Standardized Clinical Assessment and Management Plan Enhances Neonatal Outcomes in Prenatally Diagnosed Congenital Heart Disease | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Standardized Clinical Assessment and Management Plan Enhances Neonatal Outcomes in Prenatally Diagnosed Congenital Heart Disease Lior Kashani Ligumsky, Angela Desmond, Vanessa Kirschner, Guadalupe Martinez, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6260387/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 14 Jun, 2025 Read the published version in Pediatric Cardiology → Version 1 posted 7 You are reading this latest preprint version Abstract Objective Congenital heart disease (CHD) remains a leading cause of neonatal morbidity and mortality. The University of California Fetal Consortium (UCfC) implemented a Standardized Clinical Assessment and Management Plan (SCAMP) to optimize birth timing and mode of birth in pregnancies complicated by fetal CHD. This study evaluates the impact of SCAMP implementation on neonatal outcomes, specifically survival to hospital discharge, birth weight, and hospital length of stay. Methods A retrospective cohort study was conducted comparing neonates with prenatally diagnosed CHD before (historical cohort) and after (intervention cohort) SCAMP implementation. Neonatal data, including mode of birth, birth weight, survival to discharge, and CHD classification was collected from five UC medical centers. Comparative analyses were performed using t-tests for continuous variables and chi-square tests for categorical variables. Results A total of 414 neonates met inclusion criteria (167 in the historical cohort, 247 in the intervention cohort). The overall neonatal survival rate to discharge was significantly higher in the intervention cohort (91.1% vs. 83.1%, p = 0.04). Survival following cesarean birth was also improved in the intervention cohort (89.1% vs. 78.1%, p = 0.04), while no significant differences were found for induction of labor or spontaneous vaginal births. Birth weight was significantly higher post-SCAMP (3068 g vs. 2935 g, p = 0.01), and hospital length of stay was significantly shorter (11.5 vs. 26 days, p < 0.01). Survival differences by CHD risk classification were not statistically significant. Conclusion SCAMP implementation was associated with improved neonatal survival, increased birth weight, and reduced hospitalization duration in CHD-affected pregnancies. These findings underscore the importance of standardized perinatal management in optimizing outcomes for neonates with CHD. Introduction Congenital heart disease (CHD) remains one of the most prevalent congenital anomalies, affecting approximately 1% of live births globally, and is a major contributor to infant morbidity and mortality [1,2]. Despite significant advancements in prenatal screening and postnatal medical and surgical interventions, managing pregnancies complicated by fetal CHD continue to present unique challenges [3–5]. While a prenatal diagnosis of CHD facilitates early coordination of neonatal care, it has also been associated with unintended consequences, including increased rates of early-term and preterm delivery and cesarean births —both of which are linked to poor neonatal outcomes, including respiratory distress syndrome (RDS), transient tachypnea of the newborn (TTN), feeding difficulties, hyperbilirubinemia, hypoglycemia, and hypothermia. These complications lead to increased ICU admissions, prolonged hospital stays, and higher healthcare costs, with potential long-term neurodevelopmental implications even for late preterm neonates. Given these risks, evaluating neonatal outcomes such as survival to discharge and hospital length of stay is critical to assessing the impact of standardized perinatal management strategies like SCAMP [6–10]. In response to these challenges, the University of California Fetal Consortium (UCfC) implemented a Standardized Clinical Assessment and Management Plan (SCAMP) to improve maternal and neonatal outcomes in pregnancies affected by CHD. The SCAMP standardized decision-making around the timing and mode of delivery, prioritizing delivery at ≥ 39 weeks to reduce unnecessary early-term births and promote vaginal birth over elective cesarean. Our previous study demonstrated a 11% reduction in non-medically indicated cesarean births and a 15% decrease in early-term deliveries. However, its impact on neonatal survival remains incompletely understood[11]. In fetal CHD cases, a SCAMP-driven approach aims to mitigate iatrogenic premature birth while maintaining neonatal stability, thereby improving birth weight and survival outcomes. Building on this success, the present study evaluated the impact of the SCAMP on neonatal outcomes, focusing on survival to discharge, birth weight, and hospital length of stay. By comparing neonatal data from historical cohorts and those managed under the SCAMP, we seek to investigate how standardized management of CHD, that have already been shown to improve maternal outcomes, influences neonatal outcomes in this vulnerable population. Methods A multi-institutional retrospective study review board reliance registry provided approval for the study (IRB #10‐04093) and informed consent was waived. Neonatal data were collected and analyzed from historical (pre-SCAMP) and intervention (post-SCAMP implementation) cohorts. The historical cohort consisted of neonates delivered between January 2016 and December 2016, and the intervention cohort comprised neonates born between May 2018 and December 2019. Neonates with complete data on birth mode, birth weight, and survival at discharge were included for analysis. Study Population The intervention cohort included neonates whose mothers were part of the multi-institutional University of California Fetal Consortium (UCfC) SCAMP program. The UCfC comprises