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Status unknownNCT02765971Updated Sep 23, 2019

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

A Phase 4 interventional study of gums and picolax drops in Intestinal Recovery After Cesarean Section, sponsored by Ahmed M Maged, MD. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-09-23.

Sponsored by Ahmed M Maged, MD · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
540
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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 .
Read the detailed description

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 .

02

Conditions studied

  • Intestinal Recovery After Cesarean Section

Keywords

  • chewing gums
  • laxatives
  • bowel function
03

In context

Lead sponsor

Ahmed M Maged, MD is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
540 participants (estimated)

Study arms

  • Active comparator
    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

    Other: gums

  • Active comparator
    laxatives group

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

    Drug: picolax drops

  • Placebo comparator
    control

    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

  • Othergums

    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

  • Drugpicolax drops

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

  • Drugnormal saline

    Group C received 500 cc of normal saline, Intravenous fluid

    Also known as: .9%saline infusion

06

What researchers measure

Primary outcomes

  1. appearance of intestinal sounds postoperative evaluated by stethoscope

    Time frame: 4-6 hours after CS

07

Study locations

1 of 1 sites recruiting
  • Kasr Alainy medical school
    Cairo, 12151, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02765971
Lead sponsor
Ahmed M Maged, MD
Responsible party
Ahmed M Maged, MD (Assistant professor, Cairo University) — Sponsor-investigator
First posted
May 9, 2016
Start date
May 2016
Primary completion
Sep 2019 (estimated)
Completion
Oct 2019 (estimated)
Last update
Sep 23, 2019

Study contacts

Ahmed Maged
Contact
dr_ahmedmaged@kasralainy.edu.eg
0020201005227404
Asmaa Ogila
Contact
drasmaaibrahim@hotmail.com
+20201001936908
Ahmed Maged
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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