NCT03547284

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

May 24, 2018

Last Update Submit

September 9, 2018

Conditions

Effect of Gum Chewing on Regaining Bowel Motility After Cesarean Section

Outcome Measures

Primary Outcomes (1)

  • first bowel sound in hours

    4-6 hours

Secondary Outcomes (1)

  • first passage of flatus in hours,the first defecation in hours

    4-6 hours

Study Arms (2)

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

sugarless gumDRUG

81 patients will receive 1 stick of sugarless gum(Samara gum) for 15 minutes every 2 hours

Also known as: Samara Gum
81 patients,group 1

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-35
  • Spinal anesthesia
  • Pfannensteil incision

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo University Hospital,obstetrics and gynecology departement, Egypt

Cairo, Egypt

Location

Woman's Health University Hospital, Egypt

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate obgyn professor

Study Record Dates

First Submitted

May 24, 2018

First Posted

June 6, 2018

Study Start

June 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations

EG(2)