[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461118":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":348,"collaborators":350,"id":357,"slug":12,"hasResults":358,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":358,"sex":364,"minAge":365,"maxAge":12,"enrollmentInfo":366,"targetDuration":12,"studyType":369,"phases":370,"briefSummary":372,"conditions":373,"keywords":377,"overallStatus":383,"whyStopped":12,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":388,"completionDateStruct":389,"leadSponsor":391,"locationsCount":392},{"fullName":5,"class":6},"Hospital Universitari Vall d'Hebron Research Institute","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","NO_INTERVENTION","Small fetuses will be classified into 5 severity stages and managed as follows:\n\n* SGA: Estimated fetal weight (EFW) between p3 and p10 with normal Dopplers. Ultrasound\u002F2 weeks, elective vaginal delivery at ≥39-40 weeks.\n* Stage I: EFW ≤p3 p or EFW p3-10 + UA PI \\>p95 and\u002For UtA PI \\>p95, and, at ≥32 weeks, CPR and\u002For MCA PI \\\u003Cp5, in 2 occasions \\>12 hours apart. Ultrasound weekly, elective vaginal delivery at ≥37 weeks.\n* Stage II: AEDF UA in 2 occasions \\>12 hours apart. Ultrasound every 48-72h, elective Cesarean delivery at ≥34 weeks.\n* Stage III: DV PI \\> p95 (or absent DV \"a\" wave) or reversed end-diastolic UA \\>50% of cycles, in both cases in two occasions \\> 6 hours apart. Ultrasound every 24-48h, elective Cesarean delivery at ≥30 weeks.\n* Stage IV: reversed DV \"a\" wave in two occasions \\> 6 hours apart. Elective Cesarean delivery at ≥26 weeks.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Study","EXPERIMENTAL","Doppler protocol (as in controls) + sFlt-1\u002FPlGF ratio cutoffs will be incorporated as follows:\n\n* \\\u003C38: Ultrasound biweekly in stage I FGR and every four weeks in SGA. In both cases delivery at ≥39-40 weeks.\n* 38-110: In stage I FGR and SGA ultrasound weekly. Delivery at ≥37 weeks.\n* \\>110: In stage I FGR and SGA ultrasound weekly. Delivery at ≥36 weeks.\n* \\>110 and concurrent preeclampsia: In stage I FGR and SGA ultrasound every 48h-72h. Delivery at ≥34 weeks.\n* \\>201: Ultrasound every 48-72h, delivery at ≥34+0 weeks. If concurrent preeclampsia, delivery at ≥32+0 weeks.\n* \\>655: Ultrasound every 48-72h, delivery at ≥32+0 weeks. If concurrent preeclampsia, delivery at ≥30+0 weeks.\n* \\>1000: In cases with concurrent PE, delivery at ≥29+0 weeks.",[18],"Diagnostic Test: soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1\u002FPlGF)",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DIAGNOSTIC_TEST","soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1\u002FPlGF)","soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1\u002FPlGF) will be incorporated to the management of early-onset small fetuses (estimated fetal weight ≤10th percentile)",[14],[26],{"name":27,"affiliation":28,"role":29},"Manel Mendoza, MD, PhD","Vall d'Hebron Institute Research","PRINCIPAL_INVESTIGATOR",[31],{"name":27,"role":32,"phone":33,"phoneExt":34,"email":35},"CONTACT","+34934893000","3085","manel.mendoza@vallhebron.cat",[37,51,63,75,87,96,105,117,129,141,153,165,177,189,201,213,225,237,246,258,270,282,291,303,315,324,336],{"facility":38,"status":12,"city":39,"state":12,"zip":12,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Complejo Hospitalario Universitario de A Coruña","A Coruña","Spain",{"type":42,"coordinates":43},"Point",[44,45],-8.396,43.37135,{"lat":45,"lon":44},[48],{"name":49,"role":32,"phone":12,"phoneExt":12,"email":50},"Nuria Valiño","nuvalino@gmail.com",{"facility":52,"status":12,"city":53,"state":12,"zip":12,"country":40,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Hospital