| CTRI Number |
CTRI/2021/05/033545 [Registered on: 11/05/2021] Trial Registered Prospectively |
| Last Modified On: |
10/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Depression in Pregnant women due to COVID-19 pandemic in India |
|
Scientific Title of Study
|
To assess the impact of COVID-19 pandemic on depression among pregnant women-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 ROOPA B S |
| Designation |
LECTURER |
| Affiliation |
JSS COLLEGE OF PHARMACY,OOTY |
| Address |
DEPARTMENT OF PHARMACY PRACTICE,
ROCKLANDS
The Nilgiris
TAMIL NADU
643001
India |
| Phone |
6384845560 |
| Fax |
|
| Email |
roopabs@jssuni.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa B S |
| Designation |
LECTURER |
| Affiliation |
JSS COLLEGE OF PHARMACY,OOTY |
| Address |
DEPARTMENT OF PHARMACY PRACTICE
ROCKLANDS,
The Nilgiris
TAMIL NADU
643001
India |
| Phone |
9047155003 |
| Fax |
|
| Email |
roopabs@jssuni.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
SHONITHA S |
| Designation |
PHARM.D STUDENT |
| Affiliation |
JSS COLLEGE OF PHARMACY, OOTY |
| Address |
Department of Pharmacy Practice
ROCKLANDS
The Nilgiris
TAMIL NADU
643001
India |
| Phone |
6384845560 |
| Fax |
|
| Email |
shonithasagadevan@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JSS college of Pharmacy Ooty |
| Address |
JSS college of Pharmacy, Rocklands,Ooty The NIlgiris 643001,Tamilnadu, India |
| Type of Sponsor |
Research institution |
|
|
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 |
| ShonithaS |
Government Medical College and Hospital, Ooty |
Department of Obstetrics and Gynecology, Government Medical College and Hospital,Ooty,Near S.P office, Jail Hill Quarters, Hospital Road, Ooty, The Nilgiris, TamilNadu
The Nilgiris
TAMIL NADU |
6384845560
shonithasagadevan@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe of JSS College of Pharmacy, Rocklands, Ooty |
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, |
|
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Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Maternal age of 18 years or greater at the time of consent.
Gestational week: 32 to 40 weeks (Third trimester)
The ability to provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
Pregnant women with the gestational week under six (Early first trimester)
Pregnant women with chronic disease like chronic hypertension, kidney and liver disease, pre-pregnancy diabetes mellitus
Patient with reported depression in the past
History of use of anti-depressants and other drugs which cause depression.
History of high-risk pregnancy including abruption placenta, placenta previa, gestational diabetes, coagulation disorders, thrombocytopenia or history of drug abuse.
History of autoimmune diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Whether COVID-19 pandemic is a possible risk factor for the development of depression among the pregnant and non-pregnant women. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Whether the COVID-19 pandemic has an impact on the maternal outcomes at delivery and neonatal outcomes at birth |
6 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/05/2021 |
| Date of Study Completion (India) |
21/06/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
The research paper was published in the journal of Obstetrics and Gynecology in the month of September 2021. The volume, issue and page number are 71(S1): S28-S35. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The COVID-19 pandemic has affected the pregnant women both physically and mentally. The perceptions, appetite, sleep cycle, behavioral patterns, impact is not only with the pregnant women but also the newborn babies. However, there are only limited studies stating the major complications faced by the pregnant women during this pandemic.
Owing to the rapid increase in the virus spread India, mortality rate there is an increased burden among the pregnant women than that of the general population. When compared to other countries, only limited studies are conducted about the substantial increase in conditions like anxiety, stress, depression and panic in pregnant women who are undertaking medical care or want to seek medical care during this pandemic. Thus, this study focuses on to determine whether the COVID-19 pandemic is associated with antenatal depression during pregnancy and depression among non-pregnant women using Edinburgh Postnatal Depression Scale (EPDS), and to assess the maternal outcomes at delivery and neonatal outcomes at birth in Obstetrics and Gynecology department of Government Medical College Hospital. |