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CTRI Number  CTRI/2026/01/100939 [Registered on: 13/01/2026] Trial Registered Prospectively
Last Modified On: 12/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Postpartum Blues in New Mothers and it's effect on early breastfeeding. 
Scientific Title of Study   Prevalence of postpartum blues and its impact on early breastfeeding - A cross sectional study 
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 Hina Jakirhusen Vadgaonkar 
Designation  MBBS , MD-PSYCHIATRY RESIDENT 
Affiliation  Jawaharlal Nehru Medical college ,KLE University,Nehru Nagar,Belagavi. 
Address  Department of Psychiatry,Jawaharlal Nehru Medical college ,KLE Academy of Higher Education and Research,Belagavi. Belgaum KARNATAKA Pin -590001

Belgaum
KARNATAKA
590001
India 
Phone  8080062120  
Fax    
Email  vadgaonkarhina@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bheemsain Tekkalaki 
Designation  Associate Professor (MD Psychiatry), Department of Psychiatry 
Affiliation  Jawaharlal Nehru Medical college ,KLE University,Nehru Nagar,Belagavi. 
Address  Department of Psychiatry,Jawaharlal Nehru Medical college ,KLE Academy of Higher Education and Research ,Belagavi. Belgaum KARNATAKA Pin -590001

Belgaum
KARNATAKA
590001
India 
Phone  9886674849  
Fax    
Email  tbheemsain@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bheemsain Tekkalaki 
Designation  Associate Professor (MD Psychiatry), Department of Psychiatry 
Affiliation  Jawaharlal Nehru Medical college ,KLE University,Nehru Nagar,Belagavi. 
Address  Department of Psychiatry,Jawaharlal Nehru Medical college ,KLE Academy of Higher Education and Research ,Belagavi. Belgaum KARNATAKA Pin -590001

Belgaum
KARNATAKA
590001
India 
Phone  9886674849  
Fax    
Email  tbheemsain@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College ,KLE University ,Belagavi- 590001 
 
Primary Sponsor  
Name  Dr Hina Vadgaonkar 
Address  Department of Psychiatry ,KAHER ,Jawaharlal Nehru Medical College,Belagavi ,Karnataka 590010 
Type of Sponsor  Other [SELF] 
 
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 
Dr Hina Vadgaonkar  KLES Dr Prabhakar Kore Hospital and MRC, BELAGAVI  Maternity Ward, KLES Dr Prabhakar Kore hospital and MRC,Belagaum, Karnataka
Belgaum
KARNATAKA 
8080062120

vadgaonkarhina@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ALL POSTPARTUM WOMEN WHO DELIVERED IN PAST 1 WEEK 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.ALL POSTPARTUM WOMEN WHO RECENTLY DELIVERED IN PAST 1 WEEK ,IN MATERNITY WARD IN KLES DR. PRABHAKAR KORE HOSPITAL AND MRC .

2.THOSE WHO ARE WILLING TO GIVE CONSENT. 
 
ExclusionCriteria 
Details  1.MOTHERS WITH KNOWN PSYCHIATRIC ILLNESS BEFORE PREGNANCY.
2.MOTHERS WHOSE BABIES ARE SUFFERING FROM DEBILITATING MEDICAL ILLNESS.
3.MOTHERS WHOSE BABIES WERE STILLBORN/WITH NEONATAL DEATHS.
4.MOTHERS WITH SUBSTANCE ABUSE EXCEPT NICOTINE USE DISORDER. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To estimate prevalence of postpartum blues in postpartum mothers.  At the time of evaluation i.e within 1 week after pregnancy. 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the impact of postpartum blues on early breatfeeding practices.

2.To evaluate the sociodemographic & clinical factors association with postpartum blues. 
At the time of evaluation i.e within 1 week of postpartum period. 
 
Target Sample Size   Total Sample Size="290"
Sample Size from India="290" 
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)   26/01/2026 
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="3"
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 - NO
Brief Summary  

Title –Prevalence of Postpartum Blues and it’s impact on early breastfeeding –A cross sectional study.


Postpartum blue is a transient, mild mood disturbances such as mood swings , irritability ,sadness, tearfulness , anxiety along with sleep disturbances that occurs in days following childbirth which peaks around fifth day postpartum.

Postpartum blues interfere with the maternal-infant bonding and breastfeeding. Maternity blues is a strong warning sign of postpartum depression.This study will be conducted in KLES Dr Prabhakar Kore Hospital and MRC, Belagavi.

This will include postpartum women who recently delivered in past 1 week and are admitted in maternity ward of KLES Dr. Prabhakar Kore Hospital and MRC ,Belagavi and those who are willing to give consent.


Mothers with known psychiatric illness before pregnancy , mothers whose babies are suffering from debilitating medical illness , mothers whose babies are stillborn and mothers with substance use except nicotine use disorders are excluded from the study.

Data samples of all postpartum mothers will be collected ,their sociodemographic details will be taken. Following this they will be interviewed through a questionnaire to assesss postpartum blues. This data will be compared with mothers who have postpartum blues and those who do not have postpartum blues.

Later, Mothers will also be interviewed through a questionnaire to assess the impact of postpartum blues on  breatfeeding.This study will ultimately aim to promote timely interventions in mothers with postpartum blues and to give better postnatal care.

 
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