Universitario General de Alicante","Alicante",{"type":42,"coordinates":55},[56,57],-0.48149,38.34517,{"lat":57,"lon":56},[60],{"name":61,"role":32,"phone":12,"phoneExt":12,"email":62},"Ana Palacios","ana.palacios.marques@gmail.com",{"facility":64,"status":12,"city":65,"state":12,"zip":12,"country":40,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Hospital Universitari Germans Trias i Pujol","Badalona",{"type":42,"coordinates":67},[68,69],2.24741,41.45004,{"lat":69,"lon":68},[72],{"name":73,"role":32,"phone":12,"phoneExt":12,"email":74},"Ivan Hurtado","ivan.hurtado85@gmail.com",{"facility":76,"status":12,"city":77,"state":12,"zip":78,"country":40,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Vall d'hebron Barcelona Hospital Campus","Barcelona","08035",{"type":42,"coordinates":80},[81,82],2.15899,41.38879,{"lat":82,"lon":81},[85],{"name":27,"role":32,"phone":86,"phoneExt":34,"email":35},"934893000",{"facility":88,"status":12,"city":77,"state":12,"zip":12,"country":40,"cosmosGeoPoint":89,"geoPoint":91,"contacts":92},"Hospital de la Santa Creu i Sant Pau",{"type":42,"coordinates":90},[81,82],{"lat":82,"lon":81},[93],{"name":94,"role":32,"phone":12,"phoneExt":12,"email":95},"Johana Ullmo","jullmo@santpau.cat",{"facility":97,"status":12,"city":77,"state":12,"zip":12,"country":40,"cosmosGeoPoint":98,"geoPoint":100,"contacts":101},"Hospital Universitari Dexeus",{"type":42,"coordinates":99},[81,82],{"lat":82,"lon":81},[102],{"name":103,"role":32,"phone":12,"phoneExt":12,"email":104},"Pilar Prats","pilpra@dexeus.com",{"facility":106,"status":12,"city":107,"state":12,"zip":12,"country":40,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Hospital Universitario Puerta del Mar","Cadiz",{"type":42,"coordinates":109},[110,111],-6.2891,36.52672,{"lat":111,"lon":110},[114],{"name":115,"role":32,"phone":12,"phoneExt":12,"email":116},"Maria Angeles Anaya","manaya2404@gmail.com",{"facility":118,"status":12,"city":119,"state":12,"zip":12,"country":40,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Hospital General Universitario de Elche","Elche",{"type":42,"coordinates":121},[122,123],-0.70107,38.26218,{"lat":123,"lon":122},[126],{"name":127,"role":32,"phone":12,"phoneExt":12,"email":128},"Ada Harrington","ada.herrington@gmail.com",{"facility":130,"status":12,"city":131,"state":12,"zip":12,"country":40,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Hospital Universitario de Getafe","Getafe",{"type":42,"coordinates":133},[134,135],-3.73295,40.30571,{"lat":135,"lon":134},[138],{"name":139,"role":32,"phone":12,"phoneExt":12,"email":140},"Elena Pintado","elenapintadoparedes@gmail.com",{"facility":142,"status":12,"city":143,"state":12,"zip":12,"country":40,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Hospital Universitario de Cabueñes","Gijón",{"type":42,"coordinates":145},[146,147],-5.66152,43.53573,{"lat":147,"lon":146},[150],{"name":151,"role":32,"phone":12,"phoneExt":12,"email":152},"Esther Perez","estherpcarbajo@hotmail.com",{"facility":154,"status":12,"city":155,"state":12,"zip":12,"country":40,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Hospital Universitari de Girona Doctor Josep Trueta","Girona",{"type":42,"coordinates":157},[158,159],2.82493,41.98311,{"lat":159,"lon":158},[162],{"name":163,"role":32,"phone":12,"phoneExt":12,"email":164},"Alexandra Bonmatí","abonmatis.girona.ics@gencat.cat",{"facility":166,"status":12,"city":167,"state":12,"zip":12,"country":40,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Hospital Universitario San Cecilio","Granada",{"type":42,"coordinates":169},[170,171],-3.60667,37.18817,{"lat":171,"lon":170},[174],{"name":175,"role":32,"phone":12,"phoneExt":12,"email":176},"Maria