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Jackson, Mississippi
Abstract Our objective was to determine the factors involved in the development of shoulder dystocia in
association with operative vaginal delivery. In this prospective study, patients who were candidates for operative
vaginal delivery were randomized either to forceps (N 5 315) or vacuum with M-cup (N 5 322) and timed from
initial placement of instrument to final delivery. Data were gathered prior to and after instrumental delivery.
Statistics used were Pearson chi square, Fisher’s exact, analysis of variance, and multiple logistic regression. There
were a total of 21 patients with shoulder dystocia in both groups (3.3% incidence). Discriminant factors that did
not meet significance included use of epidural analgesia (P 5 .12), station (P 5 .99), previous vaginal delivery
(P 5 .99), fetal gender (P 5 .54), indication for operative vaginal delivery (P 5 .63), .45 degree rotation
(P 5 .68), use of episiotomy (P 5 .62), maternal weight (P 5 .26), and maternal diabetes (P 5 .08). Nearly
attaining significance in univariate analysis was randomization to vacuum (P 5 .052). Significant factors
included gestational age (P 5 .03), time required to effect delivery (P 5 .007), and birthweight (P 5 .0001).
When these factors were subjected to stepwise multiple logistic regression, three factors remained as significant
associations with shoulder dystocia: randomization to vacuum (P 5 .04), time for delivery (P 5 .03), and
birthweight (P 5 .0001). In this operative vaginal delivery trial, shoulder dystocia was strongly associated with
large fetal size, longer time to delivery, and the use of vacuum for delivery. J. Matern.–Fetal Med. 6:220–224,
1997. r 1997 Wiley-Liss, Inc.
SUBJECTS AND METHODS purposes of our study, shoulder dystocia was defined as the
Over a 10-month period (October 1994 through July requirement for ancillary maneuvers (e.g., McRobert’s posi-
1995), women who were candidates for operative vaginal tion, suprapubic pressure, delivery of posterior arm, etc.) for
delivery were randomized to be delivered either by obstetric the delivery of the fetal shoulders. Statistics used were the
forceps or by one of two vacuum extraction techniques Pearson chi square, Fisher’s Exact, analysis of variance
(continuous or intermittent suction). For this study, the (ANOVA), and multiple stepwise logistic regression (SAS
vacuum arms were combined into one group because there Cary, NC).
were no differences is maternal or fetal outcome or in the
respective rates of shoulder dystocia [9]. In this trial all of RESULTS
the data were collected and analyzed on an ‘‘intent to treat’’ This operative vaginal delivery trial included 637 women:
basis, and patients remained in their randomized groups for 315 women randomized to obstetric forceps and 322 to
all statistical purposes. The M-cup (Neward Enterprises, vacuum. Thirty-five of the women in the forceps group were
Rancho Cucamonga, CA) was the only vacuum cup used in delivered by other means (12 spontaneously, 16 by vacuum,
this study, but the physicians were free to choose the type of and seven by cesarean). Twenty-one women who random-
forceps for the patients who randomized to that instrument. ized to the vacuum group were delivered in another manner
Only women with pregnancies $34 weeks or with fetuses (five spontaneously, 11 by forceps, and five by cesarean).
expected to weigh $1,800, if gestational dating was uncer- Overall, there was no difference in the efficacy rates of these
tain, were considered for this trial. These are the lower two instruments [8]. The indications for these operative
limits that have traditionally been used for vacuum extrac- vaginal deliveries are described in another report [8].
