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Observational Study
. 2022 Jan 29;22(1):80.
doi: 10.1186/s12884-021-04305-3.

Tamil Nadu Pregnancy and Heart Disease Registry (TNPHDR): design and methodology

Justin Paul Gnanaraj  1 , S Anne Princy  2 , Karen Sliwa-Hahnle  3 , Sowmya Sathyendra  4 , Nambirajan Jeyabalan  5 , Ragothaman Sethumadhavan  6 , Selvarani G  7 , N Sumathi  7 , Vinotha S  8 , Pachaiappan P  9 , Vimali Murali  10 , Shanthirani B  11 , Gomathi T  12 , Muthuprabha P  13 , Panniyammakal Jeemon  14 , E Elavarasi  10 , Rajarajeshwari R  12 , Vijaya S  10 , Kanmani K  10 ; TNPHDR investigators
Affiliations
Observational Study

Tamil Nadu Pregnancy and Heart Disease Registry (TNPHDR): design and methodology

Justin Paul Gnanaraj et al. BMC Pregnancy Childbirth. .

Abstract

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 ).

Keywords: Heart disease; Maternal outcome; Mortality; Pregnancy; Risk prediction.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
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)
Fig. 2
Fig. 2
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
See this image and copyright information in PMC

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