| CTRI Number |
CTRI/2025/03/081670 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study To Assess Awareness And Attitude Towards Labor Analgesia |
|
Scientific Title of Study
|
A Study To Assess Awareness And Attitude Towards Labor Analgesia In Pregnant Women Attending Antenatal Clinic In A Tertiary Care Hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudeshna Pal |
| Designation |
Post Graduate Trainee |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
IPGMER and SSKM Hospital
Bhowanipore Kolkata
West Bengal 700020
Department of Anaesthesiology
Main Block,2nd Floor
Bhowanipore Kolkata
Department of Anaesthesiology
Main Block,2nd Floor
Kolkata
WEST BENGAL
700020
India |
| Phone |
8620987361 |
| Fax |
|
| Email |
sudeshnapal0901@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Baisakhi Laha |
| Designation |
Professor |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
IPGMER and SSKM Hospital
Bhowanipore Kolkata
West Bengal 700020
Department of Anaesthesiology
Main Block,2nd Floor
Bhowanipore Kolkata
Department of Anaesthesiology
Main Block,2nd Floor
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830148042 |
| Fax |
|
| Email |
blowfans@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sudeshna Pal |
| Designation |
Post Graduate Trainee |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
IPGMER and SSKM Hospital
Bhowanipore Kolkata
West Bengal 700020
Department of Anaesthesiology
Main Block, 2nd Floor
Bhowanipore Kolkata
Department of Anaesthesiology
Main Block,2nd Floor
Kolkata
WEST BENGAL
700020
India |
| Phone |
8620987361 |
| Fax |
|
| Email |
sudeshnapal0901@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGMER AND SSKM HOSPITAL
244,A.J.C.Bose Road,Kolkata-700020,West Bengal,India
|
|
|
Primary Sponsor
|
| Name |
Sudeshna Pal |
| Address |
IPGMER AND SSKM HOSPITAL
Bhowanipore Kolkata
700020 |
| 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 |
| DrSudeshna Pal |
IPGMER AND SSKM HOSPITAL |
Antenatal ward and Antenatal clinic
Department of Gynecology and obstetrics, 1st Floor,Gynecology building
Kolkata
WEST BENGAL |
8620987361
sudeshnapal0901@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER RESEARCH OVERSIGHT COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O749||Complication of anesthesia duringlabor and delivery, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant women both primi and multigravida
2.Third trimester antenatal women
3.Multigravida with previous experience of labour
pain
|
|
| ExclusionCriteria |
| Details |
1.Age less than 18 years
2.Not conversant with language of interviewer
3.In active labor or false pain
4.Any acute physical condition at the time of
interview
5.Mentally challenged
6.Any other condition which in opinion of the
interviewer is unsuitable for participation in
this study
7.Patient want MTP |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess level of awareness and attitude towards labor analgesia |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare awareness & attitude amongst different group on basis of age, education & socioeconomic status |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="426"
Sample Size from India="426"
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)
|
15/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is an observational study to evaluate the awareness and attitude of pregnant women about labor analgesia and explore their willingness to receive obstetric analgesic services in the tertiary care hospitals , in order to work on the betterment of the existing services. |