The study nature did not allow blinding after

The primary outcome measure was the time to first passage
of stool, while secondary outcomes were the time of the first flatus, the first
hearing of normal intestinal sounds, the duration of hospital stay, the
duration of parenteral therapy either intravenous antibiotics or fluids, the
time of initiation of breast feeding and the cost of hospital stay. Also, the secondary outcome measures
included tolerance of gum chewing, complications in all groups entailing febrile morbidity, blood
transfusion, the
occurrence of vomiting, abdominal distension or postoperative paralytic ileus
requiring nasogastric tube placement or hospital re-admission.

600 women aged between 20 and
35 years scheduled for elective CS; either first or repeated, with term,
singleton, viable and healthy pregnancy were assessed for enrolment in this
trial. Our exclusion criteria were emergency caesarean section, multiple
pregnancies, polyhydramnios, abnormal placentation (placenta praevia andor
accreta), and past history of medical disorders, bowel disease or gastrointestinal
operations. All eligible women were fully counselled about the trial potential
side effects before an informed written consent was signed by each participant.

400 eligible and consented
women were enrolled and divided randomly into three groups through sealed
envelope method which was withdrawn by the patient herself. Each envelope was
marked with a serial number and had a card defines the intervention type. Once
participant had been allocated, it could not be changed. The ratio of one to
one was determined as the allocation ratio during the allocation process. The
study nature did not allow blinding after application of the assigned intervention postoperatively.

Women in group (A) received
sugarless gum (Nova gum, Batook chewing gum IND. LTD, Saudi Arabia) two hours
after their operating room (OR) discharge. They were instructed to chew it at
least for half an hour and at two hours interval during daytime. Gum chewing
was stopped all over the night (12:00 PM) to allow the women to sleep. Counting
and recording the number of empty sticks were done during the routine vital
signs observations in order to assure the women’s compliance to gum use. Women
were instructed to stop chewing gum with the passage of stool and they were
allowed to start regular oral intake.  

Group (B) women started oral
clear fluids after OR discharge by six hours. Group (C) was the control group;
women of this group were kept on intravenous fluids for 24 hours, unless
resumption of intestinal function took place. Then, clear fluids and soft foods
were allowed orally to start with their first bowel motion. Intestinal sounds
for all groups were checked at six to eight hours intervals postoperatively by
two of the authors (WA, MA).

 All the operations were performed in the
morning under general anaesthesia using Pfennanstiel’s incision. The time when
surgery was ended discharging the woman from the operating theatre (OR) after
full recovery marked as the zero hour. For analgesia, two rectal doses of 100
mg diclofenac sodium
(Voltaren, Novartis Pharma, Saudi Arabia), if not contraindicated. The need for
additional use
of pethidine was recorded. No oral or rectal bowel stimulants were used after CS. The same
postoperative program for ambulation was used for all groups.

Women demographic data were
collected including
their age, body mass index (BMI), obstetric history, past medical and surgical histories,
gestational age at delivery and caesarean section indications. The operative data were also
recorded, including the operative time, need of blood transfusion, operative complications and the
presence of
severe adhesions or uterine extension.

Moreover, the postoperative data like feeding time, time
of hunger feeling, time of passing flatus, time of passing stool, absent or
hypoactive intestinal sounds,
inability to pass flatus or stool, vomiting, abdominal distension with or without pain and tolerance of gum chewing were recorded. The criteria to
consider the woman fit for hospital discharge were stable vital signs for at least 24 hours, full
ambulation without assistance, passage of a stool and urine, tolerance to solid food and absence of
postoperative complications.

The women were followed till
the final discharge from hospital and on outpatient basis. However, any events presented by the participants
during the postpartum period were recorded. Operative and postoperative
exclusion criteria were caesarean hysterectomy, extensive adhesions, uterine
extensions, bowel injury and any operative complication that can affect the woman normal recovery
or plan of the trial.