The Efficacy of Chewing Gums Versus Laxative in Early Return of Bowel Function After CS

NCT ID: NCT02765971

Last Updated: 2019-09-23

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

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-10-31

Brief Summary

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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 .

Detailed Description

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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 .

Conditions

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Intestinal Recovery After Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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chewing gum group

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 Type ACTIVE_COMPARATOR

gums

Intervention Type OTHER

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.

laxatives group

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

Group Type ACTIVE_COMPARATOR

picolax drops

Intervention Type DRUG

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

control

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

Group C received 500 cc of normal saline, Intravenous fluid

Interventions

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gums

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.

Intervention Type OTHER

picolax drops

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

Intervention Type DRUG

normal saline

Group C received 500 cc of normal saline, Intravenous fluid

Intervention Type DRUG

Other Intervention Names

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non sweet gums .9%saline infusion

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ahmed M Maged, MD

OTHER

Sponsor Role lead

Responsible Party

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Ahmed M Maged, MD

Assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ahmed Maged

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Kasr Alainy medical school

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Maged

Role: CONTACT

0020201005227404

Asmaa Ogila

Role: CONTACT

+20201001936908

Facility Contacts

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Ahmed Maged, MD

Role: primary

01005227404

Other Identifiers

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143

Identifier Type: -

Identifier Source: org_study_id

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