[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646476":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":26,"responsibleParty":43,"collaborators":26,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":26,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":26,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":26},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Misoprostol Plus Cervical Balloon","EXPERIMENTAL","Participants receive 25 μg misoprostol placed in the posterior vaginal fornix, combined with a Cervical balloon catheter (80 mL inflation) placed intracervically for 12-24 hours on the first day of induction. Misoprostol may be repeated up to 3-4 times based on uterine contraction response.",[13],"Device: Misoprostol plus Cervical Balloon",{"label":15,"type":16,"description":17,"interventionNames":18},"Misoprostol Alone","ACTIVE_COMPARATOR","Participants receive 25 μg misoprostol placed in the posterior vaginal fornix alone on the first day of induction. Misoprostol may be repeated up to 3-4 times based on uterine contraction response.",[19],"Drug: Misoprostol",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Misoprostol","25 μg misoprostol tablet placed in the posterior vaginal fornix for cervical ripening and labor induction on the first day. May be repeated up to 3-4 times based on uterine contraction response (monitored every 2-4 hours).",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DEVICE","Misoprostol plus Cervical Balloon","A Cervical balloon with 80 mL sterile water inflation placed intracervically for mechanical cervical dilation. The balloon is left in place for up to 12-24 hours or until spontaneous expulsion.",[9],[33],{"name":34,"affiliation":5,"role":35},"Ye Feng, M.D.","PRINCIPAL_INVESTIGATOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","8618001203634","fengye_bjmu@163.com",{"name":42,"role":38,"phone":26,"phoneExt":26,"email":26},"Jianhua Niu, M.D.",{"type":44,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100646476","phase-4-combined-misoprostol-and-cervical-balloon-vs-misoprostol-alone-for-induction-on-the-first-day-in-primiparas-100646476",false,"NCT07690007","Combined Misoprostol and Cervical Balloon vs Misoprostol Alone for Induction on the First Day in Primiparas","Efficacy of Intravaginal Misoprostol Combined With Cervical Balloon Versus Misoprostol Alone for Induction of Labor on the First Day in Primiparous Women: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 20-45 years at delivery\n* Singleton pregnancy\n* Primiparous\n* Cephalic presentation\n* Cervical Bishop score ≤ 5\n* No history of stillbirth\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Contraindications to vaginal delivery\n* Mental disorders (depression or anxiety)\n* Preterm labor (\\\u003C 37 weeks)\n* Intrauterine fetal death\n* Previous uterine surgery\n* Premature rupture of membranes\n* Abnormal fetal heart rate tracing","FEMALE","20 Years","45 Years",{"count":56,"type":57},220,"ESTIMATED","INTERVENTIONAL",[60],"PHASE4","Misoprostol (a prostaglandin E1 analog) is commonly used for cervical ripening and labor induction via vaginal administration. The cervical balloon is another commonly used method that provides mechanical cervical dilation. Both methods are low-cost and widely available. Some meta-analyses have suggested that combined use may shorten the duration of labor, reduce the frequency of tachysystole, and lower NICU admission rates without increasing the risk of cesarean section. However, existing studies are heterogeneous and lack data from Asian populations.\n\nThis study is being done to see whether combining two common methods of labor induction-misoprostol (a medicine placed in the vagina) and a cervical balloon (placed in the cervix) on the first day of induction-can shorten the time from the start of induction to delivery in first-time mothers during pregnancy .\n\nParticipants will be randomly assigned to one of two groups: one group will receive misoprostol alone (standard care) on the first day of induction, and the other group will receive misoprostol plus a cervical balloon on the first day of induction. The main outcome measured is the time from the start of induction to delivery. The study will also look at safety outcomes, including the rate of cesarean section, maternal complications, and newborn outcomes.",[63],"Primiparous Women",[65,66,67],"labor induction","misoprostol","foley balloon catheter","NOT_YET_RECRUITING","2026-07-07",{"date":71,"type":72},"2026-07-08","ACTUAL",{"date":74,"type":57},"2026-06-30",{"date":76,"type":57},"2026-12-31",{"name":5,"class":6}]