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DOI: 10.1111/j.1471-0528.2007.01591.

General obstetrics

www.blackwellpublishing.com/bjog

The effect of early versus delayed postcaesarean


feeding on womens satisfaction: a randomised
controlled trial
GH Izbizky, L Minig, MA Sebastiani, L Otano
Division of Obstetrics, Hospital Italiano de Buenos Aires, Potos, Buenos Aires, Argentina
Correspondence: Dr GH Izbizky, Division of Obstetrics, Hospital Italiano de Buenos Aires, Potos 4135 (C1199ACI),
Buenos Aires, Argentina. Email gustavo.izbizky@hospitalitaliano.org.ar
Accepted 13 October 2007.

Objective To evaluate the effect of early versus delayed feeding

after caesarean section on the womans satisfaction.


Design Randomised, controlled trial.
Setting Tertiary care hospital.
Population Healthy pregnant women were enrolled for the study

during antenatal care visits.


Methods Uncomplicated singleton pregnancies undergoing
a planned or intrapartum caesarean section performed under
regional anaesthesia were randomly assigned to either (1)
a delayed feeding group who started oral fluids 4 hours after
surgery with diet introduced at 24 hours; or (2) an early
feeding group who were offered a regular diet within the first
8 hours.
Main outcome measures Primary outcome was the womans

satisfaction measured with a visual analogue scale (VAS) before


their hospital discharge. The secondary outcomes were: pain,

anorexia, abdominal distension, persistent nausea and/or vomiting,


time to the first bowel movement and passage of flatus.
Results Two hundred women were recruited, with 103 randomised
to delayed feeding and 97 to early feeding. The womans
satisfaction (mean VAS SD) was similar in both groups; 73
17 mm in the delayed feeding group and 77 13 mm in the early
feeding group (P = 0.12). A statistically significant difference was
observed in mean postoperative pain: 29 13 mm in the delayed
feeding group versus 24 11 mm in the early feeding group
(P = 0.008). No other significant differences in postoperative
variables were recorded, and there were no major postoperative
complications observed in either group.
Conclusion Early feeding after uncomplicated caesarean in

low-risk women is equivalent in terms of the womans satisfaction


and the reduced perceived pain.
Keywords Caesarean section, satisfaction, postoperative early

feeding.

Please cite this paper as: Izbizky G, Minig L, Sebastiani M, Otano L. The effect of early versus delayed postcaesarean feeding on womens satisfaction: a randomised
controlled trial. BJOG 2008;115:332338.

Introduction
Caesarean section is the most common major hospital surgical procedure performed in the industrialised world, accounting for more than one-fourth of all deliveries in the USA in
20031 and 21% of all deliveries in England in 2001.2 Even
higher rates have been reported in Latin America.3,4 An
increasing number of women are, therefore, being exposed
to this procedure.
Traditionally, women who had a caesarean section had
solid food withheld for the first 24 hours in the belief that
this would prevent gastrointestinal complications. However,
several clinical trials512 and a systematic reviews13 have
shown that early feeding is as safe as the traditional progres-

332

sive approach. Moreover, some additional benefits have been


reported such as a more rapid return of bowel sounds and
regular oral diet and a shorter hospital stay.12,13 Although
information about the safety of early feeding after caesarean
section appears conclusive, the effect of the different postoperative feeding approaches on womens satisfaction has
not been well evaluated with the only data available being from
one quasi-randomised trial14 and an audit.15 In addition, in
2007 Teoh et al. published a randomised trial in which satisfaction pertaining to the feeding regimen was measured as
a secondary outcome on a visual analogue scale (VAS).16 The
aim of the present study was to evaluate the effect of early
versus delayed feeding after uncomplicated caesarean section
on the womans satisfaction.

