Chewing Gums to Stimulate Intestinal Motility After Cesarean Section
NCT02386748 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450
Last updated 2017-03-10
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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