Gum Chewing And Bowel Motility in Patients Undergoing Cesarean Section. Kasr el Ainy Experience

NCT ID: NCT02533830

Last Updated: 2016-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-07-31

Brief Summary

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The aim of the present study was to evaluate the effect of chewing gum on the recovery of bowel function after cesarean section in women.

Detailed Description

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This study Will Be conducted on 162 Patients Undergoing caesarean section in The Obstetrics \& Gynecology Department "kasr el ainy teaching hospital".

Methods:

Women Were Randomized into Two Groups: Group A (81 Women) Who Received One Stick of Sugarless Gum (Samara for food \& Chocolates Product Company)"S.A.E." , for 15 Minutes Every 2 hours After Surgery Tell Defecation , Group B (81 Women) had Traditional Management (Oral Intake of Clear Fluid Allowed After Passage of Flatus and Regular Diet With The Passage of Bowel Movement.

Each Women in Both Groups Was Examined Abdominal Using A Stethoscope Detect The Intestinal Movement Every 4 Hours And Asked to Report Immediately The Time of Either Passing Flatus or stool .

Conditions

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Gum Chewing Bowel Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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gum chewing group.

Group A (81 Women) Who Received One Stick of Sugarless Gum (Samara for food \& Chocolates Product Company)"S.A.E." , for 15 Minutes Every 2 hours After Surgery Tell Defecation

Group Type ACTIVE_COMPARATOR

sugarless gum

Intervention Type BIOLOGICAL

One Stick of Sugarless Gum (Samara for food \& Chocolates Product Company)"S.A.E." , for 15 Minutes Every 2 hours After Surgery Tell Defecation

Placebo group

Group B (81 Women) had Traditional Management (Oral Intake of Clear Fluid Allowed After Passage of Flatus and Regular Diet With The Passage of Bowel Movement.

Group Type PLACEBO_COMPARATOR

traditional management

Intervention Type OTHER

Traditional Management (Oral Intake of Clear Fluid Allowed After Passage of Flatus and Regular Diet With The Passage of Bowel Movement.

Interventions

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sugarless gum

One Stick of Sugarless Gum (Samara for food \& Chocolates Product Company)"S.A.E." , for 15 Minutes Every 2 hours After Surgery Tell Defecation

Intervention Type BIOLOGICAL

traditional management

Traditional Management (Oral Intake of Clear Fluid Allowed After Passage of Flatus and Regular Diet With The Passage of Bowel Movement.

Intervention Type OTHER

Other Intervention Names

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Samara Gum

Eligibility Criteria

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Inclusion Criteria

1. Age between 18 - 35 Years.
2. Spinal Anesthesia.
3. Pfannenstiel incision.

Exclusion Criteria

1. History of Drug Consumption Especially Opioids.
2. Water and Electrolyte Disturbances.
3. Pancreatitis.
4. Peritonitis.
5. History of Abdominal Surgery except Cesarean Section.
6. No Willingness to Cooperative.
7. Intra and Sever Post-Operative Complications.
8. Inability to Chew Gum with Drawl.
9. Diabetes.
10. Pre-eclampsia
11. Prolonged Rupture of Membranes.
12. Hypothyroidism.
13. Muscular and Neurological Disorders.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mohamed El-Sharkawy

Lecturer of obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kasr El Ainy

Role: STUDY_CHAIR

kasr el ainy street,cairo,egypt

Locations

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Mohamed Abdel Aziz El Sharkawy

Cairo, , Egypt

Site Status RECRUITING

Mohqmed El Sharkawy

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed Ab El Sharkawy

Role: CONTACT

00201221731328

Facility Contacts

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Mohmed AA El Sharkawy, M.D.

Role: primary

01221731328

Dina L Hatem

Role: backup

01226609129

Other Identifiers

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KasrELAini hospital

Identifier Type: -

Identifier Source: org_study_id

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