the 5 University of California campuses affiliated with university medical centers that offer prenatal diagnosis and treatment (UCfC: UC Davis, UC Irvine, UC Los Angeles, UC San Diego, and UC San Francisco). The UCfC was established to better study pregnancies affected with maternal and fetal diseases, including CHD and to define treatment practices within our health system. This multi-institution consortium developed a SCAMP for pregnant women with a prenatal diagnosis of fetal CHD, based on current practices and best available evidence. The SCAMP guidelines included recommendations for delivery timing and mode, specifically routine delivery at ≥ 39 weeks and planned vaginal birth unless cesarean birth as indicated for obstetrical or fetal reasons, such as complete heart block or anticipated hemodynamic instability. Neonates were then further categorized by their fetal CHD lesions. The CHD lesions were categorized based on predicted risk of hemodynamic instability in the delivery room or first days of life, based on the American Heart Association guidelines [12]. This included category 1, CHD without predicted risk of hemodynamic instability in the delivery room or first days of life (ventricular septal defects, atrioventricular septal defects); category 2, CHD with minimal risk of hemodynamic instability in the delivery room but requires postnatal catheterization/surgery (ductal-dependent lesions); category 3, CHD with likely hemodynamic instability in the delivery room requiring immediate specialty care for stabilization (D-transposition of the great arteries); category 4, CHD with expected hemodynamic instability with placental separation requiring immediate catheterization/surgery to improve survival (hypoplastic left heart syndrome or D-transposition of the great arteries with restrictive of intact atrial septum), unknown/other cardiac lesion (Table 3). Data Collection Neonatal data, including mode of birth (vaginal birth, induction of labor, and cesarean birth), birth weight, survival to discharge and cardiac classification were collected via retrospective chart review at each of the participating sites. Outcome Measures The primary outcome was survival to discharge. Secondary outcomes included birth weight and survival differences based on birth mode and cardiac classification. Additional data on site-specific standard management practices were gathered from maternal-fetal medicine physicians and pediatric cardiologists to maintain site confidentiality. Statistical Analysis Outcomes were compared between the intervention cohort (post-SCAMP) and historical control cohort. Comparative statistical analyses were performed using t-tests (or Wilcoxon rank sum test) for continuous variables (e.g., birth weight) and chi-square tests (or Fisher’s exact tests) for categorical variables (e.g., birth mode, survival). Analyses were conducted using de-identified data, and results were stored in a Health Insurance Portability and Accountability Act-compliant Research Electronic Data Capture (REDCap) database. Results A total of 414 neonates met the inclusion criteria, with 167 in the historical cohort and 247 in the intervention cohort. The overall survival rate to discharge was higher in the intervention cohort (91.1%) compared to the historical cohort (83.1%, p = 0.04). In the cesarean birth group, survival rates were higher in the intervention cohort (89.1%) compared to the historical cohort (78.1%, p = 0.04). There were no significant differences in survival rates for induction of labor and spontaneous births between the historical and intervention cohorts (p = 0.8 and p = 0.1, respectively). The demographic and neonatal outcomes of the intervention (SCAMP) and historical cohorts were compared. Maternal age was higher in the intervention cohort (33 years) compared to the historical cohort (31 years) (p = 0.05). There were no significant differences between the cohorts in terms of gravida and parity, with both cohorts having a median gravida of 2 and median parity of 1 (p = 0.12 and p = 0.90, respectively). Neonatal birth weight was significantly higher in the intervention cohort (2977+/-709.3 g) compared to the historical cohort (2838+/-641.7 g) (p = 0.01). The average length of stay was significantly shorter in the intervention cohort (11.5 days) compared to the historical cohort (26 days) (p < 0.01). For the sub analysis of survival by cardiac classification, only 216 neonates had complete cardiac classification data in the intervention cohort and 167 in the historical cohort. Regarding cardiac classification, a smaller proportion of patients in the intervention cohort were classified as cardiac class 0 (20.4%) compared to the historical cohort (40.1%, p = 0.03). Conversely, a higher proportion of patients in the intervention cohort were classified as cardiac category 1 (50.9% vs. 36.9%, p < 0.01) and cardiac category 2 (16.2% vs. 9.6%, p = 0.03) compared to the historical cohort. There were no significant differences in the proportion of patients in categories 3 or 4 between the two cohorts (p = 0.53, p = 0.48, respectively). When examining survival by cardiac classification, survival for low-risk cardiac lesions(Category 1) showed no significant difference between the intervention cohort (95.4%) and historical cohort (83.6%, p = 0.06). Similarly, there was no significant difference in survival for high-risk cardiac lesions( Category2-4) between the intervention cohort (88.6%) and historical cohort (84.5%) (p = 0.34). Discussion Our study found that the implementation of a fetal congenital heart disease (CHD) standardized clinical assessment and management plan (SCAMP) was associated with a significant improvement in neonatal survival when compared to the historical cohort. Specifically, the overall survival rate was significantly higher in the SCAMP cohort compared