General obstetrics
www.blackwellpublishing.com/bjog
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-
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2008 The Authors Journal compilation RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology
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
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
2008 The Authors Journal compilation RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology
333
Izbizky et al.
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
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)
2008 The Authors Journal compilation RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology
Margin of equivalence
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.
Early
20
40
60
80
Delayed
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***
2008 The Authors Journal compilation RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology
335
Izbizky et al.
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*
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
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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
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
References
1 Hamilton BE, Martin JA, Sutton PD. Births: Preliminary Data for 2003.
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2 Thomas J, Paranjothy S; Royal College of Obstetricians and Gynaecologists Clinical Effectiveness Support Unit. National Sentinel Caesarean
Section Audit Report. RCOG Press. 2001. [www.rcog.org.uk/resources/
public/pdf/nscs_audit.pdf] Accessed 1 July 2007.
3 Belizan JM, Althabe F, Barros FC, Alexander S. Rates and implications
of caesarean sections in Latin America: ecological study. BMJ 1999;
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4 Villar J, Valladares E, Wojdyla D, Zavaleta N, Carroli G, Velazco A, et al.
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WHO Global survey on maternal and perinatal health in Latin America.
Lancet 2006;367:181929.
5 Burrows WR, Gingo AJ, Rose SM, Zwick SI, Kosty DL, Dierker LJ, et al.
Safety and efficacy of early post operative solid food consumption after
caesarean section. J Reprod Med 1995;40:4637.
6 Kramer RL, Van Someren JK, Qualls CR, Curet LB. Postoperative management of cesarean patients: the effect of immediate feeding on the
incidence of ileus. Obstet Gynecol 1996;88:2932.
7 Hilliard R, Patolia DS, Toy EC, Baker B. Early feeding after cesarean
delivery. Obstet Gynecol 2000;95(4 Suppl):44S.
8 Patolia DS, Hilliard RL, Toy EC, Baker B. Early feeding after cesarean:
randomized trial. Obstet Gynecol. 2001;98:11316.
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cesarean: a randomized clinical trial [abstract]. Obstet Gynecol 2000;
95(4 Suppl):64S.
10 Weinstein L, Dyne PL, Duerbeck NB. The PROEF dieta new postoperative
regimen for oral early feeding. Am J Obstet Gynecol 1993;168:12831.
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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.
2008 The Authors Journal compilation RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology
337
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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2008 The Authors Journal compilation RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology