European Journal of Obstetrics & Gynecology and Reproductive Biology 227 (2018) 52–59

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European Journal of Obstetrics & Gynecology and

Reproductive Biology
journal homepage: www.elsevier.com/locate/ejogrb

Full length article

Prevention of shoulder dystocia: A randomized controlled trial

to evaluate an obstetric maneuver
Olivier Poujadea,b,* , Elie Azriab,c,d, Pierre-François Ceccaldia,b,d, Carine Davitiana ,
Carine Khatera , Paul Chatela,b,d , Emilie Pernina,b,d , Nizar Aflaka , Martin Koskasb,c,d ,
Agnès Bourgeois-Moineb,c , Laurence Hamou-Plotkineb,c, Morgane Valentinb,c ,
Jean-Paul Rennere, Carine Royf,g , Candice Estellatf,g,h , Dominique Lutona,b,c,d
a
AP-HP, Beaujon Hospital, Department of Obstetrics and Gynecology, 100 Boulevard du General Leclerc, 92110, Clichy, France
b
DHU Risks in Pregnancy, 75014, Paris, France
c
AP-HP, Bichat-Claude Bernard Hospital, Department of Obstetrics and Gynecology, 46 rue Henri-Huchard, 75018, Paris, France
d
Université Paris VII, Paris Diderot, Sorbonne Paris Cité, 75205, Paris, France
e
Université Versailles Saint-Quentin-En-Yvelines, 78035, Versailles, France
f
AP-HP, Bichat-Claude Bernard Hospital, Département d’Epidémiologie et Recherche Clinique, URC Paris-Nord, 46 rue Henri-Huchard, 75018, Paris, France
g
CIC-EC 1425, UMR 1123, INSERM, Paris, France
h
UMR 1123, Université Paris Diderot, Sorbonne Paris Cité, Paris, France

A R T I C L E I N F O A B S T R A C T

Article history: Objective: Shoulder dystocia is a major obstetric emergency defined as a failure of delivery of the fetal
Received 3 January 2017 shoulder(s). This study evaluated whether an obstetric maneuver, the push back maneuver performed
Received in revised form 26 April 2018 gently on the fetal head during delivery, could reduce the risk of shoulder dystocia.
Accepted 2 June 2018
Study design: We performed a multicenter, randomized, single-blind trial to compare the push back
maneuver with usual care in parturient women at term. The primary outcome, shoulder dystocia, was
Keywords: considered to have occurred if, after delivery of the fetal head, any additional obstetric maneuver, beginning
Push back maneuver
with the McRoberts maneuver, other than gentle downward traction and episiotomy was required.
Obstetric maneuver
Shoulder dystocia
Results: We randomly assigned 522 women to the push back maneuver group (group P) and 523 women to
McRoberts maneuver the standard vaginal delivery group (group S). Finally, 473 women assigned to group P and 472 women
Brachial plexus injury assigned to group S delivered vaginally. The rate of shoulder dystocia was significantly lower in group P
(1
5%) than in group S (3
8%) (odds ratio [OR] 0
38 [0
16-0
92]; P = 0
03). After adjustment for predefined
main risk factors, dystocia remained significantly lower in group P than in group S. There were no
significant between-group differences in neonatal complications, including brachial plexus injury, clavicle
fracture, hematoma and generalized asphyxia.
Conclusion: In this trial in 945 women who delivered vaginally, the push back maneuver significantly
decreased the risk of shoulder dystocia, as compared with standard vaginal delivery.
© 2018 Elsevier B.V. All rights reserved.

Introduction dystocia includes transient or permanent brachial plexus palsy,

Shoulder dystocia is a major obstetric emergency that
represents the failure of delivery of the fetal shoulder(s) after
delivery of the fetal head, despite a downward traction of the fetal
head. It occurs in approximately 0.2–3% of deliveries and is
principally due to fetal macrosomia and gestational diabetes
mellitus (GDM) [1,2]. Neonatal morbidity associated with shoulder
* Corresponding author at: Service de Gynécologie-Obstétrique, Hôpital Beaujon
AP-HP, 100 bd Gén Leclerc, 92110, Clichy, France.
E-mail address: olivierpoujade@hotmail.com (O. Poujade).
clavicle or humerus fracture, a 5-minute Apgar score of less than 7,
neonatal hematoma and neonatal death [3,4].
Two main problems are related to shoulder dystocia. Firstly, this
obstetric emergency remains unpredictable and antepartum risk
factors (parity, maternal weight gain during pregnancy, history of a
previous large baby, effects of diabetes, increasing birth weight)
are not useful in predicting shoulder dystocia [5,6]. Secondly, in
suspected fetal macrosomia, there is no procedure, notably labor
induction, that is effective in preventing shoulder dystocia.
The push back maneuver is a preventive obstetric maneuver that
is performed gently on the fetal head, with the aim of helping the
anterior shoulder slip behind the symphysis pubis, to give the

