| CTRI Number |
CTRI/2025/11/097132 [Registered on: 10/11/2025] Trial Registered Prospectively |
| Last Modified On: |
23/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To determine the effect of lumbar epidural analgesia in prevention of postpartum depression |
|
Scientific Title of Study
|
To determine the efficacy of epidural labor analgesia in prevention of postpartum depression a case controlled 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 |
Nitesh kumar |
| Designation |
Junior Resident |
| Affiliation |
Kgmu Lucknow up |
| Address |
Office room Ground floor Anaesthesiology Department Kgmu Lucknow uttar pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
08427654097 |
| Fax |
|
| Email |
Sharmacherry7866@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammad Parvez Khan |
| Designation |
Professor |
| Affiliation |
Kgmu Lucknow up |
| Address |
Anaesthesiology Department Kgmu Lucknow uttar pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
5222311192 |
| Fax |
|
| Email |
mpk_786@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohammad Parvez Khan |
| Designation |
Professor |
| Affiliation |
Kgmu Lucknow up |
| Address |
Office room Ground floor Anesthesiology department kgmu Lucknow uttar pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
5222311192 |
| Fax |
|
| Email |
mpk_786@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Kgmu Lucknow uttar pradesh
Pincode 226003 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| 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 |
| DrNitesh kumar |
King George’s Medical University |
Ground floor office room Anaesthesiology Department Kgmu Lucknow uttar pradesh
Lucknow
UTTAR PRADESH |
08427654097
Sharmacherry7866@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kgmu Lucknow institutional ethics committee UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postpartum depression in mother following normal vaginal delivery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural catheter insertion |
18 G Epidural catheter placement after local infiltration at level L3-L4,L4-L5 when cervical dilatation will reach 3-5cm
Test dose of 3ml Lidocaine 1.5 %with adr [1:200000] will be given
Patient will receive a bolus dose of ropivacaine 0.2% [ 10 -20ml] plus fentanyl 10mcg via epidural catheter
Followed by continuous infusion of 0.2% ropivacaine 20ml Plus 40mcg fentanyl at rate of 6 to 10ml per hr
Duration of epidural catheter insitu 24hrs
Duration of postpartum depression followup =6weeks |
| Comparator Agent |
Without epidural catheter |
In this group patient receive no epidural labor analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion criteria
Patient of age group of 18-30 years, planning to give birth electively via normal vaginal route
American Society of Anesthesiologists (ASA)physical status I-III
Singleton pregnancy |
|
| ExclusionCriteria |
| Details |
Exclusion criteria
Patient refusal
Infection at intervention site
Coagulation disorder
Intracranial pathology
Allergy to study drugs
Active neurological/Psychiatry disease
Complicated obsteteic conditions [ twin,GDM,SPE] |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the efficacy of epidural labor analgesia in prevention of postpartum depression using Edinburgh Postnatal Depression Scale [EDPS]
|
At 2weeks 4weeks 6weeks from date of delivery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the effect of epidural analgesia on duration of labour
To study the effect of epidural analgesia on fetal outcome using APGAR score
To study the maternal satisfaction using Maternal satisfaction scale. |
Pain [ vas score] measure before epidural, 30min after epidural, 2Hourly upto delivery of the baby
APGAR score measure at 1min & 5min
maternal satisfaction score after 24hrs of epidural catheter placement |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
23/11/2025 |
| 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="1"
Months="6"
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 Institutional Ethics Committee approval and Informed Patient Consent, a total 72, patients of ASA I-III, and age group of 18 to 30 years planning to give birth electively via a normal vaginal route, allocated into two groups (36 in each group), In this study Group I Epidural Labor Analgesia Group II No intervention Patient preference for the decision of the group slection will be done In group 1 18 G Epidural catheter placement after local infiltration at level L3-L4,L4-L5 when cervical dilatation will reach 3-5cm Test dose of 3ml Lidocaine 1.5 %with adr [1:200000] will be given Patient will receive a bolus dose of ropivacaine 0.2% [ 10 -20ml] plus fentanyl 10mcg via epidural catheter Followed by continuous infusion of 0.2% ropivacaine 20ml Plus 40mcg fentanyl at rate of 6 to 10ml per hr Then following parameters to be study 1 maternal Hemodynamics 2fetal heart rate 3 pain [ vas score] 4Apgar score 5 edinburgh postnatal depression scale 6 maternal satisfaction scale
|