| CTRI Number |
CTRI/2024/09/074396 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| 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 study whether if adequate pain relief during labour results in reduction of incidence of postpartum depression |
|
Scientific Title of Study
|
An observational study to evaluate relation of intrapartum VAS scores with postpartum depression |
| 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 Anesthesiology, Indira Gandhi Medical College, Shimla, Himachal Pradesh
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418059643 |
| Fax |
|
| Email |
dara-negi556@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GURMANPAL SINGH |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College |
| Address |
Department Of Anesthesiology, Indira Gandhi Medical College, Shimla, Himachal Pradesh
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9914415252 |
| Fax |
|
| Email |
gurmananaesthesia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GURMANPAL SINGH |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College |
| Address |
Department Of Anesthesiology, Indira Gandhi Medical College, Shimla, Himachal Pradesh
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9914415252 |
| Fax |
|
| Email |
gurmananaesthesia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anesthesiology, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India, Pin code :171001. |
|
|
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 DARA SINGH NEGI |
Indira Gandhi Medical College, Shimla, Himachal Pradesh, India |
Department Of Anesthesiology, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India, Pin code :171001 Shimla
HIMACHAL PRADESH
Shimla
HIMACHAL PRADESH |
9418059643
dara-negi556@hotmail.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: O758||Other specified complications of labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural Labor Analgesia |
Epidural labour analgesia will be given to the parturients who opt for labor analgesia via epidural with injection 0.1% Ropivacaine 8-10 ml with 2micrograms/ml of injection fentanyl as a bolus dose followed by hourly topup of injection 0.1% ropivacaine 2-3ml till the parturient is delivered. |
| Comparator Agent |
No treatment |
The patrurients who opt out will not receive epidural labor analgesia for pain relief. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida, singleton pregnancy, cephalic presentation with no cpd, gestational age of 37 weeks or more, active stage of labour, normal obstetrics and medical history. |
|
| ExclusionCriteria |
| Details |
History of depression/psychiatric illness, multiple gestation, preterm pregnancy, malpresentation, presence of medical complications (preeclampsia, diabetes, neurological disorders), allergy to local anaesthetics, fetal distress. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the relationship between intrapartum pain relief with incidence of postpartum depression in primigravida females undergoing normal vaginal delivery. |
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare patient satisfaction in patients opting for epidural labour analgesia with those opting for normal labour without any analgesia. |
Till delivery |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
29/09/2024 |
| 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 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
|
The labor pain is probably the most severe pain that most women endure in their lifetime. Since pain relief in labor has always been surrounded by myths and controversies, providing effective and safe analgesia in labor have remained a perennial challenge. In the non-obstetric population, the association between chronic pain and depression has been well established.For most women, childbirth is one of the most painful and stressful events during their lives and can result in long-term maternal morbidity. The association between the intensity of childbirth pain and mood disorders, including post-traumatic stress and postpartum depression , in the immediate postpartum period has been proposed, but this association has not been well studied. Central neuraxial analgesia is the gold standard technique for pain relief in labour. Among these, epidural blockade comes close to being the ideal analgesic technique in labour. It provides continuous analgesia for an unpredictable period of time and to convert analgesia to anaesthesia if an operative intervention becomes necessary.After thorough search of literature , we could not find any study that could provide significant evidence that effective labour analgesia could result in decrease in incidence of postpartum depression , hence we would like to proceed with our study of finding relation between intrapartum VAS scores with postpartum depression.
|