to the historical cohort. This finding underscores the importance of a structured, evidence-based perinatal management approach that can improve neonatal survival outcomes, particularly in cases of fetal CHD, while also optimizing maternal care and outcomes. Additionally, we observed that the SCAMP was associated with a significant increase in birth weight and shorter neonatal hospital stays, suggesting that this structured approach not only improved survival but also optimized other neonatal outcomes. The difference in survival between the two cohorts supports the notion that delaying delivery to ≥39 weeks in the absence of obstetric or fetal indications does not negatively impact survival. In fact, this approach may offer protective benefits for neonates with CHD, as evidenced by the improved survival in the SCAMP cohort[7]. Beyond survival, later gestational age at birth is associated with increased maturity, leading to a lower likelihood of NICU admission and reduced risk of respiratory and metabolic complications. Infants born at ≥39 weeks are less likely to require respiratory support, intravenous fluids, or prolonged hospitalization, which not only improves immediate neonatal health but also reduces healthcare costs and long-term developmental risks. Additionally, avoiding unnecessary early-term birth promotes earlier parental bonding and facilitates breastfeeding initiation, contributing to improved neurodevelopmental outcomes.[13] Furthermore, while our study found a significant improvement in survival after cesarean birth in the SCAMP cohort compared to the historical cohort, there were no significant differences in survival based on other modes of delivery—including spontaneous vaginal delivery or induction of labor (IOL). This aligns with previous studies indicating that, in the absence of medical indications, planned vaginal birth is a safe option for most fetuses with CHD[14,15]. Historically, there has been a tendency to schedule cesarean births for coordination of care needs due to concerns about perinatal hemodynamic instability in CHD-affected pregnancies[15–17]. However, our findings suggest that while cesarean birth may be associated with improved survival in some cases, routine cesarean birth does not necessarily confer a universal survival advantage and may instead lead to prolonged neonatal hospitalizations without improving overall outcomes. Therefore, consideration of mode of delivery for previous pregnancies is critical. The SCAMP's emphasis on avoiding early-term elective deliveries and promoting routine delivery at ≥39 weeks’ gestation, unless medically indicated, likely contributed to the increased birth weights observed in the intervention cohort (2977+/-709.3 g Vs (2838+/-641.7 g) 0.04)[11]. Longer gestation periods associated with SCAMP implementation may have provided neonates with more time to thrive, resulting in higher birth weights. This improves surgical outcomes. Additionally, the significant reduction in neonatal hospital length of stay in the SCAMP cohort (11.5 days vs. 26 days, p < 0.01) highlights improved neonatal stability, as well as potential improvements in care delivery efficiency and reduced healthcare burden[7,18]. Shorter hospitalizations are associated with fewer complications and a quicker return to normalcy for families, further supporting the benefits of a structured clinical approach. In terms of outcomes within different fetal CHD lesions, we found no significant difference in survival outcomes between low-risk and high-risk cardiac lesions in neonates after implementing SCAMP. This suggests that a SCAMP framework may provide consistency across a broad spectrum of congenital cardiac lesions. Implementing SCAMP might reduce variability in care across lesion types by providing a more structured, systems-based approach, which may help raise overall survival rates in a comparable way. Despite these promising results, there are certain limitations that come with multicenter studies, including variation in practice patterns that might not be taken into consideration. Additionally, our sample size was limited, which may have impacted the power to detect statistically significant differences in secondary outcomes, and confounding variables such as socioeconomic factors and variations in institutional care practices that may influence survival and hospital length of stay. The implementation of a fetal CHD SCAMP in a multi-institutional cohort was associated with improved neonatal survival, higher birth weight, and reduced length of hospital stay. These findings suggest that an evidence-based, standardized approach to perinatal CHD management can improve outcomes for neonates affected by CHD. Future studies warrant further investigation with a larger sample size and should focus on long-term outcomes to assess the broader impact of SCAMP on neonatal health beyond the perinatal period. Declarations Disclosures: Y.A is a consultant for Mirvie and Bio-Rad and has an investigator-initiated project with Natera unrelated to placenta accreta. The remaining authors have no disclosures to report. Author Contribution L.K.L., A.D., and Y.A. conceptualized and designed the study. A.D. and G.M. collected the data. V.K. performed statistical analysis. L.K.L. drafted the initial manuscript, with critical revisions provided by A.D. and Y.A. G.S. and K.C. contributed to data interpretation and manuscript review. All authors reviewed and approved the final manuscript. References Hoffman JIE, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol . 2002;39(12):1890-1900. doi:10.1016/S0735-1097(02)01886-7 van der Linde D, Konings EEM, Slager MA, et al. Birth Prevalence of Congenital Heart Disease Worldwide: A Systematic Review and Meta-Analysis. J Am Coll Cardiol . 