The Efficacy of Chewing Gums Versus Laxative in Early Return of Bowel Function After CS

Ahmed M Maged, MD

Status and phase: Unknown; Phase 4

Conditions: Intestinal Recovery After Cesarean Section

Treatments: Other: gums; Drug: picolax drops; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02765971

143

Details and patient eligibility

About

540 consented women for being enrolled in this clinical trial and candidates for elective cesarean section will be divided into 3 groups:

• Group A, 180 women will receive sugarless gum after their operating room discharge by 3 hours for at least half an hour at two hours interval.
• Group B, 180 women will receive laxatives after their operating room discharge by 3 hours.
• Group C, 180 women as control group, they will not receive neither gum nor oral fluids. They will be on intravenous fluid. starting oral fluids after hearing intestinal sounds .

Full description

540 consented women for being enrolled in this clinical trial and candidates for elective cesarean section will be divided into 3 groups:

• Group A, 180 women will receive sugarless gum after their operating room discharge by 3 hours for at least half an hour at two hours interval.
• Group B, 180 women will receive laxatives after their operating room discharge by 3 hours.

Group C, 180 women as control group, they will not receive neither gum nor oral fluids. They will be on intravenous fluid. starting oral fluids after hearing intestinal sounds .

Enrollment: 540 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all women undergoing elective cesarean section in Kasr Al AI Aini hospital will be candidate for this trial after full explanation of the trial and informed consent to be taken from the women.

Exclusion criteria

• cesarean hysterectomy,
• surgical management of severe postpartum hemorrhage
• previous bowel surgery
• women with history of drug consumption,especially opioids
• water and electrolyte disturbances
• pancreatitis or peritonitis
• inability to chew gum
• diabetes, pregnancies accompanied by coagulopathy like pre-eclampsia, hypothyroidism, muscular and neurological disorders
• postoperative admission to intensive care unit
• history of abdominal surgery except cesarean section
• history of postoperative ileus
• patients with drains

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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540 participants in 3 patient groups, including a placebo group

chewing gum group

Active Comparator group

Description:

180 women will receive sugarless gum after their operating room discharge by 3 hours for at least half an hour at two hours interval

Treatment:

Other: gums

laxatives group

Active Comparator group

Description:

180 women will receive laxatives after their operating room discharge by 3 hours

Treatment:

Drug: picolax drops

control

Placebo Comparator group

Description:

they will not receive neither gum nor oral fluids. They will be on intravenous fluid. starting oral fluids after hearing intestinal sounds

Treatment:

Drug: normal saline