{"id":3100,"date":"2020-01-07T07:51:56","date_gmt":"2020-01-07T07:51:56","guid":{"rendered":"http:\/\/fetalradiology.in\/?p=3100"},"modified":"2020-01-13T07:14:55","modified_gmt":"2020-01-13T07:14:55","slug":"content-validity-of-a-fetal-radiology-assessment-and-diagnostic-score-india-fetrads-india-for-early-identification-of-at-risk-pregnant-women","status":"publish","type":"post","link":"https:\/\/fetalradiology.co.in\/?p=3100","title":{"rendered":"Content validity of a Fetal Radiology Assessment and Diagnostic Score-India (FetRADS- India) for early identification of at-risk pregnant women"},"content":{"rendered":"\n<p><b>Authors: <\/b><span style=\"font-weight: 400;\">Rijo M Choorakuttil, Devarajan P, Lalit K Sharma, Ramesh S Shenoy, Amel Antony, M.R. Balachandran Nair, Praveen K Nirmalan&nbsp;<\/span><\/p>\n\n\n\n<ol class=\"wp-block-list\"><li><span style=\"font-weight: 400;\">Rijo M Choorakuttil, National Coordinator for Samrakshan IRIA, AMMA Center for Diagnosis and Preventive Medicine, Kochi, Kerala, India<\/span><\/li><li><span style=\"font-weight: 400;\">Devarajan P, Nethra Scans and Genetic Clinic, Tiruppur, Tamil Nadu, India<\/span><\/li><li><span style=\"font-weight: 400;\">Lalit K Sharma, Raj Sonography &amp; X- Ray Clinic, Baiju Choraha, Nayapura, Guna, Madhya Pradesh, India<\/span><\/li><li><span style=\"font-weight: 400;\">Ramesh S Shenoy, Consultant Radiologist, Lisie Hospital, Kochi, Ernakulam, India<\/span><\/li><li><span style=\"font-weight: 400;\">Amel Antony, Head, Department of Radiology, Lisie Hospital, Kochi, Ernakulam, India<\/span><\/li><li><span style=\"font-weight: 400;\">M.R. Balachandran Nair, Department of Radiology, Jubilee Mission Hospital, Thrissur, Kerala, India&nbsp;<\/span><\/li><li><span style=\"font-weight: 400;\">Praveen K Nirmalan, Chief Research Mentor, AMMA ERF, AMMA Center for Diagnosis and Preventive Medicine, Kochi, Kerala, India&nbsp;<\/span><\/li><\/ol>\n\n\n\n<p><b>Short Title<\/b><span style=\"font-weight: 400;\">: FetRADS-India&nbsp;<\/span><\/p>\n\n\n\n<p><b>Corresponding Author<\/b><span style=\"font-weight: 400;\">: Rijo M Choorakuttil, National Coordinator for Samrakshan IRIA, AMMA Center for Diagnosis and Preventive Medicine, Kochi, Kerala, India. E mail: <\/span><a href=\"mailto:samrakshaniria@gmail.com\"><span style=\"font-weight: 400;\">samrakshaniria@gmail.com<\/span><\/a><\/p>\n\n\n\n<p><b>Key words<\/b><span style=\"font-weight: 400;\">: Fetal Radiology, Imaging, TIFFA, Pregnancy, Risk stratification<\/span><\/p>\n\n\n\n<p><b>Abstract<\/b><span style=\"font-weight: 400;\">:&nbsp;<\/span><\/p>\n\n\n\n<p><i><span style=\"font-weight: 400;\">Context<\/span><\/i><span style=\"font-weight: 400;\">: Non-invasive radiology imaging techniques can be used to identify pregnant women at risk for adverse fetal and maternal events.&nbsp;<\/span><\/p>\n\n\n\n<p><i><span style=\"font-weight: 400;\">Aim<\/span><\/i><span style=\"font-weight: 400;\">: To describe the conceptual development of a comprehensive Fetal Radiology Assessment and Diagnostic Score- India (FetRADS-India) for risk stratification and early identification of pregnant women at risk for adverse fetal events.<\/span><\/p>\n\n\n\n<p><i><span style=\"font-weight: 400;\">Methods<\/span><\/i><span style=\"font-weight: 400;\">: The FetRADS-India item pool of variables pertinent to the score were generated using formative research including literature search to identify variables of interest to measure and content validation. A content validity ratio &gt;0.49 was considered necessary for the retention of variables in the item pool. A composite score was generated combining the radiology imaging assessment and therapeutic weighted score.&nbsp;<\/span><\/p>\n\n\n\n<p><i><span style=\"font-weight: 400;\">Results<\/span><\/i><span style=\"font-weight: 400;\">: The FetRADS-India score has six levels with increasing scores indicating increasing risk for adverse fetal events. Subset scores predictive of obstetric adverse events based on assessment of fetal structure, growth and environment were developed.<\/span><\/p>\n\n\n\n<p><i><span style=\"font-weight: 400;\">Conclusions<\/span><\/i><span style=\"font-weight: 400;\">: The FetRADS-India categories have been developed, using content validation, for the risk stratification of pregnant women to help initiate appropriate early management for high risk cases including referral to advanced care or tertiary care units.&nbsp;&nbsp;<\/span><\/p>\n\n\n\n<p><b>Introduction<\/b><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">National and regional health care delivery systems including the National Health Mission in India have a strong focus on improving maternal and child health.[1] These programs aim to improve the quality of obstetric and neonatal\/child health care and surveillance with improved infrastructure, access, availability and affordability of services including antenatal and postpartum services and training of human resources to provide optimal care.[1] Improvements in health care delivery systems resulted in declining trends of maternal mortality, neonatal, infant and under-5 mortality and perinatal mortality rates in India although wide variations remain in maternal and child health by state, district and urban rural locations in India.