Chewing Gums to Stimulate Intestinal Motility After Cesarean Section

NCT02386748 | Completed

• 1 other identifier: AFHSR 1-3-2015
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Care

Keywords

Cesarean section; Chewing gums; Intestinal motility

Outcome Measures

Primary Outcomes (1)

• Passage of stools

  72 hours

Secondary Outcomes (1)

• Passage of flatus

  72 hours

Study Arms (3)

Chewing gum

EXPERIMENTAL

Chewing sugarless gum

Dietary Supplement: Chewing gum; Other: Intravenous fluids

Oral fluids

ACTIVE COMPARATOR

Clear oral fluids

Dietary Supplement: Oral fluids; Other: Intravenous fluids

Intravenous fluids

OTHER

No chewing gum No oral fluids Only intravenous fluids (Lactated Ringer's solution)

Other: Intravenous fluids

Interventions

Chewing gum DIETARY_SUPPLEMENT

Chewing sugarless gum after the discharge from the operating room by two hours for at least half an hour at two hours intervals.

Chewing gum

Oral fluids DIETARY_SUPPLEMENT

Starting clear oral fluids after operating room discharge by six hours, then hearing intestinal sounds on second day before initiating full regular diet.

Oral fluids

Intravenous fluids OTHER

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

Chewing gum; Intravenous fluids; Oral fluids

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead
• Armed Forces Hospitals, Southern Region, Saudi Arabia: collaborator

Study Sites (1)

Postpartum ward of Armed Forces Hospital, Southern Region.

Khamis Mushait, 'Asir Region, 101, Saudi Arabia

Location

Related Publications (1)

• Altraigey A, Ellaithy M, Atia H, Abdelrehim W, Abbas AM, Asiri M. The effect of gum chewing on the return of bowel motility after planned cesarean delivery: a randomized controlled trial. J Matern Fetal Neonatal Med. 2020 May;33(10):1670-1677. doi: 10.1080/14767058.2018.1526913. Epub 2018 Oct 29.

  PMID: 30231787 DERIVED

MeSH Terms

Interventions

Chewing Gum; Fluid Therapy

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Drug Therapy; Therapeutics

Study Officials

• Mohamed I Ellaithy, MD

  Armed Forces Hospital, Southern Region

  STUDY CHAIR

• Ahmed Traigey, MD

  Armed Forces Hospital, Southern Region

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 12, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: March 10, 2017

Record last verified: 2017-03

Locations

SA (1)