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CTRI Number  CTRI/2021/06/034253 [Registered on: 15/06/2021] Trial Registered Prospectively
Last Modified On: 19/01/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Biomechanics and anthropometric parameters in the three trimesters of pregnancy 
Scientific Title of Study   Cross sectional study of biomechanics and anthropometric parameters in the three trimesters of pregnancy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANU ARORA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  School of Physiotherapy, D.Y.Patil University, Nerul 
Address  School of Physiotherapy, D.Y.Patil University, Nerul
Nerul , Navi Mumbai
Thane
MAHARASHTRA
400706
India 
Phone  08452842895  
Fax    
Email  anu.arora@dypatil.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Anu Arora 
Designation  Associate Professor 
Affiliation  D.Y.Patil University,School of Physiotherapy 
Address  L 305, Army Colony, Sector 9, Nerul , Navi Mumbai
L 305, Army Colony, Sector 9, Nerul , Navi Mumbai
Thane
MAHARASHTRA
400706
India 
Phone  08452842895  
Fax    
Email  anu.arora@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Esha Shetty 
Designation  PG Physiotherapist 
Affiliation  D.Y.Patil University,School of Physiotherapy 
Address  D.Y.Patil University,School of Physiotherapy

Thane
MAHARASHTRA
400706
India 
Phone    
Fax    
Email  esha6.shetty@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  School of Physiotherapy DYPU 
Address  School of Physiotherapy, D.Y.Patil University 
Type of Sponsor  Private 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 
Dr Anu Arora  D.Y.Patil Hospital and Research Centre  D.Y.Patil Hospital and Research Centre, OBGY OPD and Physiotherapy OPD(No 27), Nerul, Navi Mumbai
Thane
MAHARASHTRA 		 08452842895

anu.arora@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Females during pregnancy and puerperium 
Patients  (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1. Consenting pregnant and postnatal (puerperium) females.
2. Prior permission for study participation was taken from consultant gynaecologists. 
 
ExclusionCriteria 
Details  Unwilling to participate
With any pre-existing musculoskeletal and neurological conditions which may interfere with the study. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Hip Flexion Range of Motion
Ankle Range of Motion
Trunk Range of Motion
Lumbar Spinal Curvature
Pelvic inclination
Abdominal girth measurement
Foot Posture Index-6  		 Same day measures 
 
Secondary Outcome  
Outcome  TimePoints 
Balance and Gait Parameters  Same day measures 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   17/06/2021 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not yet finalized 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

 Pregnancy is associated with significant physiological and anatomical changes in order to support optimum foetal growth and successful labour.1 It induces various immunological, physiological and metabolic changes that has an effect on the woman’s body.2 As the pregnancy progresses the foetal enlargement results in changes in mother’s centre of mass and hence changes the weight distribution pattern of mother.3 This also leads to changes in the centre of pressure which is the point where the resultant of all the forces act . The postural changes is counter balanced with compensatory changes in spinal posture. The changes in spinal posture may eventually even cause changes in the lower extremities as a compensatory mechanism to keep the line of gravity over the base of support. These postural changes could alter the biomechanics of the weight bearing joints of the lower extremities. The mentioned biomechanical and anthropometric changes are further augmented by pregnancy induced hormonal variations. Altered position of the joints alter the afferent feedback which further result in postural changes.

 

         In view of the various hormone induced and postural changes through pregnancy, this study proposes to assess and compare effects of pregnancy on the biomechanics and anthropometrics of the body through the various trimesters and during puerperium.

 

 

 

 

 

 

 

 

 

 

 

 
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