[2-5] Maternal mortality in India has declined from 212 per 100,000 live births in 2007-09 to 178 per 100,000 live births in 2010-12.[1,2]&nbsp; Infant mortality rates in India have reduced from 47 per 1000 live births in 2010 to 42 per 1000 live births in 2012.[1,4,6,7] Neonatal mortality in India has reduced from 52 per 1000 live births in 1990 to about 28 per 1000 live births in 2013.[1,3,6,7] Under-5 mortality rates in India have also shown a declining trend, reducing from 55 per 1000 live births in 2011 to 29 per 1000 live births in 2015.[5-7] Despite these improvements, India remains a significant contributor towards the global maternal, neonatal, infant and under 5 mortality rates as well as the global stillbirth rates. Current perinatal mortality rates in India are estimated at 26 per 1000 live births (approximately 592,100 stillbirths) or 22.6% of the global still birth rates in 2015. [1,7]&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">The use of radiology, especially ultrasonography, is widely prevalent in obstetric care in India. Ultrasonography studies during pregnancy are used to identify fetal abnormalities that may impact the health of the fetus as well as that of the child post-delivery.[8-11] Appropriate radiology and imaging studies, including Doppler studies and placental studies, can be used to identify and predict adverse maternal conditions that may influence the well-being of the pregnant woman and the growing fetus.&nbsp; Radiological assessments and imaging thus supplement the obstetric decision making around childbirth. In this manuscript, we describe the development of a comprehensive Fetal Radiology Assessment and Diagnostic Score-India (FetRADS-India) focused on fetal structures, fetal growth and fetal environment that can be used for the early identification of pregnant women at risk for adverse maternal or fetal events in India and other developing economies.<\/span><\/p>\n\n\n\n<p><b>Material and Methods<\/b><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">The FetRADS-India was developed using a multiphase approach. The first phase involved generation of the parameters of interest using formative research. A thorough literature search was done from January 1980 up to December 2015 using PubMed, MD Consult, Cochrane Library and EMBASE databases to identify articles of interest pertaining to radiological imaging for maternal and fetal well-being during pregnancy.&nbsp; The literature search was facilitated by the use of several key words or Medical Subject Headings (MeSH) terms. Several key words including but not limited to pregnancy, pregnancy risk factors, imaging in pregnancy, targeted imaging, fetal abnormalities, ultrasonography in pregnancy, 4D imaging studies, magnetic resonance imaging, placenta and placental abnormalities, Doppler studies, amniotic fluid, umbilical cord, cervix and uterine abnormalities, adnexal and ovarian masses, fetal growth, pregnancy induced hypertension, postpartum hemorrhage, maternal morbidity, maternal mortality, perinatal mortality, congenital abnormalities, and stillbirths were used to retrieve articles of interest. The literature obtained using these key words were critically evaluated to filter articles that could provide information on radiological and imaging parameters that potentially affect the health of a pregnant patient and to develop a list of radiological and imaging parameters that impact the health of the pregnant woman and the growing fetus. Parameters of interest included those that predicted fetal environment, fetal growth and fetal structure abnormalities and an increasing risk profile that ranged from low risk to a very high risk of adverse fetal events. The range of normality or abnormality for each parameter was also assessed through the literature search.<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">These parameters were further categorized based on the trimester of pregnancy or gestational age(s) at which the radiology study was performed. Identified radiology and imaging study parameters were further categorized based as structural and functional parameters influencing fetal structure, fetal growth and fetal environment. Structural parameters included structural integrity as well as location, while functional parameters explored the potential influence on specific functions (for example, flow velocities). Evidence pertaining to parameters was assessed in isolation, as well as in a sequential or simultaneous pattern. Thus, evidence was assessed for a single abnormal parameter, for multiple abnormal parameters in a single imaging study at a single time point, and for changing abnormalities in sequential imaging studies at multiple time points.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">An item pool of parameters of interest, identified through the comprehensive search detailed above, was generated as part of the second phase of the development of FetRADS-India. These included structural and functional parameters at the three trimesters of pregnancy and involved sequential scans through the course of pregnancy. Briefly, the parameters of interest looked at the growth and structural integrity of the growing fetus in the first trimester (11-13<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> week), structural and functional integrity in the second trimester including Targeted Imaging for Fetal Anomaly (TIFFA) scan, and placental studies, fetal growth studies, Doppler studies and fetal well-being studies in the third trimester.