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CTRI Number  CTRI/2025/11/096814 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 01/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Anthropometric changes, postural alignment, gait analysis and balance in pregnancy and puerperium 
Scientific Title of Study   Longitudinal Study of Biomechanical Changes in Pregnant and Postpartum Women 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anu Arora 
Designation  Professor 
Affiliation  D.Y.Patil University 
Address  School Of Physiotherapy, D.Y.Patil Deemed To Be University, Sector 5, Nerul, Navi Mumbai, India

Thane
MAHARASHTRA
400706
India 
Phone  08452842895  
Fax    
Email  anu.arora@dypatil.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anu Arora 
Designation  Professor 
Affiliation  D.Y.Patil University 
Address  School Of Physiotherapy, D.Y.Patil Deemed To Be University, Sector 5, Nerul, Navi Mumbai, India

Thane
MAHARASHTRA
400706
India 
Phone  08452842895  
Fax    
Email  anu.arora@dypatil.edu  
 
Details of Contact Person
Public Query
 
Name  Almas Aktar 
Designation  Physiotherapist 
Affiliation  D.Y.Patil University 
Address  School Of Physiotherapy, D.Y.Patil Deemed To Be University, Sector 5, Nerul, Navi Mumbai, India

Thane
MAHARASHTRA
400706
India 
Phone  8692887818  
Fax    
Email  almasaktar2001@gmail.com  
 
Source of Monetary or Material Support  
D.Y.Patil Hospital & Research Centre, OPD No 27, Sector 5, Nerul, Navi Mumbai, India 
 
Primary Sponsor  
Name  School of Physiotherapy 
Address  School of Physiotherapy, Sector 5, Navi Mumbai 
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 & Research Centre  OPD no 27, D.Y.Patil Hospital & Research Centre,Sector 5,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 (IEC) for Biomedical and Health Research D. Y. Patil Deemed to be University School of Medicine, Navi-Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant and post partum women who have been given physician clearance by Gynecologist 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Females during pregnancy and puerperium matching the inclusion criteria

1.Pregnant females
2.Prior permission taken from the consulting gynecologist
3.Females who will voluntarily consent for the study
 
 
ExclusionCriteria 
Details  Exclusion Criteria :
1.Pregnant and Postpartum (Puerperium) females with any complications that prohibit them to perform the tests/ OBGY clearance not obtained/ Multiple pregnancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
gait parameters (step length, stride length, cadence)
postural alignment changes (craniovertebral angle, spinal curvature, pelvic inclination, foot posture) 
Baseline, Three ,six and nine months 
 
Secondary Outcome  
Outcome  TimePoints 
joint laxity & proprioception using Beighton score & ankle proprioception tests.  Baseline,three,six & nine months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   28/11/2025 
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="2"
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  

Pregnancy is a dynamic physiological process that brings about numerous changes in a woman’s body. It is a complex and transformative process that involves a wide range of physiological, hormonal, and biomechanical changes. These changes, which occur in response to the developing foetus and the body’s adaptations to support pregnancy, vary across the three trimesters. Each trimester of pregnancy marks a distinct phase, presenting unique challenges and requiring specific adaptations that influence maternal health.

The first trimester is characterized by early embryonic development and hormonal shifts that prepare the body for sustaining the pregnancy. The second trimester sees significant physical changes, such as the growth of the uterus and increased weight, which can affect posture, gait, and musculoskeletal health. By the third trimester, the body undergoes further adaptations, with increased weight gain and changes in the centre of gravity, which may lead to discomfort and postural imbalances. The assessment of pregnancy across these three trimesters is essential to understand the evolving physiological demands to maternal health. [1]

Lumbopelvic–hip region is primarily responsible for transferring the loads generated by body weight and gravity during functional activities such as sitting standing and walking. Child bearing age has a detrimental impact on the musculoskeletal system of mother and is associated with many physical impairments. Physiologically occurring hormonal changes during childbearing years lead to joint laxity particularly in pelvic joints. An impairment of the ability of transferring load between the trunk and lower limbs by sacroiliac joint.[1]

The continuous postural changes occurring during pregnancy is counterbalanced with compensatory changes in spinal column. These compensatory adaptations may lead to changes in pelvic inclination, lumbar and thoracic curvatures and foot posture.[3]

In the process of delivery, body weight increases greatly in the trunk (belly) during foetus growth, which leads to physique changes. Thus, the motor system adjusts accordingly to compensate these changes to keep postural balance and gait stability.[2]

 

 

Though the postural changes during pregnancy has been an area of study globally but in India especially, longitudinal research capturing trimester-wise biomechanical and anthropometric changes are sparse, making this study particularly relevant. Lack of trimester-wise biomechanical profiling limits intervention design for antenatal care in Indian contexts.

Hence, this study aims to study the anthropometric changes, postural alignment, gait analysis and balance, throughout the three trimesters of pregnancy and puerperium

By examining the changes in these key parameters during the course of pregnancy and Puerperium, this research will contribute to a better understanding of the challenges faced during different trimesters of pregnancy.

This knowledge is vital for developing targeted strategies to support women through the pregnancy journey, promoting a healthier and more comfortable experience for both the mother and the baby.

 

 

 

 

 

 

 

 

 

 

 
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