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Background: Cardiac disease in pregnancy is a major contributor to maternal mortality in high, middle and low-income countries. Availability of data on outcomes of pregnancy in women with heart disease is important for planning resources to reduce maternal mortality. Prospective data on outcomes and risk predictors of mortality in pregnant women with heart disease (PWWHD) from low- and middle-income countries are scarce. Methods: The Tamil Nadu Pregnancy and Heart Disease Registry (TNPHDR) is a prospective, multicentric and multidisciplinary registry of PWWHD from 29 participating sites including both public and private sectors, across the state of Tamil Nadu in India. The TNPHDR is aimed to provide data on incidence of maternal and fetal outcomes, adverse outcome predictors, applicability of the modified World Health Organization (mWHO) classification of maternal cardiovascular risk and the International risk scoring systems (ZAHARA and CARPREG I & II) in Indian population and identify possible gaps in the existing management of PWWHD. Pregnancy and heart teams will be formed in all participating sites. Baseline demographic, clinical, laboratory and imaging parameters, data on counselling received, antenatal triage and management, peripartum management and postpartum care will be collected from 2500 eligible participants as part of the TNPHDR. Participants will be followed up at one, three and six-months after delivery/termination of pregnancy to document study outcomes. Predictors of maternal and foetal outcome will be identified. Discussion: The TNPHDR will be the first representative registry from low- and middle-income countries aimed at providing crucial information on pregnancy outcomes and risk predictors in PWWHD. The results of TNPHDR could help to formulate steps for improved care and to generate a customised and practical guideline for managing pregnancy in women with heart disease in limited resource settings. Trial registration: The TNPHDR is registered under Clinical Trials Registry-India (CTRI/2020/01/022736).
The TNPHDR is aimed to (i) analyze the socio-demographic and clinical profile of various heart diseases observed during pregnancy, (ii) measure the fetal and maternal outcomes and identify predictors of those outcomes, (iii) examine the applicability of the modified World Health Organization (mWHO) classification of maternal cardiovascular risk [18, 19] (Table (Table1),1), and the appropriateness of the available risk prediction scoring systems based on data from high-income countries such as CARPREG I & II score [20, 21] and ZAHARA score [22] (Table (Table2)2) in LMICs, (iv) propose a risk scoring system unique for LMIC population, and (v) develop an evidence-based guideline for management of PWWHD in LMIC settings. Modified WHO Classification of heart disease in pregnancy [17, 18] • Small or mild (Pulmonary stenosis, patent ductus arteriosus, mitral valve prolapse • Successfully repaired simple lesions (atrial or ventricular septal defect, patent ductus arteriosus, anomalous pulmonary venous drainage) • Atrial or ventricular ectopic beats-isolated • Unoperated atrial septal defect or ventricular septal defect • Repaired tetralogy of Fallot • Most arrhythmias (supraventricular arrhythmias) • Turner syndrome without aortic dilatation • Mild LV impairment (EF >45%) • Hypertrophic cardiomyopathy • Native or tissue valve disease not considered WHO I or IV (mild MS, moderate AS) • Marfan or other HTAD syndrome without aortic dilatation • Aorta <45 mm in BAV pathology • Repaired coarctation • Atrioventricular septal defect • Moderate LV impairment (EF 30–45%) • Previous PPCM without any residual LV impairment • Mechanical valve • Systemic RV with good or mildly decreased ventricular function • Fontan circulation- uncomplicated, stable patient • Unrepaired CHD • Other complex heart disease • Moderate MS • Severe asymptomatic AS • Moderate aortic dilatation (40–45 mm in Marfan syndrome or other HTAD; 45–50 mm in BAV, Turner syndrome ASI 20–25 mm/m2, TOF <50 mm) • Ventricular tachycardia • Pulmonary arterial hypertension • Severe systemic ventricular dysfunction (EF 45 mm in Marfan syndrome or other HTAD, >50 mm in BAV, Turner syndrome ASI >25 mm/m2, TOF >50 mm) • Vascular EDS • Severe (re)coarctation, Fontan with any complication PPCM Peripartum Cardiomyopathy, LV Left Ventricle, RV Right Ventricle, EF Ejection fraction, EDS Ehlers Danlos syndrome, MS Mitral Stenosis, AS Aortic Stenosis, HTAD Heritable Thoracic Aortic Disease, ASI Aortic Size Index, CHD Cyanotic Heart Disease, BAV Bicuspid Aortic Valve Details of risk scores analysed in the TNPHDR (Parameters with points assigned) * LV ejection fraction < 55%; # Aortic Valve area 30 mm of Hg or Mitral stenosis 50 mm of Hg or AVA < 1 cm2 HF Heart Failure, TIA Transient Ischemic Attack, AVA Aortic valve area, LV Left ventricle, RVSP right ventricular systolic pressure, AV Atrioventricular valve, CHD Congenital Heart disease, MVA Mitral Valve Area, LVOT Left Ventricular Outflow Tract All public and private hospitals with inhouse cardiology and obstetric services across the state of Tamil Nadu were eligible for enrollment as a participating site in the TNPHDR. The interested sites were requested to form a pregnancy and heart team with members from the departments of obstetrics, cardiology, pediatrics/neonatology and anesthesia to be responsible for the care of those participants enrolled in TNPHDR. The government of Tamil Nadu organized pregnancy and heart teams in all the eligible 23 government medical college teaching hospitals in Tamil Nadu and ensured their participation in the registry. Additionally, six leading private hospitals in Tamil Nadu also enrolled in the registry (Additional file 1, online supplement). The spread of the selected sites across the state of Tamil Nadu is given in Fig. 1. A premier public hospital at the state capital was chosen as the nodal coordinating center of TNPHDR. The pregnancy and heart team sensitization and TNPHDR sensitization training are conducted at each of the participating sites by the nodal center. Site investigators and co-investigators are chosen from the pregnancy and heart team of the participating