Fetal cardiac function in pregnancy affected by congenital heart disease: protocol for a multicentre prospective cohort study
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 paramet...
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2025-01-01
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| Series: | BMC Pregnancy and Childbirth |
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| Online Access: | https://doi.org/10.1186/s12884-025-07145-7 |
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| author | Anna Erenbourg Tracie Barber Vera Cecotti Stefano Faiola Ilaria Fantasia Tamara Stampaljia Hagai Avnet Beata Radzymińska-Chruściel Neama Meriki Alec Welsh |
| author_facet | Anna Erenbourg Tracie Barber Vera Cecotti Stefano Faiola Ilaria Fantasia Tamara Stampaljia Hagai Avnet Beata Radzymińska-Chruściel Neama Meriki Alec Welsh |
| author_sort | Anna Erenbourg |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-edcf0c6dcf02480bb84142707bbd51f5 |
| institution | Kabale University |
| issn | 1471-2393 |
| language | English |
| publishDate | 2025-01-01 |
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| series | BMC Pregnancy and Childbirth |
| spelling | doaj-art-edcf0c6dcf02480bb84142707bbd51f52025-02-02T12:46:53ZengBMCBMC Pregnancy and Childbirth1471-23932025-01-012511910.1186/s12884-025-07145-7Fetal cardiac function in pregnancy affected by congenital heart disease: protocol for a multicentre prospective cohort studyAnna Erenbourg0Tracie Barber1Vera Cecotti2Stefano Faiola3Ilaria Fantasia4Tamara Stampaljia5Hagai Avnet6Beata Radzymińska-Chruściel7Neama Meriki8Alec Welsh9UNSW School of Clinical Medicine, Perinatal Imaging Research Group (PIRG), Level 0, Royal Hospital for WomenUNSW School of Mechanical & Manufacturing Engineer, Ainsworth BuildingCentre Hospitalier de MayotteDepartment of Obstetrics and Gynaecology, Department of Clinical Sciences, Buzzi Children’s Hospital, University University of MilanDepartment of Life, Health and Environmental Sciences, Obstetrics & Gynaecology Unit, University of L’Aquila, San Salvatore HospitalDepartment of Medicine, Surgery and Health Science, Maternal and Child Health Institute - IRCCS Burlo Garofolo, University of TriesteInstitute of Obstetrics and Gynecological Imaging and Fetal Therapy, Sheba Medical Center and the Sackler School of Medicine, Tel Aviv UniversityFetal Cardiology Unit, Medical Center, Ujastek, Cracow, Department of Pediatric Cardiology, Faculty of Medicine, Institute of Paediatrics, Jagiellonian University Medical CollegeMaternal Fetal Medicine, King Khalid University HospitalRoyal Hospital for Women and UNSW, School of Clinical Medicine, Level 0, Royal Hospital for WomenAbstract 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.https://doi.org/10.1186/s12884-025-07145-7Automated fetal cardiac functionMPITAPSEMAPSESAPSE |
| spellingShingle | Anna Erenbourg Tracie Barber Vera Cecotti Stefano Faiola Ilaria Fantasia Tamara Stampaljia Hagai Avnet Beata Radzymińska-Chruściel Neama Meriki Alec Welsh Fetal cardiac function in pregnancy affected by congenital heart disease: protocol for a multicentre prospective cohort study BMC Pregnancy and Childbirth Automated fetal cardiac function MPI TAPSE MAPSE SAPSE |
| title | Fetal cardiac function in pregnancy affected by congenital heart disease: protocol for a multicentre prospective cohort study |
| title_full | Fetal cardiac function in pregnancy affected by congenital heart disease: protocol for a multicentre prospective cohort study |
| title_fullStr | Fetal cardiac function in pregnancy affected by congenital heart disease: protocol for a multicentre prospective cohort study |
| title_full_unstemmed | Fetal cardiac function in pregnancy affected by congenital heart disease: protocol for a multicentre prospective cohort study |
| title_short | Fetal cardiac function in pregnancy affected by congenital heart disease: protocol for a multicentre prospective cohort study |
| title_sort | fetal cardiac function in pregnancy affected by congenital heart disease protocol for a multicentre prospective cohort study |
| topic | Automated fetal cardiac function MPI TAPSE MAPSE SAPSE |
| url | https://doi.org/10.1186/s12884-025-07145-7 |
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