&nbsp; Intrauterine growth restriction was defined as a fetal weight &lt;10<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> centile for the gestational age and mean uterine and umbilical artery Doppler PI&gt;95<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> centile. Early onset fetal growth restriction at 18-20 gestational weeks was defined as mean uterine and umbilical artery Doppler PI&gt;95<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> centile and cerebroplacental ratio (CPR) &lt;5<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> percentile with normal growth parameters. In the third trimester, late onset FGR was considered if one or more of the following three were present: fetal weight or AC is less than 10<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> percentile, mean uterine artery PI &gt; 95<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> percentile or CPR &lt; 5<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> percentile. In the third trimester, small for gestation age fetus was considered if the fetal weight was less than 10th percentile with normal Doppler parameters of uterine artery and CPR. A retroplacental hemorrhage, defined as a hypoechoeic area between the basal plate and myometrium that lifted the placental parenchyma towards the amniotic cavity, was categorized as small if the maximum diameter was less than 5 cm and large if the maximum diameter was more than 5 cm.&nbsp; The presence of septations, solid elements and colour Doppler low resistance waveform with PI &lt; 1 and RI &lt;0.4 are considered as some of the changes suggestive of malignancy. The thickness of the placenta is measured perpendicular to the basal and chorionic plates in the mid portion of the placenta. Anterior placentas &gt;33mm and posterior placentas &gt; 40mm were considered as thick. A single largest vertical pocket &lt; 2 was considered as oligamnios, &lt; 1 as severe and &gt;8 as hydramnios at gestational ages &lt; 28 weeks.&nbsp; For gestational ages &gt; 28 weeks, a four quadrant amniotic fluid index of 5 to 8 was considered as mild, between 2 to 5 as moderate and less than 2 as severe reduction of amniotic fluid volume. The percentage of cervical funnelling and shape of the funnel (V or U shaped) and depth and width of the funnel was considered. Standard definitions were considered for structural anomalies; a complete list of structural anomalies and definitions is beyond the scope of this manuscript.<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">The third phase of the development of FetRADS-India involved assessing the content validity of the item pool of parameters generated as part of the second phase.&nbsp; Content validity is a non-statistical method that systematically examines the test content to determine if it covers a representative sample of the domain to be measured.[12-15] Content validity provides preliminary evidence on the construct validity of an instrument and is essential to establish reliability.[12-15]&nbsp; Each parameter was assessed as either not necessary, useful but not essential, or essential. A content validity ratio was ascertained for each parameter. Acceptance of the parameter was conditional on the content validity ration being greater than 0.49.[16]&nbsp;<\/span><\/p>\n\n\n\n<p><b>Results<\/b><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">A six-stage composite scoring system based on the use of a radiological assessment score and a therapeutic weighted score was developed. The addition of a therapeutic weighted score ensured that higher scores reflected greater risk to maternal and\/or fetal well-being and required more interventions or more intense surveillance.&nbsp; The lowest score indicated an incomplete or inadequate radiological study that limited the predictive ability (see Table-1). Several subset scores predictive of obstetric complications and obstetric monitoring were developed for each trimester (see Tables-2 to 4) to complete a comprehensive fetal assessment of structural anomalies, fetal growth and fetal environment.<\/span><\/p>\n\n\n\n<p><b>Table-1<\/b><span style=\"font-weight: 400;\">: Broad scoring patterns of the Fetal Radiology Assessment and Diagnostic Score (FetRADS- India) system&nbsp;<\/span><\/p>\n\n\n\n<table class=\"wp-block-table has-subtle-pale-blue-background-color has-fixed-layout has-background is-style-stripes\"><tbody><tr><td><b>Score<\/b><\/td><td><b>Brief Description<\/b><\/td><\/tr><tr><td><span style=\"font-weight: 400;\">FetRADS-0<\/span><\/td><td><span style=\"font-weight: 400;\">Incomplete or inadequate fetomaternal study due to conditions like&nbsp;<\/span>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">a) maternal body habitus (obesity\/overweight)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">b) unfavourable fetal position<\/span><\/p>\n<p><span style=\"font-weight: 400;\">c) oligamnios<\/span><\/p>\n<p><span style=\"font-weight: 400;\">d) problems with equipment resolution and technical parameters<\/span><\/p>\n<p><span style=\"font-weight: 400;\">e) informed consent not obtained<\/span><\/p>\n<\/td><\/tr><tr><td><span style=\"font-weight: 400;\">FetRADS-1<\/span><\/td><td><span style=\"font-weight: 400;\">Normal fetal growth and Maternal environment<\/span>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">No findings or predictors of obstetric risk or perinatal complications<\/span><\/p>\n<p><span style=\"font-weight: 400;\">No structural anomalies or genetic markers visualized<\/span><\/p>\n<\/td><\/tr><tr><td><span style=\"font-weight: 400;\">FetRADS-2<\/span><\/td><td><span style=\"font-weight: 400;\">Findings and predictors of low risk obstetric and perinatal complications<\/span><\/td><\/tr><tr><td><span style=\"font-weight: 400;\">FetRADS-3<\/span><\/td><td><span style=\"font-weight: 400;\">Presence of major genetic markers or multiple minor markers or a combination of both<\/span>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">Structural abnormalities that require antenatal interventions or definite postnatal interventions, with nil or minimal complications associated with interventions and good outcomes<\/span><\/p>\n<\/td><\/tr><tr><td><span style=\"font-weight: 400;\">FetRADS-4<\/span><\/td><td><span style=\"font-weight: 400;\">Findings of high risk obstetric and perinatal complications, high risk for genetic syndromes, structural abnormalities that has poor prognosis or&nbsp; severe complications<\/span><\/td><\/tr><tr><td><span style=\"font-weight: 400;\">FetRADS-5<\/span><\/td><td><span style=\"font-weight: 400;\">Very high risk of obstetric and perinatal morbidity and mortality, fetal anomalies not sustainable with life or lethal.<\/span><\/td><\/tr><\/tbody><\/table>\n\n\n\n<p><b>Table 2:<\/b><span style=\"font-weight: 400;\"> FetRADS-India for 1<\/span><span style=\"font-weight: 400;\">st<\/span><span style=\"font-weight: 400;\"> trimester (11-14 weeks scan)<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">&nbsp;<\/span><\/p>\n\n\n\n<table class=\"wp-block-table has-subtle-pale-blue-background-color has-fixed-layout has-background is-style-stripes\"><tbody><tr><td><b>STRUCTURE<\/b><\/td><td><b>ENVIRONMENT<\/b><\/td><td><b>GROWTH<\/b><\/td><td><b>FetRADS-India<\/b><\/td><\/tr><tr><td><span style=\"font-weight: 400;\">Previous h\/o Downs\/Aneuploidy<\/span><\/td><td><span style=\"font-weight: 400;\">Obesity<\/span>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">Short stature<\/span><\/p>\n<\/td><td><span style=\"font-weight: 400;\">\u2022Previous h\/o Preeclampsia \/Fetal growth restriction,&nbsp;<\/span>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">\u2022Pre-existing Hypertension\/Diabetes Mellitus<\/span><\/p>\n<\/td><td><span style=\"font-weight: 400;\">FetRADS 2<\/span><\/td><\/tr><tr><td><span style=\"font-weight: 400;\">NT &gt;95<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> percentile for GA<\/span><\/td><td><span style=\"font-weight: 400;\">Presence of adnexal Mass (es)<\/span><\/td><td><span style=\"font-weight: 400;\">Increased combined Pulsatility Index of uterine artery and early diastolic notch<\/span><\/td><td><span style=\"font-weight: 400;\">FetRADS 3<\/span><\/td><\/tr><tr><td><span style=\"font-weight: 400;\">\u2022NT &gt;3.5 mm,&nbsp;<\/span>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">\u2022Cystic hygroma<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Un ossified Nasal Bone<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022DV abnormality<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022TR present<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Omphalocele, Gastrochisis<\/span><\/p>\n<\/td><td><span style=\"font-weight: 400;\">Presence of Mass (es) with red degeneration\/torsion\/<\/span><\/td><td>&nbsp;<\/td><td><span style=\"font-weight: 400;\">FetRADS 4<\/span><\/td><\/tr><tr><td><span style=\"font-weight: 400;\">Major Structural anomalies:<\/span>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">Anencephaly\/ Neural tube defects\/Holoproencephaly<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Monoventricle in heart<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Limb reduction defects<\/span><\/p>\n<\/td><td><span style=\"font-weight: 400;\">Adnexal masses with changes suggestive of malignancy<\/span><\/td><td>&nbsp;<\/td><td><span style=\"font-weight: 400;\">FetRADS 5<\/span><\/td><\/tr><\/tbody><\/table>\n\n\n\n<p><b>Table 3:<\/b><span style=\"font-weight: 400;\"> FetRADS-India score for 2<\/span><span style=\"font-weight: 400;\">nd<\/span><span style=\"font-weight: 400;\"> trimester scan&nbsp;<\/span><\/p>\n\n\n\n<table class=\"wp-block-table has-subtle-pale-blue-background-color has-fixed-layout has-background is-style-stripes\"><tbody><tr><td><b>STRUCTURE<\/b><\/td><td><b>ENVIRONMENT<\/b><\/td><td><b>GROWTH<\/b><\/td><td><b>FET RADS<\/b><\/td><\/tr><tr><td><span style=\"font-weight: 400;\">\u2022PrevIous h\/o Downs\/Aneuploidy<\/span>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">\u2022Presence of Mild Urinary tract dilatation<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Isolated Choroid Plexus cyst<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Asymmetric lateral ventricles of brain, measurement &gt; 8mm and &lt; 10 mm<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Single