[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595636":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":39,"responsibleParty":65,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":18,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":18,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"digital fetal scalp stimulation dFSS","EXPERIMENTAL","Digital fetal scalp stimulation will be performed for a period of 30 seconds prior to obtaining the fetal blood sample. Digital fetal scalp stimulation will be performed by vaginal touch with a gauze pad and applying rubbing pressure over the fetal scalp for 30 to 60 seconds. This procedure will be recorded on the same RCTG. The FHR pattern on the cardiotocographic recording is closely monitored for 1 to 10 minutes, using a 5-minute mean, following fetal stimulation the fetus should respond with an acceleration of FHR defined as an increase in FHR ≥ 15 bpm (beats per minute for at least 15 seconds or normal FHR variability (5 to 25 bpm), or both. The presence of an acceleration of FHR or an increase in variability when it was previously reduced, or both, is interpreted as a positive response, comparable to a normal fetal blood scalp sample FBS result.",[13],"Diagnostic Test: Digital fetal scalp stimulation dFSS",{"label":15,"type":16,"description":17,"interventionNames":18},"NO digital fetal scalp stimulation dFSS","NO_INTERVENTION","The fetal blood sampling will be performed, since in our environment it is the gold standard method included in the SEGO recommendations.\n\nThere is NO intervention.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Digital fetal scalp stimulation dFSS","Digital fetal scalp stimulation will be performed for a period of 30 seconds, prior to obtaining the fetal blood sample. Digital fetal scalp stimulation will be performed by vaginal touch with a gauze pad and rubbing the fetal scalp with pressure for 30 to 60 seconds.",[9],[26],"dFSS",[28],{"name":29,"affiliation":30,"role":31},"JAVIER PLAZA ARRANZ, Doctor","Hospital Fundación Jiménez Diaz","STUDY_DIRECTOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"RAQUEL MAQUEDA, MATRONA","CONTACT","+34 915504800","2561","raquel.maquedamoreno@usp.ceu.es",[40,60],{"facility":41,"status":42,"city":43,"state":18,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Fundación Jimenez Diaz Y Hospital La Zarzuela","RECRUITING","Madrid","28040","Spain","ES",{"type":48,"coordinates":49},"Point",[50,51],-3.70256,40.4165,{"lat":51,"lon":50},[54,55,58],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},{"name":56,"role":57,"phone":18,"phoneExt":18,"email":18},"MIGUEL ALVARO NAVIDAD, DOCTOR","SUB_INVESTIGATOR",{"name":59,"role":57,"phone":18,"phoneExt":18,"email":18},"ANA VIRSEDA DE ANTONIO, DOCTOR",{"facility":61,"status":42,"city":43,"state":18,"zip":18,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":64,"contacts":18},"Hospital Universitario Sanitas La Zarzuela",{"type":48,"coordinates":63},[50,51],{"lat":51,"lon":50},{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Raquel Maqueda Moreno","Investigator name",[70,72],{"name":71,"class":6},"CEU San Pablo University",{"name":61,"class":6},"100595636","evaluation-of-the-fetal-response-to-intrapartum-digital-fetal-scalp-stimulation-to-identify-intrapartum-fetal-hypoxia-100595636",false,"NCT07035028","Evaluation of the Fetal Response to Intrapartum Digital Fetal Scalp Stimulation to Identify Intrapartum Fetal Hypoxia.","Evaluation of Fetal Response to Intrapartum Digital Fetal Scalp Stimulation Upon Detection of Suspected Loss of Fetal Well-being in Suspicious and Pathologic Cardiotocographic Recordings, to Identify Intrapartum Fetal Hypoxia.","Inclusion criteria:\n\nWomen with singleton pregnancy.\n\nCephalic presentation.\n\nGestational age greater than or equal to 37 weeks.\n\nPathological cardiotocographic record according to the criteria published by FIGO and with indication to perform a second-line complementary test, in our case a gold standard test of fetal scalp blood FBS, which confirms or not if there is a risk of loss of fetal well-being and the need for fetal extraction.\n\nSignature of HIP and CI for data collection.\n\nExclusion criteria:\n\nUnder 18 years of age.\n\nContraindication for FBS\n\nUterine dilatation that does not make FBS possible.\n\nHIV\n\nHepatitis\n\nFetuses at increased risk of hemorrhage.","FEMALE","18 Years","50 Years",{"count":84,"type":85},182,"ESTIMATED","INTERVENTIONAL",[88],"NA","The main objective of this study is to evaluate whether digital fetal scalp stimulation improves fetal well-being in fetuses with suspicious or pathological cardiotocographic recordings, showing an improvement in cardiotocographic recording patterns and normal values in intrapartum fetal scalp blood results.\n\nUpon detection of a suspicious or pathologic cardiotocographic recording, the investigators need to perform an objective verification of fetal well-being.\n\nCurrently, fetal scalp blood is the reference test to assess intrapartum fetal hypoxia, according to the protocols of the Spanish Society of Gynecology and Obstetrics.\n\nThis procedure lasts about 5 minutes and consists of taking a small sample of the fetal scalp, through a vaginal exploration, the blood is collected in a thin tube and analyzed by a machine in the delivery room obtaining the results in a few minutes.\n\nThe investigators emphasize that this test is not part of the study, as long as the monitor is suspicious or pathological, it will be performed according to protocol to objectively assess fetal well-being.\n\nCurrently there are studies that support the use of fetal scalp stimulation as an alternative technique to assess intrapartum fetal well-being and predict neonatal outcomes, but they also highlight its limited evidence.\n\nDigital fetal scalp stimulation is a NON-invasive method, as no instrument is required and fetal stimulation is a 30-60 second surface rubbing pressure, which is performed manually, through vaginal exploration, the same technique the investigators use to assess dilation during the labor process.\n\nEach patient will be randomly assigned to a study group:\n\nExperimental group: before the extraction of capillary blood from the fetal scalp, fetal head stimulation will be performed, a technique that poses no risk to the baby. The researchers need the consent of the participants to perform this technique and collect data.\n\nControl group: fetal head stimulation will not be applied, but data from the clinical history necessary for this study will be collected.\n\nIn no case will extraordinary or unnecessary tests be performed for participation in this study.\n\nThis study will have an Informed Consent document.\n\nThis study will be carried out at the Fundación Jiménez Díaz and Zarzuela and will include 182 patients for 24 months.",[91,92],"Fetal Hypoxia","Fetal Monitoring",[9,94,95,96,97,98,99,100],"fetal monitoring","fetal blood sampling FBS","fetal scalp blood","cardiotocography","umbilical cord blood","acidemia","Intrapartum care","2025-06-16",{"date":103,"type":104},"2025-06-24","ACTUAL",{"date":106,"type":104},"2024-01-01",{"date":108,"type":85},"2025-12",{"name":5,"class":6},2]