[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461118":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":349,"collaborators":351,"id":358,"slug":359,"hasResults":360,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":360,"sex":366,"minAge":367,"maxAge":12,"enrollmentInfo":368,"targetDuration":12,"studyType":371,"phases":372,"briefSummary":374,"conditions":375,"keywords":379,"overallStatus":385,"whyStopped":12,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":390,"completionDateStruct":391,"leadSponsor":393,"locationsCount":394},{"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",[37,52,64,76,88,97,106,118,130,142,154,166,178,190,202,214,226,238,247,259,271,283,292,304,316,325,337],{"facility":38,"status":12,"city":39,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Complejo Hospitalario Universitario de A Coruña","A Coruña","Spain","ES",{"type":43,"coordinates":44},"Point",[45,46],-8.396,43.37135,{"lat":46,"lon":45},[49],{"name":50,"role":32,"phone":12,"phoneExt":12,"email":51},"Nuria Valiño","nuvalino@gmail.com",{"facility":53,"status":12,"city":54,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Hospital Universitario General de Alicante","Alicante",{"type":43,"coordinates":56},[57,58],-0.48149,38.34517,{"lat":58,"lon":57},[61],{"name":62,"role":32,"phone":12,"phoneExt":12,"email":63},"Ana Palacios","ana.palacios.marques@gmail.com",{"facility":65,"status":12,"city":66,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Hospital Universitari Germans Trias i Pujol","Badalona",{"type":43,"coordinates":68},[69,70],2.24741,41.45004,{"lat":70,"lon":69},[73],{"name":74,"role":32,"phone":12,"phoneExt":12,"email":75},"Ivan Hurtado","ivan.hurtado85@gmail.com",{"facility":77,"status":12,"city":78,"state":12,"zip":79,"country":40,"countryCode":41,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Vall d'hebron Barcelona Hospital Campus","Barcelona","08035",{"type":43,"coordinates":81},[82,83],2.15899,41.38879,{"lat":83,"lon":82},[86],{"name":27,"role":32,"phone":87,"phoneExt":34,"email":35},"934893000",{"facility":89,"status":12,"city":78,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":90,"geoPoint":92,"contacts":93},"Hospital de la Santa Creu i Sant Pau",{"type":43,"coordinates":91},[82,83],{"lat":83,"lon":82},[94],{"name":95,"role":32,"phone":12,"phoneExt":12,"email":96},"Johana Ullmo","jullmo@santpau.cat",{"facility":98,"status":12,"city":78,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},"Hospital Universitari Dexeus",{"type":43,"coordinates":100},[82,83],{"lat":83,"lon":82},[103],{"name":104,"role":32,"phone":12,"phoneExt":12,"email":105},"Pilar Prats","pilpra@dexeus.com",{"facility":107,"status":12,"city":108,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Hospital Universitario Puerta del Mar","Cadiz",{"type":43,"coordinates":110},[111,112],-6.2891,36.52672,{"lat":112,"lon":111},[115],{"name":116,"role":32,"phone":12,"phoneExt":12,"email":117},"Maria Angeles Anaya","manaya2404@gmail.com",{"facility":119,"status":12,"city":120,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Hospital General Universitario de Elche","Elche",{"type":43,"coordinates":122},[123,124],-0.70107,38.26218,{"lat":124,"lon":123},[127],{"name":128,"role":32,"phone":12,"phoneExt":12,"email":129},"Ada Harrington","ada.herrington@gmail.com",{"facility":131,"status":12,"city":132,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Hospital Universitario de Getafe","Getafe",{"type":43,"coordinates":134},[135,136],-3.73295,40.30571,{"lat":136,"lon":135},[139],{"name":140,"role":32,"phone":12,"phoneExt":12,"email":141},"Elena Pintado","elenapintadoparedes@gmail.com",{"facility":143,"status":12,"city":144,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Hospital Universitario de Cabueñes","Gijón",{"type":43,"coordinates":146},[147,148],-5.66152,43.53573,{"lat":148,"lon":147},[151],{"name":152,"role":32,"phone":12,"phoneExt":12,"email":153},"Esther Perez","estherpcarbajo@hotmail.com",{"facility":155,"status":12,"city":156,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Hospital Universitari de Girona Doctor Josep Trueta","Girona",{"type":43,"coordinates":158},[159,160],2.82493,41.98311,{"lat":160,"lon":159},[163],{"name":164,"role":32,"phone":12,"phoneExt":12,"email":165},"Alexandra Bonmatí","abonmatis.girona.ics@gencat.cat",{"facility":167,"status":12,"city":168,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Hospital Universitario San Cecilio","Granada",{"type":43,"coordinates":170},[171,172],-3.60667,37.18817,{"lat":172,"lon":171},[175],{"name":176,"role":32,"phone":12,"phoneExt":12,"email":177},"Maria del Carmen Jimenez","mcarmenjimenezhernandez@gmail.com",{"facility":179,"status":12,"city":180,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Hospital Universitario de Jerez de la Frontera","Jerez de la Frontera",{"type":43,"coordinates":182},[183,184],-6.13606,36.68645,{"lat":184,"lon":183},[187],{"name":188,"role":32,"phone":12,"phoneExt":12,"email":189},"Cristina Romero","CRGARRI@GMAIL.COM",{"facility":191,"status":12,"city":192,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Hospital Materno Infantil de Gran Canaria","Las Palmas de Gran Canaria",{"type":43,"coordinates":194},[195,196],-15.41573,28.10178,{"lat":196,"lon":195},[199],{"name":200,"role":32,"phone":12,"phoneExt":12,"email":201},"Laura