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. 2025 Jan 30;25(1):99.
doi: 10.1186/s12884-025-07145-7.

Fetal cardiac function in pregnancy affected by congenital heart disease: protocol for a multicentre prospective cohort study

Anna Erenbourg  1 , Tracie Barber  2 , Vera Cecotti  3 , Stefano Faiola  4 , Ilaria Fantasia  5 , Tamara Stampaljia  6 , Hagai Avnet  7 , Beata Radzymińska-Chruściel  8 , Neama Meriki  9   10 , Alec Welsh  11
Affiliations

Fetal cardiac function in pregnancy affected by congenital heart disease: protocol for a multicentre prospective cohort study

Anna Erenbourg et al. BMC Pregnancy Childbirth. .

Abstract

Background: Congenital heart disease (CHD) is the most common fetal malformation, and it can result first in cardiac remodeling and dysfunction and later in cardiac failure and hydrops. A limited number of studies have evaluated cardiac function in fetuses affected by CHD. Functional parameters could potentially identify fetuses at risk of cardiac failure before its development. However, these techniques have not translated from research to clinical settings, due to a lack of standardization and poor repeatability. We seek to evaluate whether application of automated techniques to a cohort with fetal pathology could overcome these factors.

Methods: A multicenter cohort study will be carried out in eight teaching hospitals across Europe, Australia, and Middle East. Based on a previous observed standard deviation, a total sample of 381 pregnancies is required to achieve 80% power to detect a difference of 0.03 in mean myocardial performance index (MPI) with a two-sided type I error rate of 5%. After adjustments allowing for patient exclusions or incomplete datasets, a total of 330 healthy singleton pregnancies and 165 diagnosed with CHD will be recruited. Two fetal cardiac function evaluations at 19 + 6-28 + 6 and 32 + 6-36 + 6 weeks will be offered assessing automated pulsed wave doppler (PWD) MPI, spatio-temporal image correlation (STIC) annular and septal plane excursion (TAPSE, MAPSE and SAPSE), alongside cardiac morphometric and Doppler evaluations of flow across the valves. A secondary nested case-control study will evaluate fetuses with hydrops compared to those without. Differences in functional parameters between cases and controls and over time will be assessed using generalized linear mixed models. Logistic regression will estimate the association between cardiac parameters and hydrops' incidence.

Discussion: This study will provide evidence as to whether automated functional parameters could be significantly different in pregnancy affected by CHD versus healthy pregnancies. The primary objective is to compare automated PWD-MPI and STIC TAPSE, MAPSE and SAPSE in fetuses affected by CHD versus healthy. The secondary objective is to estimate whether these automated parameters could improve the predictive value of the classical cardiovascular profile score in case of hydrops.

Trial registration: The study protocol has been registered in the ClinicalTrials.gov Protocol Registration System, identification number NCT05698277.

Keywords: Automated fetal cardiac function; MAPSE; MPI; SAPSE; TAPSE.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study obtained ethical approval (2022/ETH00943) by the South Eastern Sydney Local Health District Human Research Ethics Committee. The research will be performed in accordance with the Declaration of Helsinki. Informed consent will be obtained from all the participants. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Patient recruitment and study flow chart
Fig. 2
Fig. 2
Heart chambers measurements. LV Left ventricle, RV Right ventricle, MB Moderator band, LA Left atrium, RA Right atrium, PV Pulmonary veins. LCD Longitudinal cardiac diameter, TCD transverse cardiac diameter. LVLD Left ventricular longitudinal diameter, RVLD Right ventricular longitudinal diameter, LVMTD Left ventricular mid-transverse diameter, RVMTD Right ventricular mid-transverse diameter, LVBD Left ventricular basal diameter, RVBD Right ventricular basal diameter, LATD Left atrial transverse diameter, RATD Right atrial transverse diameter, LALD Left atrial longitudinal diameter, RALD Right atrial longitudinal diameter
See this image and copyright information in PMC

References

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