| CTRI Number |
CTRI/2020/10/028232 [Registered on: 05/10/2020] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Psychological effect of coronavirus disease 2019 on pregnant women |
|
Scientific Title of Study
|
Psychological impact of coronavirus disease 2019 on pregnant women presenting to our dedicated COVID hospital: A cross sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poonam Kumari |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of anaesthesia ,B block ,5th floor ,OT complex ,faculty lounge, AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
9473199126 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Kumari |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of anaesthesia ,B block ,5th floor ,OT complex ,faculty lounge, AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
9473199126 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Kumari |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of anaesthesia ,B block ,5th floor ,OT complex ,faculty lounge, AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
9473199126 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
Department of Obstetrics, AIIMS Patna |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS Patna |
Department of Obstetrics, AIIMS Patna |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Poonam Kumari |
Department of obstetric,AIIMS Patna |
Department of obstetric,AIIMS Patna,Phulwarisharif
Patna
BIHAR |
9473199126
drpoonam1981@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
consenting uncomplicated antenatal women in any the first to third trimester of pregnancy, with single fetus, confirmed by obstetrical examination and ultrasonography. |
|
| ExclusionCriteria |
| Details |
multiple pregnancies, complications of pregnancy (severe medical-surgical or psychiatric illness), physical handicap, and who suffered a major stressful life event in 6 months before conceiving (e.g., death of spouse or a close family member, marital separation or divorce,Pregnant patients with psychiatric illness, inability to comprehend |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| determine the stress or anxiety faced by COVID positive pregnant patients in due to their disease |
4 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| determine the stress or anxiety faced by COVID positive pregnant patients in due to their disease |
4 month |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
14/10/2020 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Covid 19 pandemic has become one of the central health emergencies of this generation. Our tertiary care hospital is catering to COVID positive pregnant patients who are presenting for obstetric care and covid related care in antenatal period. Stress and anxiety level may increase during infectious disease outbreaks. women may experience stress and anxiety associated with potential adverse obstetrical outcomes such as fetal death or fetal abnormalities. The cross-sectional study would be conducted among covid positive pregnant women admitted in our institute.The psychological impact of COVID-19 will be measured using an Indian version of the Impact of Event Scale-Revised (IES-R). Anxiety of COVID-19 will be measured by a Indian version of the 20-item of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). |