del Carmen Jimenez","mcarmenjimenezhernandez@gmail.com",{"facility":178,"status":12,"city":179,"state":12,"zip":12,"country":40,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Hospital Universitario de Jerez de la Frontera","Jerez de la Frontera",{"type":42,"coordinates":181},[182,183],-6.13606,36.68645,{"lat":183,"lon":182},[186],{"name":187,"role":32,"phone":12,"phoneExt":12,"email":188},"Cristina Romero","CRGARRI@GMAIL.COM",{"facility":190,"status":12,"city":191,"state":12,"zip":12,"country":40,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Hospital Materno Infantil de Gran Canaria","Las Palmas de Gran Canaria",{"type":42,"coordinates":193},[194,195],-15.41573,28.10178,{"lat":195,"lon":194},[198],{"name":199,"role":32,"phone":12,"phoneExt":12,"email":200},"Laura Molero","laura.molerosala@gmail.com",{"facility":202,"status":12,"city":203,"state":12,"zip":12,"country":40,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Hospital Universitari Arnau de Vilanova","Lleida",{"type":42,"coordinates":205},[206,207],0.62218,41.61674,{"lat":207,"lon":206},[210],{"name":211,"role":32,"phone":12,"phoneExt":12,"email":212},"Sandra Borderia","sb.rabassa@gmail.com",{"facility":214,"status":12,"city":215,"state":12,"zip":12,"country":40,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Hospital Clínico San Carlos","Madrid",{"type":42,"coordinates":217},[218,219],-3.70256,40.4165,{"lat":219,"lon":218},[222],{"name":223,"role":32,"phone":12,"phoneExt":12,"email":224},"Ricardo Saviron","ricardo.saviron@salud.madrid.org",{"facility":226,"status":12,"city":227,"state":12,"zip":12,"country":40,"cosmosGeoPoint":228,"geoPoint":232,"contacts":233},"Hospital Universitari Son Espases","Palma de Mallorca",{"type":42,"coordinates":229},[230,231],2.65024,39.56939,{"lat":231,"lon":230},[234],{"name":235,"role":32,"phone":12,"phoneExt":12,"email":236},"Maria Vila","mariavilacortes@gmail.com",{"facility":238,"status":12,"city":227,"state":12,"zip":12,"country":40,"cosmosGeoPoint":239,"geoPoint":241,"contacts":242},"Hospital Universitari Son Llàtzer",{"type":42,"coordinates":240},[230,231],{"lat":231,"lon":230},[243],{"name":244,"role":32,"phone":12,"phoneExt":12,"email":245},"Beatriz Soriano","bea180680@gmail.com",{"facility":247,"status":12,"city":248,"state":12,"zip":12,"country":40,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"Corporació Sanitària Parc Taulí","Sabadell",{"type":42,"coordinates":250},[251,252],2.10942,41.54329,{"lat":252,"lon":251},[255],{"name":256,"role":32,"phone":12,"phoneExt":12,"email":257},"Anna Moreno","annmorenoba@gmail.com",{"facility":259,"status":12,"city":260,"state":12,"zip":12,"country":40,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"Hospital Universitario de Canarias","Santa Cruz de Tenerife",{"type":42,"coordinates":262},[263,264],-16.25462,28.46824,{"lat":264,"lon":263},[267],{"name":268,"role":32,"phone":12,"phoneExt":12,"email":269},"Merecedes Hernandez","mercedes021281@hotmail.com",{"facility":271,"status":12,"city":272,"state":12,"zip":12,"country":40,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"Hospital Universitario Virgen de Valme","Seville",{"type":42,"coordinates":274},[275,276],-5.97317,37.38283,{"lat":276,"lon":275},[279],{"name":280,"role":32,"phone":12,"phoneExt":12,"email":281},"Carlota Borrero","carlotaborrero@gmail.com",{"facility":283,"status":12,"city":272,"state":12,"zip":12,"country":40,"cosmosGeoPoint":284,"geoPoint":286,"contacts":287},"Virgen Macarena",{"type":42,"coordinates":285},[275,276],{"lat":276,"lon":275},[288],{"name":289,"role":32,"phone":12,"phoneExt":12,"email":290},"Eva