ArticleBMC pregnancy and childbirth2026
Development and validation of a prognostic model of postnatal circulation in fetuses with pulmonary atresia or critical pulmonary stenosis with intact ventricular septum: protocol for an observational cohort study with prospective validation.
Article in BMC pregnancy and childbirth, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07095829 (Development and Validation of a Prognostic Model of Postnatal Circulation in Fetuses With a Diagnosis of Pulmonary Atresia-critical Stenosis With Intact Ventricular Septum A Prospective Observational Cohort Study), which is not on this map. Not yet cited in PubMed.
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Development and Validation of a Prognostic Model of Postnatal Circulation in Fetuses With a Diagnosis of Pulmonary Atresia-critical Stenosis With Intact Ventricular Septum A Prospective Observational Cohort Study
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8 authors.
Funding
Abstract
backgroundPulmonary atresia or critical pulmonary stenosis with intact ventricular septum (PA/CS-IVS) is a rare and heterogeneous congenital heart disease with highly variable postnatal outcomes. Existing prenatal prognostic models are limited by small sample sizes, heterogeneity in echocardiographic variables, and suboptimal validation. Robust prenatal prediction of postnatal circulation is essential for parental counselling, perinatal planning, and selection of candidates for potential fetal intervention.
methodsThis international observational cohort study will include non-intervened fetuses with a prenatal diagnosis of PA/CS-IVS diagnosed between 16 + 0 and 28 + 6 weeks of gestation. Retrospective cases (from 2013 onwards) will be used for model development, and prospectively recruited cases for external validation. Standardized prenatal and postnatal echocardiographic data will be collected using predefined protocols and reviewed by a central core laboratory. Multivariable logistic regression models will be developed following TRIPOD recommendations, with internal validation by bootstrapping. Secondary analyses will explore longitudinal prenatal data and machine-learning approaches. DISCUSSION: This study aims to develop and validate a clinically applicable prognostic model for PA/CS-IVS using standardised, multicentre data. The results are expected to improve prenatal counselling and perinatal management, and will support the design of future interventional trials.
trial registrationClinicalTrials.gov, NCT07095829.
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