| CTRI Number |
CTRI/2019/12/022232 [Registered on: 03/12/2019] Trial Registered Prospectively |
| Last Modified On: |
02/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Factors affecting satisfaction after labour analgesia |
|
Scientific Title of Study
|
‘Maternal, anaesthetic & obstetric factors affecting satisfaction in women receiving epidural analgesia for labour pain ’ |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dipali Vidole |
| Designation |
Junior Resident |
| Affiliation |
Lokmanya Tilak Municipal Medical college, Mumbai |
| Address |
Department of anesthesiology, Lokmanya Tilak municipal medical College and hospital,sion Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9503422771 |
| Fax |
|
| Email |
dipalividole1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Rustagi |
| Designation |
Assistant professor |
| Affiliation |
Lokmanya Tilak Municipal Medical college, Mumbai |
| Address |
Department of anesthesiology, Lokmanya Tilak municipal medical College and hospital,sion Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9769215359 |
| Fax |
|
| Email |
drpreetirustagi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Rustagi |
| Designation |
Assistant professor |
| Affiliation |
Lokmanya Tilak Municipal Medical college, Mumbai |
| Address |
Department of anesthesiology, Lokmanya Tilak municipal medical College & hospital,sion Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9769215359 |
| Fax |
|
| Email |
drpreetirustagi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology Lokmanya Tilak Municipal medical College & hospital Sion Mumbai 400022 |
|
|
Primary Sponsor
|
| Name |
Lokmanya Tilak Municipal medical College |
| Address |
Department of anesthesiology
Lokmanya tilak municipal medical college & hospital Sion Mumbai 400022 |
| Type of Sponsor |
Government 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 |
| dipali vidole |
okmanaya tilak municipal medical college and general hospital |
lokmanaya tilak municipal medical college and general hospital , sion , mumbai
Mumbai
MAHARASHTRA |
9503422771
dipalividole1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
-Parturient in active labour with Cervical dilatation >3cm
-Parturient with >34weeks of gestation |
|
| ExclusionCriteria |
| Details |
Patient not giving consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Maternal factors like reduction in VAS for pain , anxiety, age, education can influence maternal satisfaction
Obstetric factors like parity and Anesthetic factors can influence maternal satisfaction after labor epidural |
Every 10min till 1hr then every 15 min till baby delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="155"
Sample Size from India="155"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/12/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Epidural analgesia is the criterion standard for pain
relief during labour and is constantly being improved to ensure that analgesia
is reliable, has the minimum possible negative effect on maternal and neonatal
health and is satisfactory for the mother.
maternal satisfaction is not only dependant on
the pain relief but is a complex entity influenced by many factors. [3,4] Apart
from the efficacy of the epidurallly administered drugs and the incidence of
side effects many other anaesthetic, obstetrics and maternal psychosocial
factors play a role.Therefore this study is taken to identify the
potentially modifiable factors, which are associated with maternal satisfaction.
|