2011;58(21):2241-2247. doi:10.1016/j.jacc.2011.08.025 Quartermain MD, Pasquali SK, Hill KD, et al. Variation in Prenatal Diagnosis of Congenital Heart Disease in Infants. Pediatrics . 2015;136(2):e378-385. doi:10.1542/peds.2014-3783 Levy DJ, Pretorius DH, Rothman A, et al. Improved Prenatal Detection of Congenital Heart Disease in an Integrated Health Care System. Pediatr Cardiol . 2013;34(3):670-679. doi:10.1007/s00246-012-0526-y Pinto NM, Morris SA, Moon-Grady AJ, Donofrio MT. Prenatal cardiac care: Goals, priorities & gaps in knowledge in fetal cardiovascular disease: Perspectives of the Fetal Heart Society. Prog Pediatr Cardiol . 2020;59:101312. doi:10.1016/j.ppedcard.2020.101312 For The University of California Fetal Consortium (UCfC), Peyvandi S, Nguyen TATT, et al. Timing and Mode of Delivery in Prenatally Diagnosed Congenital Heart Disease- an Analysis of Practices within the University of California Fetal Consortium (UCfC). Pediatr Cardiol . 2017;38(3):588-595. doi:10.1007/s00246-016-1552-y Costello JM, Pasquali SK, Jacobs JP, et al. Gestational Age at Birth and Outcomes After Neonatal Cardiac Surgery: An Analysis of the Society of Thoracic Surgeons Congenital Heart Surgery Database. Circulation . 2014;129(24):2511-2517. doi:10.1161/CIRCULATIONAHA.113.005864 Goff DA, Luan X, Gerdes M, et al. Younger gestational age is associated with worse neurodevelopmental outcomes after cardiac surgery in infancy. J Thorac Cardiovasc Surg . 2012;143(3):535-542. doi:10.1016/j.jtcvs.2011.11.029 Parikh LI, Reddy UM, Männistö T, et al. Neonatal outcomes in early term birth. Am J Obstet Gynecol . 2014;211(3):265.e1-265.e11. doi:10.1016/j.ajog.2014.03.021 Tita ATN, Jablonski KA, Bailit JL, et al. Neonatal outcomes of elective early-term births after demonstrated fetal lung maturity. Am J Obstet Gynecol . 2018;219(3):296.e1-296.e8. doi:10.1016/j.ajog.2018.05.011 Afshar Y, Hogan WJ, Conturie C, et al. Multi‐Institutional Practice‐Patterns in Fetal Congenital Heart Disease Following Implementation of a Standardized Clinical Assessment and Management Plan. J Am Heart Assoc . 2021;10(15):e021598. doi:10.1161/JAHA.121.021598 Diagnosis and Treatment of Fetal Cardiac Disease | Circulation. Accessed January 29, 2025. https://www.ahajournals.org/doi/10.1161/01.cir.0000437597.44550.5d?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed Morniroli D, Tiraferri V, Maiocco G, et al. Beyond survival: the lasting effects of premature birth. Front Pediatr . 2023;11:1213243. doi:10.3389/fped.2023.1213243 Costello JM, Polito A. Birth Before 39 Weeks’ Gestation Is Associated With Worse Outcomes in Neonates With Heart Disease. 2010;126(2). Landis BJ, Levey A, Levasseur SM, et al. Prenatal Diagnosis of Congenital Heart Disease and Birth Outcomes. Pediatr Cardiol . 2013;34(3):597-605. doi:10.1007/s00246-012-0504-4 Trento LU, Pruetz JD, Chang RK, Detterich J, Sklansky MS. Prenatal diagnosis of congenital heart disease: impact of mode of delivery on neonatal outcome. Prenat Diagn . 2012;32(13):1250-1255. doi:10.1002/pd.3991 Parikh LI, Grantz KL, Iqbal SN, et al. Neonatal outcomes in fetuses with cardiac anomalies and the impact of delivery route. Am J Obstet Gynecol . 2017;217(4):469.e1-469.e12. doi:10.1016/j.ajog.2017.05.049 Farias M, Jenkins K, Lock J, et al. Standardized Clinical Assessment And Management Plans (SCAMPs) Provide A Better Alternative To Clinical Practice Guidelines. Health Aff (Millwood) . 2013;32(5):911-920. doi:10.1377/hlthaff.2012.0667 Tables Tables 1 and 2 are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Tables.docx Supplementary.docx Cite Share Download PDF Status: Published Journal Publication published 14 Jun, 2025 Read the published version in Pediatric Cardiology → Version 1 posted Editorial decision: Revision requested 14 Apr, 2025 Reviews received at journal 10 Apr, 2025 Reviewers agreed at journal 20 Mar, 2025 Reviewers invited by journal 19 Mar, 2025 Editor assigned by journal 19 Mar, 2025 Submission checks completed at journal 19 Mar, 2025 First submitted to journal 19 Mar, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6260387","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":431725641,"identity":"7d9e4262-d5e7-4339-a327-a6a23df155de","order_by":0,"name":"Lior Kashani Ligumsky","email":"","orcid":"","institution":"Tel Aviv University","correspondingAuthor":false,"prefix":"","firstName":"Lior","middleName":"Kashani","lastName":"Ligumsky","suffix":""},{"id":431725642,"identity":"092c93d5-2a08-4abb-abcd-15cdb67c22a6","order_by":1,"name":"Angela Desmond","email":"","orcid":"","institution":"Department of Pediatrics, Division Neonatal Research 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remains one of the most prevalent congenital anomalies, affecting approximately 1% of live births globally, and is a major contributor to infant morbidity and mortality [1,2]. Despite significant advancements in prenatal screening and postnatal medical and surgical interventions, managing pregnancies complicated by fetal CHD continue to present unique challenges [3\u0026ndash;5].\u003c/p\u003e \u003cp\u003eWhile a prenatal diagnosis of CHD facilitates early coordination of neonatal care, it has also been associated with unintended consequences, including increased rates of early-term and preterm delivery and cesarean births \u0026mdash;both of which are linked to poor neonatal outcomes, including respiratory distress syndrome (RDS), transient tachypnea of the newborn (TTN), feeding difficulties, hyperbilirubinemia, hypoglycemia, and hypothermia. These complications lead to increased ICU admissions, prolonged hospital stays, and higher healthcare costs, with potential long-term neurodevelopmental implications even for late preterm neonates. Given these risks, evaluating neonatal outcomes such as survival to discharge and hospital length of stay is critical to assessing the impact of standardized perinatal management strategies like SCAMP [6\u0026ndash;10].