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CTRI Number  CTRI/2026/03/107208 [Registered on: 30/03/2026] Trial Registered Prospectively
Last Modified On: 13/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   This study checks how often pregnant women and new mothers feel very sad, worried, or anxious. It looks at these feelings during pregnancy and after the baby is born. It also studies whether these emotional problems are connected to health problems during pregnancy. 
Scientific Title of Study   PREVALANCE OF DEPRESSION AND ANXIETY IN PREGNANCY AND POSTPARTUM PERIOD AND THEIR ASSOCIATION WITH COMPLICATIONS OF PREGNANCY 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHWETA 
Designation  PRIMARY DNB RESIDENT 
Affiliation  DR BABA SAHEB AMBEDKAR MEDICAL COLEGE AND HOSPITAL SECTOR 6 ROHINI DELHI 
Address  OBG DEPARTMENT DR BABA SAHEB AMBEDKAR MEDICAL COLEGE AND HOSPITAL SECTOR 6 ROHINI DELHI

North West
DELHI
110085
India 
Phone  9878613878  
Fax    
Email  msbsahosp.delhi@nic.in  
 
Details of Contact Person
Scientific Query  
Name  Shikha Chadha 
Designation  SPECIALIST 
Affiliation  OBG DEPARTMENT DR BABA SAHEB AMBEDKAR MEDICAL COLLEGE AND HOSPITAL SECTOR 6 ROHINI DELHI 
Address  OBG DEPARTMENT DR BABA SAHEB AMBEDKAR MEDICAL COLLEGE AND HOSPITAL SECTOR 6 ROHINI DELHI

North West
DELHI
110085
India 
Phone  7065023133  
Fax    
Email  shikhapasrija@gmail.com  
 
Details of Contact Person
Public Query  
Name  SHIKHA CHADHA  
Designation  SPECIALIST 
Affiliation  OBG DEPARTMENT DR BABA SAHEB AMBEDKAR MEDICAL COLLEGE AND HOSPITAL SECTOR 6 ROHINI DELHI 
Address  OBG DEPARTMENT DR BABA SAHEB AMBEDKAR MEDICAL COLLEGE AND HOSPITAL SECTOR 6 ROHINI DELHI

North West
DELHI
110085
India 
Phone  7065023133  
Fax    
Email  msbsahosp.delhi@nic.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr baba saheb ambedkar medical college and hospital 
Address  OBG Department Dr baba saheb ambedkar medical college and hospital Sector 6 Rohini Delhi 110085 India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SHWETA  DR BABA SAHEB AMBEDKAR HOSPITAL AND MEDICAL COLLEGE  OPD ROOM 1203 FIRST FLOOR OBG DEPARTMENT DR BABA SAHEB AMBEDKAR HOSPITAL AND MEDICAL COLLEGE SECTOR 6 ROHINI DELHI 110085 INDIA
North West
DELHI 		 9878613878

shwetabullar27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr baba saheb ambedkar medical college and hospital ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O288||Other abnormal findings on antenatal screening of mother,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1 Women aged more than 18 years of age
2 Women in first trimester of pregnancy attending ANC 
 
ExclusionCriteria 
Details  Women with known psychiatric disorders who are receiving treatment for mental health disorders.
Women who are unable to understand or respond to the questionnaires 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the prevalence of depression generalised anxiety and pregnancy related anxiety in pregnant women over the course of pregnancy and postpartum period  First trimester second trimester third trimester and postpartum period 
 
Secondary Outcome  
Outcome  TimePoints 
To examine the association of these mental health issues with complications of maternal and fetal outcome
To find the clinical and demographic corelates of depression and anxiety 		 First trimester second trimester third trimester and postpartum period 
 
Target Sample Size   Total Sample Size="346"
Sample Size from India="346" 
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)   30/03/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - NO
Brief Summary  

We intend to find the prevalence of antenatal depression, generalized anxiety and pregnancy specific anxiety in the population served by our institute. We will be using three questionnaires: Edinburgh Postnatal Depression Scale (EPDS), GAD7 and PRAQ R2 for depression, generalised anxiety and pregnancy specific anxiety respectively (Annexure 1, 2, 3). Prospective follow up of patients will allow us to better understand the trends of these mental health issues in pregnancy. Descriptive insight into changes in depression and anxiety with treatment may also be obtained. We will also study the association of these mental health issues to the pregnancy complications and fetal outcome. The study will also help us find clinicodemographic corelates of these mental health issues.

 
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