tion at our institution. The delivery physicians were di- There were 21 cases of shoulder dystocia (the study
rected to perform episiotomy selectively, not electively. group) recorded for an incidence of 3.3% (21/637). In 20
Patients gave consent for this trial only after the decision cases McRobert’s position and suprapubic pressure sufficed
had been made that they were candidates for operative to relieve the impaction of the anterior shoulder behind the
vaginal delivery. These patients signed an informed consent symphysis. In one case delivery of the posterior arm was
document which was approved by the Institutional Review required to relieve the obstruction. There were nine cases in
Board of the University of Mississippi. After the consent which shoulder dystocia was diagnosed after an episiotomy
process, the next in a series of numbered, opaque envelopes had been performed, and in one of these cases the episi-
was opened which designated the patient to be delivered otomy was extended to create space. In ten other cases an
either by forceps or by vacuum. Randomization envelopes episiotomy was not performed before or after the diagnosis
were prepared using a table of random numbers by an of shoulder dystocia. In two instances an episiotomy was
uninvolved third party prior to the initiation of the study. performed only after the diagnosis of shoulder dystocia was
Randomization was usually accomplished while the patient established. For statistical purposes the two cases in which
was being transported from the labor to the delivery room. episiotomy was performed after the diagnosis of shoulder
Data were gathered prior to, during, and after each dystocia were considered to be in the ‘‘no episiotomy’’
delivery. Maternal demographics, gestational age, the indi- group.
cation for operative delivery, and whether the parturient There were 15 cases of shoulder dystocia in the women
had ever delivered vaginally were prospectively recorded. that randomized to the vacuum (incidence 4.7%), while
Data gathered in the delivery room but prior to the only six of the deliveries on the forceps arm had this
application of the delivery instrument included the station complication (incidence 1.9%) (P 5 .052). There was one
and position of the fetal head. The type of analgesia and the case of deep transverse arrest which randomized to the
requirement for episiotomy were also recorded. Patients forceps and was abandoned secondary to a poor forceps
underwent routine urinary bladder catheterization prior to application. The delivery physician completed a vacuum
the application of the randomized delivery instrument. delivery of a 4,300-g fetus which resulted in shoulder
Deliveries were timed with stopwatches from the insertion dystocia and a clavicular fracture. For statistical purposes
of the instrument into the vagina (vacuum cup or first blade this case remained in the forceps group. Table 1 demon-
of the forceps) until the complete delivery of the infant. strates that several factors were not significantly correlated
Instrumental rotation, if required, was likewise recorded. with shoulder dystocia in univariate analysis. These in-
These deliveries were accomplished by obstetric house cluded maternal demographic factors such as age, weight,
officers under the supervision of maternal-fetal medicine previous vaginal delivery, or maternal diabetes. Intrapartum
fellows with extensive experience in both types of operative factors not associated with shoulder dystocia included
vaginal delivery. epidural analgesia, pelvic station, indication for operative
Neonatal data gathered after delivery included Apgar intervention, .45 degree rotational maneuvers, and use of
scores and cord arterial blood gas specimens. For the episiotomy.
222 BOFILL ET AL.
The variables that appeared to be associated with shoul- Our prospective study does have limitations. Even though
der dystocia were then subjected to multiple logistic regres- this is the largest randomized forceps versus vacuum trial
sion analysis. Interestingly, vacuum delivery achieved signifi- reported thus far, the number of patients included cannot
cance in the logistic regression (P 5 .045), whereas it was compete with the larger populations described in the
only of borderline importance in simple univariate analysis. retrospective analyses. A small sample size is a hindrance
The variable of gestational age was forced out of the model when attempting to study rare events such as shoulder
by birthweight (P 5 .0001), whereas the time required to dystocia. The finding of a trend with regard to maternal
achieve an operative vaginal delivery retained its signifi- diabetes and shoulder dystocia (P 5 .08) may well be a Type
cance (P 5 .027). II statistical error. There was no evidence that the pelvic
station from which the operative vaginal delivery was
DISCUSSION initiated was a significant risk factor for shoulder dystocia.
