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CTRI Number  CTRI/2025/10/096336 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 21/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To know the prevalence and risk levels of heart diseases in pregnancy and its impact on the mothers and the baby. 
Scientific Title of Study   A cross sectional study of prevalence and risk stratification of cardiac disease (congenital and acquired cardiac diseases) in pregnancy as per Modified WHO Classification and maternal and perinatal outcomes. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gundapaneni venkatapriyanka 
Designation  MBBS, Post Graduate in MS Obstetrics and Gynaecology 
Affiliation  KLEH, JNMC, BELAGAVI 
Address  G-1 Labour room, Wards, MICU ICCU Department of Obstetrics and Gynaecology, KLES Dr. Prabhakar Kore Hospital and Medical Research Centre,JNMC,Belagavi.
New Pg hostel, JNMC, Belgum
Belgaum
KARNATAKA
590010
India 
Phone  7093779289  
Fax    
Email  gundapanenipriyanka1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrGauri Prabhu 
Designation  Associate Professor Department of Obstetrics and Gynaecology 
Affiliation  JNMC, Belgavi,  
Address  Nanawadi, Belagavi, Karnataka 590009

Belgaum
KARNATAKA
590009
India 
Phone  9743779674  
Fax    
Email  gaurikudchadkar@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Gundapaneni venkatapriyanka 
Designation  MBBS, Post Graduate in MS Obstetrics and Gynaecology 
Affiliation  KLEH, JNMC, BELAGAVI 
Address  G-1 Labour room, Wards, MICU ICCU Department of Obstetrics and Gynaecology, KLES Dr. Prabhakar Kore Hospital and Medical Research Centre,JNMC,Belagavi.

Belgaum
KARNATAKA
590010
India 
Phone  7093779289  
Fax    
Email  gundapanenipriyanka1@gmail.com  
 
Source of Monetary or Material Support  
Dr. KLES Prabhakar Kore hospital Jawaharlal nehru medical collage nehru nagar belgaum karnataka 590010  
 
Primary Sponsor  
Name  Gundapaneni Venkatapriyanka 
Address  JNMC, KLEH, BELAGAVI 
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 
Gundapaneni venkatapriyanka  KLES Dr Prabhakar Kore Hospital and Medical Research Centre, JNMC Belagavi  G-1 Labour room, Wards, MICU ICCU Department of Obstetrics and Gynaecology, KLES Dr. Prabhakar Kore Hospital and Medical Research Centre,JNMC,Belagavi.
Belgaum
KARNATAKA 		 7093779289

gundapanenipriyanka1@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 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  All pregnant women admitted in KLES Dr Prabhakar kore Hospital and MRC belgavi with congenital or acquired cardiac disease.
Age-18 to45 included in the study.
 
 
ExclusionCriteria 
Details  Pregnant women Not willing to participate in study.
Pregnant Women less than18 years or greater than 45 years 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the prevalence of cardiac disease in pregnancy (Congenital and Acquired cardiac disease) and risk stratification as per Modified WHO Classification.  First Visit To OPD and Labour room in KLEH , JNMC, BELGAVI 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the maternal and perinatal outcomes in patients with congenital and acquired cardiac disease and among corrected and uncorrected cardiac lesions.  First Visit To OPD and Labour room in KLEH , JNMC, BELGAVI 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   06/11/2025 
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="1"
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   Cardiac disease is one of the important causes of maternal mortality and morbidity in antepartum and postpartum period. Prevalence of heart disease in pregnancy vary from 0.3–3.5 %1. Pregnancy induces hemodynamic changes to meet the demands of the mother along with the fetus, which includes rise in blood volume and cardiac output and reduction in systemic vascular resistance coupled with blood pressure. This can lead to an increase in maternal and perinatal morbidity and mortality


Cardiac disease in pregnancy is broadly divided into congenital and acquired. The acquired group includes Rheumatic Heart Disease (RHD), cardiomyopathies and ischemic heart disease. In developing countries, RHD is the commonest type. Cardiomyopathies and congenital heart disease seem to be more common in developed countries2. The incidence of RHD among all cardiac disease is approximately 55.7 percent.

Hence this study is undertaken in an attempt to determine prevalence of cardiac disease in pregnancy and scientifically observe the maternal and fetal outcomes among pregnant women with heart diseases. Thus, also trying to fill the data void that is present with regards to this scenario.

We also aim to classify heart disease in pregnancy as per WHO modified classification.

 

·        Risk stratification of cardiac disease helps in management and improving prognosis of mother and baby.

·        Increased trend of post cardiac surgical cases with pregnancy has been noted over last 2 decades.

·        Study of outcomes in cardiac disease also guide us in formulating guidelines for pre conceptional counselling in cardiac disease.

 

·        Studies conducted in various parts of India highlighted the maternal and perinatal outcomes in pregnancy with heart disease . However studies focusing on Risk stratification and classification are limited. Hence we would like to do risk stratification.

 

·        This study may help to emphasize the need for development of cardio-obstetric unit in each tertiary care hospital to optimize maternal and fetal outcomes.

·        All pregnant women diagnosed with heart disease and admitted at labour room/Obstetric ward, cardiology ward and Cardiac intensive care unit of the hospital will be screened and included in the study after obtaining informed consent.

 

·        A Modified WHO Classification Criteria will be used to collect information on risk classification. It integrates all known maternal cardiovascular risk factors including underlying heart disease and comorbidity. The patients are classified as very low risk (class I), low to moderate risk (class II), high risk (class III) and extremely high risk (class IV).

·        Data is collected based on history (NYHA classification, based on symptoms any cardiac intervention done earlier, any oral cardiac medications, co-morbid conditions etc.,), clinical examination (general physical examination, chest auscultation), and investigations (ECG, Echocardiography). According to the underlying etiology, heart diseases is classified into congenital and acquired heart diseases. Each patient will be assigned under WHO risk category.

·        Maternal characteristics include age, parity, socioeconomic status,levels of education will be collected.

·        Past history-age at diagnosis of cardiac disease, h/o previous cardiac events. h/o previous cardiac correction/intervention, medication history will be taken.

·        In parous women, details of past obstetric history, mode of delivery, any antenatal/intranatal/postpartum cardiac complications and perinatal outcomes will be noted.

·        Present pregnancy history of medication details, any recent onset symptoms, any other obstetric associated high risk factors include anemia, preeclampsia, hypertension, GDM, thyroid diseases, respiratory diseases, renal diseases will be notes.

·        Mode of delivery intrapartum events, postpartum cardiac and obstetric events will be noted.

·        Information regarding neonatal outcomes in terms of birth weight, Apgar at birth, gestational age, need for NICU admission and any anomalies will be taken.

·        Status of mother and baby at discharge will be noted.


 
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