the Role of Gum Chewing in Regaining Bowel Motility in Pa... | NCT03547284

Studies
the Role of Gum Chewing in Regaining Bowel Motility in Patients Undergoing Cesarean Section

NCT03547284

Sponsor

Cairo University

Status

Completed

Last Update Posted

Sep 11, 2018Actual

Enrollment

162Actual

Phase

Not Applicable

Conditions

Effect of Gum Chewing on Regaining Bowel Motility After Cesarean Section

Interventions

sugarless gum

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Jun 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

May 24, 2018

First Submission Date that Met QC Criteria

Jun 5, 2018

First Posted Date

Jun 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2018

Last Update Posted Date

Sep 11, 2018Actual

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

162Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
81 patients,group 1	Active Comparator	81 women will receive 1 stick of sugarless gum for 15 minutes every 2 hours after surgery .	Drug: sugarless gum
81 patients,group 2	No Intervention	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)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sugarless gum	Drug	81 patients will receive 1 stick of sugarless gum(Samara gum) for 15 minutes every 2 hours	81 patients,group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
first bowel sound in hours		4-6 hours

Secondary Outcomes

Measure	Description	Time Frame
first passage of flatus in hours,the first defecation in hours		4-6 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University Hospital,obstetrics and gynecology departement, Egypt		Cairo			Egypt
Woman's Health University Hospital, Egypt