[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656041":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":26,"studyPopulation":17,"armGroups":27,"interventions":40,"overallOfficials":51,"centralContacts":62,"locations":70,"responsibleParty":89,"collaborators":17,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":17,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":17,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":115,"whyStopped":17,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Khyber Medical University Peshawar","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Time from initiation of induction of labour to vaginal delivery","Time interval from the initiation of cervical ripening intervention to vaginal delivery, measured in hours.","From initiation of induction of labour until vaginal delivery, up to 24 hours",{"measure":14,"description":15,"timeFrame":16},"Successful vaginal delivery","Proportion of participants who achieve vaginal delivery following induction of labour.","From initiation of induction of labour until delivery, up to 24 hours",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","PARALLEL","Participants will be randomly allocated to one of two parallel intervention groups: concurrent induction using Foley catheter plus PGE2 vaginal pessary, or sequential induction using Foley catheter followed by PGE2 vaginal pessary 12 hours later.","TREATMENT",{"masking":24,"maskingDescription":25,"whoMasked":17},"NONE","This is an open-label randomized controlled trial. Participants, care providers, investigators, and outcomes assessors are not masked to treatment allocation.","Induction of labour is commonly performed when continuation of pregnancy is considered less beneficial than delivery. This randomized controlled trial will compare the effectiveness and safety of two approaches to cervical ripening and induction of labour in women with term pregnancy.\n\nEligible participants will have a gestational age of 37-42 weeks and will be admitted to the hospital for induction of labour without significant comorbidities. Gestational age will be confirmed using a dating scan or last menstrual period, and baseline fetal monitoring will be performed using cardiotocography (CTG) before induction.\n\nParticipants will be randomly allocated to one of two treatment groups.\n\nIn the concurrent group, a PGE2 vaginal pessary and a Foley catheter will be inserted concurrently. The Foley catheter balloon will be inflated with 30 mL of normal saline.\n\nIn the sequential group, the Foley catheter will be inserted first, followed by insertion of the PGE2 vaginal pessary 12 hours later.\n\nThe study will primarily assess the rate of vaginal delivery within 24 hours of initiation of induction. The study will also assess the overall effectiveness and safety of the two induction approaches, including the induction-to-delivery interval and relevant maternal and fetal complications.\n\nPotential complications associated with induction of labour include failure of induction, uterine hyperstimulation, fetal distress or abnormal CTG, meconium-stained liquor, postpartum haemorrhage, uterine rupture, and chorioamnionitis. Participants will be continuously monitored during the induction process so that appropriate clinical management can be provided if complications occur.\n\nThe findings of this study may contribute to the development of safe, effective, and patient-centred induction-of-labour protocols, particularly in resource-constrained healthcare settings.",[28,35],{"label":29,"type":30,"description":31,"interventionNames":32},"Concurrent Induction of Labour","EXPERIMENTAL","Participants will receive concurrent cervical ripening with a PGE2 vaginal pessary and insertion of a Foley catheter. The Foley catheter balloon will be inflated with 30 mL of normal saline. Both interventions will be initiated concurrently at the start of induction of labour.",[33,34],"Device: Foley Catheter","Drug: PGE2 Vaginal Pessary",{"label":36,"type":37,"description":38,"interventionNames":39},"Sequential Induction of Labour","ACTIVE_COMPARATOR","Participants will receive sequential cervical ripening with a Foley catheter followed by insertion of a PGE2 vaginal pessary 12 hours later. The Foley catheter will be inserted first, followed by the PGE2 vaginal pessary after 12 hours.",[33,34],[41,46],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":17},"DEVICE","Foley Catheter","A Foley catheter will be used for mechanical cervical ripening. The balloon will be inflated with 30 mL of normal saline.",[29,36],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":17},"DRUG","PGE2 Vaginal Pessary","A PGE2 vaginal pessary will be used as a pharmacological method of cervical ripening during induction of labour.",[29,36],[52,56,59],{"name":53,"affiliation":54,"role":55},"Shahzadi Saima Hussain, MHR","Khyber Medical University Peshawar, Pakistan","PRINCIPAL_INVESTIGATOR",{"name":57,"affiliation":54,"role":58},"Dr Jawad Khan, PhD","STUDY_DIRECTOR",{"name":60,"affiliation":61,"role":55},"Dr Mehnaz Faisal, MHPE, FCPS","Lady Reading Hospital Peshawar",[63,67],{"name":53,"role":64,"phone":65,"phoneExt":17,"email":66},"CONTACT","+923337111981","saima.hussain@lrh.edu.pk",{"name":57,"role":64,"phone":68,"phoneExt":17,"email":69},"+92 334 9011681","mdrjawad@yahoo.com",[71],{"facility":72,"status":17,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Lady Reading Hospital","Peshawar","KPK","25000","Pakistan","PK",{"type":79,"coordinates":80},"Point",[81,82],71.57849,34.008,{"lat":82,"lon":81},[85,88],{"name":86,"role":64,"phone":87,"phoneExt":17,"email":66},"Shezadi Saima Hussain, MHR","+92 333 7111981",{"name":57,"role":64,"phone":68,"phoneExt":17,"email":69},{"type":90,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100656041","outcome-of-concurrent-versus-sequential-method-of-induction-of-labour-in-term-pregnancy-100656041",false,"NCT07821099","Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy","Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Pregnant women aged 18-40 years with a singleton cephalic fetus between 37 and 42 weeks of gestation who require induction of labour, with BMI 20-35 kg\u002Fm², intact membranes, and reassuring cardiotocography (CTG), will be included.\n\nExclusion Criteria:\n\n* Women with meconium-stained liquor, antepartum haemorrhage, low-lying placenta defined as placental edge less than 2 cm from the internal os on ultrasonography, pre-eclampsia, fetal growth restriction, previously scarred uterus, estimated fetal weight greater than 4 kg on ultrasound, cephalopelvic disproportion, or liquor abnormalities will be excluded.","FEMALE","18 Years","40 Years",{"count":102,"type":103},128,"ESTIMATED","INTERVENTIONAL",[106],"NA","This randomized controlled trial will compare two methods of induction of labour in women with term pregnancy: concurrent use of a Foley catheter and PGE2 vaginal pessary versus sequential use of the two methods. The study will assess whether using both methods concurrently is more effective and safe than using them sequentially. The primary focus is the rate of vaginal delivery within 24 hours after initiation of induction. Participants will be women with term pregnancy (37-42 weeks) admitted for induction of labour without significant comorbidities.",[109],"Induced; Birth",[111,112,113,114],"Vaginal delivery","Sequential induction","Cervical ripening","Induction of labor","NOT_YET_RECRUITING","2026-09-09",{"date":118,"type":119},"2026-09-15","ACTUAL",{"date":121,"type":103},"2026-09-14",{"date":123,"type":103},"2027-03-20",{"name":5,"class":6},1]