| 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
|
|
|
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
|
|
|
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. |