| CTRI Number |
CTRI/2025/09/095124 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of Epidural pain relief during labour and its influence on postpartum depression. |
|
Scientific Title of Study
|
Postpartum Depression in women with and without labor Epidural Analgesia: A prospective cohort 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 |
Dr Maramreddy Sravani |
| Designation |
DNB - Student |
| Affiliation |
Naruvi Hospitals, Vellore |
| Address |
Department of Obstetrics and Gynaecology
Naruvi hospitals, Chennai- Bengaluru Highway , 72, Collectors office road, Vellore, Tamil nadu
Vellore
TAMIL NADU
632004
India |
| Phone |
9160155101 |
| Fax |
|
| Email |
sravanimaramreddy95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeyasheela Kamaraj |
| Designation |
Senior Consultant |
| Affiliation |
Naruvi Hospitals, Vellore |
| Address |
Department of Obstetrics and Gynaecology
Naruvi hospitals, Chennai- Bengaluru Highway , 72, Collectors office road, Vellore, Tamil nadu
Vellore
TAMIL NADU
632004
India |
| Phone |
9566493852 |
| Fax |
|
| Email |
jeyasheela.kamaraj6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maramreddy Sravani |
| Designation |
DNB - Student |
| Affiliation |
Naruvi Hospitals, Vellore |
| Address |
Department of Obstetrics and Gynaecology
Naruvi hospitals, Chennai- Bengaluru Highway , 72, Collectors office road, Vellore, Tamil nadu
Vellore
TAMIL NADU
632004
India |
| Phone |
9160155101 |
| Fax |
|
| Email |
sravanimaramreddy95@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Naruvi hospitals |
| Address |
Chennai- Bengaluru highway,72, collectors office road, vellore, tamil nadu
Pin - 632004 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Maramreddy Sravani |
Naruvi hospitals |
Department of Obstetrics and Gynaecology
Chennai- Bengaluru highway, 72, collectors office road, vellore, tamil nadu
Vellore
TAMIL NADU |
9160155101
sravanimaramreddy95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Naruvi Hospitals - Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O906||Postpartum mood disturbance, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Mothers willing to participate in the study
2.Primigravida / Multigravida
3.Singleton, term pregnancies with vertex presentation |
|
| ExclusionCriteria |
| Details |
1.Mothers unwilling to participate in the study
2.Multiple gestation.
3.Elective caesarean section.
4.History of cognitive or psychiatric disturbances during pregnancy/past.
5.Thyroid and seizure disorders.
6. Intra Uterine Fetal Demise. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the association between the use of labour Epidural Analgesia and the incidence of Postpartum Depression as measured by the Edinburgh Postnatal
Depression Scale (EPDS). |
2 & 6 weeks postpartum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the association between the level of pain relief during labour (using VAS score) and postpartum depression. |
2 & 6 weeks postpartum |
To evaluate the influence of other potential confounding factors (maternal age, parity,
socio economic status, mode of delivery) on the development of postpartum depression. |
2 & 6 weeks postpartum |
| To assess neonatal outcomes (Apgar score, NICU admission) in relation to the use of labour epidural analgesia. |
Immediate post delivery |
| To study the incidence of immediate postpartum complications (e.g., fever, urinary retention, blood loss, prolonged second stage of labour) in women who received epidural analgesia and their association with postpartum depression. |
Immediate, 2 & 6 weeks postpartum |
|
|
Target Sample Size
|
Total Sample Size="196"
Sample Size from India="196"
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)
|
30/09/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 thesis presents a prospective cohort study investigating the association between labor epidural analgesia and the incidence of postpartum depression (PPD) in women delivering at Naruvi Hospitals, Vellore. The research will enroll women aged 18–35 years with term singleton pregnancies, dividing them into epidural and non-epidural groups by patient choice. Outcomes including maternal, neonatal, and PPD rates measured by the Edinburgh Postnatal Depression Scale at 2 & 6 weeks postpartum will be compared. The study aims to clarify whether pain relief during labor through epidural analgesia can reduce PPD risk and to identify related clinical and sociodemographic factors |