| CTRI Number |
CTRI/2020/07/026373 [Registered on: 06/07/2020] Trial Registered Retrospectively |
| Last Modified On: |
03/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study to compare the levels of Depression, Anxiety, Stress and domestic violence in parents with history of recent stillbirth vs parents with live born infants |
|
Scientific Title of Study
|
Prospective case control study to compare the prevalence of Depression, Anxiety, Stress and domestic violence in post partum parents with history of recent stillbirth vs Parents with live born infants |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avir Sarkar |
| Designation |
junior resident |
| Affiliation |
PGIMER |
| Address |
gynae office room number 10.
third floor Nehru hospital,
PGIMER chandigarh
House number 459, Sector 15A, Chandigarh
Chandigarh
CHANDIGARH
160015
India |
| Phone |
6280765384 |
| Fax |
|
| Email |
avirsarkar93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sujata Siwatch |
| Designation |
Associate Professor |
| Affiliation |
PGIMER |
| Address |
Obstetrics and Gynecology
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
0172-2756331 |
| Fax |
|
| Email |
siwatch1@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
avir sarkar |
| Designation |
junior resident |
| Affiliation |
PGIMER |
| Address |
gynae office room number 10.
third floor Nehru hospital,
PGIMER chandigarh
House number 459, Sector 15A, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
6280765384 |
| Fax |
|
| Email |
avirsarkar1993@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
Sector 12 Cgandigarh |
| 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 |
| Avir Sarkar |
PGIMER |
Sector 12 Chandigarh
Chandigarh
CHANDIGARH |
6280765384
avirsarkar93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparing the total calculated scores of Depression, Anxiety, Stress and Domestic Violence |
Between parents of stillborn infants with parents of live infants |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Post partum parents willing to participate
2. Parents with history of recent stillbirth(within past 4 to 6 weeks)
3. Control group shall include parents of live infants
4. Consecutive stillbirth cases coming for post partum visit to PGIMER shall be included in the study
|
|
| ExclusionCriteria |
| Details |
1. Participants who refuse to give consent
2. Participants who have known psychiatric disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the prevelance of depression in post partum Indian parents with stillborn babies vs parents with live infants |
6 weeks postpartum visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of prevalance of anxiety, stress and domestic violence among parents with history of stillbirths versus those of live births
2. Comparison of psychological and pharmacological interventions required between the two groups |
6 weeks postpartum visit |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="600" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2019 |
| Date of Study Completion (India) |
31/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL
THIS IS A CASE CONTROL STUDY, NOT AN INTERVENTIONAL TRIAL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We are going to conduct a prospective case control study to assess the prevalence of depression, anxiety, stress and domestic violence in parents of stillborn infants vs. parents of live born infants at 4-6 weeks post partum
|