https://doi.org/10.1016/j.ejogrb.2018.06.002
0301-2115/© 2018 Elsevier B.V. All rights reserved.
 O. Poujade et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 227 (2018) 52–59 53

shoulders more time to enter the pelvic cavity. This concept has
previously been suggested by Henriksen, albeit without evidence [7].
pushby 50% or more, and therefore compared this risk in two
groups, one using the push back maneuver and the other using a
standard vaginal delivery, in normal term parturient women.
Materials and methods
We conducted a prospective, randomized, open-label two-
center study. The first center was the Department of Obstetrics and
Gynecology, Beaujon Hospital, Assistance Publique-Hôpitaux de
Paris (AP-HP), Clichy, France and the second was the Department of
Obstetrics and Gynecology, Bichat Hospital, AP-HP, Paris, France.
The study ran from March 2011 to December 2013.
The French Health Products Safety Agency (AFSSAPS) approved
the study in December 2010 (reference B101169-30). Likewise, the
study received ethical approval in February 2011 (reference
P091109) from the CPP Ile de France 1, Paris Hôtel-Dieu. All
participants signed a written informed consent form before
inclusion.
The trial was conducted in accordance with the Declaration of
Helsinki and Good Clinical Practice and adhered to French
regulatory requirements.
Inclusion criteria for participants were the following: women
aged 18 years to 45 years, with health insurance (social security
system or universal health coverage system, CMU), with a
singleton vertex fetus and a presumed vaginal delivery, indepen-
dently of the type of anesthesia and the need for instrumental
extraction. Women were included during the obstetric consulta-
tion between 32 and 37 weeks of gestation.
All women had a clinical or ultrasonography fetal weight
estimation after 35 weeks of gestation. Clinical suspicion of
macrosomia was defined as an estimated fetal weight greater than
4000 g during the study (between 37 and 41 weeks of gestation).
Macrosomia was suspected if the fetal weight estimated ultra-
sonographically was greater than the 90th percentile. Fetal
measurements of the biparietal diameter, abdominal circumfer-
ence and femur length were obtained and estimated fetal weights
were calculated using the Hadlock formula [8].
Once the patient was admitted to the delivery room and before
randomization, the secondary exclusion criteria were as follows:
patients with cesarean delivery, preterm delivery (gestational age less
than 37 weeks) and breech presentation. After randomization, the only
predefined exclusion criterion was emergency cesarean delivery.
Patients were randomly assigned, in a 1:1 ratio, to the push back
maneuver group (group P) or to the standard group (group S) in the
delivery room, using an Internet-based, centralized (CleanWeb
software, Télémédecine Technologies, Boulogne, France), comput-
er-generated list stratified by center and with random block sizes
to ensure appropriate allocation concealment.
Given the intervention and the primary outcome, blinding of the
care provider and of the outcome assessor, could not be carried out.

