Postoperative CareNCT02386748
Chewing Gums to Stimulate Intestinal Motility After Cesarean Section
A study testing Chewing gum, Oral fluids and Intravenous fluids in people with Postoperative Care, run by Ain Shams University at 1 site in Saudi Arabia.
Trial summary
The study purpose is to evaluate the efficacy and safety of postoperative gum chewing on the recovery of intestinal movement after cesarean section. All women undergoing elective cesarean section in King Faisal military hospital will be candidate for this trial after full explanation of the trial and informed consent… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Postoperative Care
- What is being tested?
- Chewing gum, Oral fluids and Intravenous fluids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Mar 2015to Jan 2017
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All women undergoing elective cesarean section in King Faisal military 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
- Emergency cesarean section.
- Multiple pregnancies.
- Polyhydramnios.
- Medical disorder as hypertension or diabetes mellitus.
- Abnormal placentation ,placenta previa ,accreta.
- Past history of bowel injury or operation.
- Any complications that will increase operative duration such as uterine artery injury or uterine extension.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Postpartum ward of Armed Forces Hospital, Southern Region.
Khamis Mushait, 'Asir Region, 101
About this study
Official title: Chewing Gums to Stimulate Intestinal Motility After Cesarean Section: A Randomized Controlled Trial
The study purpose is to evaluate the efficacy and safety of postoperative gum chewing on the recovery of intestinal movement after cesarean section.
All women undergoing elective cesarean section in King Faisal military hospital will be candidate for this trial after full explanation of the trial and informed consent to be taken from the women. Exclusion criteria will include emergency cesarean section, multifetal pregnancy, polyhydramnios, medical disorders with pregnancy, abnormal placentation (previa and/or accreta), past history of bowel injury or operation, any complications that will increase operative duration such as uterine artery injury or uterine extension.
Read more
450 consented women for being enrolled in this clinical trial and candidates for elective cesarean section will be divided into 3 groups:
- Group A, 150 women will receive sugarless gum after their operating room discharge by 2 hours for at least half an hour at two hours interval.
- Group B, 150 women will receive the traditional management of starting oral fluids after operating room discharge by 6 hours and hearing intestinal sounds on second day before initiating full regular diet.
- Group C, 150 women as control group, they will not receive neither gum nor oral fluids. They will be in intravenous fluid.
All demographic data of these women, indication of operation, operation time, type of anesthesia and pathway during hospital stay will be recovered and compared between 3 groups.
Read the detailed description
Introduction; Cesarean section is the most common surgery among women which is associated with postoperative central nervous system (CNS) changes, leading to decreased bowel movements. Postoperative ileus is defined as transient cessation of coordinated bowel motility after surgical intervention. It Is one of the major problems of post-abdominal surgery which delays hospital discharge, causes abdominal pain, abdominal distension, inability to start oral feeding, breastfeeding, and eventually increases the cost of hospital care. Historically, professionals of gynecology and obstetrics waited until gut function returns allowing oral or entered feeding, characterized by symptoms such as bowel sounds, first flatus or stool, and feeling of hunger. Chewing gum can stimulate the stomach, enhances gastric secretion, increases peristaltic bowel movements and finally hastens recovery from ileus. It has also been recently considered by researchers as a strategy toward ileus reduction. It seems that a necessity is felt for more investigation on such a least-expensive physiological method in stimulating the return of bowel function.
Study purpose; To evaluate the efficacy and safety of postoperative gum chewing on the recovery of intestinal movement after cesarean section.
Intervention:
450 consented women for being enrolled in this clinical trial and candidates for elective cesarean section will be divided into 3 groups:
- Group A, 150 women will receive sugarless gum after their operating room discharge by 2 hours for at least half an hour at two hours interval.
- Group B, 150 women will receive the traditional management of starting oral fluids after operating room discharge by 6 hours and hearing intestinal sounds on second day before initiating full regular diet.
- Group C, 150 women as control group, they will not receive neither gum nor oral fluids. They will be in intravenous fluid.
All demographic data of these women, indication of operation, operation time, type of anesthesia and pathway during hospital stay will be recovered and compare between 3 groups.
