| CTRI Number |
CTRI/2024/06/068830 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Screening for depression in mothers after delivery (postpartum) whose baby/babies were admitted in NICU. |
|
Scientific Title of Study
|
A one year hospital based cross sectional study of post-partum depression in mothers with neonates admitted to Neonatal Intensive Care Unit of KAHER, JNMC - Dr. Prabhakar Kore Charitable Hospital and MRC, Belagavi, Karnataka. |
| 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 V Shubhashree |
| Designation |
MS Post graduate |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Department of Obstetrics and Gynecology, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9483603837 |
| Fax |
|
| Email |
shubhashreeraov@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Dalal |
| Designation |
Professor and Guide |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Department of Obstetrics and Gynecology, KAHERs Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448140343 |
| Fax |
|
| Email |
anitamgan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anita Dalal |
| Designation |
Professor and Guide |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Department of Obstetrics and Gynecology, KAHERs Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448140343 |
| Fax |
|
| Email |
anitamgan@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Dr. Prabhakar Kore Charitable Hospital and Medical Research Centre, Nehru Nagar, Belagavi 590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr V Shubhashree |
| Address |
Department of Obstetrics and Gynecology, KAHERs Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi 590010, Karnataka |
| 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 |
| Dr V Shubhashree |
KAHERs Dr Prabhakar Kore Hospital and Medical Reaearch Centre |
Department of Obstetrics and Gynecology, OPD 10, KAHERs Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi 590010, Karnataka
Belgaum
KARNATAKA |
9483603837
shubhashreeraov@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F063||Mood disorder due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Postnatal women with postnatal/post operative day from 0 to 42 days with neonates admitted in NICU and those who give consent for the study will be included |
|
| ExclusionCriteria |
| Details |
Mothers with prior psychiatric illness and those mothers who denied giving consent will be excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the prevalence of postpartum depression in the mothers of neonates admitted to Neonatal Intensive Care unit |
postpartum period day 1 to day 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the socio-demographic, maternal & neonatal factors associated with postpartum depression |
postpartum period day 1 to day 42 |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
01/07/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shubhashreeraov@gmail.com].
- For how long will this data be available start date provided 31-08-2025 and end date provided 01-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to estimate the prevalence of postpartum depression in the mothers with neonates admitted to NICU and also to determine the socio-demographic, maternal and neonatal factors associated with it. This observational, hospital based, cross sectional study conducted in KAHER, JNMC - Dr Prabhakar Kore Charitable Hospital and MRC, Belagavi, Karnataka for a period of one year involve mothers with neonates admitted in NICU. The present study involves systematic random sampling technique and the methodology and data collection procedure include mothers with neonates admitted in NICU, who are called at around 6 to 10 weeks postpartum for an interview to screen for postpartum depression. Telecommunication method is also encouraged. Currently, postpartum depression screening is not regarded as a standard of care. But recommendations suggest health care providers should assess and monitor postpartum depression symptoms throughout the initial year of childbirth. Due to time constraints, negligence and concerns about the social acceptability of screening, these disorders are often undiagnosed and untreated. Additionally, there is limited exploration of this field in Indian studies. Thus, the current study was initiated to assess postpartum depression in mothers with neonates admitted in NICU. |