| CTRI Number |
CTRI/2025/03/081757 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A retrospective observational study on peripartum cardiomyopathy in pregnancy and postpartum |
|
Scientific Title of Study
|
Peripartum cardiomyopathy A rare and threatening form of heart failure |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MDC/JNMCIEC/434 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mrutyunjaya B Bellad |
| Designation |
Professor |
| Affiliation |
KAHER’s DR PRABHAKAR KORE MEDICAL HOSPITAL AND RESEARCH CENTRE |
| Address |
KAHER’s Jawahar Lal Nehru Medical college Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448124893 |
| Fax |
|
| Email |
mbbellad@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrutyunjaya B Bellad |
| Designation |
Professor |
| Affiliation |
KLE’s Dr PRABHAKAR KORE MEDICAL HOSPITAL AND RESEARCH CENTRE |
| Address |
KAHERsJawahar Lal Nehru Medical College ,Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448124893 |
| Fax |
|
| Email |
mbbellad@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrutyunjaya B Bellad |
| Designation |
Professor |
| Affiliation |
KLE’s Dr PRABHAKAR KORE MEDICAL HOSPITAL AND RESEARCH CENTRE |
| Address |
KLE’s JAWAHAR LAL NEHRU MEDICAL COLLEGE , Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448124893 |
| Fax |
|
| Email |
mbbellad@hotmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs DR PRABHAKAR KORE HOSPITAL and MEDICAL RESEARCH CENTRE ,
Nehru Nagar
Belagavi
INDIA
590010 |
|
|
Primary Sponsor
|
| Name |
Dr Mrutyunjaya B Bellad |
| Address |
KAHERs DR PRABHAKAR KORE HOSPITAL and MEDICAL RESEARCH CENTRE ,
Nehru Nagar
Belagavi
INDIA 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 Mrutyunjaya Bellad |
KAHERs DR Prabahakar Kore Medical Hospital and Research Centre |
ROOM NUMBER 10 Department of OBSTETRICS AND GYNAECOLOGY, Floor 1 Division left wing
Belgaum
KARNATAKA |
9448124893
mbbellad@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I420||Dilated cardiomyopathy, |
|
|
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 |
All women aged 18 years and above admitted to kle hospital in view of peripartum cardiomyopathy |
|
| ExclusionCriteria |
| Details |
Pregnant women with known cause of heart disease with LVEF dysfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the maternal and Fetal outcomes in PPCM |
Jan 2017 to March 2024 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Follow up after delivery |
6 months post partum |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
23/03/2025 |
| 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="7"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
This is a retrospective observational study for knowing the maternal and Fetal outcomes of peripartum cardiomyopathy . This study is conducted at IPD patients at KAHER’s JNMC MEDICAL COLLEGE BELAGAVI after waiver of ethical clearance and informed consents There has been an increase in peripartum cardiomyopathy in recent times , which can be owed to increasing trends in pre eclampsia and thyroid diseases . This study aimed at knowing the outcomes of peripartum cardiomyopathy in mother and neonates and the associated risk factors , so that it can be prevented in next conception. |