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the Role of Gum Chewing in Regaining Bowel Motility in Patients Undergoing Cesarean Section (RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03547284
Recruitment Status : Completed
First Posted : June 6, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Mona M Shaban, Cairo University

Study Description
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Brief Summary:
Aim:to evaluate the efficacy of postoperative gum chewing on the recovery of bowel motility after cesarean section.

Condition or disease Intervention/treatment Phase
Effect of Gum Chewing on Regaining Bowel Motility After Cesarean Section Drug: sugarless gum Not Applicable

Detailed Description:
this study will be conducted on 162 patients undergoing cesarean section in obstetrics and gynecology department at Kasr el Ainy Hospital,Kairo university.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Official Title: The Role of Sugarless Gum Chewing in Regaining Bowel Motility in Patients Undergoing Cesarean Section
Study Start Date : June 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 81 patients,group 1
81 women will receive 1 stick of sugarless gum for 15 minutes every 2 hours after surgery .
 Drug: sugarless gum
81 patients will receive 1 stick of sugarless gum(Samara gum) for 15 minutes every 2 hours
Other Name: Samara Gum
No Intervention: 81 patients,group 2
81 patients will have traditional management(oral intake of clear fluids after hearing of first intestinal sounds or passage of flatus and regular diet after passage of stool)


Outcome Measures
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Primary Outcome Measures :
  1. first bowel sound in hours [ Time Frame: 4-6 hours ]

Secondary Outcome Measures :
  1. first passage of flatus in hours,the first defecation in hours [ Time Frame: 4-6 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-35

    --Spinal anesthesia

  • Pfannensteil incision

Exclusion Criteria:

  • History of drug consumption especially opioids
  • water and electrolyte disturbance
  • History of abdominal surgery except cesarean section
  • Intra and severe post operative complications
  • diabetes
  • Pre-eclampsia
  • Hypothyroidism
  • Muscular and neurological disorder
  • Inability to chew gums
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547284


Locations
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Egypt
Cairo University Hospital,obstetrics and gynecology departement, Egypt
Cairo, Egypt
Woman's Health University Hospital, Egypt
Cairo, Egypt
Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Mona M Shaban, associate obgyn professor, Cairo University
ClinicalTrials.gov Identifier: NCT03547284    
Other Study ID Numbers: Woman Health University Egypt
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018