Chewing Gums to Stimulate Intestinal Motility After Cesarean Section

NCT02386748 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2017-03-10

No results posted yet for this study

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

Interventions

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.

DIETARY_SUPPLEMENT

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).

Sponsors & Collaborators

  • Armed Forces Hospitals, Southern Region, Saudi Arabia

    collaborator OTHER_GOV
  • Ain Shams University

    lead OTHER

Principal Investigators

  • Mohamed I Ellaithy, MD · Armed Forces Hospital, Southern Region

  • Ahmed Traigey, MD · Armed Forces Hospital, Southern Region

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-12-31
Completion
2017-01-31

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02386748 on ClinicalTrials.gov