[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647298":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":42,"responsibleParty":81,"collaborators":26,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":26,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":26,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":107,"whyStopped":26,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Balloon Group","EXPERIMENTAL","Participants in this group will receive bionic balloon-assisted delivery in addition to routine labor management. After entering the active phase of labor, when cervical dilation reaches 4-5 cm or more and the fetal head is engaged, bionic balloon-assisted delivery will be performed using the KCB-II automatic bionic balloon-assisted delivery device. Other labor management procedures will follow routine clinical practice.",[13],"Device: Bionic Balloon-assisted Delivery",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","ACTIVE_COMPARATOR","Participants in this group will receive routine labor management for vaginal delivery. This includes close monitoring after the onset of labor, artificial rupture of membranes when cervical dilation reaches more than 4-5 cm and the fetal head is engaged, observation of uterine contractions, fetal heart rate, and amniotic fluid characteristics, and operative vaginal delivery or emergency cesarean section when clinically indicated.",[19],"Procedure: Routine Labor Management",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Bionic Balloon-assisted Delivery","Bionic balloon-assisted delivery will be performed using the KCB-II automatic bionic balloon-assisted delivery device with a sterile latex balloon dilation handle. The balloon will be placed in the upper vagina near the fornix after artificial rupture of membranes and inflated according to the protocol to mechanically dilate the birth canal. Routine labor management will also be provided.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Routine Labor Management","Routine labor management includes standard monitoring and clinical management during vaginal delivery, artificial rupture of membranes when indicated, continued observation of labor progress and fetal status, operative vaginal delivery when necessary, and emergency cesarean section if indications such as arrest of labor, cephalopelvic disproportion, or abnormal fetal heart rate occur.",[15],[33],{"name":34,"affiliation":35,"role":36},"Yifeng Zhong, Associate Professor","Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College","PRINCIPAL_INVESTIGATOR",[38],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","+86 18612708860","ZYFL1026@163.com",[43,58,68,75],{"facility":44,"status":26,"city":45,"state":46,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Cangzhou Central Hospital","Cangzhou","Hebei","China","CN",{"type":50,"coordinates":51},"Point",[52,53],116.85334,38.31124,{"lat":53,"lon":52},[56],{"name":57,"role":39,"phone":40,"phoneExt":26,"email":41},"Yifeng Zhong",{"facility":59,"status":26,"city":60,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Beijing Obstetrics and Gynecology Hospital","Beijing",{"type":50,"coordinates":62},[63,64],116.39723,39.9075,{"lat":64,"lon":63},[67],{"name":57,"role":39,"phone":40,"phoneExt":26,"email":41},{"facility":69,"status":26,"city":60,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"Beijing Tongren Hospital",{"type":50,"coordinates":71},[63,64],{"lat":64,"lon":63},[74],{"name":57,"role":39,"phone":40,"phoneExt":26,"email":41},{"facility":5,"status":26,"city":60,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":76,"geoPoint":78,"contacts":79},{"type":50,"coordinates":77},[63,64],{"lat":64,"lon":63},[80],{"name":57,"role":39,"phone":40,"phoneExt":26,"email":41},{"type":36,"investigatorFullName":57,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Associate Professor","100647298","bionic-balloon-assisted-delivery-technology-on-the-labor-process-100647298",false,"NCT07707804","Bionic Balloon-assisted Delivery Technology on the Labor Process","Study on The Impact of Bionic Balloon-assisted Delivery Technology on the Labor Process and Maternal and Neonatal Outcomes","Inclusion Criteria:\n\n* Age: 18-45 years;\n* Nulliparous women with singleton, term pregnancy, cephalic presentation, and no contraindications to vaginal delivery;\n* Latent phase longer than 3 hours, cervical dilation greater than 4-5 cm (entry into the active phase), fetal head engagement, and no obvious cephalopelvic disproportion;\n* Voluntary participation in this study and signing of written informed consent.\n\nExclusion Criteria:\n\n* Multiparous women;\n* Non-cephalic presentation;\n* Genital tract infection;\n* High-risk pregnancy score classified as \"red ball,\" \"purple ball,\" or some \"orange ball\" categories, including severe medical or surgical comorbidities, placenta previa, scarred uterus, etc.;\n* Presence of cephalopelvic disproportion, abnormal fetal heart rate, or other conditions unsuitable for vaginal delivery and requiring cesarean section;\n* Other conditions considered unsuitable for enrollment by the clinician.","FEMALE","18 Years","45 Years",{"count":94,"type":95},300,"ESTIMATED","INTERVENTIONAL",[98],"NA","This multicenter, prospective, randomized controlled trial will evaluate the efficacy and safety of bionic balloon-assisted delivery technology in nulliparous women planning vaginal delivery. Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Participants in the control group will receive routine labor management, while participants in the intervention group will receive bionic balloon-assisted delivery in addition to routine labor management after entering the active phase of labor.\n\nThe primary outcome is the duration of labor, including the first, second, and third stages of labor. Secondary outcomes include intrapartum cesarean conversion rate, intrapartum and postpartum complications, neonatal outcomes, postpartum pelvic floor dysfunction, postpartum depression, and maternal satisfaction. This study aims to determine whether bionic balloon-assisted delivery can shorten labor duration, reduce intrapartum cesarean conversion, and improve maternal and neonatal outcomes without increasing adverse events.",[101],"Vaginal Delivery",[103,104,105,106],"Bionic balloon-assisted delivery","Labor duration","Maternal outcomes","Neonatal outcomes","NOT_YET_RECRUITING","2026-07-12",{"date":110,"type":111},"2026-07-16","ACTUAL",{"date":113,"type":95},"2026-07-15",{"date":115,"type":95},"2027-07-15",{"name":5,"class":6},4]