2008 The Authors Journal compilation RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology

Randomised controlled trial of postcaesarean feeding

Materials and methods

Allocation concealment was achieved by placing the allocation in sequentially numbered, opaque, sealed envelopes. The
envelopes were kept by operating room personnel and opened,
once participant data were written on it, after the end of the
caesarean section.
Women were randomly assigned to one of two interventions. The delayed feeding group started oral fluids 4 hours
after surgery, followed by regular diet at 24 hours. The early
feeding group was offered regular diet within the first 8
hours. Both groups were offered the same analgesic regimen
(dextropropoxyphene napsylate 98 mg plus dipyrone 400-mg
tablets, 8-hourly), but had the option not to take the medication if they did not need it. Analgesic use was reported as
the percentage of the total prescribed dose that was used.
The primary outcome was patient satisfaction before discharge from hospital, measured using a VAS.17,18 A 10-cmlong scale was used, with adjectival descriptions at the ends

Between December 2003 and 2004, 625 women were enrolled


for the study during antenatal care visits at the Obstetric
Division of Hospital Italiano de Buenos Aires, and those
who finally underwent a caesarean section were randomised
in the immediate postoperative period if they were eligible
(Figure 1). The study protocol and informed consent were
approved by the Institutional Review Board of the Hospital.
The inclusion criteria for randomisation were a term singleton pregnancy with a planned or intrapartum uncomplicated caesarean section performed under regional anaesthesia.
Exclusion criteria were use of tocolytic drugs, general anaesthesia, history of bowel surgery, prenatal diagnosis of fetal
anomaly, maternal disease and intraoperative or immediate
postoperative major complications. The allocation sequence
was generated by a computer random number list in permuted blocks of ten by staff not involved in patient care.

Screened
902
Patients
excluded
76

Multiple pregnancy: 15
Magnesium sulphate requirement: 14
Preterm delivery: 53
Diabetes: 3

Eligible
patients
826

Reject participation
201

Accept participation
625

Caesarean section
206

Vaginal birth
419

Intraoperative exclusion
6
Final randomisation
200

Delayed
feeding
103

Early
feeding
97

Excluded

Analysed as
intention to treat

Delayed
feeding
99

Early
feeding
101

Analysed
per protocol

Figure 1. Study profile.

2008 The Authors Journal compilation RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology

333

Izbizky et al.

and intermediate positions. Participants were provided with


a questionnaire containing the VAS, which was presented
with a statement explaining what was intended to measure.
This framing statement was introduced after initial testing of
the scale yielded a high variability. The variables evaluated as
secondary outcomes were: self-reported pain, time to first
passage of flatus and bowel movements, incidence of
anorexia, nausea/vomiting and abdominal distension. Pain
was measured and recorded daily by the woman on a 100mm VAS (0 = minimum pain, 100 = maximum pain)19,20 and
was expressed as the mean of the repeated daily measurements
for each woman. Anorexia was defined as a lack of appetite or
reluctance to accept food in the first 24 hours after surgery.
Time to first flatus passage and bowel movement was
recorded in hours after the caesarean section, as defined by
Patolia et al.8 The women were examined by a staff physician
and an obstetrics/gynaecology resident twice daily. Although
they were not told of the womans allocation, true blinding was not always possible because of the nature of the
intervention.
From a previous pilot study, the prior estimate of the variance of the VAS satisfaction score in the delayed feeding
women was 1600. After framing the question, with a clear
statement of what was intended to measure, the variance
was reduced to 250. A difference of 10 mm to each side
between groups was considered clinically relevant according
to this experience. The trial was designed to demonstrate the
equivalence between the two groups (defined as <10 mm).
With a power of 90%, a two-sided type I error of 0.05, and
considering a 10% loss, the sample size was estimated to be 94
women per group.21,22 The two treatments were considered
equivalent if the 95% CI of the difference between the means
was within the limits of 10 to +10 and contained the bound
zero.
Normality was checked through graphic methods and the
ShapiroWilk test. Differences between continuous variables
were tested for significance by an unpaired t test if normally
distributed, and the Wilcoxon ranksum test otherwise. For
categorical variables, the chi-square test or Fishers exact test
was used. Subgroup analysis by type of caesarean section was
planned. The primary analysis was based on treatment
received (per protocol), and a secondary intention-to-treat
analysis was performed. For data entry MS Excel (Microsoft
Corporation, One Microsoft Way, Redmond, WA, USA) was
used and STATA version 8.0 (StataCorp., TX, USA) for data
analysis.