\u003c/p\u003e \u003cp\u003eIn response to these challenges, the University of California Fetal Consortium (UCfC) implemented a Standardized Clinical Assessment and Management Plan (SCAMP) to improve maternal and neonatal outcomes in pregnancies affected by CHD. The SCAMP standardized decision-making around the timing and mode of delivery, prioritizing delivery at \u0026ge;\u0026thinsp;39 weeks to reduce unnecessary early-term births and promote vaginal birth over elective cesarean. Our previous study demonstrated a 11% reduction in non-medically indicated cesarean births and a 15% decrease in early-term deliveries. However, its impact on neonatal survival remains incompletely understood[11]. In fetal CHD cases, a SCAMP-driven approach aims to mitigate iatrogenic premature birth while maintaining neonatal stability, thereby improving birth weight and survival outcomes.\u003c/p\u003e \u003cp\u003eBuilding on this success, the present study evaluated the impact of the SCAMP on neonatal outcomes, focusing on survival to discharge, birth weight, and hospital length of stay. By comparing neonatal data from historical cohorts and those managed under the SCAMP, we seek to investigate how standardized management of CHD, that have already been shown to improve maternal outcomes, influences neonatal outcomes in this vulnerable population.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e A multi-institutional retrospective study review board reliance registry provided approval for the study (IRB #10‐04093) and informed consent was waived. Neonatal data were collected and analyzed from historical (pre-SCAMP) and intervention (post-SCAMP implementation) cohorts. The historical cohort consisted of neonates delivered between January 2016 and December 2016, and the intervention cohort comprised neonates born between May 2018 and December 2019. Neonates with complete data on birth mode, birth weight, and survival at discharge were included for analysis.\u003c/p\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eStudy Population\u003c/h2\u003e \u003cp\u003eThe intervention cohort included neonates whose mothers were part of the multi-institutional University of California Fetal Consortium (UCfC) SCAMP program. The UCfC comprises the 5 University of California campuses affiliated with university medical centers that offer prenatal diagnosis and treatment (UCfC: UC Davis, UC Irvine, UC Los Angeles, UC San Diego, and UC San Francisco). The UCfC was established to better study pregnancies affected with maternal and fetal diseases, including CHD and to define treatment practices within our health system. This multi-institution consortium developed a SCAMP for pregnant women with a prenatal diagnosis of fetal CHD, based on current practices and best available evidence. The SCAMP guidelines included recommendations for delivery timing and mode, specifically routine delivery at \u0026ge;\u0026thinsp;39 weeks and planned vaginal birth unless cesarean birth as indicated for obstetrical or fetal reasons, such as complete heart block or anticipated hemodynamic instability. Neonates were then further categorized by their fetal CHD lesions. The CHD lesions were categorized based on predicted risk of hemodynamic instability in the delivery room or first days of life, based on the American Heart Association guidelines [12]. This included category 1, CHD without predicted risk of hemodynamic instability in the delivery room or first days of life (ventricular septal defects, atrioventricular septal defects); category 2, CHD with minimal risk of hemodynamic instability in the delivery room but requires postnatal catheterization/surgery (ductal-dependent lesions); category 3, CHD with likely hemodynamic instability in the delivery room requiring immediate specialty care for stabilization (D-transposition of the great arteries); category 4, CHD with expected hemodynamic instability with placental separation requiring immediate catheterization/surgery to improve survival (hypoplastic left heart syndrome or D-transposition of the great arteries with restrictive of intact atrial septum), unknown/other cardiac lesion (Table\u0026nbsp;3).\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eData Collection\u003c/h3\u003e\n\u003cp\u003eNeonatal data, including mode of birth (vaginal birth, induction of labor, and cesarean birth), birth weight, survival to discharge and cardiac classification were collected via retrospective chart review at each of the participating sites.\u003c/p\u003e\n\u003ch3\u003eOutcome Measures\u003c/h3\u003e\n\u003cp\u003eThe primary outcome was survival to discharge. Secondary outcomes included birth weight and survival differences based on birth mode and cardiac classification. Additional data on site-specific standard management practices were gathered from maternal-fetal medicine physicians and pediatric cardiologists to maintain site confidentiality.\u003c/p\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis\u003c/h2\u003e \u003cp\u003eOutcomes were compared between the intervention cohort (post-SCAMP) and historical control cohort. Comparative statistical analyses were performed using t-tests (or Wilcoxon rank sum test) for continuous variables (e.g., birth weight) and chi-square tests (or Fisher\u0026rsquo;s exact tests) for categorical variables (e.g., birth mode, survival). Analyses were conducted using de-identified data, and results were stored in a Health Insurance Portability and Accountability Act-compliant Research Electronic Data Capture (REDCap) database.