Fig. 1. Combined fetal and maternal illustration of standard vaginal delivery and “Push back” maneuver.
A: Standard vaginal delivery;
A1: the operator (obstetrician or midwife) does not maintain the fetal head flexion and pushes the perineal ring under the neonate's chin, making a rise of the anterior fetal
shoulder;
A2: impaction of the anterior shoulder behind the pubic symphysis.
B: “Push back” maneuver;
B1: application of the “push back” maneuver during maternal expulsive efforts, giving the shoulders more time to enter the pelvic cavity and promoting the fetal head flexion;
B2: the “push back” maneuver facilitates the shift of the anterior shoulder from behind the symphysis, allowing delivery to proceed without shoulder dystocia.
54 O. Poujade et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 227 (2018) 52–59
Only patients were blinded to group assignment. Data were extracted
from medical records and were collected by two trained research
technicians enrolled for the study, covering both clinical sites. Data
collection was performed on a computerized, secured case-record
form accessible online and was controlled by an independent clinical
research assistant and a data management center.
The objective of this study was to evaluate the push back
maneuver, an obstetric maneuver which was precisely detailed in
the study protocol. This maneuver was performed with one hand
applied gently to the fetal head, from the crowning of the fetal head
(appearance of the fetal scalp at the introitus between pushes), to
hold back the fetal head during the final stage of delivery. This push
back maneuver was performed simultaneously with active
expulsive efforts, during a maximum of one uterine contraction
and three expulsive efforts. In the case of operative delivery, the
push back maneuver was performed in the same way, once the
forceps or the vacuum was removed.
The push back maneuver was evaluated in comparison with
standard vaginal delivery including either expectant management
during the expulsion of the fetal head or active sliding of the
perineal ring when most of the head was out, with the aim of
hastening the delivery (Fig. 1).
All doctors and midwives participating in this trial attended
training sessions to ensure compliance with the study protocol and
correct achievement of the push back maneuver, one month before
the study started. Moreover, these training sessions provided a
reappraisal of obstetric techniques including the McRoberts
maneuver, the Woods screw maneuver and the Jacquemier
maneuver for posterior arm extraction).
The first part of the training sessions incorporated an
interactive CD-ROM based on obstetric techniques focused on
the management of shoulder dystocia. Three-dimensional models
and interactive sequences included in the CD-ROM content were
detailed to the participants (obstetric techniques for delivery and
shoulder dystocia, Guigoz Laboratories, Marne-la-Vallee, France).
The second part of the training included hands-on training on a
pelvic delivery model. Birth simulations were carried out with the
help of an anatomically correct pelvis model with full term
newborn model, with a view to teaching the push back maneuver
(Simulaids, Saugerties, New York, USA). Each participant per-
formed a delivery with the push back maneuver using the fetal
head of the mannequin and practiced various obstetric maneuvers
to manage shoulder dystocia. Finally, the midwives or doctors
themselves performed the delivered in the clinical setting, under
the instructor's supervision during the first procedure. Once the
study had started, other training sessions were organized every
three months for review of the protocol and obstetric techniques
and to check that the push back maneuver was being implemented
correctly.
The primary outcome, shoulder dystocia, was considered to
have occurred if, after delivery of the fetal head, an additional
obstetric maneuver, the McRoberts maneuver (maternal hip
flexion) or other than gentle downward traction, was required.
Therefore this included all putative cases of shoulder dystocia,
regardless of its actual severity and outcomes.
Once shoulder dystocia occurred, the first step of the
management algorithm was to place the patient in the McRoberts
position [9] involving hyperflexion and abduction of the mother’s
hips, leading to cephalad rotation of the symphysis pubis and
flattening of the lumbar lordosis, allowing freeing of the impacted
shoulder [10]. In the case of failure of the McRoberts maneuver, the
management algorithm included two alternative maneuvers.
Firstly, the Woods screw maneuver was used if the posterior
shoulder was sufficiently engaged in the pelvic inlet [11]. The
Woods maneuver entailed applying pressure to the posterior
shoulder and rotating it 180 through the maternal pelvis in order
to dislodge the anterior shoulder. Secondly, if the previous
maneuvers failed to alleviate the shoulder dystocia, posterior
arm extraction (Jacquemier maneuver) [12] was attempted. This
maneuver consisted of sweeping the posterior arm across the fetal
chest and delivering it through the vagina.
Secondary outcomes were neonatal complications, to assess
safety of the maneuver: neurological damage (brachial plexus
injury), generalized asphyxia, hematoma, clavicle and humerus
fractures. All newborns were examined clinically by a pediatrician,
within five days after delivery.
Results were described as mean and standard deviation for
continuous variables and as frequency and percentage for
categorical variables. Comparison of baseline characteristics of
women and newborns involved the chi-square test or Fisher’s
exact test for categorical variables, and Student’s t-test or the
Wilcoxon rank-sum test as appropriate for continuous ones. The
frequency of shoulder dystocia was compared between group P
and group S using the chi-square test. The main analysis was the
predefined modified intention-to-treat analysis: all randomized
women who did not undergo emergency cesarean.
In secondary analysis, the effect of the group on occurrence of
shoulder dystocia was adjusted in a multiple logistic regression
model for the center and for factors known to increase the risk of
shoulder dystocia: neonatal macrosomia (defined as a fetal weight
of more than 4000 g), maternal age, prior shoulder dystocia,
maternal parity, maternal BMI before pregnancy, gestational
diabetes mellitus (GDM) with diet only, GDM with insulin therapy,
occipital-posterior position of the fetal head at full dilation and
prolonged second stage of labor [5,6].
The interaction between macrosomia suspected on prenatal
ultrasound and randomization group was studied in a logistic
regression model in order to determine if the effect of the push
back maneuver differed according to suspicion of macrosomia. A
term of interaction was added to the model, to check for a
differential effect of the push back maneuver according to
macrosomia.
Secondary outcomes were compared between the two groups
of patients using the chi-square test or Fisher’s exact test in the
modified intention-to-treat population. The main analysis was
repeated in the per protocol population (i.e. only on women who
received the treatment corresponding to their randomization
group).
The trial was designed to include 3700 women in order to
randomize 3068 of them to have an 80% power to detect, with a
two-sided type 1 error of 5%, a 50% reduction in shoulder dystocia
in group P, assuming a prevalence of dystocia of 3% in group S. Due
to a lower inclusion rate than expected we could not reach this
recruitment target. Decision to not extend inclusion period was
taken for financial constraint and before any interim analysis. The
trial finally allowed the inclusion of 1523 pregnant women. All
statistical analyses were performed using SAS 9.2 (SAS Institute,
Cary, NC).
Results
Between March 2011 and September 2013, a total of 2139
women with a presumed vaginal delivery were asked to participate
in the study, and 1523 gave written informed consent. As expected,
data collection was stopped in December 2013.
Fig. 2 depicts the recruitment flow of trial participants. Four
hundred and seventy-eight women could not be randomized: 72
cesarean deliveries, 11 preterm deliveries, 7 breech presentations,
16 consent withdrawals, 1 intrauterine fetal death, 272 organiza-
tional issues and 99 other reasons. The remaining 1045 women
were randomly assigned to group S (n = 523) or to group P
(n = 522). After randomization, respectively 51 and 49 women
 O. Poujade et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 227 (2018) 52–59 55

Fig. 2. Flow chart.