Molero","laura.molerosala@gmail.com",{"facility":203,"status":12,"city":204,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"Hospital Universitari Arnau de Vilanova","Lleida",{"type":43,"coordinates":206},[207,208],0.62218,41.61674,{"lat":208,"lon":207},[211],{"name":212,"role":32,"phone":12,"phoneExt":12,"email":213},"Sandra Borderia","sb.rabassa@gmail.com",{"facility":215,"status":12,"city":216,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Hospital Clínico San Carlos","Madrid",{"type":43,"coordinates":218},[219,220],-3.70256,40.4165,{"lat":220,"lon":219},[223],{"name":224,"role":32,"phone":12,"phoneExt":12,"email":225},"Ricardo Saviron","ricardo.saviron@salud.madrid.org",{"facility":227,"status":12,"city":228,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Hospital Universitari Son Espases","Palma de Mallorca",{"type":43,"coordinates":230},[231,232],2.65024,39.56939,{"lat":232,"lon":231},[235],{"name":236,"role":32,"phone":12,"phoneExt":12,"email":237},"Maria Vila","mariavilacortes@gmail.com",{"facility":239,"status":12,"city":228,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":240,"geoPoint":242,"contacts":243},"Hospital Universitari Son Llàtzer",{"type":43,"coordinates":241},[231,232],{"lat":232,"lon":231},[244],{"name":245,"role":32,"phone":12,"phoneExt":12,"email":246},"Beatriz Soriano","bea180680@gmail.com",{"facility":248,"status":12,"city":249,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":250,"geoPoint":254,"contacts":255},"Corporació Sanitària Parc Taulí","Sabadell",{"type":43,"coordinates":251},[252,253],2.10942,41.54329,{"lat":253,"lon":252},[256],{"name":257,"role":32,"phone":12,"phoneExt":12,"email":258},"Anna Moreno","annmorenoba@gmail.com",{"facility":260,"status":12,"city":261,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"Hospital Universitario de Canarias","Santa Cruz de Tenerife",{"type":43,"coordinates":263},[264,265],-16.25462,28.46824,{"lat":265,"lon":264},[268],{"name":269,"role":32,"phone":12,"phoneExt":12,"email":270},"Merecedes Hernandez","mercedes021281@hotmail.com",{"facility":272,"status":12,"city":273,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":274,"geoPoint":278,"contacts":279},"Hospital Universitario Virgen de Valme","Seville",{"type":43,"coordinates":275},[276,277],-5.97317,37.38283,{"lat":277,"lon":276},[280],{"name":281,"role":32,"phone":12,"phoneExt":12,"email":282},"Carlota Borrero","carlotaborrero@gmail.com",{"facility":284,"status":12,"city":273,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":285,"geoPoint":287,"contacts":288},"Virgen Macarena",{"type":43,"coordinates":286},[276,277],{"lat":277,"lon":276},[289],{"name":290,"role":32,"phone":12,"phoneExt":12,"email":291},"Eva Carmona","evam.carmona.sspa@juntadeandalucia.es",{"facility":293,"status":12,"city":294,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":295,"geoPoint":299,"contacts":300},"Hospital Universitario Joan XXIII de Tarragona","Tarragona",{"type":43,"coordinates":296},[297,298],1.24544,41.11905,{"lat":298,"lon":297},[301],{"name":302,"role":32,"phone":12,"phoneExt":12,"email":303},"Monica Lopez","monicalopez4099@gmail.com",{"facility":305,"status":12,"city":306,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":307,"geoPoint":311,"contacts":312},"Consorci Sanitari de Terrassa","Terrassa",{"type":43,"coordinates":308},[309,310],2.01667,41.56667,{"lat":310,"lon":309},[313],{"name":314,"role":32,"phone":12,"phoneExt":12,"email":315},"Angels Vives","vivesangels@gmail.com",{"facility":317,"status":12,"city":306,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":318,"geoPoint":320,"contacts":321},"Hospital Universitari Mútua Terrassa",{"type":43,"coordinates":319},[309,310],{"lat":310,"lon":309},[322],{"name":323,"role":32,"phone":12,"phoneExt":12,"email":324},"Eva Lopez","evalq@hotmail.com",{"facility":326,"status":12,"city":327,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":328,"geoPoint":332,"contacts":333},"Hospital Universitario de Torrejón","Torrejón de Ardoz",{"type":43,"coordinates":329},[330,331],-3.46973,40.45535,{"lat":331,"lon":330},[334],{"name":335,"role":32,"phone":12,"phoneExt":12,"email":336},"Raquel Martin, MD","raqmaral@gmail.com",{"facility":338,"status":12,"city":339,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":340,"geoPoint":344,"contacts":345},"Hospital Clínico Universitario Lozano Blesa","Zaragoza",{"type":43,"coordinates":341},[342,343],-0.87734,41.65606,{"lat":343,"lon":342},[346],{"name":347,"role":32,"phone":12,"phoneExt":12,"email":348},"Patricia Ibañez","patribanez@hotmail.com",{"type":350,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[352,355],{"name":353,"class":354},"Instituto de Salud Carlos III","OTHER_GOV",{"name":356,"class":357},"Roche Diagnostics GmbH","INDUSTRY","100461118","management-of-early-onset-fetal-growth-restriction-angiogenic-factors-versus-feto-placental-doppler-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":369,"type":370},340,"ESTIMATED","INTERVENTIONAL",[373],"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.",[376,377,378],"Fetal Growth Retardation","Preeclampsia","Placenta Diseases",[380,381,382,383,384],"fetal growth restriction","small for gestational age","PlGF","sFlt-1","Doppler","NOT_YET_RECRUITING","2024-06-03",{"date":388,"type":389},"2024-06-04","ACTUAL",{"date":386,"type":370},{"date":392,"type":370},"2026-12-30",{"name":5,"class":6},27]