Australian and New Zealand Journal of Obstetrics and Gynaecology 2013; 53: 369–374 DOI: 10.1111/ajo.

12079

Original Article

Maternal outcomes in women supplemented with a high-protein

drink in labour
Manuel C. VALLEJO,1 Benjamin T. COBB,2 Talora L. STEEN,2 Sukhdip SINGH1 and
Amy L. PHELPS3
1
Department of Anesthesiology, Magee-Womens Hospital of UPMC, 2University of Pittsburgh School of Medicine, and 3Duquesne
University School of Business, Pittsburgh, Pennsylvania, USA

Background: Because of the potential aspiration risk, oral intake is restricted during labour.
Aims: To determine whether high-protein drink supplementation in labour decreases nausea and emesis and promotes
patient satisfaction.
Materials and Methods: The study was registered with www.clinicaltrials.gov (NCT01414478). Labouring women were
randomised into two groups: Group P received a high-protein drink (325 mL) with ice chips/water PRN; and Group C
served as control and received only ice chips/water PRN (Study 1). Incidences of nausea and emesis were measured
hourly until delivery and at 1 h postdelivery. Patient satisfaction was measured the following day. A secondary aim was to
evaluate the rate of gastric emptying (t½) in women who ingested either 325 mL of a high-protein drink or ice chips/water
(Study 2) using ultrasound.
Results: In Study 1, 150 women were recruited (Group P = 75; Group C = 75). There were no differences in the overall
incidences of nausea (P = 0.14), emesis (P = 0.15) or in the incidences at the measured time periods (MANOVA,
P > 0.05). Median patient satisfaction scores were higher in Group P than in Group C (P = 0.007). In Study 2, 18
additional patients (Group PG = 9; Group CG = 9) were analysed to determine US gastric emptying t½ rates (PG:
25.56
15.90 min [95% CI: 15.17 – 35.94] compared with CG: 20.00
8.70 min [95% CI: 14.34 – 25.66], P = 0.19).
Conclusion: In labour, patient satisfaction is improved with high-protein drink supplementation compared with ice chips/
water with comparable gastric emptying rates.
Key words: emesis, gastric emptying, ice chips/water, protein drink, satisfaction.

Introduction To date, we are not aware of any study that has

It is traditionally thought that gastric emptying in
pregnancy is delayed due to increased abdominal pressure
on the gastrum, changes in progesterone, and labour
pain.1,2 Labour pain can also promote nausea and
emesis,3 and, due to the fear of aspiration, women who
receive labour epidural analgesia (LEA) are frequently
subjected to restrictions in oral intake.3–5 These
restrictions can be a leading cause of patient
dissatisfaction, which can negatively impact the labour and
delivery experience.3,5,6
Correspondence: Dr Manuel C. Vallejo, Professor and
Director, Obstetric Anesthesia, Department of Anesthesiology,
Magee-Womens Hospital of UPMC, 300 Halket Street,
Pittsburgh, PA 15213, USA.
Email: vallejomc@anes.upmc.edu
Received 19 November 2012; accepted 12 February 2013.
evaluated the use of a high-protein drink during labour
or its rate of gastric emptying in labouring women. The
purpose of this study was to evaluate the incidence of
nausea, emesis and overall patient satisfaction with
their birthing experience after the addition of a high-
protein drink during labour. A secondary aim was to
evaluate the rate of gastric emptying (t½) with
ultrasound in women who have ingested a high-protein
drink.
Materials and Methods
After local institutional investigator review board (IRB)
approval and informed verbal and written consent, 150
consecutive labouring women requesting LEA were enrolled
in this prospective, randomised controlled study (www.
clinicaltrials.gov registration number NCT01414478) after
LEA placement (Study 1). Inclusion criteria included
gestation  36 weeks, singleton pregnancy in vertex
presentation, cervical dilatation  5 cm at the time of LEA

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The Australian and

New Zealand Journal
of Obstetrics and
Gynaecology
M. C. Vallejo et al.