*Randomization difficulties included problems with regard to access to computer software, Internet connection problems, organizational problems and randomization
performed too late.
†Except one case of intrauterine fetal death, other reasons for non randomization (N = 17) were eligibility criteria eventually not met and women included in another
interventional study.

undergoing an emergency cesarean delivery during labor were
excluded. Finally, 472 women assigned to group S and 473 women
assigned to group P delivered vaginally and were analyzed. The
mean duration of follow-up was 4.2 weeks (SD 2.3).
Table 1 depicts the baseline characteristics of the study
population (n = 945). The baseline characteristics of women and
newborns were similar in the two groups, except for the rate of
macrosomic newborns: 9.7% (n = 46) in group S versus 5.9% (n = 28)
in group P (P = 0.03). However, there was no between-group
difference in the rate of clinically or ultrasonographically
suspected macrosomia. Similar results were observed in the
1045 women randomized.
Primary and secondary outcomes according to the obstetric
maneuver are detailed in Table 2. The rate of shoulder dystocia was
significantly lower in group P (odds ratio [OR], 0.38; 95%
confidence interval [CI], 0.16 to 0.92; P = 0.03): 7 (1.5%) women
versus 18 (3.8%) women in group S presented shoulder dystocia. Of
the 25 cases of shoulder dystocia (2.6% of all women), 19 (76%)
were resolved by the McRoberts maneuver alone (14 in group S and
5 in group P), 2 (8%) by the Woods screw maneuver and 4 (16%) by
fetal posterior arm extraction. Sensitivity analysis in the per
protocol population confirmed a significantly lower rate of
shoulder dystocia in group P (P = 0.02).
Table 3 details the results of the association between shoulder
dystocia and each factor known to increase risk of shoulder
dystocia (maternal age, maternal parity, prior shoulder dystocia,
maternal BMI before pregnancy, GDM, prolonged second stage of
labor, neonatal macrosomia).
After adjustment for these factors, group P was still associated
with a lower rate of dystocia (OR, 0.36; 95% CI, 0.14 to 0.92;
P = 0.03). Neonatal macrosomia was associated with a higher rate
of dystocia (OR, 10.07; 95% CI, 4.13–24.54; P < 0.001). The effect of
the push back maneuver on shoulder dystocia was not significantly
different in macrosomic newborns than in other newborns
(P = 0.45 for test of interaction).
Very few neonatal complications were observed (n = 15, 1.6%).
These included generalized asphyxia (n = 10), clavicle fracture
(n = 3), neonatal hematoma (n = 1) and brachial plexus injury
(n = 1). There was no significant between-group difference in the
occurrence of any of these outcomes (6 in group S and 9 in group P).
56 O. Poujade et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 227 (2018) 52–59

Table 1
Baseline characteristics of the study population.* .

P Group, S Group,
Push back maneuver Standard vaginal delivery
(N = 473) (N = 472)
Variables
Maternal characteristics
Maternal age — yr 30
5  4
8 30
7  5
0
Weight before pregnancy (kg) 65
6  13
5 64
6  12
9
Body mass index before pregnancy† 23
9  4
6 23
7  4
5
Weight gain during pregnancy (kg) 12
6  5
4 12
8  5
0
Maternal parity — no. (%)
0 248 (52
4) 238 (50
4)
1 154 (32
6) 148 (31
4)
2 71 (15) 86 (18
2)
Prior shoulder dystocia — no./total no. (%) 7 (1
5) 5 (1
1)
Pregestational diabetes mellitus — no. (%)
Gestational diabetes mellitus (GDM) — no. (%) 48 (10
1) 43 (9
1)
GDM with diet only — no. (%) 40 (8
5) 37 (7
9)
GDM with insulin therapy — no. (%) 8 (1
6) 6 (1
2)
Prior cesarean delivery — no. (%) 25 (6
3) 25 (6
4)
Ultrasonographically suspected macrosomia — no. (%) 18 (3
8) 24 (5
1)
Clinically suspected macrosomia — no. (%) 22 (4
7) 18 (3
8)

