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Clinical Trials/NCT06952985
NCT06952985CompletedNot Applicable

Role of Gum Chewing in Post-operative Gut Motility After Cesarean Section

Dr Maryam Aslam1 site in 1 country60 target enrollmentStarted: May 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Mean Time of Passage of First flatus

Study Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

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

Intervention: Sugar free chew gum (Dietary Supplement)

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

Intervention: Nil Per Oral (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Mean Duration of Hospital Stay(06 Months)

Investigators

Sponsor
Dr Maryam Aslam
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Dr Maryam Aslam

Head of Department Gynaecology and Obstetrics

Combined Military Hospital Gujranwala

Study Sites (1)

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