NCT06952985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 20, 2025

Last Update Submit

April 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    06 Months

Secondary Outcomes (1)

  • Mean Duration of Hospital Stay

    06 Months

Study Arms (2)

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

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

Other: Nil Per Oral

Interventions

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

Group A participants who were given chewing gum 6 hours after the surgery, three times a day

According to classic protocols patient were kept nil per oral till bowel sounds were audible

Group B participants who were kept nil per oral till bowel sounds were audible

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales only
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Females of age 18-40 years
  • Parity \<5
  • Presenting at gestational age ≥ 37 weeks,
  • Undergoing cesarean section (as per operational definition) under spinal anesthesia

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMH Gujranwala

Gujranwala, Punjab Province, 52230, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Department Gynaecology and Obstetrics

Study Record Dates

First Submitted

April 20, 2025

First Posted

May 1, 2025

Study Start

May 1, 2024

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations