Intestinal Recovery After Cesarean SectionPhase 4NCT02765971
The Efficacy of Chewing Gums Versus Laxative in Early Return of Bowel Function After CS
A Phase 4 study testing gums, picolax drops and normal saline in people with Intestinal Recovery After Cesarean Section, run by Ahmed M Maged, MD at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Intestinal Recovery After Cesarean Section
- What is being tested?
- gums, picolax drops and normal saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 1 siteEgypt
- Study dates
- May 2016to Oct 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy medical school
Cairo, 12151
Ahmed Maged, MD, 01005227404, prof.ahmedmaged@gmail.com
About this study
Official title: The Efficacy of Chewing Gums Versus Laxatives in Early Return of Bowel Function After Cesarean Section
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 .
- Being tested
- gums, picolax drops, normal saline
- Keywords
- chewing gums, laxatives, bowel function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gumsOther
Also called non sweet 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.
picolax dropsDrug
Group B, 180 women will receive laxatives after their operating room discharge by 3 hours.
normal salineDrug
Also called .9%saline infusion
Group C received 500 cc of normal saline, Intravenous fluid
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: gums |
| laxatives group | Active comparator | 180 women will receive laxatives after their operating room discharge by 3 hours Receives: 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 Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
appearance of intestinal sounds postoperative evaluated by stethoscope
Measured: 4-6 hours after CS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Recovery After Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed M Maged, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765971
- Sponsor's protocol ID
- 143
- Status last verified
- Sep 2019
- First submitted
- 30 Apr 2016
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Chewing Gums Versus Laxatives in Early Return of Bowel Function After Cesarean Section
- ClinicalTrials.gov ID
- NCT02765971
- Acronym / sponsor ID
- 143
- Keywords
- chewing gums, laxatives, bowel function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Ahmed M Maged, MDUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 9 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| chewing gum group | Active comparator | Other: gums180 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 | Active comparator | Drug: picolax drops180 women will receive laxatives after their operating room discharge by 3 hours |
| control | Placebo comparator | Drug: normal salinethey will not receive neither gum nor oral fluids. They will be on intravenous fluid. starting oral fluids after hearing intestinal sounds |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (12 listed)
- cesarean hysterectomy,
- surgical management of severe postpartum hemorrhage
- previous bowel surgery
- women with history of drug consumption,especially opioids
- water and electrolyte disturbances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gumsAlso: non sweet gumsGroup 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. | Other | chewing gum group |
| picolax dropsGroup B, 180 women will receive laxatives after their operating room discharge by 3 hours. | Drug | laxatives group |
| normal salineAlso: .9%saline infusionGroup C received 500 cc of normal saline, Intravenous fluid | Drug | control |
Primary outcome
appearance of intestinal sounds postoperative evaluated by stethoscope
Time frame: 4-6 hours after CS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Intestinal Recovery After Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Maged principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing gums, picolax drops and normal saline in people with Intestinal Recovery After Cesarean Section, run by Ahmed M Maged, MD at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Maged (0020201005227404, dr_ahmedmaged@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
appearance of intestinal sounds postoperative evaluated by stethoscope (time frame: 4-6 hours after CS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.