Delivery characteristics
Gestational age at delivery (weeks) 39
9  1
1 40
0  0
9
Induction of labor — no. (%) 108 (22
8) 112 (23
7)
Epidural anesthesia 443 (93
6) 441 (93
4)
Prolonged second stage of labor — no. (%)z 154 (32
6) 132 (28
0)
Length of first stage of labour (hours) 4
9  2
7 4
8  2
7
Length of second stage of labour (hours) 1
4  1
1 1
3  1
1
Oxytocin use — no. (%) 241 (51
0) 221 (46
8)
Occipital-posterior position of the fetal head at full dilation — no. (%) 4 (0
8) 11 (2
3)
Need of instrumental extraction — no. (%) 103 (21
8) 111 (23
5)
Vacuum 42 (8
9) 45 (9
5)
Forceps 61 (12
9) 66 (14)
Episiotomy — no. (%) 128 (27
1) 125 (26
5)
Second degree perineal tears— no. (%)x 2 (0
4) 3 (0
6)

Newborns characteristics
Neonatal birth weight (g) 3
389  0
404 3
407  0
425
Neonatal macrosomia — no. (%){ 28 (5
9) 46 (9
8)
Apgar score at 5 minutes  7 — no. (%) 6 (1
3) 3 (0
6)
pH umbilical artery <7
10 — no. (%) 11 (2
6) 9 (2
1)
*
Plus-minus values are means  SD. There were no significant between-group differences with respect to any of the baseline variables except for the rate of macrosomic
newborns (P = 0.02).
†
The body-mass index is the weight in kilograms divided by the square of the height in meters. Data were available for 465 women in the group C and 466 women in the
group M.
z
Prolonged second stage of labor was defined as a stage of more than 2 h in length, irrespective of parity.
x
No third or fourth degree perineal tears were diagnosed.
{
Fetal macrosomia was defined as a birth weight of more than 4000 g.

Table 2
Primary and secondary outcomes in both groups.

P Group, S Group, P value Odds ratio

Push back maneuver Standard vaginal delivery (95% CI)
(N = 473) (N = 472)
Variable
Primary outcome:
Shoulder dystocia — no. (%) 7 (1
5) 18 (3
8) 0
03 0
38 (0
16-0
92)
Success of MacRoberts maneuver — no. (%) 5 (1
1) 14 (3)
Success of Woods screw maneuver — no. (%) 0 2 (0
4)
Success of posterior arm extraction — no. (%) 2 (0
4) 2 (0
4)