insertion and NPO (nothing by mouth) for at least  4 h

prior to LEA insertion. Exclusion criteria included diabetes
(increased risk for gastroparesis), multiple gestation,
nonvertex fetal presentation, chronic opioid use (delayed
gastric emptying), history of gastric bypass surgery
(abnormal gastric anatomy and function), severe morbid
obesity (BMI >40 kg/m2 due to increased intragastric
pressure) and a history of known obstetric or medical
complication (ie severe pre-eclampsia) that may increase the
likelihood of a complicated or operative delivery (ie
caesarean section). After LEA placement, women were
placed on a standardised patient controlled epidural
analgesia (PCEA) regimen consisting of an initial (bolus)
dose of medication (8 mL of 0.08% bupivacaine and
fentanyl 100 lg) followed by a continuous infusion of 0.08%
bupivacaine with fentanyl 2 lg/mL at 8 mL/h and a PCEA
bolus dose of 8 mL every 8 min with a maximum dose of
24 mL per hour.
Women were randomised by a computer-generated
number table into one of two groups: Group P – high-
protein drink with 30 grams of protein (325 mL) and ice
chips/water PRN, or Group C – control group consisting
of ice chips/water only PRN. This study utilised The
Premier Nutrition Protein Shake® (Premier Nutrition Inc.
San Francisco, CA. 94105), which contains 30 grams of
protein, 1 gram of sugar, eight essential amino acids and
24 vitamins and minerals and has 160 calories in
325 mL.
The woman was instructed to consume the high-
protein drink or the ice chips/water within 15 min; if she
was unable to do so, she was excluded. Besides
additional ice chips/water, no other food or drinks were
allowed in either group until delivery and transfer to the
delivery floor, as is the standard of care at our
institution.
Nausea, emesis and pain at epidural placement were
measured at hourly intervals until delivery and at 1 h
postdelivery. Pain and nausea verbal rating scale (VRS)
were measured on a 0–10 scale (0 = no pain/nausea and
10 = worst possible pain/nausea). Episodes of emesis were
recorded as yes/no. The woman was seen the day
following delivery and evaluated for overall patient
satisfaction with regard to her oral intake; satisfaction was
measured using a scale from 0 to 100 (0 = not satisfied,
100 = very satisfied).
High-protein drink sample size calculation
(Study 1)
O’Sullivan et al.3 reported the emesis rate to be 35% in
women who received only ice chips/water during labour.
With an emesis rate of 35% in the control group, we
expected the incidence to decrease by 15% in the
intervention group (high-protein intake). Using a
difference between two independent proportions, with an
alpha of 0.05 and a power of 0.80, 75 patients per group
were needed (150 in total) to determine a significant
decrease of 15% in the emesis rate.
Figure 1 Antrum location using ultrasound. Legend:
EA = epigastric area, CC = costal cartilage margin.
Gastric ultrasound measurement (Study 2)
Ultrasound (US) assessment on 18 additional women was
used to evaluate the rate of gastric emptying (t½) in both
groups after LEA placement (Study 2). As per the
technique described by Perlas et al.,7 US views of the
gastric antrum were obtained in the right lateral decubitus
position (Fig. 1). Images were measured (i) at baseline
before ingestion of either 325 mL of the high-protein drink
or 325 mL of ice chips/water; (ii) immediately after
ingestion; and (iii) every 10 min (six times per hour) for
two hours (Fig. 2). No other food or drinks were allowed
during US assessments. If the woman required an
emergency caesarean section or operative delivery during
the US assessments, she was removed from the study and
no further data were collected.
The formula used to determine the CSA of the gastric
antrum with US is7 as follows:
CSA ¼ ðAPÞðCCÞp=4
where AP is the anterior–posterior diameter and CC is the
cranio-caudal diameter.
Ultrasound measurement sample size
calculation (Study 2)
Barret et al.8 determined that complete gastric emptying of
a protein solution is linear and takes approximately 2 h in
healthy nonpregnant adults. Wong et al.9,10 reported
complete emptying of water within 60 min (1 h). As we
were unaware of the gastric emptying time of protein
solution in pregnant women, we adjusted the standard
deviation for gastric emptying from 6 min to 15 min.9
Using the latter standard deviation, nine women are
required to estimate the mean to half emptying within a
10-min margin of error at a 95% level of confidence.
Interval data were analysed using the student’s t-test,
nominal data using v2 and non-normal or ordinal data
using Mann–Whitney rank sum test. A P < 0.05 was
considered significant. Multiple analysis of variance