Statistical Methods:
Analysis of the data will be done by IBM computer using SPSS (statistical product and service solution version 18). Quantitative variables will be described as mean with SD and median with range while Qualitative variables will be described as numbers and percentage. Chi-square test will be used to compare qualitative variables between groups. Independent sample t-test will be used to compare the groups as regard quantitative variables in parametric data (SD < 50% mean). Comparison between non-parametric groups will be done by using Mann-Whitney test. P value < 0.05 will be significant.
- Conditions
- Postoperative Care
- Being tested
- Chewing gum, Oral fluids, Intravenous fluids
- Keywords
- Cesarean section, Chewing gums, Intestinal motility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing gumDietary supplement
Chewing sugarless gum after the discharge from the operating room by two hours for at least half an hour at two hours intervals.
Oral fluidsDietary supplement
Starting clear oral fluids after operating room discharge by six hours, then hearing intestinal sounds on second day before initiating full regular diet.
Intravenous fluidsOther
Women in this group will not receive neither gum nor oral fluids, they will be on intravenous fluids (lactated ringer solution).
| Study group | Role | What they receive |
|---|---|---|
| Chewing gum | Experimental | Chewing sugarless gum Receives: Dietary Supplement: Chewing gum; Other: Intravenous fluids |
| Oral fluids | Active comparator | Clear oral fluids Receives: Dietary Supplement: Oral fluids; Other: Intravenous fluids |
| Intravenous fluids | Other | No chewing gum No oral fluids Only intravenous fluids (Lactated Ringer's solution) Receives: Other: Intravenous fluids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passage of stools
Measured: 72 hours
Secondary outcomes (1)
Passage of flatus
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative CareStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Armed Forces Hospitals, Southern Region, Saudi Arabia
- Responsible party
- Principal investigator, Mohamed Ellaithy, Ain Shams University
- Investigators
- Mohamed I Ellaithy, MD, Study chair, Armed Forces Hospital, Southern RegionAhmed Traigey, MD, Study director, Armed Forces Hospital, Southern Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386748
- Sponsor's protocol ID
- AFHSR 1-3-2015
- Status last verified
- Mar 2017
- First submitted
- 5 Mar 2015
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Altraigey A, Ellaithy M, Atia H, Abdelrehim W, Abbas AM, Asiri M. The effect of gum chewing on the return of bowel motility after planned cesarean delivery: a randomized controlled trial. J Matern Fetal Neonatal Med. 2020 May;33(10):1670-1677. doi: 10.1080/14767058.2018.1526913. Epub 2018 Oct 29.
PubMed 30231787
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chewing Gums to Stimulate Intestinal Motility After Cesarean Section: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02386748
- Acronym / sponsor ID
- AFHSR 1-3-2015
- Conditions
- Postoperative Care
- Keywords
- Cesarean section, Chewing gums, Intestinal motility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Armed Forces Hospitals, Southern Region, Saudi Arabia
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 12 Mar 2015 (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.
The study purpose is to evaluate the efficacy and safety of postoperative gum chewing on the recovery of intestinal movement after cesarean section.
All women undergoing elective cesarean section in King Faisal military hospital will be candidate for this trial after full explanation of the trial and informed consent to be taken from the women. Exclusion criteria will include emergency cesarean section, multifetal pregnancy, polyhydramnios, medical disorders with pregnancy, abnormal placentation (previa and/or accreta), past history of bowel injury or operation, any complications that will increase operative duration such as uterine artery injury or uterine extension.
450 consented women for being enrolled in this clinical trial and candidates for elective cesarean section will be divided into 3 groups:
- Group A, 150 women will receive sugarless gum after their operating room discharge by 2 hours for at least half an hour at two hours interval.
- Group B, 150 women will receive the traditional management of starting oral fluids after operating room discharge by 6 hours and hearing intestinal sounds on second day before initiating full regular diet.
- Group C, 150 women as control group, they will not receive neither gum nor oral fluids. They will be in intravenous fluid.
All demographic data of these women, indication of operation, operation time, type of anesthesia and pathway during hospital stay will be recovered and compared between 3 groups.