Carmona","evam.carmona.sspa@juntadeandalucia.es",{"facility":292,"status":12,"city":293,"state":12,"zip":12,"country":40,"cosmosGeoPoint":294,"geoPoint":298,"contacts":299},"Hospital Universitario Joan XXIII de Tarragona","Tarragona",{"type":42,"coordinates":295},[296,297],1.24544,41.11905,{"lat":297,"lon":296},[300],{"name":301,"role":32,"phone":12,"phoneExt":12,"email":302},"Monica Lopez","monicalopez4099@gmail.com",{"facility":304,"status":12,"city":305,"state":12,"zip":12,"country":40,"cosmosGeoPoint":306,"geoPoint":310,"contacts":311},"Consorci Sanitari de Terrassa","Terrassa",{"type":42,"coordinates":307},[308,309],2.01667,41.56667,{"lat":309,"lon":308},[312],{"name":313,"role":32,"phone":12,"phoneExt":12,"email":314},"Angels Vives","vivesangels@gmail.com",{"facility":316,"status":12,"city":305,"state":12,"zip":12,"country":40,"cosmosGeoPoint":317,"geoPoint":319,"contacts":320},"Hospital Universitari Mútua Terrassa",{"type":42,"coordinates":318},[308,309],{"lat":309,"lon":308},[321],{"name":322,"role":32,"phone":12,"phoneExt":12,"email":323},"Eva Lopez","evalq@hotmail.com",{"facility":325,"status":12,"city":326,"state":12,"zip":12,"country":40,"cosmosGeoPoint":327,"geoPoint":331,"contacts":332},"Hospital Universitario de Torrejón","Torrejón de Ardoz",{"type":42,"coordinates":328},[329,330],-3.46973,40.45535,{"lat":330,"lon":329},[333],{"name":334,"role":32,"phone":12,"phoneExt":12,"email":335},"Raquel Martin, MD","raqmaral@gmail.com",{"facility":337,"status":12,"city":338,"state":12,"zip":12,"country":40,"cosmosGeoPoint":339,"geoPoint":343,"contacts":344},"Hospital Clínico Universitario Lozano Blesa","Zaragoza",{"type":42,"coordinates":340},[341,342],-0.87734,41.65606,{"lat":342,"lon":341},[345],{"name":346,"role":32,"phone":12,"phoneExt":12,"email":347},"Patricia Ibañez","patribanez@hotmail.com",{"type":349,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[351,354],{"name":352,"class":353},"Instituto de Salud Carlos III","OTHER_GOV",{"name":355,"class":356},"Roche Diagnostics GmbH","INDUSTRY","100461118",false,"NCT05284474","Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler","Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler (Early GRAFD)","earlyGRAFD","Inclusion Criteria:\n\n* Pregnant women of at least 18 years old\n* Singleton pregnancy\n* Ultrasonographic EFW ≤10th percentile between 26+0 and 31+6 weeks of gestation\n* Gestational age confirmed by fetal crown-rump length measurement during the first trimester scan (from 11+0 to 13+6 weeks of gestation) or by in vitro fertilization dates.\n\nExclusion Criteria:\n\n* Major fetal malformations or genetic disorders\n* Fetal death\n* Refusal to give informed consent\n* Stage IV FGR","FEMALE","18 Years",{"count":367,"type":368},340,"ESTIMATED","INTERVENTIONAL",[371],"NA","This is a multicentre, open-label, randomized controlled trial. A total of 340 singleton pregnancies with an EFW ≤10th percentile between 26+0 and 31+6 weeks will be recruited and randomly allocated to either the control or the intervention group. In the control group, standard Doppler-based management will be used. In the intervention group, different soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1\u002FPlGF) cutoffs will be incorporated to the current protocol to adjust the frequency of ultrasounds and to plan elective delivery.",[374,375,376],"Fetal Growth Retardation","Preeclampsia","Placenta Diseases",[378,379,380,381,382],"fetal growth restriction","small for gestational age","PlGF","sFlt-1","Doppler","NOT_YET_RECRUITING","2024-06-03",{"date":386,"type":387},"2024-06-04","ACTUAL",{"date":384,"type":368},{"date":390,"type":368},"2026-12-30",{"name":5,"class":6},27]