NCT02765971

Brief Summary

540 consented women for being enrolled in this clinical trial and candidates for elective cesarean section will be divided into 3 groups:

  • Group A, 180 women will receive sugarless gum after their operating room discharge by 3 hours for at least half an hour at two hours interval.
  • Group B, 180 women will receive laxatives after their operating room discharge by 3 hours.
  • Group C, 180 women as control group, they will not receive neither gum nor oral fluids. They will be on intravenous fluid. starting oral fluids after hearing intestinal sounds .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
540

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 30, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 9, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

3.3 years

First QC Date

April 30, 2016

Last Update Submit

September 20, 2019

Conditions

Intestinal Recovery After Cesarean Section

Keywords

chewing gumslaxativesbowel function

Outcome Measures

Primary Outcomes (1)

  • appearance of intestinal sounds postoperative evaluated by stethoscope

    4-6 hours after CS

Study Arms (3)

chewing gum group

ACTIVE COMPARATOR

180 women will receive sugarless gum after their operating room discharge by 3 hours for at least half an hour at two hours interval

Other: gums

laxatives group

ACTIVE COMPARATOR

180 women will receive laxatives after their operating room discharge by 3 hours

Drug: picolax drops

control

PLACEBO COMPARATOR

they will not receive neither gum nor oral fluids. They will be on intravenous fluid. starting oral fluids after hearing intestinal sounds

Drug: normal saline

Interventions

gumsOTHER

Group A, 180 women will receive sugarless gum after their operating room discharge by 3 hours for at least half an hour at two hours interval.

Also known as: non sweet gums
chewing gum group
picolax dropsDRUG

Group B, 180 women will receive laxatives after their operating room discharge by 3 hours.

laxatives group
normal salineDRUG

Group C received 500 cc of normal saline, Intravenous fluid

Also known as: .9%saline infusion
control

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • all women undergoing elective cesarean section in Kasr Al AI Aini hospital will be candidate for this trial after full explanation of the trial and informed consent to be taken from the women.

You may not qualify if:

  • cesarean hysterectomy,
  • surgical management of severe postpartum hemorrhage
  • previous bowel surgery
  • women with history of drug consumption,especially opioids
  • water and electrolyte disturbances
  • pancreatitis or peritonitis
  • inability to chew gum
  • diabetes, pregnancies accompanied by coagulopathy like pre-eclampsia, hypothyroidism, muscular and neurological disorders
  • postoperative admission to intensive care unit
  • history of abdominal surgery except cesarean section
  • history of postoperative ileus
  • patients with drains

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

RECRUITING

MeSH Terms

Interventions

Chewing GumSaline Solution

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ahmed Maged

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged

CONTACT

0020201005227404dr_ahmedmaged@kasralainy.edu.eg

Asmaa Ogila

CONTACT

+20201001936908drasmaaibrahim@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 30, 2016

First Posted

May 9, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

September 23, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)