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 414 neonates met the inclusion criteria, with 167 in the historical cohort and 247 in the intervention cohort. The overall survival rate to discharge was higher in the intervention cohort (91.1%) compared to the historical cohort (83.1%, p\u0026thinsp;=\u0026thinsp;0.04). In the cesarean birth group, survival rates were higher in the intervention cohort (89.1%) compared to the historical cohort (78.1%, p\u0026thinsp;=\u0026thinsp;0.04). There were no significant differences in survival rates for induction of labor and spontaneous births between the historical and intervention cohorts (p\u0026thinsp;=\u0026thinsp;0.8 and p\u0026thinsp;=\u0026thinsp;0.1, respectively).\u003c/p\u003e \u003cp\u003eThe demographic and neonatal outcomes of the intervention (SCAMP) and historical cohorts were compared. Maternal age was higher in the intervention cohort (33 years) compared to the historical cohort (31 years) (p\u0026thinsp;=\u0026thinsp;0.05). There were no significant differences between the cohorts in terms of gravida and parity, with both cohorts having a median gravida of 2 and median parity of 1 (p\u0026thinsp;=\u0026thinsp;0.12 and p\u0026thinsp;=\u0026thinsp;0.90, respectively). Neonatal birth weight was significantly higher in the intervention cohort (2977+/-709.3 g) compared to the historical cohort (2838+/-641.7 g) (p\u0026thinsp;=\u0026thinsp;0.01). The average length of stay was significantly shorter in the intervention cohort (11.5 days) compared to the historical cohort (26 days) (p\u0026thinsp;\u0026lt;\u0026thinsp;0.01).\u003c/p\u003e \u003cp\u003eFor the sub analysis of survival by cardiac classification, only 216 neonates had complete cardiac classification data in the intervention cohort and 167 in the historical cohort. Regarding cardiac classification, a smaller proportion of patients in the intervention cohort were classified as cardiac class 0 (20.4%) compared to the historical cohort (40.1%, p\u0026thinsp;=\u0026thinsp;0.03). Conversely, a higher proportion of patients in the intervention cohort were classified as cardiac category 1 (50.9% vs. 36.9%, p\u0026thinsp;\u0026lt;\u0026thinsp;0.01) and cardiac category 2 (16.2% vs. 9.6%, p\u0026thinsp;=\u0026thinsp;0.03) compared to the historical cohort. There were no significant differences in the proportion of patients in categories 3 or 4 between the two cohorts (p\u0026thinsp;=\u0026thinsp;0.53, p\u0026thinsp;=\u0026thinsp;0.48, respectively). When examining survival by cardiac classification, survival for low-risk cardiac lesions(Category 1) showed no significant difference between the intervention cohort (95.4%) and historical cohort (83.6%, p\u0026thinsp;=\u0026thinsp;0.06). Similarly, there was no significant difference in survival for high-risk cardiac lesions( Category2-4) between the intervention cohort (88.6%) and historical cohort (84.5%) (p\u0026thinsp;=\u0026thinsp;0.34).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eOur study found that the implementation of a fetal congenital heart disease (CHD) standardized clinical assessment and management plan (SCAMP) was associated with a significant improvement in neonatal survival when compared to the historical cohort. Specifically, the overall survival rate was significantly higher in the SCAMP cohort compared to the historical cohort. This finding underscores the importance of a structured, evidence-based perinatal management approach that can improve neonatal survival outcomes, particularly in cases of fetal CHD, while also optimizing maternal care and outcomes. Additionally, we observed that the SCAMP was associated with a significant increase in birth weight and shorter neonatal hospital stays, suggesting that this structured approach not only improved survival but also optimized other neonatal outcomes.\u003c/p\u003e\n\u003cp\u003eThe difference in survival between the two cohorts supports the notion that delaying delivery to ≥39 weeks in the absence of obstetric or fetal indications does not negatively impact survival. In fact, this approach may offer protective benefits for neonates with CHD, as evidenced by the improved survival in the SCAMP cohort[7].\u003c/p\u003e\n\u003cp\u003eBeyond survival, later gestational age at birth is associated with increased maturity, leading to a lower likelihood of NICU admission and reduced risk of respiratory and metabolic complications. Infants born at ≥39 weeks are less likely to require respiratory support, intravenous fluids, or prolonged hospitalization, which not only improves immediate neonatal health but also reduces healthcare costs and long-term developmental risks. Additionally, avoiding unnecessary early-term birth promotes earlier parental bonding and facilitates breastfeeding initiation, contributing to improved neurodevelopmental outcomes.[13]\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Furthermore, while our study found a significant improvement in survival after cesarean birth in the SCAMP cohort compared to the historical cohort, there were no significant differences in survival based on other modes of delivery—including spontaneous vaginal delivery or induction of labor (IOL). This aligns with previous studies indicating that, in the absence of medical indications, planned vaginal birth is a safe option for most fetuses with CHD[14,15]. Historically, there has been a tendency to schedule cesarean births for coordination of care needs due to concerns about perinatal hemodynamic instability in CHD-affected pregnancies[15–17]. However, our findings suggest that while cesarean birth may be associated with improved survival in some cases, routine cesarean birth \u0026nbsp;does not necessarily confer a universal survival advantage and may instead lead to prolonged neonatal hospitalizations without improving overall outcomes. Therefore, consideration of mode of delivery for previous pregnancies is critical.