
article

Article
Published or
presented
2016
country
Netherlands
RCT

No
Study period and
duration of training
2001 e2010
38 mo before
24 mo training w
38 mo after
Key components of training
NOELLE and PROMPT Birth-
ing Trainer
Maneuvers to relief SD
Communication
Training by, attended by, and
mandatory

- Senior obstetrician, CNM

- MD, CNM, RN
- NM if mandatory

No focus on documentation
Jof
Weiner et al25 Article 2016 United States No 2006 e2014 PROMPT program - All hospital personnel
24 mo before Modules and drills assigned to obstetric and
&
72 mo later
M
nursery units
Fransen et al16 Article 2017 Netherlands 2009 e2011 - Facilitators: obstetrician and
A
Forks 1-d (8-h), simulation-based,
multiprofessional obstetric communication expert
team training, focusing on - Multiprofessional staff of the
CRM skills (ie, teamwork obstetric units
2
skills)
Medical simulation center
(Medsim)
Orientation, simulation,
debrief

Gurewitsch et al27 Article 2017 United States No 1993 e2015 Simulation training - Mandatory for interns
144 mo before All PGY-I - MFM, OB, CNM, RN
No training or gap Avoid lateral traction, episi- - Mandated debriefing after
24 mo later otomy, repeating failed every SD
maneuvers
Assess shoulder's position
Head in axial position
Prioritize fetal maneuvers
Keep track of time
Documentation

Sienas et al26 Article 2017 United States No 2011 e2015 Low-fidelity simulation - Ob providers, RN
33 mo before Lecture and drills - Mandatory for RN
No training/gap NOELLE simulation
21 mo after Debrief

Kumar et al28 Article 2018 Australia No 2011 e2015 Lectures and drills - Ob providers, CNM
24 mo before PROMPT program - Mandatory every 2 and
12 mo training
24 mo later

Dahlberg et al30 Article 2018 Sweden No 2004 e2015 Prelearning, lecture, simulation - Ob providers, CNM, RN
36 mo before training assistant
No training gaps PROBE program - Mandatory for Ob providers,
96 mo after CNM, RN assistant

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Study characteristics (continued)
Abstract or Published or Study period and Training by, attended by, and
Authors article presented country RCT duration of training Key components of training mandatory

Seligman et al31 Abstract 2019 United States No 2015 e2018 Prelearning - N.M.
3 mo before Team-based simulation - Ob providers, RN
28th intervention Documentation - NM if mandatory
3 mo after

Kim et al32 Article 2019 United States No 2008 e2014 Video developed by ACOG - Experienced Ob-Gyn
15 mo before PROMPT birthing simulator - Ob providers, CNM, FP, RN
No training gaps Maneuvers practiced - Mandatory course
48 mo after

Alsafi Abstract 2018 United Arab Emirates No 28 mo before Lecture followed by practical - Multiprofessional
et al29 No training gaps session - All providers
24 mo later - Mandatory
ACOG, American College of Obstetricians and Gynecologists; CNM, certified nurse-midwives; FP, family practice; HELPEER, Help, Episiotomy, Legs (McRoberts), Pressure (suprapubic), Enter vagina to reduce impacted shoulder, Reduce the posterior arm, Rotate the
patient to her hand and legs (Gaskin maneuver); L&D, labor and delivery unit; MFM, maternal-fetal medicine; NM, no mention; Ob, obstetrical; Ob-Gyn, obstetrician-gynecologist; PGY, postgraduate year; RCT, randomized clinical trial; RN, registered nurses; S.D.,
shoulder dystocia.
to
Not included in the analysis.

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Outcomes of interest

Author, year

Reisner and Landers,21 2010 Not defined

Grobman et al,12 2011

Neonatal brachial
plexus palsy
defined

Not defined
Assessed by Follow-up until
No mention

Pediatrician
Download

Download
Shoulder dystocia defined as
Not defined

Not defined
Indication for
cesarean delivery
No mention

No mention

Inglis et al,13 2011 Decreased arm movement Neonatologist Download Tight or difficult shoulders, or turtle sign that required No mention
Jof
additional maneuvers to accomplish delivery
&
Walsh et al,15 2011 Not defined Not applicable >1 already Failure to deliver the shoulders at the first attempt in No mention
M
singleton cephalic vaginal deliveries
A
Nguyen et al,22 2011 Not defined Not applicable No Not defined No mention

Croft et al,23 2016 Not defined No mention 12 mo or requiring surgeryb Difficulty with shoulders Elective or emergency
2
van de Ven et al,24 2016 Not defined Pediatrician At birth Additional obstetric maneuvers other than gentle No mention
downward traction were required
Weiner CP et al25 Not defined No mention Download Not defined No mention

Fransen et al,16 2017 Not defined No mention Download Not defined No mention

Gurewitsch et al,27 2017 Not defined No mention Download The prospective recognition of probable shoulder No mention
impaction based upon the clinician's subjective
appreciation of failure of the anterior shoulder to
deliver with application of customary traction

Sienas et al,26 2017 Not defined No mention Download Not defined No mention

Kumar et al,28 2018 Not defined No mention Download Not defined No mention

Dahlberg et al,30 2018 Not defined No mention 6 gp Not defined No mention

Seligman et al,31 2019 Not defined No mention Download Not defined No mention

Kim et al,32 2019 Not defined No mention Download Need for relief maneuvers No mention

Alsafi et al,29 2018 Not defined No mention Download Not defined No mention

to b
Describes the rate of overall neonatal brachial plexus palsy, irrespective of shoulder dystocia; Describes the rate of neonatal brachial plexus palsy subsequent to shoulder dystocia.

Wagner. Interventions for shoulder dystocia. Am J Obstet Gynecol 2021.