sites. Map of participating sites in the TNPHDR. This figure shows the location of the 28 participating sites and the nodal center in the political map of Tamil Nadu, the southernmost state of India. ( adapted from www.d-maps.com) The TNPHDR is a prospective observational registry enrolling all antenatal women seeking outpatient or inpatient care in any of the participating sites with known or newly diagnosed structural heart disease, cardiac rhythm disorders or aortopathy/vascular diseases from 15th of January 2020 to 31st March 2021 or till at least 2500 eligible participants are enrolled. Antenatal patients will be enrolled at any trimester when they first enter the institution. Women with eligible heart disease seen after delivery will be included in the first six weeks postpartum. Inclusion for women with peripartum cardiomyopathy will be allowed up to six months postpartum. Collected data will be protected for privacy with all standard precautions. For example, each enrolled participant will be assigned a unique autogenerated TNPHDR identification number by which they will be identified subsequently. The unique number will remain the same despite inter-institutional transfer. Patients with pregnancy related complications like gestational hypertension, anemia, eclampsia, and gestational diabetes without structural heart disease will be excluded from the TNPHDR. Patients with trivial / mild regurgitation of the cardiac valves will be excluded, unless associated with other eligible heart diseases. The “case report form (CRF) booklet” (provided as Additional file 2, online supplement) was developed based on the inputs of investigators of the participating sites and was finalized at the first investigators meeting organized at the National Health Mission, Government of Tamil Nadu, Chennai. The study variables will include baseline demographics, presenting symptoms, NYHA class, modified WHO classification, TNPHDR classification, clinical findings, baseline investigations, ECG and echocardiographic data, risk scores such as CARPREG I and CARPREG II and ZAHARA (Table (Table2).2). Data will be collected in the printed CRF booklets distributed to all participating sites. It will then be converted to an electronic format by using an online CRF web application platform. In addition, an Android/ iOS application will be also made available with facilities for both online and offline data entry. All the investigators will be provided with a username and password for restricted access to the data application. The nodal center will access, guide and support the online CRF data entry by the participating sites. The TNPHDR data will be stored in an encrypted format. The necessary backup of the database will be done every day in the evening (5 PM) to local servers at the nodal center as an added security measure. A standard operating procedure (SOP) will be formulated and circulated to all the participating centers (Additional file 3, online supplement) to enable understanding of the registry process and CRF entry. The antenatal patients with cardiac disease will be initially triaged as high-risk cardiac illness and low-risk cardiac illness during their registration based on the mWHO classification of maternal cardiovascular risk (Table (Table1).1). Patients belonging to mWHO I and II will be classified as low-risk, and patients belonging to mWHO II-III, III and IV as high-risk groups. More frequent follow up as per existing guidelines [23] will be recommended for high-risk patients including early hospitalization for safe delivery and child birth as appropriate. However, the frequency and components of follow up will be decided as per the discretion of the participating site investigators or according to the institutional protocol of each participating sites. Antenatal mothers and their families will be counselled about their cardiac condition, its impact on maternal and fetal outcome, the importance of periodic monitoring and pharmacotherapy and the role of healthcare in supporting them through the pregnancy. Termination of pregnancy will be advised for the mWHO IV patients as applicable. However, if the patient chooses to continue the pregnancy against the medical advice, she will be under close monitoring and supervision throughout pregnancy. Details of optimisation of cardiac medications, safe delivery and childbirth in high-risk patients, anticoagulant management of patients with prosthetic valve in the first trimester, management of complications, interventional procedures like valvotomy will be documented. The intra and postpartum management will be taken care by the respective pregnancy and heart teams. Details of the mode of delivery, the type of anesthesia/analgesia, outcome, complications, and management will be documented for all the patients. Patients will undergo a detailed clinical examination and echocardiographic assessment before discharge. Counselling provided will include discussions on need and timing of further follow up, cardiac medications, appropriate contraceptive methods, spacing, breast feeding etc. All patients enrolled in the TNPHDR will be actively followed up for a period of 6 months from the date of delivery/termination of pregnancy. During this time data will be collected at one month, three-month and six-month time points either during the clinical visits or by telephonic calls. At least one clinical follow up including an echocardiographic assessment is mandatory during follow up (Fig. (Fig.22). The process of TNPHDR. This figure illustrates the typical process of how a patient is enrolled in the TNPHDR and is followed up till completion of the data collection at 6 months post termination Initial sensitization cum training program about the TNPHDR and about pregnancy and heart team was conducted for all the site investigators in December 2019. In addition, periodic refresher trainings will be done at the individual sites. The site investigators are encouraged to train their team on data collection and entry in the online platform. Online pregnancy and heart team groups have been formed for each site, which also includes members from the central coordinating nodal team, to discuss any queries on patient management and data entry.
