| CTRI Number |
CTRI/2024/11/076105 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To compare VAS scores in parturients after giving labor epidural analgesia to those without any analgesia and further assessing the lactation in them. |
|
Scientific Title of Study
|
A comparative study to determine the relationship of intrapartum pain (VAS) scores with lactation in parturients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dara Singh Negi |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Medical College |
| Address |
Department of Anaesthesia, Indira Gandhi Medical College, Ridge- Sanjauli Road, Lakkar Bazar, Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418059643 |
| Fax |
|
| Email |
dara_negi556@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dara Singh Negi |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Medical College |
| Address |
Department of Anaesthesia, Indira Gandhi Medical College, Ridge- Sanjauli Road, Lakkar Bazar, Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418059643 |
| Fax |
|
| Email |
dara_negi556@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi Gupta |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College |
| Address |
Department of Anaesthesia, Indira Gandhi Medical College, Ridge- Sanjauli Road, Lakkar Bazar, Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
8859276207 |
| Fax |
|
| Email |
guptamansi142@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Medical College , ridge Sanjauli Road, Lakkar Bazar, Shimla, Himachal Pradesh-171001, India |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College, |
| Address |
Ridge- Sanjauli Road, Lakkar Bazar, Shimla, Himachal Pradesh - 171001 |
| 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 |
| Dr Mansi Gupta |
Indira Gandhi Medical College |
Department of Anaesthesia, IGMC, Ridge- Sanjauli Road, Lakkar Bazar-171001,
Shimla
HIMACHAL PRADESH |
8859276207
guptamansi142@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira Gandhi Medical College, Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Labor epidural analgesia |
All the women opting for labor epidural analgesia will be given epidural analgesia whenever they demand keeping in mind the hypothesis that those receiving epidural analgesia will be having significantly lower VAS scores as compared to those who are not receiving any form of analgesia. This will be done in time period of 12 months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Women included in this study are with singleton pregnancy with cephalic presentation with POG of 37weeks or more. Women with active stage of labor who are willing for epidural anaesthesia and with no contraindication for epidural analgesia are to be taken.
|
|
| ExclusionCriteria |
| Details |
Women denying for epidural analgesia will not be taken in he study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the initiation of lactation in women with significantly lower VAS scores after receiving epidural analgesia to those with higher VAS scores. |
24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the relationship of maternal hyperthermia in patients with epidural analgesia and subsequently relating it with fetal hyperthermia and APGAR score. |
12hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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="0"
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
|
After thorough search of literature , we found that the effect of epidural analgesia in labor and effective breastfeeding is still being controversial. Therefore, we would like to proceed with our study to determine the relationship of labor epidural analgesia and lactation by comparing it with intraprtum pain (VAS) scores. |