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

Intestinal Recovery After Cesarean Section Clinical Trial

Official title:

The Efficacy of Chewing Gums Versus Laxatives in Early Return of Bowel Function After Cesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02765971
• Other study ID #: 143
• Status: Recruiting
• Phase: Phase 4
• Start date: May 2016
• Est. completion date: October 2019

Study information

• Verified date: September 2019
• Source: Cairo University
• Contact: Ahmed Maged
• Phone: 0020201005227404
• Email: dr_ahmedmaged[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 .

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: October 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Recovery After Cesarean Section

Intervention

Other:
• gums
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.

Drug:
• picolax drops
Group B, 180 women will receive laxatives after their operating room discharge by 3 hours.
• normal saline
Group C received 500 cc of normal saline, Intravenous fluid

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed M Maged, MD

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	appearance of intestinal sounds postoperative evaluated by stethoscope		4-6 hours after CS