Cesarean SectionNCT06952985
Role of Gum Chewing in Post-operative Gut Motility After Cesarean Section
A study testing Sugar free chew gum and Nil Per Oral in people with Cesarean Section and Gum Chewing, run by Dr Maryam Aslam at 1 site in Pakistan.
Trial summary
Many women deliver by caesarean section nowadays. The proportion of women who deliver by caesarean section ranges from 15% to over 50%, in some countries. After a caesarean section it is common for the bowel to stop working for several hours or days. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Gum Chewing, Gut Motility
- What is being tested?
- Sugar free chew gum and Nil Per Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2024to 31 Oct 2024
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females of age 18-40 years
- Parity <5
- Presenting at gestational age ≥ 37 weeks,
- Undergoing cesarean section (as per operational definition) under spinal anesthesia
Who cannot join
- Females with history of chronic constipation (medical record)
- Females with obstructed labour, hypothyroidism (TSH>5IU)
- Females with intra operative complications such as bowel injury, history of gastrointestinal surgery, and water and electrolyte disturbances (on medical record), abnormal placenta (accrete, increta, previa, abruption)
Trial locations and contacts
1 site in 1 country.
About this study
Many women deliver by caesarean section nowadays. The proportion of women who deliver by caesarean section ranges from 15% to over 50%, in some countries. After a caesarean section it is common for the bowel to stop working for several hours or days. Although this usually resolves by itself in a few days, it may be very uncomfortable. The retained gases and stools can cause the mother's belly to become swollen and painful with cramps and she may feel nauseated and vomit so she is not able to eat. She may need additional medications to ease these symptoms and her hospital discharge may be delayed. The use of medications that relieve pain during labour and painkillers following the surgery can also delay bowel function. Small intestine activity after abdominal operations returns to normal function within a few hours, gastric activity returns to normal within 24-48 hours, and colon activity returns to normal within 48-72 hours. Due to the delayed motility of the gastrointestinal system in the postoperative period, gas and secretions accumulate in the stomach and small and large intestines, which causes abdominal distension, nausea, vomiting, and pain, all of which negatively affect the comfort level of the patients. Chewing sugar-free gum after cesarean section can promote the early recovery of gastrointestinal function, but the side effects of chewing gum are still unclear, which needs more clinical, large sample and high-quality studies to further verify.
- Conditions
- Cesarean Section, Gum Chewing, Gut Motility
- Being tested
- Sugar free chew gum, Nil Per Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar free chew gumDietary supplement
Chew gum has a role in ERAS protocol which is significant in early post operative recovery as compared to normal routine care methods
Nil Per OralOther
According to classic protocols patient were kept nil per oral till bowel sounds were audible
| Study group | Role | What they receive |
|---|---|---|
| Group A participants who were given chewing gum 6 hours after the surgery, three times a day | Active comparator | In group A participants were given chewing gum 6 hours after the surgery, three times a day till passage of flatus Receives: Dietary Supplement: Sugar free chew gum |
| Group B participants who were kept nil per oral till bowel sounds were audible | Active comparator | In group B, participants were managed as per standard routine protocol i.e. allowing oral when gut sound were audible Receives: Other: Nil Per Oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Time of Passage of First flatus
In group A, females were given chewing gum 6 hours after the surgery, three times a day till passage of flatus. In group B, females were managed as per standard routine protocol i.e. allowing oral when bowel sounds are audible. Mean time of passage of first flatus since procedure was noted in terms of hours.
Measured: 06 Months
Secondary outcomes (1)
Mean Duration of Hospital Stay
In both groups mean duration of hospital stay was noted in terms number of days required to stay in the hospital after cesarean. Patients were discharged once they were pain free and on oral medication.
Measured: 06 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 May 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Maryam Aslam
- Sponsor type
- University, hospital or other
- Collaborators
- CMH Gujranwala
- Responsible party
- Sponsor-investigator, Dr Maryam Aslam, Combined Military Hospital Gujranwala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952985
- Sponsor's protocol ID
- 275
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Gum Chewing in Post-operative Gut Motility After Cesarean Section
- ClinicalTrials.gov ID
- NCT06952985
- Acronym / sponsor ID
- 275
- Conditions
- Cesarean Section, Gum Chewing, Gut Motility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dr Maryam AslamUniversity, hospital or other
- Collaborators
- CMH Gujranwala
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 1 May 2025 (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.
Many women deliver by caesarean section nowadays. The proportion of women who deliver by caesarean section ranges from 15% to over 50%, in some countries. After a caesarean section it is common for the bowel to stop working for several hours or days. Although this usually resolves by itself in a few days, it may be very uncomfortable. The retained gases and stools can cause the mother's belly to become swollen and painful with cramps and she may feel nauseated and vomit so she is not able to eat. She may need additional medications to ease these symptoms and her hospital discharge may be delayed. The use of medications that relieve pain during labour and painkillers following the surgery can also delay bowel function. Small intestine activity after abdominal operations returns to normal function within a few hours, gastric activity returns to normal within 24-48 hours, and colon activity returns to normal within 48-72 hours. Due to the delayed motility of the gastrointestinal system in the postoperative period, gas and secretions accumulate in the stomach and small and large intestines, which causes abdominal distension, nausea, vomiting, and pain, all of which negatively affect the comfort level of the patients. Chewing sugar-free gum after cesarean section can promote the early recovery of gastrointestinal function, but the side effects of chewing gum are still unclear, which needs more clinical, large sample and high-quality studies to further verify.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A participants who were given chewing gum 6 hours after the surgery, three times a day | Active comparator | Dietary Supplement: Sugar free chew gumIn group A participants were given chewing gum 6 hours after the surgery, three times a day till passage of flatus |
| Group B participants who were kept nil per oral till bowel sounds were audible | Active comparator | Other: Nil Per OralIn group B, participants were managed as per standard routine protocol i.e. allowing oral when gut sound were audible |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females of age 18-40 years
- Parity <5
- Presenting at gestational age ≥ 37 weeks,
- Undergoing cesarean section (as per operational definition) under spinal anesthesia
Key exclusion criteria (3 listed)
- Females with history of chronic constipation (medical record)
- Females with obstructed labour, hypothyroidism (TSH>5IU)
- Females with intra operative complications such as bowel injury, history of gastrointestinal surgery, and water and electrolyte disturbances (on medical record), abnormal placenta (accrete, increta, previa, abruption)
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 |
|---|---|---|
| Sugar free chew gumChew gum has a role in ERAS protocol which is significant in early post operative recovery as compared to normal routine care methods | Dietary supplement | Group A participants who were given chewing gum 6 hours after the surgery, three times a day |
| Nil Per OralAccording to classic protocols patient were kept nil per oral till bowel sounds were audible | Other | Group B participants who were kept nil per oral till bowel sounds were audible |
Primary outcome
Mean Time of Passage of First flatus
Time frame: 06 Months
In group A, females were given chewing gum 6 hours after the surgery, three times a day till passage of flatus. In group B, females were managed as per standard routine protocol i.e. allowing oral when bowel sounds are audible. Mean time of passage of first flatus since procedure was noted in terms of hours.
1 secondary outcome
Mean Duration of Hospital Stay
Time frame: 06 Months
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 1 May 2025.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar free chew gum and Nil Per Oral in people with Cesarean Section and Gum Chewing, run by Dr Maryam Aslam at 1 site in Pakistan.
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 4 inclusion and 3 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 1 May 2025. 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 Pakistan. 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?
Mean Time of Passage of First flatus (time frame: 06 Months). 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 1 May 2025.