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe SCAMP's emphasis on avoiding early-term elective deliveries and promoting routine delivery at ≥39 weeks’ gestation, unless medically indicated, likely contributed to the increased birth weights observed in the intervention cohort (2977+/-709.3 g Vs (2838+/-641.7 g) 0.04)[11]. Longer gestation periods associated with SCAMP implementation may have provided neonates with more time to thrive, resulting in higher birth weights. This improves surgical outcomes. Additionally, the significant reduction in neonatal hospital length of stay in the SCAMP cohort (11.5 days vs. 26 days, p \u0026lt; 0.01) highlights improved neonatal stability, as well as potential improvements in care delivery efficiency and reduced healthcare burden[7,18]. Shorter hospitalizations are associated with fewer complications and a quicker return to normalcy for families, further supporting the benefits of a structured clinical approach.\u003c/p\u003e\n\u003cp\u003eIn terms of outcomes within different fetal CHD lesions, we found no significant difference in survival outcomes between low-risk and high-risk cardiac lesions in neonates after implementing SCAMP. This suggests that a SCAMP framework may provide consistency across a broad spectrum of congenital cardiac lesions. Implementing SCAMP might reduce variability in care across lesion types by providing a more structured, systems-based approach, which may help raise overall survival rates in a comparable way. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDespite these promising results, there are certain limitations that come with multicenter studies, including variation in practice patterns that might not be taken into consideration. Additionally, our sample size was limited, which may have impacted the power to detect statistically significant differences in secondary outcomes, and confounding variables such as socioeconomic factors and variations in institutional care practices that may influence survival and hospital length of stay.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe implementation of a fetal CHD SCAMP in a multi-institutional cohort was associated with improved neonatal survival, higher birth weight, and reduced length of hospital stay. These findings suggest that an evidence-based, standardized approach to perinatal CHD management can improve outcomes for neonates affected by CHD. Future studies warrant further investigation with a larger sample size and should focus on long-term outcomes to assess the broader impact of SCAMP on neonatal health beyond the perinatal period.\u0026nbsp;\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e \u003ch2\u003eDisclosures:\u003c/h2\u003e \u003cp\u003eY.A is a consultant for Mirvie and Bio-Rad and has an investigator-initiated project with Natera unrelated to placenta accreta. The remaining authors have no disclosures to report.\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eL.K.L., A.D., and Y.A. conceptualized and designed the study. A.D. and G.M. collected the data. V.K. performed statistical analysis. L.K.L. drafted the initial manuscript, with critical revisions provided by A.D. and Y.A. G.S. and K.C. contributed to data interpretation and manuscript review. All authors reviewed and approved the final manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eHoffman JIE, Kaplan S. The incidence of congenital heart disease. \u003cem\u003eJ Am Coll Cardiol\u003c/em\u003e. 2002;39(12):1890-1900. doi:10.1016/S0735-1097(02)01886-7\u003c/li\u003e\n\u003cli\u003evan der Linde D, Konings EEM, Slager MA, et al. Birth Prevalence of Congenital Heart Disease Worldwide: A Systematic Review and Meta-Analysis. \u003cem\u003eJ Am Coll Cardiol\u003c/em\u003e. 2011;58(21):2241-2247. doi:10.1016/j.jacc.2011.08.025\u003c/li\u003e\n\u003cli\u003eQuartermain MD, Pasquali SK, Hill KD, et al. Variation in Prenatal Diagnosis of Congenital Heart Disease in Infants. \u003cem\u003ePediatrics\u003c/em\u003e. 2015;136(2):e378-385. doi:10.1542/peds.2014-3783\u003c/li\u003e\n\u003cli\u003eLevy DJ, Pretorius DH, Rothman A, et al. Improved Prenatal Detection of Congenital Heart Disease in an Integrated Health Care System. \u003cem\u003ePediatr Cardiol\u003c/em\u003e. 2013;34(3):670-679. doi:10.1007/s00246-012-0526-y\u003c/li\u003e\n\u003cli\u003ePinto NM, Morris SA, Moon-Grady AJ, Donofrio MT. Prenatal cardiac care: Goals, priorities \u0026amp; gaps in knowledge in fetal cardiovascular disease: Perspectives of the Fetal Heart Society. \u003cem\u003eProg Pediatr Cardiol\u003c/em\u003e. 2020;59:101312. doi:10.1016/j.ppedcard.2020.101312\u003c/li\u003e\n\u003cli\u003eFor The University of California Fetal Consortium (UCfC), Peyvandi S, Nguyen TATT, et al. Timing and Mode of Delivery in Prenatally Diagnosed Congenital Heart Disease- an Analysis of Practices within the University of California Fetal Consortium (UCfC). \u003cem\u003ePediatr Cardiol\u003c/em\u003e. 2017;38(3):588-595. doi:10.1007/s00246-016-1552-y\u003c/li\u003e\n\u003cli\u003eCostello JM, Pasquali SK, Jacobs JP, et al. Gestational Age at Birth and Outcomes After Neonatal Cardiac Surgery: An Analysis of the Society of Thoracic Surgeons Congenital Heart Surgery Database. \u003cem\u003eCirculation\u003c/em\u003e. 2014;129(24):2511-2517. doi:10.1161/CIRCULATIONAHA.113.005864\u003c/li\u003e\n\u003cli\u003eGoff DA, Luan X, Gerdes M, et al. Younger gestational age is associated with worse neurodevelopmental outcomes after cardiac surgery in infancy. \u003cem\u003eJ Thorac Cardiovasc Surg\u003c/em\u003e. 2012;143(3):535-542. doi:10.1016/j.jtcvs.2011.11.029\u003c/li\u003e\n\u003cli\u003eParikh LI, Reddy UM, M\u0026auml;nnist\u0026ouml; T, et al. Neonatal outcomes in early term birth. \u003cem\u003eAm J Obstet Gynecol\u003c/em\u003e. 2014;211(3):265.e1-265.e11. doi:10.1016/j.ajog.2014.03.021\u003c/li\u003e\n\u003cli\u003eTita ATN, Jablonski KA, Bailit JL, et al. Neonatal outcomes of elective early-term births after demonstrated fetal lung maturity. \u003cem\u003eAm J Obstet Gynecol\u003c/em\u003e. 