Effect of Gum Chewing on Regaining Bowel Motility After Cesarean SectionRCTNCT03547284
the Role of Gum Chewing in Regaining Bowel Motility in Patients Undergoing Cesarean Section
A study testing sugarless gum in people with Effect of Gum Chewing on Regaining Bowel Motility After Cesarean Section, run by Cairo University at 2 sites in Egypt.
Trial summary
Aim:to evaluate the efficacy of postoperative gum chewing on the recovery of bowel motility after cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of Gum Chewing on Regaining Bowel Motility After Cesarean Section
- What is being tested?
- sugarless gum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 2 sitesEgypt
- Study dates
- Jun 2015to Jul 2016
- Phase
- Interventional
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-35
- --Spinal anesthesia
- Pfannensteil incision
Who cannot join
- 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
Show all 9Show fewer
- Hypothyroidism
- Muscular and neurological disorder
- Inability to chew gums
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Cairo University Hospital,obstetrics and gynecology departement, Egypt
Cairo
Woman's Health University Hospital, Egypt
Cairo
About this study
Official title: The Role of Sugarless Gum Chewing in Regaining Bowel Motility in Patients Undergoing Cesarean Section
Aim:to evaluate the efficacy of postoperative gum chewing on the recovery of bowel motility after cesarean section.
Read the detailed description
this study will be conducted on 162 patients undergoing cesarean section in obstetrics and gynecology department at Kasr el Ainy Hospital,Kairo university.
- Being tested
- sugarless gum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugarless gumDrug
Also called Samara Gum
81 patients will receive 1 stick of sugarless gum(Samara gum) for 15 minutes every 2 hours
| Study group | Role | What they receive |
|---|---|---|
| 81 patients,group 1 | Active comparator | 81 women will receive 1 stick of sugarless gum for 15 minutes every 2 hours after surgery . Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
first bowel sound in hours
Measured: 4-6 hours
Secondary outcomes (1)
first passage of flatus in hours,the first defecation in hours
Measured: 4-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study startJun 2015
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Gum Chewing on Regaining Bowel Motility After Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona M Shaban, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547284
- Sponsor's protocol ID
- Woman Health University Egypt
- Acronym
- RCT
- Status last verified
- Sep 2018
- First submitted
- 24 May 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sugarless Gum Chewing in Regaining Bowel Motility in Patients Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT03547284
- Acronym / sponsor ID
- RCT / Woman Health University Egypt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 6 Jun 2018 (actual)
- 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.
Aim:to evaluate the efficacy of postoperative gum chewing on the recovery of bowel motility after cesarean section.
Detailed description
this study will be conducted on 162 patients undergoing cesarean section in obstetrics and gynecology department at Kasr el Ainy Hospital,Kairo university.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 81 patients,group 1 | Active comparator | Drug: sugarless gum81 women will receive 1 stick of sugarless gum for 15 minutes every 2 hours after surgery . |
| 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) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-35
- --Spinal anesthesia
- Pfannensteil incision
Key exclusion criteria (9 listed)
- History of drug consumption especially opioids
- water and electrolyte disturbance
- History of abdominal surgery except cesarean section
- Intra and severe post operative complications
- diabetes
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 |
|---|---|---|
| sugarless gumAlso: Samara Gum81 patients will receive 1 stick of sugarless gum(Samara gum) for 15 minutes every 2 hours | Drug | 81 patients,group 1 |
Primary outcome
first bowel sound in hours
Time frame: 4-6 hours
1 secondary outcome
first passage of flatus in hours,the first defecation in hours
Time frame: 4-6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sugarless gum in people with Effect of Gum Chewing on Regaining Bowel Motility After Cesarean Section, run by Cairo University at 2 sites 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
first bowel sound in hours (time frame: 4-6 hours). 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 11 Sep 2018.