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

A

Ahmed M Maged, MD

Status and phase

Unknown
Phase 4

Conditions

Intestinal Recovery After Cesarean Section

Treatments

Other: gums
Drug: normal saline
Drug: picolax drops

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

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

Trial contacts and locations

1

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Central trial contact

Ahmed Maged; Asmaa Ogila

Data sourced from clinicaltrials.gov

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