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CTRI Number  CTRI/2024/07/071220 [Registered on: 24/07/2024] Trial Registered Prospectively
Last Modified On: 21/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [SUGAR FREE CHEWING GUM]  
Study Design  Single Arm Study 
Public Title of Study   The Effect Of Gum Chewing On Bowel Functions After Cesarean Section  
Scientific Title of Study   Effectiveness Of Gum Chewing On The Post Operative Recovery Of Gastrointestinal Functions After Caesarean Section  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Partha Pratim Sanfui 
Designation  Post Graduate Trainee 
Affiliation  Chittaranjan Seva Sadan 
Address  Chittaranjan Seva Sadan College Of Obstetrics, Gynaecology and Child Health Department Of Obstetrics And Gynecology 83,S P Mukherji Road, Kolkata 700026
Chittaranjan Seva Sadan College Of Obstetrics, Gynaecology and Child Health Department Of Obstetrics And Gynecology 83, S P Mukherji Road, Kolkata 700026
Kolkata
WEST BENGAL
700026
India 
Phone  9038013809  
Fax  03324754584  
Email  psanfui.29@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gita Banerjee Basu 
Designation  Professor 
Affiliation  Chittaranjan Seva Sadan College of Obstetrics, Gynaecology and Child Health  
Address  Office Of The MSVP Chittaranjan Seva Sadan College Of Obstetrics, Gynaecology and Child Health Department Of Obstetrics And Gynecology 83, S P Mukherji Road, Kolkata 700026

Kolkata
WEST BENGAL
700026
India 
Phone  9163203263  
Fax  03324754584  
Email  gitabanerjeebasu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gita Banerjee Basu 
Designation  Professor 
Affiliation  Chittaranjan Seva Sadan College of Obstetrics, Gynaecology and Child Health  
Address  Office Of The MSVP Chittaranjan Seva Sadan College Of Obstetrics, Gynaecology and Child Health Department Of Obstetrics And Gynecology 83, S P Mukherji Road, Kolkata 700026

Kolkata
WEST BENGAL
700026
India 
Phone  9163203263  
Fax  03324754584  
Email  gitabanerjeebasu@gmail.com  
 
Source of Monetary or Material Support  
Chittaranjan Seva Sadan College Of Obstetrics,Gynecology And Child Health 83, S P Mukherji Road, Kolkata 700026, West Bengal, India 
 
Primary Sponsor  
Name  Partha Pratim Sanfui  
Address  Chittaranjan Seva Sadan College Of Obstetrics ,Gynecology And Child Health Department Of Obstetrics And Gynecology 83, S P Mukherji Road, Kolkata 700026, West Bengal, India 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gita Banerjee Basu  Chittaranjan Seva Sadan   Cittaranjan Seva Sadan College Of Obstetrics And Gynaecology 37 S P Mukherji Road, Kolkata 700026
Kolkata
WEST BENGAL 		 9163203263

gitabanerjeebasu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chittaranjan Seva Sadan College of Obs. Gynae and Child Health Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NOT APPLICABLE 
Intervention  Sugar Free Chewing Gum  Sugar Free Chewing Gum To 100 Post Caesarean Patients From 4 Hours Postoperatively For 20 Minutes Once In Every 4 Hours Still Passage Of Flatus. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  All women undergoing elective caesarean section at Chittaranjan Seva Sadan without any medical disorder that predisposing to Paralytic Ileus. 
 
ExclusionCriteria 
Details  Overt Diabetes
General Anesthesia
Any medical disorder predisposing to Paralytic Ileus. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Early passing of first flatus
2. Early detection of first bowel movements  		 1. From 2 hours postoperatively the patient will be given one stick of xylitol gum to be chewed for 15 minutes. This will be repeated every 2 hourly till the first flatus passed or first IPS ausculted.
1. IPS will be checked hourly from 2 hours post operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Decrease use of post operative antiemetics
2. Decrease incidence of post operative abdominal distention
3. Decrease use of post operative analgesia
4. Early passage of faeces
5. Decrease duration of hospital stay 		 18 Months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   11/08/2026 
Date of Study Completion (India) 28/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [psanfui.29@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Sham feeding has been reported to stimulate early bowel movement  in post operative patient. In my study i will use this same hypothesis by selecting sugarless chewing to test this same hypothesis. Total 100 post operative mother will be selected for caesarean section randomly,  using computer generated sequence  strictly following the exclusion and inclusion criteria. Written consent will be taken from pregnant mothers after explaining the procedure to them. Standard pre operative  and post operative care will be given as per hospital protocol. Prophylactic antibiotics will be given  and prokinetic drugs will be avoided. Among 100 post operative mothers, 50 mother will be given one xylitol gum, 2 hours post operatively for 15 minutes. It will be repeated 2 hourly till the first bowel sound appeared or first flatus passed. There will be no intervention in the rest 50 post operative mother i.e. control groups. Time taken for first bowel sound to appear or the first flatus to be passed are recorded ,  analyzed and compared. Any incidence of bloating, nausea, abdominal distention will also be recorded, analyzed and compared.

 
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