[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621110":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":34,"locations":44,"responsibleParty":65,"collaborators":33,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":33,"enrollmentInfo":77,"targetDuration":33,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":46,"whyStopped":33,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"National Hospital of Obstetrics and Gynecology","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dinoprostone (Propess) + Oxytocin","EXPERIMENTAL","Participants in this arm will receive a 10-mg vaginal dinoprostone insert (Propess) for cervical ripening. After 6 hours, if active labor has not begun or uterine contractions are inadequate, intravenous oxytocin will be started according to the hospital's standardized induction protocol. Continuous fetal monitoring and standardized management of uterine tachysystole will be applied. This approach reflects a sequential induction method commonly used for women with term PROM and an unfavorable cervix.",[13],"Drug: Sequential Induction: Dinoprostone Followed by Oxytocin",{"label":15,"type":16,"description":17,"interventionNames":18},"Immediate Oxytocin Induction","ACTIVE_COMPARATOR","Participants in this arm will receive immediate induction of labor using intravenous oxytocin according to the hospital's standardized induction protocol. No cervical ripening agent will be used before starting oxytocin. Maternal and fetal status will be monitored throughout labor, and uterine tachysystole will be managed in line with institutional guidelines. This arm represents the comparator strategy of inducing labor directly with oxytocin in women with term PROM and an unfavorable cervix.",[19],"Drug: Immediate Oxytocin Induction",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sequential Induction: Dinoprostone Followed by Oxytocin","A sequential induction strategy in which a 10-mg vaginal dinoprostone insert (Propess) is placed for cervical ripening. After 6 hours, if active labor has not begun or uterine contractions are inadequate, intravenous oxytocin is initiated according to the hospital's standardized induction protocol. Continuous fetal monitoring is applied, and tachysystole is managed per institutional guidelines.",[9],[27],"Dinoprostone (Propess)",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Intravenous oxytocin is used for immediate induction of labor in women with term prelabor rupture of membranes and an unfavorable cervix. Oxytocin is started according to the hospital's standardized induction protocol without prior use of cervical ripening agents. Maternal and fetal status are monitored throughout labor, and uterine tachysystole is managed according to institutional guidelines.",[15],[32],"Oxytocin",null,[35,40],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Khuyen T.H Truong, MD","CONTACT","+84983851754","khuyenth.hmu@gmail.com",{"name":41,"role":37,"phone":42,"phoneExt":33,"email":43},"Anh T Ngo, MD, PhD","+84931686600","dr.anhngo@nhog.vn",[45],{"facility":5,"status":46,"city":47,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Hanoi","100000","Vietnam","VN",{"type":52,"coordinates":53},"Point",[54,55],105.84117,21.0245,{"lat":55,"lon":54},[58,63],{"name":59,"role":37,"phone":60,"phoneExt":61,"email":62},"Ha T.T Nguyen, MD, PhD","+84989661093","+84965995599","dr.hanguyen.nhog@gmail.com",{"name":36,"role":37,"phone":38,"phoneExt":33,"email":64},"truonghakhuyen@hmu.edu.vn",{"type":66,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100621110","pge2-followed-by-oxytocin-vs-oxytocin-in-term-prom-poxy-prom-100621110",false,"NCT07366359","PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM)","Comparison of the Effectiveness of Labor Induction Using Dinoprostone Followed by Oxytocin Versus Oxytocin Alone in Term Pregnancies With Premature Rupture of Membranes and an Unfavorable Cervix - A Randomized Clinical Trial","POXY-PROM","Inclusion Criteria\n\n* Maternal age ≥ 18 years\n* Gestational age from 37 to 42 weeks, determined by last menstrual period or by a first- or second-trimester ultrasound\n* Live singleton fetus\n* Prelabor rupture of membranes (PROM) confirmed by at least one of the following:\n\n  * Amniotic fluid visibly draining from the cervical os during sterile speculum examination\n  * Pool of fluid in the posterior fornix\n* Cephalic presentation\n* Bishop score ≤ 6\n* No spontaneous uterine contractions\n* No contraindications for vaginal delivery\n\nExclusion Criteria:\n\n* Active labor\n* Previous uterine surgery (e.g., cesarean section)\n* Chorioamnionitis or non-reassuring fetal status\n* Major fetal anomalies\n* Contraindications to prostaglandin or vaginal delivery\n* Refusal to participate","FEMALE","18 Years",{"count":78,"type":79},450,"ESTIMATED","INTERVENTIONAL",[82],"NA","This study is being done to learn more about the best way to start labor for pregnant women whose water breaks at term before labor begins, a condition called term prelabor rupture of membranes (term PROM). When this happens and the cervix is not ready for labor, it is unclear which induction method works best and is safest for mother and baby.\n\nThe purpose of this study is to compare two common ways to induce labor in women with term PROM and an unfavorable cervix (Bishop score ≤ 6). One group will receive a vaginal dinoprostone insert (Propess) for 6 hours to soften the cervix, followed by oxytocin if labor does not start. The other group will receive immediate oxytocin through a vein.\n\nPregnant women aged 18 years or older with a single baby in head-down position at 37-42 weeks, whose water has broken and whose cervix is not yet favorable, may be able to join this study. All care will be provided at the National Hospital of Obstetrics and Gynecology in Hanoi, Vietnam, where both medicines are already used in routine practice.\n\nThe main outcome is how many women have a vaginal birth. The study will also look at how long it takes from induction to birth, complications for mothers and babies, and women's experiences of labor. The results may help doctors choose the safest and most effective way to induce labor for women with term PROM in the future.",[85,86,87],"Premature Rupture of Fetal Membranes","Labor, Induced","Cervical Ripening",[85,89,90,32,87,91],"Labor Induction","Dinoprostone","Vaginal Delivery","2026-02-18",{"date":94,"type":95},"2026-02-20","ACTUAL",{"date":97,"type":95},"2026-02-10",{"date":99,"type":79},"2028-01",{"name":5,"class":6},1]