Results
During the study period, 625 women were enrolled for the study
antenatally. Two hundred were randomised immediately
following their caesarean section: 103 were assigned to the
delayed feeding group and 97 to early feeding group (Figure 1).

334

Table 1. Womens characteristics, surgical procedures and neonatal


outcomes according to groups
Delayed
feeding (n 5 99)

Early feeding
(n 5 101)

Maternal age,
31.9 (5)
32.2 (5)
mean years (SD)
Nulliparity (%)
52
40
Gestational age at delivery,
39.3 (1)
39.3 (1)
mean weeks (SD)
Previous abdominal
48 (48)
54 (54)
surgery (%)
Surgical procedure
Planned caesarean
64 (64)
69 (68)
section (%)
Intrapartum caesarean
35 (35)
32 (32)
section (%)
Fasting, mean
11.6 (4.6)
11.8 (4.6)
hours (SD)
Surgery length,
36.4 (12)
39.6 (14)
mean minimum (SD)
Severe abdominal
4 (4)
8 (8)
adhesions (%)
Visceral peritoneum
22 (22)
18 (18)
closure (%)
Parietal peritoneum
31 (31)
36 (36)
closure (%)
Indication for caesarean section as reported by clinicians
Repeat caesarean
43 (44)
54 (53)
section (%)
Malpresentation
6 (6)
6 (6)
(including breech) (%)
Failure to progress
37 (37)
26 (26)
(induction/in labour) (%)
Presumed fetal
6 (6)
5 (5)
compromise (%)
Other (%)
7 (7)
10 (10)

The baseline characteristics of women in the two groups were


similar (Table 1).
Four women in the delayed feeding group received food in
the first eight postoperative hours. No crossover was observed
in the opposite direction. Mean satisfaction SD was 73 17
mm in the delayed feeding group and 77 13 mm in the early
feeding group. The difference was not statistically significant
(3.6, 95% CI 7.57 to 0.96, Figure 2). A statistically significant difference was observed in the mean pain expressed as
VAS: 29 13 mm in the delayed feeding group versus 24
11 mm in the early feeding group (P = 0.008, Figure 3). Use
of the prescribed analgesia was similar in the two groups.
(70 versus 71%, P = 0.48). There were no significant differences in other postoperative variables recorded, including
hospital stay (Table 2).
Subgroup analysis by type of caesarean section showed that
the early feeding group had a higher satisfaction level than the

2008 The Authors Journal compilation RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology

Randomised controlled trial of postcaesarean feeding

Margin of equivalence

Overall3.6 (95% CI 7.57 to 0.96)

Elective caesarean section 6.4


(CI 95% 11.7 to 1.1)

Intrapartum caesarean section


2.4 (CI 95% 4.9 to 9.7)

10

10

Absolute difference of the mean (VAS in mm) early versus delayed feeding groups
Figure 2. Mean satisfaction according to treatment received. The confidence interval comparison approach is illustrated, in which equivalence
is established when the bounds of the two-sided 95% CI lies within the equivalence zone. Top, margin of equivalence established according to previous
experience. Middle, equivalence is established for the absolute difference (mm VAS) between early feeding and delayed feeding groups. Bottom,
subgroup analysis shows that in the planned caesarean section group the confidence interval covers at least some points that lie outside the
equivalence range, so that differences of potential clinical importance remain a real possibility and equivalence cannot safely be concluded.

late feeding group when they undergo planned caesarean section


(absolute difference 6.4, 95% CI 11.7 to 1.1), but no difference in the experience of pain. Conversely, in the emergency
intrapartum caesarean section group, in those who had early
feeding there was no difference in satisfaction compared
with the late feeding group but significantly less pain. (Table 3,
Figure 2).
No major postoperative complications were observed prior
to discharge in either group. In the early feeding group, one
obese woman with three previous abdominal operations and
a midline incision was readmitted on tenth day with an inci-

Table 2. Trial outcomes

Early

20

40

60

80

Delayed

sional hernia, and a second woman was readmitted due to


appendicitis on the 15th postoperative day.
The intention-to-treat analysis showed a small but statistically significant difference in the womans satisfaction in
favour of early feeding group (difference 4.29, 95% CI
8.55 to 0.04). This did not, however, reach the ten points
that was defined a priori as clinically relevant. The rest of
the variables showed similar results to the per protocol
analysis.

