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CTRI Number  CTRI/2024/02/062323 [Registered on: 06/02/2024] Trial Registered Prospectively
Last Modified On: 03/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Prevalence of back pain in pregnant women  
Scientific Title of Study   Prevalence of pelvic girdle pain and low back pain in pregnant women in Indian suburban population- A Cross sectional study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Subbulakshmi sundaram 
Designation  Associate Professor  
Affiliation  Dept of Anaesthesia Government Cuddalore Medical College ( Erstwhile Rajah Muthaiah Medical College) 
Address  Department of Anaesthesiology Government Cuddalore Medical College ( Erstwhile Rajah Muthaiah Medical College)Chidambaram

Cuddalore
TAMIL NADU
608001
India 
Phone  9442176327  
Fax    
Email  subbulakshmisundaram76@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Subbulakshmi sundaram 
Designation  Associate Professor  
Affiliation  Dept of Anaesthesia Government Cuddalore Medical College ( Erstwhile Rajah Muthaiah Medical College) 
Address  Department of Anaesthesiology Government Cuddalore Medical College ( Erstwhile Rajah Muthaiah Medical College)Chidambaram

Cuddalore
TAMIL NADU
608001
India 
Phone  9442176327  
Fax    
Email  subbulakshmisundaram76@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Subbulakshmi sundaram 
Designation  Associate Professor  
Affiliation  Dept of Anaesthesia Government Cuddalore Medical College ( Erstwhile Rajah Muthaiah Medical College) 
Address  Department of Anaesthesiology Government Cuddalore Medical College ( Erstwhile Rajah Muthaiah Medical College)Chidambaram

Cuddalore
TAMIL NADU
608001
India 
Phone  9442176327  
Fax    
Email  subbulakshmisundaram76@gmail.com  
 
Source of Monetary or Material Support  
Government Cuddalore Medical College( Erstwhile Rajah Muthaiah Medical College), Chidambaram  
 
Primary Sponsor  
Name  Subbulakshmi sundaram 
Address  Department of Anaesthesia, Government Cuddalore Medical College ( Erstwhile Rajah Muthaiah Medical College), Chidambaram  
Type of Sponsor  Other [Self] 
 
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 Subbulakshmi sundaram  Government Cuddalore Medical College ( Erstwhile Rajah Muthaiah Medical college  Room no 131, Out patient Clinic, Department of obstetrics and gynecology,Government Cuddalore Medical College,,Chidambaram
Cuddalore
TAMIL NADU 
9442176327

subbulakshmisundaram76@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant women 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Healthy Pregnant women 
 
ExclusionCriteria 
Details  Any obstetric complication, Bad obstetric history, previous history of back pain, trauma and surgery in back 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the prevalence of pelvic girdle pain and low back pain in pregnant women   1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Time of occurrence of pelvic girdle pain and low back pain  1 year 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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)   29/02/2024 
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  

After obtaining written informed consent, All healthy  pregnant women     of age  between 18 to 40 years from first trimester  till delivery attending  obstetric outpatient department will be included in the study. Their demographic and socioeconomic profile  will be recorded. History of previous low back pain, spine surgery and trauma,  will be ruled out. All pregnant women will be provided with a diagram projecting the anterior and posterior view of human body with marked areas such as  low back , right and left pelvic girdle  and symphysis pubis . if they have pain they will be instructed to mark the area  of pain. If  the patient is having pain, detailed evaluation of pain  using numerical rating pain scale, aggravating and relieving factors,  limitation of activities, sleep disturbances will be recorded.  Atleast 2 of the following   physical examination test  should be positive  on the side of reported symptoms: posterior pelvic provocation test,  Patrick’s test, active straight leg raise test and modified Trendelenburg test. If patient is having pain, she will be sent to pain clinic for further management. All  patients will be followed up till their delivery. 

 
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