umbilical artery<\/span><\/p>\n<\/td><td><span style=\"font-weight: 400;\">\u2022 Oligo amnios <\/span><br><span style=\"font-weight: 400;\">(SDP &lt;2 )<\/span> <p>&nbsp;<\/p> <p><span style=\"font-weight: 400;\">\u2022Mild poly hydramnios (SDP: 8-12cm)<\/span><\/p> <p><span style=\"font-weight: 400;\">&nbsp;\u2022Increased Placental thickness<\/span><\/p> <p><span style=\"font-weight: 400;\">\u2022Low lying placenta-less than 2 cm from internal OS<\/span><\/p> <p><span style=\"font-weight: 400;\">\u2022Small retroplacental hemorrhage<\/span><\/p> <p><span style=\"font-weight: 400;\">\u2022Marginal Cord Insertion<\/span><\/p> <\/td><td><span style=\"font-weight: 400;\">\u2022Previous h\/o Preeclampsia\/<\/span>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">FGR<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Pre-existing Hypertension\/<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Diabetes Mellitus<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022EFW or AC &lt; 10th percentile<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Uterine Artery Mean PI &gt;90th percentile<\/span><\/p>\n<\/td><td><span style=\"font-weight: 400;\">FetRADS 2<\/span><\/td><\/tr><tr><td><span style=\"font-weight: 400;\">\u2022Mild Ventriculomegaly (&gt;10mm) with no associated finding.<\/span>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">\u2022Mild hypo or hypertelorism<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Unilateral cleft lip and cleft palate<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Unilateral or bilateral clubfoot with no associated anomalies.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Congenital pelvi-ureteric junction Obstruction<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Unilateral multicystic dysplastic kidney with contralateral normal kidney and normal liquor<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Arachnoid Cyst\/Blake\u2019s Pouch Cyst<\/span><\/p>\n<\/td><td><span style=\"font-weight: 400;\">\u2022 Oligo amnios (SDP &lt;2)<\/span> <p>&nbsp;<\/p> <p><span style=\"font-weight: 400;\">\u2022Moderate polyhydramnios (SDP: 12-15cm)<\/span><\/p> <p><span style=\"font-weight: 400;\">\u2022Circumvallate Placenta&nbsp;<\/span><\/p> <p><span style=\"font-weight: 400;\">\u2022Placenta previa-covering the OS<\/span><\/p> <p><span style=\"font-weight: 400;\">\u2022Large retroplacental hemorrhage &gt; 2\/3rd of surface<\/span><\/p> <p><span style=\"font-weight: 400;\">\u2022Short Cervix &lt; 2.5 cm in transvaginal assessment \u2022Presence of adnexal Mass (es)<\/span><\/p> <\/td><td><span style=\"font-weight: 400;\">\u2022EFW or AC &lt; 3<\/span><span style=\"font-weight: 400;\">rd<\/span><span style=\"font-weight: 400;\"> percentile<\/span>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">\u2022Uterine Artery \u2022Mean PI &gt;95th percentile<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Cerebroplacental Ratio &lt;5<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> percentile<\/span><\/p>\n<\/td><td><span style=\"font-weight: 400;\">FetRADS 3<\/span><\/td><\/tr><tr><td><span style=\"font-weight: 400;\">\u2022Major genetic markers: Absent NB, Increased Nuchal fold thickness, ARSA<\/span>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">\u2022Correctable congenital heart defects: VSD, ASD, TOF, TGA, CoA&nbsp;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Hydrops fetalis<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Dandy walker malformation \/vermian hypoplasia<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Non-lethal skeletal dysplasias<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Minor Neural tube defects<\/span><\/p>\n<\/td><td><span style=\"font-weight: 400;\">\u2022Severe oligo hydramnios (SDP: &lt;1cm);&nbsp;<\/span> <p>&nbsp;<\/p> <p><span style=\"font-weight: 400;\">\u2022Severe Poly hydramnios;<\/span><\/p> <span style=\"font-size: inherit; font-family: inherit; background-color: transparent;\">SDP&gt;15cm<\/span> <p><span style=\"font-weight: 400;\">\u2022Funnelled Cervix with Bulging of Membranes, Anterior cervical angle &gt; 105 degree<\/span><\/p> <p><span style=\"font-weight: 400;\">\u2022Velamentous cord insertion and Vasa Praevia,&nbsp;<\/span><\/p> <p><span style=\"font-weight: 400;\">\u2022Placental lucencies, Thinned out retroplacental clear space<\/span><\/p> <p><span style=\"font-weight: 400;\">\u2022Definite signs of placenta accreta spectrum&nbsp;<\/span><\/p> <p><span style=\"font-weight: 400;\">&nbsp;\u2022Presence of adnexal mass with red degeneration\/ torsion\/malignancy<\/span><\/p> <p><span style=\"font-weight: 400;\">\u2022Chorioangioma of placenta<\/span><\/p> <\/td><td><span style=\"font-weight: 400;\">\u2022EFW or AC &lt; 3<\/span><span style=\"font-weight: 400;\">rd<\/span><span style=\"font-weight: 400;\"> percentile<\/span>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">\u2022Uterine Artery Mean PI &gt;99th percentile<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Increased Umbilical artery PI: &gt;95<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> percentile&nbsp;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">&nbsp;\u2022Reversal of CPR<\/span><\/p>\n<\/td><td><span style=\"font-weight: 400;\">FetRADS 