Chewing Gums to Stimulate Intestinal Motility After Cesarean Section

Postoperative Care Clinical Trial

Official title:

Chewing Gums to Stimulate Intestinal Motility After Cesarean Section: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386748
• Other study ID #: AFHSR 1-3-2015
• Status: Completed
• Phase: N/A
• First received: March 5, 2015
• Last updated: March 9, 2017
• Start date: March 2015
• Est. completion date: January 2017

Study information

• Verified date: March 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study purpose is to evaluate the efficacy and safety of postoperative gum chewing on the recovery of intestinal movement after cesarean section.

All women undergoing elective cesarean section in King Faisal military hospital will be candidate for this trial after full explanation of the trial and informed consent to be taken from the women. Exclusion criteria will include emergency cesarean section, multifetal pregnancy, polyhydramnios, medical disorders with pregnancy, abnormal placentation (previa and/or accreta), past history of bowel injury or operation, any complications that will increase operative duration such as uterine artery injury or uterine extension.

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

• Group A, 150 women will receive sugarless gum after their operating room discharge by 2 hours for at least half an hour at two hours interval.

• Group B, 150 women will receive the traditional management of starting oral fluids after operating room discharge by 6 hours and hearing intestinal sounds on second day before initiating full regular diet.

• Group C, 150 women as control group, they will not receive neither gum nor oral fluids. They will be in intravenous fluid.

All demographic data of these women, indication of operation, operation time, type of anesthesia and pathway during hospital stay will be recovered and compared between 3 groups.

Description:

Introduction; Cesarean section is the most common surgery among women which is associated with postoperative central nervous system (CNS) changes, leading to decreased bowel movements. Postoperative ileus is defined as transient cessation of coordinated bowel motility after surgical intervention. It Is one of the major problems of post-abdominal surgery which delays hospital discharge, causes abdominal pain, abdominal distension, inability to start oral feeding, breastfeeding, and eventually increases the cost of hospital care. Historically, professionals of gynecology and obstetrics waited until gut function returns allowing oral or entered feeding, characterized by symptoms such as bowel sounds, first flatus or stool, and feeling of hunger. Chewing gum can stimulate the stomach, enhances gastric secretion, increases peristaltic bowel movements and finally hastens recovery from ileus. It has also been recently considered by researchers as a strategy toward ileus reduction. It seems that a necessity is felt for more investigation on such a least-expensive physiological method in stimulating the return of bowel function.

Study purpose; To evaluate the efficacy and safety of postoperative gum chewing on the recovery of intestinal movement after cesarean section.

Intervention:

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

• Group A, 150 women will receive sugarless gum after their operating room discharge by 2 hours for at least half an hour at two hours interval.

• Group B, 150 women will receive the traditional management of starting oral fluids after operating room discharge by 6 hours and hearing intestinal sounds on second day before initiating full regular diet.

• Group C, 150 women as control group, they will not receive neither gum nor oral fluids. They will be in intravenous fluid.

All demographic data of these women, indication of operation, operation time, type of anesthesia and pathway during hospital stay will be recovered and compare between 3 groups.

Statistical Methods:

Analysis of the data will be done by IBM computer using SPSS (statistical product and service solution version 18). Quantitative variables will be described as mean with SD and median with range while Qualitative variables will be described as numbers and percentage. Chi-square test will be used to compare qualitative variables between groups. Independent sample t-test will be used to compare the groups as regard quantitative variables in parametric data (SD < 50% mean). Comparison between non-parametric groups will be done by using Mann-Whitney test. P value < 0.05 will be significant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• All women undergoing elective cesarean section in King Faisal military hospital will be candidate for this trial after full explanation of the trial and informed consent to be taken from the women.

Exclusion Criteria:

• Emergency cesarean section.

• Multiple pregnancies.

• Polyhydramnios.

• Medical disorder as hypertension or diabetes mellitus.

• Abnormal placentation ,placenta previa ,accreta.

• Past history of bowel injury or operation.

• Any complications that will increase operative duration such as uterine artery injury or uterine extension.

Related Conditions & MeSH terms

• Postoperative Care

Intervention

Dietary Supplement:
• Chewing gum
Chewing sugarless gum after the discharge from the operating room by two hours for at least half an hour at two hours intervals.
• Oral fluids
Starting clear oral fluids after operating room discharge by six hours, then hearing intestinal sounds on second day before initiating full regular diet.

Other:
• Intravenous fluids
Women in this group will not receive neither gum nor oral fluids, they will be on intravenous fluids (lactated ringer solution).

Locations

Country	Name	City	State
Saudi Arabia	Postpartum ward of Armed Forces Hospital, Southern Region.	Khamis Mushait	Asir

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Armed Forces Hospital, Southern Region, Khamis Mushayt, Saudi Arabia

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Passage of stools		72 hours
Secondary	Passage of flatus		72 hours