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ANZJOG © 2013 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists
 Protein supplementation in labour

(a)

(b)

Figure 2 Gastric ultrasound assessment of protein drink (a), and ice chips/water (b). Legend: (a) = note the white granular
(hyperechoic) appearance of the protein drink in the gastric antrum, (b) = note the dark (hypoechoic) appearance of the ice chips/water
in the gastric antrum.

Assessed for decreased emesis

Enrolment eligibility (n = 150)

Randomised (n = 150)

Allocated to Group P (n = 75) Allocated to Group C (n = 75)

♦ Received High Protein intervention (n = 75) ♦ Received Ice Chips/Water intervention (n = 75)
♦ Did not receive any allocated intervention (n = 0) ♦ Did not receive any allocated intervention (n = 0)
Allocation

Excluded (n = 12),
unable to finish drink Excluded (n = 0)

Follow-Up Lost to follow-up (n = 0)

Discontinued intervention (n = 0)
Lost to follow-up (n = 0)
Discontinued intervention (n = 0)

Analysed (n = 63) Analysed (n = 75)

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

Figure 3 High-Protein Satisfaction: CONSORT diagram of enrolment, allocation, follow-up and data analysis for Study 1.

(MANOVA) was used for analysing nausea and emesis
over the repeated measured time periods.
Results
A total of 150 women were recruited in Study 1 (Group
P = 75; Group C = 75) from August 2010 through July
2011. In Group P, 12 women were unable to finish the
protein drink and were excluded (Fig. 3). In Study 2, an
additional 24 women were recruited to obtain 18
completed study patients (Group PG = 9; Group CG = 9,
Fig. 4) from June 2012 through September 2012 for
determining US gastric emptying half-time rates. In the
gastric US analysis, a total of six women were excluded;

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M. C. Vallejo et al.

Assessed for Gastric Emptying

Enrolment eligibility (n = 24)

Randomised (n = 24)

Allocated to Group PG (n = 12) Allocated to Group CG (n = 12)

♦ Received High Protein intervention (n = 12) ♦ Received Ice Chips/Water intervention (n = 12)
Allocation ♦ Did not receive any allocated intervention (n = 0) ♦ Did not receive any allocated intervention (n = 0)

Excluded* (n = 3) Excluded* (n = 3)

Follow-Up ♦ Lost to follow-up (n = 0) ♦ Lost to follow-up (n = 0)

Analysed (n = 9) Analysed (n = 9)
Analysis ♦ Excluded from analysis (n = 0) ♦ Excluded from analysis (n = 0)

Figure 4 Gastric Emptying: CONSORT diagram of enrolment, allocation, follow-up and data analysis for Study 2. Legend: * = urgent
caesarean section and/or protocol violation rendering them unable to finish the study.