4<\/span><\/td><\/tr><tr><td><span style=\"font-weight: 400;\">\u2022Neural tube defects associated with cerebellar or brainstem defects,<\/span>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">\u2022Cerebellar dysplasia&nbsp;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Agenesis of corpus callosum<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022HLHS, AVSD, Ebsteins anomaly<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Lethal skeletal dysplasias<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Bilateral multi cystic renal dysplasia,&nbsp;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Post urethral valve<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2022Tracheo-oesophageal fistula\/ atresia<\/span><\/p>\n<\/td><td><span style=\"font-weight: 400;\">\u2022Anhydramnios (Nil liquor)<\/span>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">\u2022Partial hydatidiform mole<\/span><\/p>\n<\/td><td><span style=\"font-weight: 400;\">\u2022Ductus Venosus Doppler abnormality<\/span><\/td><td><span style=\"font-weight: 400;\">FetRADS 5<\/span><\/td><\/tr><\/tbody><\/table>\n\n\n\n<p><b>Table 4-<\/b><span style=\"font-weight: 400;\"> FetRADS-India score for 3rd trimester*<\/span><\/p>\n\n\n\n<table class=\"wp-block-table has-subtle-pale-blue-background-color has-fixed-layout has-background is-style-stripes\"><tbody><tr><td><b>EFW Percentiles<\/b><\/td><td><b>Uterine Artery PI<\/b><\/td><td><b>CPR &amp; Umbilical Artery Doppler<\/b><\/td><td><b>AOI<\/b><\/td><td><b>DV<\/b><\/td><td><b>FetRADS<\/b><\/td><\/tr><tr><td><span style=\"font-weight: 400;\">10-95<\/span><\/td><td><span style=\"font-weight: 400;\">Normal<\/span><\/td><td><span style=\"font-weight: 400;\">Normal<\/span><\/td><td><span style=\"font-weight: 400;\">Normal<\/span><\/td><td><span style=\"font-weight: 400;\">Normal<\/span><\/td><td><span style=\"font-weight: 400;\">FetRADS-1<\/span><\/td><\/tr><tr><td><span style=\"font-weight: 400;\">&lt;10<\/span> or &gt;95<\/td><td><span style=\"font-weight: 400;\">Normal<\/span><\/td><td><span style=\"font-weight: 400;\">Normal<\/span><\/td><td><span style=\"font-weight: 400;\">Normal<\/span><\/td><td><span style=\"font-weight: 400;\">Normal<\/span><\/td><td><span style=\"font-weight: 400;\">FetRADS-2<\/span><\/td><\/tr><tr><td><span style=\"font-weight: 400;\">&lt;10<\/span><\/td><td><span style=\"font-weight: 400;\">&gt;95<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> percentile<\/span><\/td><td><span style=\"font-weight: 400;\">CPR &lt;5<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> percentile<\/span><\/td><td><span style=\"font-weight: 400;\">Normal&nbsp;<\/span><\/td><td><span style=\"font-weight: 400;\">Normal<\/span><\/td><td><span style=\"font-weight: 400;\">FetRADS-3<\/span><\/td><\/tr><tr><td><span style=\"font-weight: 400;\">&lt;3<\/span><\/td><td><span style=\"font-weight: 400;\">Normal<\/span><\/td><td><span style=\"font-weight: 400;\">Normal<\/span><\/td><td><span style=\"font-weight: 400;\">Normal<\/span><\/td><td><span style=\"font-weight: 400;\">Normal<\/span><\/td><\/tr><tr><td><span style=\"font-weight: 400;\">10-95<\/span><\/td><td><span style=\"font-weight: 400;\">&gt;95<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> percentile<\/span><\/td><td><span style=\"font-weight: 400;\">CPR &lt;5<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> percentile&nbsp;<\/span><\/td><td><span style=\"font-weight: 400;\">Normal<\/span><\/td><td><span style=\"font-weight: 400;\">Normal<\/span><\/td><\/tr><tr><td><span style=\"font-weight: 400;\">&lt;3 \/&lt;10<\/span><\/td><td><span style=\"font-weight: 400;\">&gt;95<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> percentile&nbsp;<\/span><\/td><td><span style=\"font-weight: 400;\">CPR &lt;5<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> percentile&nbsp;<\/span>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">Umbilical Artery absent or reversal of EDV<\/span><\/p>\n<\/td><td><span style=\"font-weight: 400;\">Abnormal&nbsp;<\/span><\/td><td><span style=\"font-weight: 400;\">Normal&nbsp;<\/span><\/td><td><span style=\"font-weight: 400;\">FetRADS-4<\/span><\/td><\/tr><tr><td><span style=\"font-weight: 400;\">&lt;3 \/&lt;10<\/span><\/td><td><span style=\"font-weight: 400;\">&gt;95<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> percentile&nbsp;<\/span><\/td><td><span style=\"font-weight: 400;\">CPR &lt;5<\/span><span style=\"font-weight: 400;\">th<\/span><span style=\"font-weight: 400;\"> percentile&nbsp;<\/span>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">Umbilical Artery absent or reversal of EDV<\/span><\/p>\n<\/td><td><span style=\"font-weight: 400;\">Abnormal&nbsp;<\/span><\/td><td><span style=\"font-weight: 400;\">Abnormal or Biophysical score (BPP) &lt;4<\/span><\/td><td><span style=\"font-weight: 400;\">FetRADS-5<\/span><\/td><\/tr><\/tbody><\/table>\n\n\n\n<p><span style=\"font-weight: 400;\">* Structural anomaly score and environment score are similar for the 2nd and 3rd trimester<\/span>. Evolving structural abnormalities are also considered based on the 2nd trimester structural anomaly scores. For gestational ages > 28 weeks, a four quadrant amniotic fluid index of 5 to 8 was considered as mild, between 2 to 5 as moderate and less than 2 as severe reduction of amniotic fluid volume. Both oligoamnios and polyhydramnios in the 3rd trimester are considered similar to 2nd trimester categories.