2018;219(3):296.e1-296.e8. doi:10.1016/j.ajog.2018.05.011\u003c/li\u003e\n\u003cli\u003eAfshar Y, Hogan WJ, Conturie C, et al. Multi‐Institutional Practice‐Patterns in Fetal Congenital Heart Disease Following Implementation of a Standardized Clinical Assessment and Management Plan. \u003cem\u003eJ Am Heart Assoc\u003c/em\u003e. 2021;10(15):e021598. doi:10.1161/JAHA.121.021598\u003c/li\u003e\n\u003cli\u003eDiagnosis and Treatment of Fetal Cardiac Disease | Circulation. Accessed January 29, 2025. https://www.ahajournals.org/doi/10.1161/01.cir.0000437597.44550.5d?url_ver=Z39.88-2003\u0026amp;rfr_id=ori:rid:crossref.org\u0026amp;rfr_dat=cr_pub%20%200pubmed\u003c/li\u003e\n\u003cli\u003eMorniroli D, Tiraferri V, Maiocco G, et al. Beyond survival: the lasting effects of premature birth. \u003cem\u003eFront Pediatr\u003c/em\u003e. 2023;11:1213243. doi:10.3389/fped.2023.1213243\u003c/li\u003e\n\u003cli\u003eCostello JM, Polito A. Birth Before 39 Weeks\u0026rsquo; Gestation Is Associated With Worse Outcomes in Neonates With Heart Disease. 2010;126(2).\u003c/li\u003e\n\u003cli\u003eLandis BJ, Levey A, Levasseur SM, et al. Prenatal Diagnosis of Congenital Heart Disease and Birth Outcomes. \u003cem\u003ePediatr Cardiol\u003c/em\u003e. 2013;34(3):597-605. doi:10.1007/s00246-012-0504-4\u003c/li\u003e\n\u003cli\u003eTrento LU, Pruetz JD, Chang RK, Detterich J, Sklansky MS. Prenatal diagnosis of congenital heart disease: impact of mode of delivery on neonatal outcome. \u003cem\u003ePrenat Diagn\u003c/em\u003e. 2012;32(13):1250-1255. doi:10.1002/pd.3991\u003c/li\u003e\n\u003cli\u003eParikh LI, Grantz KL, Iqbal SN, et al. Neonatal outcomes in fetuses with cardiac anomalies and the impact of delivery route. \u003cem\u003eAm J Obstet Gynecol\u003c/em\u003e. 2017;217(4):469.e1-469.e12. doi:10.1016/j.ajog.2017.05.049\u003c/li\u003e\n\u003cli\u003eFarias M, Jenkins K, Lock J, et al. Standardized Clinical Assessment And Management Plans (SCAMPs) Provide A Better Alternative To Clinical Practice Guidelines. \u003cem\u003eHealth Aff (Millwood)\u003c/em\u003e. 2013;32(5):911-920. doi:10.1377/hlthaff.2012.0667\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 and 2 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
[email protected]","identity":"pediatric-cardiology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pedc","sideBox":"Learn more about [Pediatric Cardiology](http://link.springer.com/journal/246)","snPcode":"246","submissionUrl":"https://submission.nature.com/new-submission/246/3","title":"Pediatric Cardiology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-6260387/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6260387/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eObjective\u003c/h2\u003e \u003cp\u003eCongenital heart disease (CHD) remains a leading cause of neonatal morbidity and mortality. The University of California Fetal Consortium (UCfC) implemented a Standardized Clinical Assessment and Management Plan (SCAMP) to optimize birth timing and mode of birth in pregnancies complicated by fetal CHD. This study evaluates the impact of SCAMP implementation on neonatal outcomes, specifically survival to hospital discharge, birth weight, and hospital length of stay.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eA retrospective cohort study was conducted comparing neonates with prenatally diagnosed CHD before (historical cohort) and after (intervention cohort) SCAMP implementation. Neonatal data, including mode of birth, birth weight, survival to discharge, and CHD classification was collected from five UC medical centers. Comparative analyses were performed using t-tests for continuous variables and chi-square tests for categorical variables.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eA total of 414 neonates met inclusion criteria (167 in the historical cohort, 247 in the intervention cohort). The overall neonatal survival rate to discharge was significantly higher in the intervention cohort (91.1% vs. 83.1%, p\u0026thinsp;=\u0026thinsp;0.04). Survival following cesarean birth was also improved in the intervention cohort (89.1% vs. 78.1%, p\u0026thinsp;=\u0026thinsp;0.04), while no significant differences were found for induction of labor or spontaneous vaginal births. Birth weight was significantly higher post-SCAMP (3068 g vs. 2935 g, p\u0026thinsp;=\u0026thinsp;0.01), and hospital length of stay was significantly shorter (11.5 vs. 26 days, p\u0026thinsp;\u0026lt;\u0026thinsp;0.01). Survival differences by CHD risk classification were not statistically significant.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eSCAMP implementation was associated with improved neonatal survival, increased birth weight, and reduced hospitalization duration in CHD-affected pregnancies. These findings underscore the importance of standardized perinatal management in optimizing outcomes for neonates with CHD.\u003c/p\u003e","manuscriptTitle":"Standardized Clinical Assessment and Management Plan Enhances Neonatal Outcomes in Prenatally Diagnosed Congenital Heart Disease","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-03-28 12:18:26","doi":"10.21203/rs.3.rs-6260387/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-04-15T01:12:59+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-11T02:59:39+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"185666863131322567888139620726900710024","date":"2025-03-20T17:39:10+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-03-19T22:06:43+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-03-19T11:02:23+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-03-19T11:02:10+00:00","index":"","fulltext":""},{"type":"submitted","content":"Pediatric Cardiology","date":"2025-03-19T09:55:36+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"
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