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CTRI Number  CTRI/2022/09/045873 [Registered on: 26/09/2022] Trial Registered Prospectively
Last Modified On: 27/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Screening for vascular changes in legs during pregnancy 
Scientific Title of Study   Screening for peripheral vascular symptoms during pregnancy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Narjuma Choudhury  
Designation  Postgraduate student 
Affiliation  Manipal College of Health Professions, Manipal 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9706415303  
Fax    
Email  narjuma.choudhury@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr G Arun Maiya 
Designation  Dean and Professor 
Affiliation  Manipal College of Health Professions, Manipal 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845350823  
Fax    
Email  arun.maiya@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Narjuma Choudhury 
Designation  Postgraduate student 
Affiliation  Manipal College of Health Professions, Manipal 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9706415303  
Fax    
Email  narjuma.choudhury@learner.manipal.edu  
 
Source of Monetary or Material Support  
Self(Narjuma Choudhury) 
 
Primary Sponsor  
Name  Narjuma Choudhury 
Address  Department of Physiotherapy, Manipal Academy of Health Professions, Manipal Academy of Higher Secondary,Manipal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Not applicable   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Narjuma Choudhury  Kasturba hospital, Manipal  Room no-12,Ground floor, OBG OPD, Women and child block, Kasturba hospital,Manipal Udupi Karnataka
Udupi
KARNATAKA 		 9706415303

narjuma.choudhury@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2(Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O229||Venous complication in pregnancy,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Pregnant women between 16th and 40th weeks of gestation

2. Able to understand English or Kannada 
 
ExclusionCriteria 
Details  1. Women with medical or obstetric complications who have been advised bed rest

2. Any neuromuscular disorders, patient with unstable or exertional angina, resting limb pain,recent orthopaedic surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Percentage of Peripheral Vascular symptoms
2. Ankle brachial index 		 At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Physical activity level MET-min/week  At baseline 
 
Target Sample Size   Total Sample Size="174"
Sample Size from India="174" 
Final Enrollment numbers achieved (Total)= "174"
Final Enrollment numbers achieved (India)="174" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/09/2022 
Date of Study Completion (India) 30/12/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Permission to conduct the study is obtained from Institutional Research Committee (IRC), MCHP, MAHE as well as from the HOD, Department of Obstetrics and Gynecology, Kasturba Hospital,Manipal.After obtaining approval,the study will be registered under the Clinical Trials Registry- India(CTRI). Pregnant women are coming to Department of Obstetrics and Gynaecology, Kasturba Hospital,will be screened for inclusion and exclusion criteria. After explaining the procedure in details,written informed consent will be taken from eligible participants. Edinburgh Claudication Questionnaire will be administered to know pain score. Global Physicsl Activity Questionnaire will be administered to determine their physical activity level.  Ankle brachial index will record by measuring participants brachial systolic pressure and ankle systolic pressure in supine position by using a sphygmomanometer and stethoscope. height and body weight will be recorded by using a stadiometer and weighing machine. After that data will be analysed. 
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