<\/p>\n\n\n\n<p><b>Discussion<\/b><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">Radiology image reporting and data systems have been used to improve diagnostic and prognostic assessments in various conditions including thyroid disorders, breast disorders, and prostate disorders and for liver disorders. [17-21] Risk stratification systems have been used for several clinical conditions to provide a framework for clinical decision making and resource allocation. The use of scoring systems may help improve consistency in evidence-based management across practices and institutions.&nbsp;&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">The focus of perinatal health care delivery in India has been on improving physical infrastructure, human resource training and access, availability and affordability of services. Evidence for the use of diagnostic tests, including biochemical tests and genetic markers, primarily to determine maternal and fetal morbidity in the course of pregnancy is increasing. [22-25] However, biochemical and genetic tests have certain limitations. Availability, affordability and accessibility to such expert services is currently a limitation in developing economies. Additionally, the invasive nature of sample collection and turnaround time to receiving the report are limitations for biochemical and genetic tests especially in developing economies where follow up visits are suboptimal.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">Non-invasive radiology and imaging studies are currently part of antenatal care for the pregnant woman and are usually done in each trimester of pregnancy.&nbsp; Targeted Imaging for Fetal Anomalies scan (TIFFA or fetal anomaly scan) done in pregnancy provides useful information on the structural integrity of the growing fetus including fetal anatomy and presence of any fetal anomalies.[26-29] Congenital anomalies are identified as one of the top ten causes for mortality in children and a TIFFA Scan can provide early information on the presence of lethal and non-lethal congenital anomalies.[30]&nbsp; Information from the TIFFA scan, when combined with information from the first trimester ultrasound study and the third trimester ultrasound study, provides a comprehensive assessment of the fetal environment and growth that aids obstetricians in clinical decision making about childbirth. Integrating Doppler studies in the first trimester to detect pregnancy induced hypertension and to differentiate and manage fetal growth restriction in the third trimester and the use of supplemental multimodality imaging and synergistic fetal imaging\/radiology with Ultrasound, placental exams, 3D or 4D imaging studies and Magnetic Resonance Imaging completes a comprehensive assessment of the fetus. Sequential scans (at least one in each trimester) are advised for optimal results, however, not all pregnant women may opt for or undergo sequential scans.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">Technical aspects including types of equipment, resolutions, and technical competency maybe potential limitations in the use of the FetRADS-India categories. However, these potential limitations maybe reduced as several training programs and workshops are planned as part of a new initiative (Samrakshan) by the Indian Radiological &amp; Imaging Association to improve competency in fetal ultrasonography and multimodality imaging. [31-33]&nbsp; An ultrasound study may not always be possible in a pregnant woman due to maternal and fetal factors like maternal obesity, unfavourable fetal positions, and oligamnios. We have considered this potential limitation and assigned a FIRADS 0 score for incomplete or inadequate studies. Women who are assigned a FIRADS-0 score should be referred to a higher center for further evaluation with higher end machines and multimodality approaches including fetal MRI at appropriate intervals.<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">In this manuscript, we have described the development of a comprehensive scoring system for the early identification and risk stratification of the pregnant woman, with particular relevance to the Indian subcontinent context, which can be used to aid decision making around childbirth without the need for additional resources. The scoring system can be incorporated into routine antenatal care and provide the obstetrician with information for the early identification of at-risk pregnancies potentially reducing perinatal mortality. The scoring system aims to provide a systematic sequential assessment framework for risk moving through several multi modality imaging techniques. The scoring system also expands the focus of fetal assessment to fetal environment and growth beyond the current focus on identifying abnormalities. The details of the validity, reliability, diagnostic effectiveness and discriminant ability of the FetRADS-India categories, tested in a multi center clinical setting, will be presented in a separate manuscript. Individual parameters and scores assigned to each parameter, based on statistical analyses, will be described to provide composite and specific scores to predict adverse events.