Graphs by per protocol

Figure 3. Box plot showing mean pain perception (mm VAS) according
to treatment received. The line inside the box represents the median
of the distribution. The extremes of that box are the 25th and 75th
percentile. The extremities of the whiskers are the minimum and
maximum values of the data.

Satisfaction level,
mean minimum (SD)
Pain, mean
minimum (SD)
Time to bowel
movement, mean
hours (SD)
Time to passage
of flatus, mean
hours (SD)
Hospital stay,
mean days (SD)
Abdominal
distension (%)

Delayed
feeding
(n 5 99)

Early
feeding
(n 5101)

73 (17)

77 (13)

0.12*

29 (13)

24 (11)

0.008*

15 (11)

12 (11)

0.50**

23 (12)

22 (14)

0.72**

2.5 (0.5)

2.4 (0.5)

0.16**

16 (17)

16 (16)

0.95***

* Wilcoxon ranksum test.


** t test.
***Chi-square test.

2008 The Authors Journal compilation RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology

335

Izbizky et al.

Table 3. Trial outcomes stratified by type of caesarean section


(planned versus intrapartum)
Delayed
feeding
(n 5 99)
Satisfaction level, mean mm (6SD)
Planned caesarean
71.5 (13)
section (n 5 133)
Intrapartum caesarean
76.1 (14)
section (n 5 67)
Pain, mean mm (6SD)
Planned caesarean
27.3 (614)
section (n 5 133)
Intrapartum caesarean
30.8 (611)
section (n 5 67)

Early
feeding
(n 5 101)

78.0 (17)

0.01*

73.8 (15)

0.51*

24.5 (611)

0.22*

22.9 (611)

0.005*

*Wilcoxon ranksum test.

Discussion
This study shows that the satisfaction rates obtained following
early feeding after caesarean section are equivalent to those
obtained following delayed feeding. However, those in the
early feeding group reported lower levels of postoperative
pain, especially when the caesarean section was conducted
as an emergency. To our knowledge this is the first randomised control equivalence trial to evaluate the impact of
postpartum medical care recommendations on womens satisfaction and perceptions as a primary outcome.
We are aware that satisfaction is a complex and multidimensional psychological response to life events.23 Although
there is no such thing as a single index of satisfaction, the
approach used in this trial has been previously validated.
Several studies have assessed satisfaction using VAS16,24,25
and these have also been adopted in quality-of-life instruments.18 Health professionals are increasingly encouraged to
involve women in treatment decisions, recognising them as
experts with a unique knowledge of their own health and their
preferences for treatments,26 and recent evidence supports
this view.27,28 Although women may wish to be more involved
in the decisions concerning their obstetric interventions,
information is lacking on the experiences and perceptions
concerning postoperative caesarean birth care.
This clinical trial places the focus upon equivalence
between the randomised groups. The next step is to determine
whether the observed results are clinically relevant. The interpretation of satisfaction or quality-of-life scores is not
always straightforward, and it is not easy to identify a single
value that will serve as a clinically relevant measurement.
However, it is important that in assessing the benefits of
healthcare interventions, researchers should not only include

