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CTRI Number  CTRI/2025/08/092204 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Fruitful otcomes of early ambulation after caesarean delivery 
Scientific Title of Study   Effectiveness of Early Ambulation in Reducing Postoperative Complications Among Post-Cesarean Section Mothers: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAbin Varghese 
Designation  Associate Professor 
Affiliation  AIIMS,Nagpur 
Address  Associate Professor,College of Nursing,MIHAN,AIIMS,Nagpur Department:Psychiatric Nursing Room No:412

Nagpur
MAHARASHTRA
441108
India 
Phone  8848955869  
Fax    
Email  abinvarghese143@aiimsnagpur.edu.in  
 
Details of Contact Person
Scientific Query  
Name  DrAbin Varghese 
Designation  Associate Professor 
Affiliation  AIIMS,Nagpur 
Address  Associate Professor,College of Nursing,MIHAN,AIIMS,Nagpur Department:Psychiatric Nursing Room No:412

Nagpur
MAHARASHTRA
441108
India 
Phone  8848955869  
Fax    
Email  abinvarghese143@aiimsnagpur.edu.in  
 
Details of Contact Person
Public Query  
Name  DrAbin Varghese 
Designation  Associate Professor 
Affiliation  AIIMS,Nagpur 
Address  Associate Professor,College of Nursing,MIHAN,AIIMS,Nagpur Department:Psychiatric Nursing Room No:412

Nagpur
MAHARASHTRA
441108
India 
Phone  8848955869  
Fax    
Email  abinvarghese143@aiimsnagpur.edu.in  
 
Source of Monetary or Material Support  
No funding support self funded,the infrastructural support is provided by ALL India Institute of Medical Sciences,Nagpur in the HDU and wards of Obstertical and Gynaecological Department,MIHAN,Maharashtra 
 
Primary Sponsor  
Name  The study is not sponsored by any agency or research instituttion 
Address  The infrastructural support is provided by ALL India Institute of Medical Sciences Nagpur Maharashtra 
Type of Sponsor  Government medical college 
 
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 
DrAbin Varghese  AIIMS Nagpur  Ward no 301,302,HDU unit in Obsterics and Gynaecological Deaprtment of the iNpatient department of AIIMS Nagpur
Nagpur
MAHARASHTRA 		 8848955869

abinvarghese143@aiimsnagpur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O871||Deep phlebothrombosis in the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Early ambulation  . The participants in the experimental group will receive a specifically designed early ambulation which will be under the supervision of co-investigators. • The intervention will be initiated after 8 to 10 hours of Caesarean section. Firstly, the mothers will be guided to perform deep breathing exercises for two minutes (5 times) to promote lung expansion and reduce the risk of respiratory complications • The flexion and extension of the extremities for 3 times to enhance peripheral circulation to prevent venous thromboembolism and promote neuro muscular activity. The exercises will be conducted in the bed. • The participant will be encouraged and assisted to perform position changes in bed including turning side to side for three days to facilitate bowel motility with a chart given to mention the number of times position changes happened . • Sitting at the edge of the bed for short duration starting with 5 to 10 minutes gradually increasing as tolerated will be initiated to prepare for ambulation • Mothers will be encouraged to begin assisted ambulation aided by the PI. Pedometer will be used to measure and record the number of steps taken each day to assess the physical activity level. • After giving the intervention on day 0, the mothers will be shifted from the HDU to the ward. Henceforth there will be no contamination of the sample.  
Comparator Agent  Standard Treatment  Ambulation as per the tolerability  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Those who are willing to participate
Those who received spinal anaesthesia
Those who undergone LSCS
Those who are hemodynamically stable after LSCS
 
 
ExclusionCriteria 
Details  1. Mother with PPH
2. Those who undergone classical C section
3. Those who are advised for total bedrest
4. Diagnosed with psychiatric illness
5. Those who received general anaesthesia
6. Those who already had DVT
7. Those who have increased intracranial pressure
8. Mother with baby in NICU
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain,headache,Involution of uterus  Day Zero,Day One,Day Three 
 
Secondary Outcome  
Outcome  TimePoints 
Psychological Wellbeing,Recovery,Health  Day 1 and Day 3 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   20/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This randomized controlled trial aims to assess the effectiveness of early ambulation in reducing postoperative complications among post cesarean section mothers. Participants who meet the inclusion criteria will be randomly allocated to two groups using day wise block randomization. The intervention group will receive structured early ambulation beginning 8 to 10 hours after surgery, while the control group will receive routine postoperative care. The early ambulation protocol includes deep breathing exercises, limb movements, position changes in bed, assisted sitting and walking, and daily step count monitoring using a pedometer. Outcomes such as pain, uterine involution, wound healing, headache, psychological wellbeing, and physical activity will be assessed using validated tools like the Numerical Pain Rating Scale, Obstetric Quality of Recovery Score Hindi version, Edinburg Postnatal Depression Scale Hindi, GAD 7 Hindi, Southampton Wound Assessment Scale, and Homan’s sign. The study will be conducted at a tertiary care institute in India and will follow ethical guidelines. The findings are expected to provide evidence for integrating early ambulation into routine post cesarean care to improve recovery and reduce complications.

 
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