Only one delivery initiated from the midpelvis resulted in a
The diagnosis of shoulder dystocia is subject to the
shoulder dystocia. This probably represents a careful selec-
discretion of the delivery physician, and it is possible that
tion process for attempted midpelvic deliveries. When fetal
this diagnosis is underreported secondary to medicolegal
macrosomia is a concern and there is second-stage midpel-
concerns. Indeed, Gonik et al. noted that only 29% of
vic arrest the most likely recourse is cesarean section
infants who were delivered with injuries usually associated
without the benefit of a trial of operative vaginal delivery.
with the diagnosis of shoulder dystocia had a maternal chart
Antenatal prediction of birthweight, whether deter-
with that designation [5]. Neonatal brachial plexus impair-
ment is the condition most often considered to be related to mined clinically or by ultrasonography, is notoriously impre-
shoulder dystocia, and it is second only to asphyxia with cise. Importantly, the time required for delivery is unlikely
regard to long-term morbidity. However, cases of neonatal to be measured in most centers when forceps are utilized. It
brachial plexus impairment have been documented in should be stressed that of the three factors we identified as
which there was no evidence of shoulder dystocia suggesting being associated with shoulder dystocia only the use of
that some cases may not result from events at delivery [10]. vacuum is known prior to the delivery. This certainly adds
Indeed, cases of neonatal brachial plexus impairment have credence to the assertion that shoulder dystocia, even when
been reported in which the infants were delivered by associated with operative vaginal delivery, is unpredictable
cesarean section without instrumental or any other type of and unpreventable.
traction in an attempt to effect vaginal delivery [1,10]. It is This is not the first study to suggest that use of the
likely that brachial plexus impairment may occur without vacuum extractor is more likely to cause shoulder dystocia.
shoulder dystocia, without extreme lateral traction imposed In a 1978 study, Benedetti and Gabbe [6] noted a trend
on the fetal head, and with the best of intrapartum care [10]. toward a higher incidence of shoulder dystocia with vacuum
It is clear that the diagnosis of shoulder dystocia should be extraction as opposed to Kielland forceps. They reasoned
standardized and made less subjective. Spong and colleagues that the vacuum extractor may be able to deliver a larger
have demonstrated that only 16 of 27 patients in whom infant than the Kielland forceps. Obstetric forceps are
ancillary maneuvers were used for delivery had shoulder instruments that laterally cradle the head of the infant and
dystocia listed as a clinical diagnosis [11]. Going even thereby add to the volume of material that must negotiate
further, this group measured the head-to-body delivery time the pelvis and introitus. It is certainly possible that if a
intervals and noted that the upper limit of normal (mean 6 2 particular infant is only marginally suited to the size of the
standard deviations) was 60 seconds [11]. In their study, if pelvis the extra space taken up by the forceps blade may not
shoulder dystocia was a combined diagnosis of ancillary allow for delivery of the fetal head. The vacuum extractor,
maneuvers and/or prolonged head-to-body delivery time which takes up no room in the pelvis, may allow for the
then a group of infants was identified that had higher delivery of the infant who is only marginally suited for the
birthweights and lower 1-minute Apgar scores than control size and architecture of the maternal pelvis. We have not
infants [11]. Our data seem to confirm the findings of Spong restricted the use of the vacuum extractor in our labor and
et al [11]. First, although we measured time from the delivery suite with regard to midpelvic applications, possible
placement of the instrument into the vagina until the fetal macrosomia, maternal diabetes, or in the situation of a
delivery was completed, it is clear that those operative prolonged second stage of labor. We continue to adhere to a
vaginal deliveries with shoulder dystocia took significantly strict time limit of 20 minutes for vacuum-assisted vaginal
longer to complete. We cannot be certain that the extra delivery although we are now aware that those deliveries
time was entirely due to a prolonged head-to-body interval. that last longer than 6 minutes more often result in shoulder
Second, the infants with shoulder dystocia in our study had dystocia. We do, however, prescribe common sense in the
significantly lower 1-minute Apgar scores and higher weights application of any instrument for delivery when one or more
than the controls. of the above clinical parameters is present.
224 BOFILL ET AL.