Secondary outcome (neonatal complication)†

Any neonatal complication — no. (%) 6 (1
3) 9 (1
9) 0
43
Generalized asphyxia — no. (%) 3 (0
6) 7 (1
5) 0
22
Neonatal hematoma — no. (%) 1 (0
2) 0 1
00
Brachial plexus injury — no. (%) 0 1 (0
2) 0
49
Clavicular fracture — no. (%) 2 (0
4) 1 (0
2) 1
00
†
No neonatal convulsions, phrenic nerve palsy, humeral fracture or shoulder subluxation were diagnosed.
 O. Poujade et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 227 (2018) 52–59
Table 3
Multivariate logistic regression adjusted on risk factors for shoulder dystocia.
No shoulder
dystocia
(N = 920)
Variables
"Push back" maneuver 466 (51)
Maternal age — yr* 30
6  4
9
Prior shoulder dystocia — no. (%) 10 (1
1)
Maternal parity — no. (%)
0 477 (51
8)
1 294 (32)
2 or more 149 (16
2)
Body mass index before pregnancy (kg/m2)* 23
7  4
5
GDM with diet only — no. (%) 72 (7
8)
GDM with insulin therapy — no. (%) 15 (1
6)
Prolonged second stage of labour — no. (%) 297 (32
3)
Neonatal macrosomia — no. (%)† 62 (6
7)
*
Plus-minus values are means  SD.
†
Neonatal macrosomia was defined as a fetal weight of more than 4000 g.
No neonatal convulsion, phrenic nerve palsy, humerus fracture or
shoulder subluxation was diagnosed after examination of all
newborns by a pediatrician.
Comment
To date, except for prophylactic cesarean delivery, no obstetric
maneuver has been proven to prevent shoulder dystocia efficiently.
Cesarean delivery avoids the occurrence of shoulder dystocia, but
increases the risks of endometritis, wound infection, wound
disruption, thrombophlebitis, and uterine rupture in a subsequent
pregnancy. A strategy of prophylactic cesarean delivery in suspected
fetal macrosomia would entail an unreasonable number of
unnecessary cesarean deliveries. Rouse and Owen proved that with
a 4000 g macrosomia threshold, 2345 cesarean would be required to
avert a single brachial plexus injury [13]. Moreover, a retrospective
assessment of a policy recommending cesarean delivery for an
estimated fetal weight of more than 4500 g found an insignificant
effect on the incidence of brachial plexus palsy [14].
Besides, the use of the McRoberts maneuver prophylactically
does not significantly decrease the risk of shoulder dystocia and
provides no reduction in the traction forces applied to the fetal
head during vaginal delivery [15,16]. Likewise, induction of labor
because of suspected macrosomia has not been shown to reduce
the incidence of shoulder dystocia and is associated with higher
rates of specific severe maternal morbidity (postpartum hemor-
rhage, puerperal sepsis and venous thromboembolism) [17–20].
In our randomized controlled study, we showed that the push
back maneuver was associated with a reduction of the rate of
shoulder dystocia from the very first sign of its manifestation (i.e.
beginning with the necessity of Mc Roberts maneuver), even after
adjustment for known risk factors of dystocia. Thus, to date, the
push back maneuver is the only known intervention to reduce the
occurrence of shoulder dystocia and more precisely to reduce
the necessity of any maneuver to counter measure it.
From the anatomical point of view, our study supports the
hypothesis that during delivery two maneuvers could contribute to
shoulder dystocia: firstly, not blocking the deflexion of the fetal
head with one hand, and secondly, pushing the perineal ring under
the neonate's chin when most of the head is out, which leads to the
turtle sign. Both maneuvers could result in raising of the anterior
fetal shoulder, which would impact behind the pubic symphysis
(Fig. 1, A and B).
Conversely, the push back maneuver in association with
repeated expulsive efforts may give the shoulders more time to
57
Shoulder Multivariate analysis
dystocia Odds ratio (95% CI) P Value
(N = 25)
7 (28) 0
36 (0
14-0
92) 0
03
31  5
2 1 (0
91-1
1) 0
98
2 (8) 1
79 (0
24-13
6) 0
57
0
39
9 (36) 0
41 (0
11-1
51)
8 (32) 0
54 (0
16-1
78)
8 (32) 1
25
5  4
5 1
05 (0
97-1
14) 0
22
5 (20) 1
95 (0
59-6
42) 0
27
1 (4) 2
59 (0
29-23
11) 0
39
10 (40) 2
01 (0
76-5
31) 0
15
12 (48) 10
7 (4
13-24
54) <0
001
enter the pelvic cavity and limit the occurrence of shoulder
dystocia (Fig. 1, C and D). Moreover the push back maneuver could
promote flexion of the fetal head, facilitate the descent of the
anterior shoulder and prevent it from becoming trapped under the
pubic symphysis, we have provided a model of all these concepts,
both static (Fig. 1), but also with a dynamic three-dimensional
animation (Video S1 and S2) strengthening our mechanical
explanation for this phenomenon.
Increase in fetal head flexion is known to enable the smallest
fetal diameters to pass through the birth canal and is associated
with lower forces opposing fetal descent [21]. The obstetric
procedure consisting in holding back the neonate's head has been
suggested previously by Henriksen, who proposed slowing the
delivery by holding back when the mother is pushing, thus giving
the shoulders time to enter the pelvic cavity [7]. Indeed, hastening
the delivery of the fetal head can impair the internal rotation of the
fetal shoulders and interfere with their spontaneous adjustment as
they engage into the mother’s pelvis, and then contribute to
shoulder dystocia [22,23]. In the same way, several authors have
suggested that delivery should be achieved using a "two-step"
approach, which includes waiting for uterine contraction to deliver
the shoulders once the fetal head is delivered, with a view to
limiting the risk of shoulder dystocia [24,25]. Although this type of
