- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06952985
Role of Gum Chewing in Post-operative Gut Motility After Cesarean Section
April 29, 2025 updated by: Dr Maryam Aslam
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Gujranwala, Punjab, Pakistan, 52230
- CMH Gujranwala
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Females of age 18-40 years
- Parity <5
- Presenting at gestational age ≥ 37 weeks,
- Undergoing cesarean section (as per operational definition) under spinal anesthesia
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A participants who were given chewing gum 6 hours after the surgery, three times a day
In group A participants were given chewing gum 6 hours after the surgery, three times a day till passage of flatus
|
Chew gum has a role in ERAS protocol which is significant in early post operative recovery as compared to normal routine care methods
|
|
Active Comparator: Group B participants who were kept nil per oral till bowel sounds were audible
In group B, participants were managed as per standard routine protocol i.e. allowing oral when gut sound were audible
|
According to classic protocols patient were kept nil per oral till bowel sounds were audible
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
06 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Duration of Hospital Stay
Time Frame: 06 Months
|
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.
|
06 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2024
Primary Completion (Actual)
October 31, 2024
Study Completion (Actual)
October 31, 2024
Study Registration Dates
First Submitted
April 20, 2025
First Submitted That Met QC Criteria
April 29, 2025
First Posted (Actual)
May 1, 2025
Study Record Updates
Last Update Posted (Actual)
May 1, 2025
Last Update Submitted That Met QC Criteria
April 29, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 275
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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