| 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
|
|
|
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
|
|
|
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. |