delivery increases slightly the length of delivery and particularly
the fetal head-to-body interval, it is not associated with umbilical
artery acidemia, defined as pH<7.10 [25]. Similarly, in the case of
shoulder dystocia, there is no statistical relationship between the
head-to-body delivery interval and fetal pH [26]. Therefore, the
fact that delivery can be slowed down with the push back
maneuver may not be associated with an increased risk of fetal
acidemia, and this was not the case in our study.
The push back maneuver could limit the potential effects of
excessive traction on the fetal head performed in the case of
shoulder dystocia, particularly the risk of transient or permanent
brachial plexus palsy. In our series, one case (0.1% of all deliveries)
of transient brachial plexus palsy was diagnosed, located within
the right C5-C6 nerve roots, in a newborn weighing 4490 g. This
infant was examined clinically by an experienced pediatric
orthopedic practitioner at one month of age and had no residual
upper limb dysfunction. Although we report here significant
results concerning shoulder dystocia, our study revealed no
significant between-group difference in the secondary outcome,
notably, neonatal brachial plexus injury. Brachial plexus injury is a
rare complication, requiring a larger sample size to detect
meaningful differences.
58 O. Poujade et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 227 (2018) 52–59
Moreover, in decreasing the risk of shoulder dystocia, the push
back maneuver could reduce the need for the McRoberts maneuver
and its potential adverse effects, including maternal symphyseal
separation and sacroiliac dislocation. Likewise, it could reduce the
need for suprapubic pressure applied to the fetus, which is
responsible for orthopedic or permanent neonatal neurological
injuries [27,28].
Our trial has strengths and limitations. Our single-blind,
multicenter, randomized trial using a modified intention-to-treat
analysis minimized systematic bias. Our hospital center staff were
motivated for this trial and the trial management team drove
center enrolment. All doctors and midwives participating in this
trial attended training sessions before and during the study, with a
pelvis model and interactive CD-ROM based on obstetric techni-
ques, ensuring that obstetric maneuvers were correctly performed
in clinical practice.
As for limitations, our trial was not initially powered to evaluate
some of the rare neonatal complications and to prove that the push
back maneuver reduces the risk of brachial plexus palsy. Moreover,
we failed to provide all the planned recruitment: we had to stop at
the preplanned end of inclusion period even if halfway targeted
sample size was reached because of financial constraints. However,
as the size effect of the push back maneuver on reduction of
shoulder dystocia was larger than we hypothesized (0.4 vs 0.5), this
limited recruitment still allowed us to show a statistically
significant difference on our primary outcome. Larger replication
studies could be useful to confirm the efficacy of the push back
maneuver on brachial plexus palsy and other rare neonatal
complications.
Another limitation could be due to the baseline characteristics
of newborns, with a higher rate of macrosomic newborns in the
“standard delivery group”. But the test of interaction demonstrated
that the effect of the push back maneuver on shoulder dystocia was
not significantly different in macrosomic newborns than other
newborns therefore invalidating this bias.
Of note our rate of shoulder dystocia could be considered as
high and this is true but this is due to the fact that our prophylactic
measure was tested on an “intention to treat” protocol and
consequently we had a larger definition of shoulder dystocia.
In our experience, this obstetric maneuver seems applicable
routinely. However, our results are based on data from only two
medical centers, thus limiting external validity and generalizabili-
ty.
Further studies are needed, with other computer models of
shoulder dystocia including both a fetus and a maternal pelvis, in
order to strengthen our hypothesis that the push back maneuver
promotes flexion of the fetal head and gives the shoulders more
time to enter the pelvic cavity. Further prospective studies testing
in other settings are required to confirm the generalizability of this
obstetric maneuver.
In summary, the results of our trial show that women who
delivered vaginally with the push back maneuver had a
significantly lower risk of shoulder dystocia than women with a
standard delivery. This obstetric maneuver could promote flexion
of the fetal head and give the shoulders more time to enter the
pelvic cavity. Shoulder dystocia remains an unpreventable obstet-
ric emergency, known to be responsible for transient or permanent
brachial plexus palsy, and humerus or clavicle fracture. It could
therefore limit the potential side effects of shoulder dystocia and
avoid medicolegal issues.
Financial support
This study was funded by a grant from the French Ministry of
Health (Programme Hospitalier de Recherche Clinique - PHRC -
AOR 10,003), and the AP-HP (Assistance Publique - Hôpitaux de
Paris) was the sponsor. The funders had no role in study design,
data collection and analysis, decision to publish, or preparation of
the manuscript.
The authors have no potential conflicts of interest to disclose.
The registration number of the clinical trial was AO1028-31 and
the name of trial registry was CONTRADYS. The full trial protocol
