[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100363356":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":44,"locations":51,"responsibleParty":67,"collaborators":49,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":49,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":53,"whyStopped":49,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"KK Women's and Children's Hospital","OTHER_GOV",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Variable volume Automated Mandatory Bolus (VVAMB)","EXPERIMENTAL","The anaesthetic drug and pain medication are prepared in an epidural infusion pump with the VVAMB programme. The programme uses higher doses with lower frequency of medication (ropivacaine and fentanyl), and a patient control button for the patient to control the additional pain relief demands depending on the requirements during labour.",[13,14,15],"Device: Epidural infusion pump","Drug: Ropivacaine","Drug: Fentanyl",{"label":17,"type":18,"description":19,"interventionNames":20},"Automated mandatory bolus (AMB) of variable-frequency (VAMB)","ACTIVE_COMPARATOR","The anaesthetic drug and pain medication are prepared in an epidural infusion pump with the VAMB programme. The programme uses lower doses with more frequency of medication (ropivacaine and fentanyl), and a patient control button for the patient to control the additional pain relief demands depending on the requirements during labour.",[13,14,15],[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","Epidural infusion pump","Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg\u002Fml fentanyl (opioid) as maintenance solution.",[17,9],[28],"Epidural delivery system",{"type":30,"name":31,"description":25,"armGroupLabels":32,"otherNames":33},"DRUG","Ropivacaine",[17,9],[34],"Amide local anaesthetic",{"type":30,"name":36,"description":25,"armGroupLabels":37,"otherNames":38},"Fentanyl",[17,9],[39],"Opioid",[41],{"name":42,"affiliation":5,"role":43},"Wan Ling Leong, FANZCA","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Ban Leong Sng, FANZCA","CONTACT","+6563941081",null,"sng.ban.leong@kkh.com.sg",[52],{"facility":5,"status":53,"city":54,"state":49,"zip":55,"country":54,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Singapore","229899","SG",{"type":58,"coordinates":59},"Point",[60,61],103.85007,1.28967,{"lat":61,"lon":60},[64],{"name":65,"role":47,"phone":49,"phoneExt":49,"email":66},"Wan Ling Leong","leong.wan.ling@singhealth.com.sg",{"type":68,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100363356","phase-3-development-of-variable-volume-automated-mandatory-boluses-for-patient-controlled-epidural-analgesia-during-labour-100363356",false,"NCT04011150","Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour","Development of Variable Volume Automated Mandatory Boluses (VVAMB) for Patient-controlled Epidural Analgesia During Labour and Delivery","VVAMB","Inclusion Criteria:\n\n* Healthy (American Society of Anesthesiologists (ASA) physical status 1 and 2) primiparous parturient at term (≥36 weeks gestation);\n* Singleton fetus;\n* In early labor stage (cervical dilation ≤5cm);\n* Request labor epidural analgesia and able to administer combined spinal epidural analgesia (CSEA) according to protocol.\n\nExclusion Criteria:\n\n* Non-cephalic fetal presentation;\n* Obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes for more than 48 hours, gestational diabetes on insulin, pregnancy-induced hypertension on medication) and uncontrolled medical (e.g. cardiac disease) complications;\n* Have contraindications to neuraxial blockade or have received parenteral opioids within last 2 hours;\n* Dural puncture\u002F suspected dural puncture at initiation of CSEA.","FEMALE","21 Years","50 Years",{"count":81,"type":82},216,"ESTIMATED","INTERVENTIONAL",[85],"PHASE3","A novel epidural delivery regimen was developed: Variable volume automated mandatory bolus (AMB) (VVAMB) will advance individualisation of labour epidural analgesia, by which a larger volume of bolus may contribute to better spread of the local anaesthetics within brief period and thereby reduces the chances of motor blockade that could reduce instrumental deliveries.",[88,89],"Labor Pain","Breakthrough Pain",[88,89,91],"Infusion pump","2024-10-08",{"date":94,"type":95},"2024-10-09","ACTUAL",{"date":97,"type":95},"2020-08-11",{"date":99,"type":82},"2026-08-31",{"name":5,"class":6},1]