| 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
|
|
|
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
|
|
|
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. |