Detailed description
Introduction; Cesarean section is the most common surgery among women which is associated with postoperative central nervous system (CNS) changes, leading to decreased bowel movements. Postoperative ileus is defined as transient cessation of coordinated bowel motility after surgical intervention. It Is one of the major problems of post-abdominal surgery which delays hospital discharge, causes abdominal pain, abdominal distension, inability to start oral feeding, breastfeeding, and eventually increases the cost of hospital care. Historically, professionals of gynecology and obstetrics waited until gut function returns allowing oral or entered feeding, characterized by symptoms such as bowel sounds, first flatus or stool, and feeling of hunger. Chewing gum can stimulate the stomach, enhances gastric secretion, increases peristaltic bowel movements and finally hastens recovery from ileus. It has also been recently considered by researchers as a strategy toward ileus reduction. It seems that a necessity is felt for more investigation on such a least-expensive physiological method in stimulating the return of bowel function.
Study purpose; To evaluate the efficacy and safety of postoperative gum chewing on the recovery of intestinal movement after cesarean section.
Intervention:
450 consented women for being enrolled in this clinical trial and candidates for elective cesarean section will be divided into 3 groups:
- Group A, 150 women will receive sugarless gum after their operating room discharge by 2 hours for at least half an hour at two hours interval.
- Group B, 150 women will receive the traditional management of starting oral fluids after operating room discharge by 6 hours and hearing intestinal sounds on second day before initiating full regular diet.
- Group C, 150 women as control group, they will not receive neither gum nor oral fluids. They will be in intravenous fluid.
All demographic data of these women, indication of operation, operation time, type of anesthesia and pathway during hospital stay will be recovered and compare between 3 groups.
Statistical Methods:
Analysis of the data will be done by IBM computer using SPSS (statistical product and service solution version 18). Quantitative variables will be described as mean with SD and median with range while Qualitative variables will be described as numbers and percentage. Chi-square test will be used to compare qualitative variables between groups. Independent sample t-test will be used to compare the groups as regard quantitative variables in parametric data (SD < 50% mean). Comparison between non-parametric groups will be done by using Mann-Whitney test. P value < 0.05 will be significant.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chewing gum | Experimental | Dietary Supplement: Chewing gum, Other: Intravenous fluidsChewing sugarless gum |
| Oral fluids | Active comparator | Dietary Supplement: Oral fluids, Other: Intravenous fluidsClear oral fluids |
| Intravenous fluids | Other | Other: Intravenous fluidsNo chewing gum No oral fluids Only intravenous fluids (Lactated Ringer's solution) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All women undergoing elective cesarean section in King Faisal military 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 (7 listed)
- Emergency cesarean section.
- Multiple pregnancies.
- Polyhydramnios.
- Medical disorder as hypertension or diabetes mellitus.
- Abnormal placentation ,placenta previa ,accreta.
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 |
|---|---|---|
| Chewing gumChewing sugarless gum after the discharge from the operating room by two hours for at least half an hour at two hours intervals. | Dietary supplement | Chewing gum |
| Oral fluidsStarting clear oral fluids after operating room discharge by six hours, then hearing intestinal sounds on second day before initiating full regular diet. | Dietary supplement | Oral fluids |
| Intravenous fluidsWomen in this group will not receive neither gum nor oral fluids, they will be on intravenous fluids (lactated ringer solution). | Other | Chewing gum, Intravenous fluids, Oral fluids |
Primary outcome
Passage of stools
Time frame: 72 hours
1 secondary outcome
Passage of flatus
Time frame: 72 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 10 Mar 2017.
- Derived from this study: PubMed 30231787Altraigey A, Ellaithy M, Atia H, Abdelrehim W, Abbas AM, Asiri M. The effect of gum chewing on the return of bowel motility after planned cesarean delivery: a randomized controlled trial. J Matern Fetal Neonatal Med. 2020 May;33(10):1670-1677. doi: 10.1080/14767058.2018.1526913. Epub 2018 Oct 29.
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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.
Mohamed I Ellaithy, MD study chair
Armed Forces Hospital, Southern Region
Ahmed Traigey, MD study director
Armed Forces Hospital, Southern Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chewing gum, Oral fluids and Intravenous fluids in people with Postoperative Care, run by Ain Shams University at 1 site in Saudi Arabia.
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 7 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 10 Mar 2017. 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 Saudi Arabia. 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?
Passage of stools (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02386748, which also lists 1 linked publication.
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 10 Mar 2017.