336

clinical endpoints but also incorporate individuals preferences in order to offer a more individually oriented outcome. In
this context, the definition of a clinically significant benefit is
a matter of a womans personal judgement as well as that of
clinicians.
Caesarean section rates have been rising progressively during recent decades all over the world. Many reasons have been
described for the increasing rate, including womens choice.20
Facilities and human resources necessary for perinatal care
could be significantly influenced by this trend, in addition
to healthcare costs. It is important, therefore, to try and
reduce morbidity and increase satisfaction rates from this
common procedure. Teoh et al.16 randomised 196 women
undergoing caesarean section under spinal anaesthesia, to
compare the incidence of ileus in early and late feeding
groups. As a secondary outcome, they measured maternal
satisfaction. Although they used a slightly different outcome
measurement from ours, they found a higher rate of satisfaction in the early-fed group (90 versus 60 on the VAS scale
P < 0.001). They also reported a very low incidence of ileus
(3%).
The strengths of this trial are the noninferiority design, the
comparison of two active policies,21,22 the high acceptance
rate (which minimised selection bias) and the minimal crossover between the study branches. To focus only on variables
of physical discomfort is a limitation of this study. Some other
attributes of womans satisfaction would deserve evaluation in further trials. Another limitation is the external
validity of our findings because our participants may represent a limited socio-economic and cultural population. This
trial was performed on low-risk, middle-income, educated
women.
The primary estimate of equivalence results from a per
protocol analysis; however, the intention-to-treat analysis
showed a small but statistical significant difference in favour
of early feeding. Our rationale for using a per protocol analysis
was that in a comparative trial, where the aim is to decide if
two treatments are different, an intention-to-treat analysis is
generally conservative: the inclusion of protocol violators and
withdrawals will tend to make the results from the two treatment groups more similar. However, for an equivalence trial
this effect is no longer conservative: any blurring of the difference between the treatment groups will increase the chance
of declaring equivalence.
This trial shows that a programme of early feeding after
a caesarean delivery in low-risk women is clinically equivalent
in terms of women satisfaction, is as safe as the traditional
approach and has beneficial effects on womens perceived
pain. These findings add to the already robust literature on
the safety and benefits of early feeding after uncomplicated
caesarean section. We believe that there is now enough
evidence for clinicians worldwide to safely implement early
feeding following caesarean section.29

2008 The Authors Journal compilation RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology

Randomised controlled trial of postcaesarean feeding

Funding
This trial was supported with the Divisions own funds for
research.

Acknowledgements
The authors thank the effort of the Residents of Obstetrics
and Gynecology, Department of Nurses and labour and delivery room personnel of the Hospital Italiano in the execution
of this trial. j

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15 Benhamou D, Tecsy M, Parry N, Mercier FJ, Burg C. Obstetrical and
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16 Teoh W, Shah M, Mah C. A randomised controlled trial on beneficial
effects of early feeding post-Caesarean delivery under regional anaesthesia. Singapore Med J 2007;48:1527.
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Journal club
It has been a strongly ingrained part of the hospital doctors ritual to listen for bowel sounds in the immediate postoperative
days following any abdominal surgery. The thought of giving women food on the same day as their caesarean irrespective of
whether bowel sounds are present or not will horrify many traditionalists. But there is now increasing evidence that early
feeding is not only safe but also may actually improve outcomes. This randomised trial from Brazil adds further weight to that
argument. Although the two regimens were equivalent in terms of maternal satisfaction, there were some secondary beneficial
effects.

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Izbizky et al.

Discussion points
1 Background: In your hospital, how long is the average woman starved preoperatively for a routine caesarean? What effect
does perioperative starving have on maternal and fetal/neonatal health? What are the potential risks of early postoperative
feeding of women who have had caesarean sections?
2 Technical: What were the two regimens compared in this study? Would you have chosen the same two regimens to
compare? The researchers chose the womens satisfaction at their main outcome: do you think that this is the most
important question? What is an equivalence trial? Do you think that its use was appropriate in this study?
3 Clinical practice: What is the current practice in your hospital regarding restarting fluids and diet after a caesarean? Do you
know of any national or local recommendations? Do you think that the evidence is now strong enough for you to give
routine early feeding?
4 Hypothetical: Do you think that day case caesareans will ever be possible? What would be the advantages and what are the
obstacles in the way of achieving this?
Correspondence: Dr A Weeks, School of Reproductive and Developmental Medicine, University of Liverpool, Crown Street,
Liverpool L8 7SS, UK. Email aweeks@liverpool.ac.uk j

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