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临床试验/CTRI/2025/10/096336
CTRI/2025/10/096336尚未招募不适用

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.

Gundapaneni Venkatapriyanka1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To study the prevalence of cardiac disease in pregnancy (Congenital and Acquired cardiac disease) and risk stratification as per Modified WHO Classification.

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 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.

排除标准

  • Pregnant women Not willing to participate in study.
  • Pregnant Women less than18 years or greater than 45 years.

结局指标

主要结局

To study the prevalence of cardiac disease in pregnancy (Congenital and Acquired cardiac disease) and risk stratification as per Modified WHO Classification.

时间窗: First Visit To OPD and Labour room in KLEH , JNMC, BELGAVI

次要结局

  • 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)

研究者

发起方
Gundapaneni Venkatapriyanka
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Gundapaneni venkatapriyanka

KLEH, JNMC, BELAGAVI

研究点 (1)

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