&nbsp; The final FetRADS-India categories and parameters in each category will be determined on completion of the multicentre study.<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">In conclusion, FetRADS-India has been developed through a systematic process including content validation to provide a systematic pathway for the risk stratification of pregnant women and to initiate appropriate early management for high risk cases including referral to advanced care or tertiary care units. The scoring system is dynamic and can be supplemented through the use of appropriate multimodality imaging techniques.&nbsp;&nbsp;<\/span><\/p>\n\n\n\n<p><b>References<\/b><\/p>\n\n\n\n<ol class=\"wp-block-list\"><li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Negandhi PH, Neogi BS, Chopra S, Phogat A, Sahota R, Gupta R, et al. Improving reporting of infant deaths, maternal deaths and stillbirths in Haryana, India. Bull World Health Organ 2016;94:370-375<\/span><\/li><li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">NITI Aayog [Internet]. New Delhi. National Institute for Transforming India, Government of India. [cited April 1, 2018]. 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Am J Obstet Gynecol 1998;178:742-9<\/span><\/li><li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Pooh RK, Kujrak A. 3D\/4D sonography moved prenatal diagnosis of fetal anomalies from the second to the first trimester of pregnancy. J Matern Fetal Neonatal Med 2012;25:433-55<\/span><\/li><li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Global Burden of Disease Pediatrics Collaboration, Kyu HH, Pinho C, Wagner JA, Brown JC, Bertozzi-Villa A et al. Global and National Burden of Diseases and Injuries among Children and Adolescents between 1990 and 2013: Findings from the Global Burden of Disease 2013 Study. JAMA Pediatr 2016;170:267-87&nbsp;<\/span><\/li><li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Choorakuttil RM, Devarajan P, Bavaharan R, Jain N, Sharma LK, Nagar S. Samrakshan: Rationale for universal 1st trimester screening to identify pregnant women at risk for preterm preeclampsia. Accessed online from Journal of Fetal Radiology&nbsp; at <\/span><a href=\"http:\/\/fetalradiology.in\/2019\/11\/14\/2908\/\"><span style=\"font-weight: 400;\">http:\/\/fetalradiology.in\/2019\/11\/14\/2908\/<\/span><\/a><span style=\"font-weight: 400;\"> on Dec 2, 2019<\/span><\/li><li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Shenoy S, Choorakuttil RM, Bavaharan R, Devarajan P, Nirmalan PK. Mobile Learning as an Integral Part of Samrakshan IRIA national program. Accessed online from Journal of Fetal Radiology at<\/span><a href=\"http:\/\/fetalradiology.in\/2019\/11\/25\/mobile-learning-as-an-integral-part-of-samrakshan-iria-national-program\/\"><span style=\"font-weight: 400;\"> http:\/\/fetalradiology.in\/2019\/11\/25\/mobile-learning-as-an-integral-part-of-samrakshan-iria-national-program<\/span><\/a><span style=\"font-weight: 400;\">\/ on Dec 2, 2019<\/span><\/li><li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Choorakuttil RM, Patel H, Bavaharan R, Devarajan P, Kanhirat S, Shenoy RS, Tiwari OP, Sodani RK, Sharma LK, Nirmalan PK. Samrakshan: An Indian radiological and imaging association program to reduce perinatal mortality in India. Indian J Radiol Imaging 2019;29:412-7<\/span><\/li><\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Authors: Rijo M Choorakuttil, Devarajan P, Lalit K Sharma, Ramesh S Shenoy, Amel Antony, M.R. Balachandran Nair, Praveen K Nirmalan&nbsp; Rijo M Choorakuttil, National Coordinator for Samrakshan IRIA, AMMA Center for Diagnosis and Preventive Medicine, Kochi, Kerala, India Devarajan P, Nethra Scans and Genetic Clinic, Tiruppur, Tamil Nadu, India Lalit K Sharma, Raj Sonography &amp; [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14],"tags":[26,29,31,32,30],"class_list":["post-3100","post","type-post","status-publish","format-standard","hentry","category-original-article","tag-fetal-radiology","tag-imaging","tag-pregnancy","tag-risk-stratification","tag-tiffa"],"_links":{"self":[{"href":"https:\/\/fetalradiology.co.in\/index.php?rest_route=\/wp\/v2\/posts\/3100","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/fetalradiology.co.in\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/fetalradiology.co.in\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/fetalradiology.co.in\/index.php?rest_route=\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/fetalradiology.co.in\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3100"}],"version-history":[{"count":10,"href":"https:\/\/fetalradiology.co.in\/index.php?rest_route=\/wp\/v2\/posts\/3100\/revisions"}],"predecessor-version":[{"id":3144,"href":"https:\/\/fetalradiology.co.in\/index.php?rest_route=\/wp\/v2\/posts\/3100\/revisions\/3144"}],"wp:attachment":[{"href":"https:\/\/fetalradiology.co.in\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3100"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/fetalradiology.co.in\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3100"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/fetalradiology.co.in\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3100"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}