three women had protocol violations, one woman went for Table 1 Demographic and maternal outcome data (Study 1)
urgent caesarean section, and two women experienced
immediate emesis upon ingestion of fluid (one protein Group P Group C
drink; one ice chips/water). (n = 63) (n = 75) P value
Demographic and maternal outcome data are presented Age (years) 28.7
5.5 28.8
5.5 0.93
in the Table 1. There were no differences in the overall Ht (cm) 164.6
6.3 164
7.4 0.62
incidences of nausea (20.6% Group P versus 33.3% Group Wt (kg) 79.7
8.9 78.6
13.8 0.61
C, P = 0.14) and emesis (4.8% Group P versus 13.3% Gravidy 2 (1–8) 2 (1–6) 0.36
Group C, P = 0.15) nor in the incidences at the measured Parity 0 (0–5) 1 (0–5) 0.94
time periods (MANOVA, P > 0.05). No differences were NPO (min) 652.6
255.6 579.7
274 0.11
noted with respect to neonatal Apgar scores at both 1 and Labour 442.4
278 398.5
268.1 0.35
5 min postdelivery. Median patient satisfaction scores were duration
higher in Group P compared with Group C (100 versus (min)
95, P = 0.007). Median satisfaction scores with first and Vaginal 88.9% 88% 0.92
third quartiles are reported because the distributions of delivery (%)
Caesarean 11.1% 12% 0.92
scores for each group were strongly skewed. Mean US
section (%)
gastric emptying (t½) in women who ingested a high-
Nausea 20.63% 33.33% 0.14
protein drink was 25.56
15.90 min (95% CI: 15.17 –
incidence (%)
35.94) compared with 20.00
8.70 min (95% CI: 14.34
Emesis 4.76% 13.33% 0.15
– 25.66) for the ice chips/water group (P = 0.19). incidence (%)
Satisfaction 100 [90–100] 95 [82.5–100] 0.007
Comment score
(0–100)
Aspiration of gastric contents is a rare but feared and
potentially fatal complication of anaesthesia that can result Legend: Data are mean
SD, median with range in parenthesis,
in severe maternal morbidity and mortality,1,2,7,11–13 with or median with interquariles in brackets, NPO = nothing per os
or nothing by mouth, labour duration = epidural insertion until
a reported incidence ranging from 15 per 10,000 to 7 per
delivery.
10,000,000.5,12 This risk dramatically increases in the rare
case that women require general anaesthesia for emergent
caesarean.1,14 Since the 1940s, physicians have attempted However, improved general anaesthetic techniques over
to lower this risk by restricting the oral intake in labouring the decades have decreased the incidence of aspiration in
women to ice chips/water.1,5,6,12,15 pregnancy.14–16 As a result, NPO fasting guidelines may

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ANZJOG © 2013 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists

now only minimally reduce the risk of aspiration while it
continues to increase the incidence of patient dehydration,
hypoglycaemia, dissatisfaction, hunger and anxiety.1,5,9
Another disadvantage of fasting is that restricting oral
intake can be viewed as controlling, which may increase
the feelings of apprehension and fear during labour for
some women.3 Conversely, women who are in control
often report a positive birthing experience,17 and offering
an option for sustenance may provide women an
improved sense of being in control.3,5
Considering the few benefits and the many drawbacks
of fasting, some have suggested that the practice of
keeping labouring women NPO is outdated.3,5 A study
by O’Sullivan et al.3 supported this claim, showing that
consumption of a light diet during labour did not
influence obstetric or neonatal outcomes in participants,
nor did it increase the incidence of vomiting. Similarly, a
Cochrane review by Singata et al.6 showed that there are
no benefits to restricting fluids and food during labour in
women at low risk of complications. Unfortunately,
adequately powered trials to definitively demonstrate the
effectiveness would be impractical.1,6,18 Furthermore,
there have been no studies that looked specifically at
women at increased risk of complications; hence, there is
no evidence to support restrictions in this group of
women.6
Despite these limitations, several national organisations
have come to advocate a more liberal NPO policy. For
example, the ASA Task Force has stated that the oral
intake of clear liquids during labour improves maternal
comfort and satisfaction without increasing maternal
complications.19 The Society of Obstetricians and
Gynecologists of Canada (SOGC) and the World Health
Organization of Europe (WHO-Euro) agree that women
in active labour should be offered a light or liquid diet
according to their preference.20,21 Additionally, European
countries such as the Netherlands and the United
Kingdom currently allow solid food intake prior to
labour.14,22 Such countries have maintained a low
incidence of adverse events, and there have been no
increase in maternal mortalities due to aspiration; in fact,
aspiration deaths have continued to decline.5,14,22
Although many agree that labouring women can safely
ingest food besides ice chips and water, some foods are
safer than others. Mendelson experimented on rabbits to
explore the effects of gastric contents on their lungs. The
rabbits only died when they aspirated material containing
hydrochloric acid, and no deaths were due to aspiration of
fluids with a neutral pH.12 Thus, Mendelson determined
that gastric volume and pH are critical determinants of
death associated with pulmonary aspiration.12 Since then,
many investigators have shown that lung injury increases
markedly when the pH of the aspirate is less than 2.5 and
when the volume is greater than 25 mL.2,18
In addition to pH and volume, researchers also
examined carbohydrate content.23 Labour can be
compared with continuous moderate aerobic exercise, and
these women can experience a state of accelerated
© 2013 The Authors
ANZJOG © 2013 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists
Protein supplementation in labour
starvation.5,22,24 This state of starvation results in the
production of ketones for an alternative source of energy.
A study carried out by Kubli et al.24 evaluated the effects
of isotonic sports drinks and the production of ketones.
They found that even though isotonic sports drinks
decreased ketosis, it had no effect on maternal or neonatal
outcome of labour.24 Scheepers et al.23 also showed that
drinking carbohydrate solutions had no beneficial effects
on labour outcomes.
After examining these and other factors, it has been
suggested that the ideal oral supplement would be in
liquid form, isotonic, normothermic and has a neutral pH
with a low residue.1 The high-protein drink used in this
study has similar characteristics while providing
carbohydrates to mitigate ketosis. Furthermore, protein
may actually decrease the incidence of nausea by
decreasing gastric arrhythmias more so than a
carbohydrate meal can (ie nonbeneficial effect of isotonic
sports drinks). For example, it has been shown that high-
protein intake decreases nausea and emesis in patients
receiving cancer chemotherapy.25 Moreover, it has been
determined that administration of a protein-rich intake
prevents nausea whether given 5 min or 45 min prior to
the nauseating stimuli (ie cancer chemotherapy).26
Although we found no difference in the incidence of
nausea or emesis, we did determine that women who
ingested the high-protein drink had a higher satisfaction
score. Hence, the high-protein drink increased satisfaction
among labouring women without increasing adverse
events. As the high-protein drink provides benefits without
negative consequences, a more liberal oral intake policy
may be considered in women who are at low risk of
complications and lack comorbidities that delay gastric
emptying (ie diabetes and narcotic medications).
Our secondary aim was to determine the rate of gastric
emptying of the high-protein drink compared with ice
chips/water. It was traditionally thought gastric emptying
was delayed in pregnancy due to changes in progesterone
and increased abdominal pressure on the gastrum.1
However, it has been shown with the use of ultrasound that
normal gastric emptying occurs even in obese pregnant
women who have reached term pregnancy.10 Thus,
pregnancy per se does not delay gastric emptying.5,9,27 On
the other hand, opioids have been shown to significantly
decrease gastric emptying.2,27 Additionally, the volume,
acidity and nature (fluid versus particulate or solid matter)
are also thought to be associated with the rate of gastric
emptying and patient outcomes.13,14
To the extent of our knowledge, there have been no
studies examining the gastric emptying rate of protein
drinks in labouring women. Our results regarding gastric
emptying of ice chips/water in pregnant women are
consistent with that of Wong et al.9 Furthermore, the rates
of gastric emptying between the high-protein drink and ice
chips/water were comparable (25.6
15.9 min versus
20.0
8.7 min, P = 0.19), and there were no differences
in the incidences of nausea and emesis between groups.
Because the gastric emptying rate and the risk of nausea
373
M. C. Vallejo et al.
and emesis are comparable, one should feel comfortable
replacing ice chips/water with the high-protein drink
supplement, especially considering the increased patient
satisfaction.
In conclusion, patient satisfaction is improved with
high-protein drink supplementation compared with ice
chips/water with comparable gastric emptying rates.
Funding
University of Pittsburgh Department of Anesthesiology.
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