can be accessed at ClinicalTrials.gov. Identifier: NCT01297439. New
Prophylactic Maneuver: the “Pushing” Maneuver, Aiming to
Reduce the Risk for Shoulder Dystocia (CONTRADYS):
http://clinicaltrials.gov/ct2/show/study/NCT01297439
Acknowledgments
The authors would like to thank the French Ministry of Health
and the AP-HP (Assistance Publique - Hôpitaux de Paris). The
authors would like to thank all the midwives from Beaujon (Clichy,
France) and Bichat (Paris, France) hospitals who participated in the
study, especially Agnès Bege, Isabelle Cons, Montaine Bosseboeuf,
Sophie Chapuis and Marie-Astrid Vetillard.
Appendix A. Supplementary data
Supplementary material related to this article can be found,
in the online version, at doi:https://doi.org/10.1016/j.
ejogrb.2018.06.002.
References
[1] Lurie S., Levy R, Ben-Arie A, Hagay Z. Shoulder dystocia: could it be deduced
from the labor partogram? Am J Perinatol 1995;12:61–2.
[2] Nesbitt TS, Gilbert WM, Herrchen B. Shoulder dystocia and associated risk
factors with macrosomic infants born in California. Am J Obstet Gynecol
1998;179:476–80.
[3] Bahar AM. Risk factors and fetal outcome in cases of shoulder dystocia
compared with normal deliveries of a similar birthweight. Br J Obstet Gynaecol
1996;103:868–72.
[4] Gherman RB. Shoulder dystocia: prevention and management. Obstet Gynecol
Clin North Am 2005;32:297–305.
[5] Geary M, McParland P, Johnson H, Stronge J. Shoulder dystocia–is it
predictable? Eur J Obstet Gynecol Reprod Biol 1995;62:15–8.
[6] Ouzounian JG, Gherman RB. Shoulder dystocia: are historic risk factors reliable
predictors? Am J Obstet Gynecol 2005;192:1933–5.
[7] Henriksen T. The macrosomic fetus: a challenge in current obstetrics. Acta
Obstet Gynecol Scand 2008;87:134–45.
[8] Hadlock FP, Harrist RB, Carpenter RJ, Deter RL, Park SK. Sonographic estimation
of fetal weight. The value of femur length in addition to head and abdomen
measurements. Radiology 1984;150:535–40.
[9] ACOG Committee on Practice Bulletins-Gynecology, The American College of
Obstetrician and Gynecologists. ACOG practice bulletin clinical management
guidelines for obstetrician-gynecologists. Number 40, november 2002. Obstet
Gynecol 2002;(100):1045–50.
[10] Gonik B, Stringer CA, Held B. An alternate maneuver for management of
shoulder dystocia. Am J Obstet Gynecol 1983;145:882–4.
[11] Ramsey PS, Ramin KD, Field CS. Shoulder dystocia. Rotational maneuvers
revisited. J Reprod Med 2000;45:85–8.
[12] Beer E, Folghera MG. [Historical observations on shoulder dystocia. 1) From the
origin to Jacquemier]. Minerva Ginecol 2001;53:219–27.
[13] Rouse DJ, Owen J. Prophylactic parameter delivery for fetal macrosomia
diagnosed by means of ultrasonography–a Faustian bargain? Am J Obstet
Gynecol 1999;181:332–8.
[14] Gonen R, Bader D, Ajami M. Effects of a policy of elective cesarean delivery in
cases of suspected fetal macrosomia on the incidence of brachial plexus injury
and the rate of cesarean delivery. Am J Obstet Gynecol 2000;183:1296–300.
[15] Beall MH, Spong CY, Ross MG. A randomized controlled trial of prophylactic
maneuvers to reduce head-to-body delivery time in patients at risk for
shoulder dystocia. Obstet Gynecol 2003;102:31–5.
[16] Poggi SH, Allen RH, Patel CR, Ghidini A, Pezzullo JC, Spong CY. Randomized trial
of McRoberts versus lithotomy positioning to decrease the force that is applied
to the fetus during delivery. Am J Obstet Gynecol 2004;191:874–8.
[17] Sandmire HF, O’Halloin TJ. Shoulder dystocia: its incidence and associated risk
factors. Int J Gynaecol Obstet 1988;26:65–73.
[18] Gonen O, Rosen DJ, Dolfin Z, Tepper R, Markov S, Fejgin MD. Induction of labor
versus expectant management in macrosomia: a randomized study. Obstet
Gynecol 1997;89:913–7.
[19] Langer O, Berkus MD, Huff RW, Samueloff A. Shoulder dystocia: should the
fetus weighing greater than or equal to 4000 grams be delivered by cesarean
section? Am J Obstet Gynecol 1991;165:831–7.
 O. Poujade et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 227 (2018) 52–59
[20] Liu S, Joseph KS, Hutcheon JA, et al. Gestational age-specific severe maternal
morbidityassociated with labor induction. Am J Obstet Gynecol 2013;209(3):e1–8.
[21] Parente MP, Natal Jorge RM, Mascarenhas T, Fernandes AA, Silva-Filho AL.
Computational modeling approach to study the effects of fetal head flexion
during vaginal delivery. Am J Obstet Gynecol 2010;203(217):e1–6.
[22] Acker DB, Gregory KD, Sachs BP, Friedman EA. Risk factors for Erb-Duchenne
palsy. Obstet Gynecol. 1988;71:389–92.
[23] Poggi SH, Stallings SP, Ghidini A, Spong CY, Deering SH, Allen RH. Intrapartum
risk factors for permanent brachial plexus injury. Am J Obstet Gynecol
2003;189:725–9.
[24] Iffy L, Varadi V, Papp Z. Epidemiologic aspects of shoulder dystocia-related
neurological birth injuries. Arch Gynecol Obstet 2015;291:769–77.
59
[25] Locatelli A, Incerti M, Ghidini A, et al. Head-to-body delivery interval using
“two-step” approach in vaginal deliveries: effect on umbilical artery pH. J
Matern Fetal Neonatal Med 2011;24:799–803.
[26] Stallings SP, Edwards RK, Johnson JW. Correlation of head-to-body delivery
intervals in shoulder dystocia and umbilical artery acidosis. Am J Obstet
Gynecol 2001;185:268–74.
[27] Heath T, Gherman RB. Symphyseal separation, sacroiliac joint dislocation and
transient lateral femoral cutaneous neuropathy associated with McRoberts’
maneuver. A case report. J Reprod Med 1999;44:902–4.
[28] Hankins GD. Lower thoracic spinal cord injury–a severe complication of
shoulder dystocia. Am J Perinatol 1998;15:443–4.