[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617365":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":42,"collaborators":26,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":26,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":26,"enrollmentInfo":56,"targetDuration":26,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":26,"overallStatus":66,"whyStopped":26,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":26},{"fullName":5,"class":6},"Western Galilee Hospital-Nahariya","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Foley Balloon Catheter Combined With Nipple Stimulation","EXPERIMENTAL","Participants in this arm will undergo cervical ripening using a single-balloon Foley catheter. One hour after catheter insertion, nipple stimulation will be initiated using a breast pump according to a standardized protocol (15 minutes per breast, alternating with 15-minute rest periods, for up to 6 hours or until active labor, membrane rupture, uterine tachysystole, or non-reassuring fetal heart rate occurs).",[13],"Procedure: Foley balloon catheter with nipple stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Foley Balloon Catheter Alone","ACTIVE_COMPARATOR","Participants in this arm will undergo cervical ripening using a single-balloon Foley catheter alone, without nipple stimulation. Labor management following catheter insertion and removal will follow standard institutional protocols.",[19],"Procedure: Mechanical cervical ripening with Foley catheter",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Foley balloon catheter with nipple stimulation","Mechanical cervical ripening will be performed using a single-balloon Foley catheter inserted transcervically under sterile conditions. The catheter balloon will be positioned above the internal cervical os and inflated with 60 mL of sterile saline solution. The catheter will remain in place for up to 12 hours or until spontaneous expulsion, onset of active labor, rupture of membranes, uterine tachysystole, or non-reassuring fetal heart rate tracing, whichever occurs first.\n\nIn participants randomized to the intervention arm, cervical ripening with the Foley catheter will be combined with nipple stimulation using an electric breast pump according to a standardized protocol, beginning one hour after catheter insertion. Participants in the control arm will undergo cervical ripening with the Foley catheter alone, without nipple stimulation.\n\nCervical status will be assessed before catheter insertion and after catheter removal using the Bishop score. Subsequent labor management will follow",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Mechanical cervical ripening with Foley catheter","Mechanical cervical ripening will be performed using a single-balloon Foley catheter inserted transcervically under sterile conditions. The catheter balloon will be positioned above the internal cervical os and inflated with 60 mL of sterile saline solution. The catheter will remain in place for up to 12 hours or until spontaneous expulsion, onset of active labor, rupture of membranes, uterine tachysystole, or non-reassuring fetal heart rate tracing, whichever occurs first.",[15],[32],{"name":33,"affiliation":34,"role":35},"Maya Frank Wolf, Prof.","Galilee Medical Center","STUDY_CHAIR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Maya Frank Wolf Frank Wolf, Prof.","CONTACT","+9729107723","mayaw@gmc.gov.il",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Dr Raneen Abu Shqara","Head of MFMU","100617365","combined-nipple-stimulation-and-foley-balloon-for-cervical-ripening-100617365",false,"NCT07317674","Combined Nipple Stimulation and Foley Balloon for Cervical Ripening","The Effect of Nipple Stimulation Combined With Foley Balloon Catheter on Bishop Score and Induction-to-delivery Interval: a Prospective Randomized Trial","Inclusion Criteria:\n\n* Pregnant individuals aged ≥18 years\n* Singleton pregnancy\n* Term gestation (37-42 weeks)\n* Cephalic fetal presentation\n* Intact membranes\n* Bishop score \\\u003C6 at enrollment\n* Medical indication for labor induction\n\nExclusion Criteria:\n\n* Multiple gestation\n* Previous cesarean delivery or uterine surgery\n* Contraindication to vaginal delivery\n* Major fetal anomalies\n* Active labor at enrollment\n* Unstable fetal lie or presentation\n* Contraindication to Foley balloon catheter insertion\n* Conditions precluding nipple stimulation (e.g., local breast infection, prior breast surgery involving the nipple)",true,"FEMALE","18 Years",{"count":57,"type":58},100,"ESTIMATED","INTERVENTIONAL",[61],"NA","Labor induction rates have increased substantially worldwide, and successful cervical ripening remains a key determinant of induction outcomes. Mechanical cervical ripening with a Foley balloon catheter is widely used and considered safe, while nipple stimulation promotes endogenous oxytocin release and represents a physiologic method for stimulating uterine contractions. However, the combined effect of nipple stimulation and balloon catheter use has not been systematically evaluated.\n\nThis prospective, randomized, double-blinded controlled trial will assess whether the addition of nipple stimulation to Foley balloon catheter cervical ripening improves Bishop score and shortens the induction-to-delivery interval compared with balloon catheter alone. Term pregnant patients (37-42 weeks' gestation) with a singleton, cephalic pregnancy and an unfavorable cervix (Bishop score \\\u003C6) requiring labor induction will be randomized to receive either Foley balloon catheter plus standardized nipple stimulation or Foley balloon catheter alone.\n\nThe primary outcomes are change in Bishop score after catheter removal and time from catheter insertion to delivery. Secondary outcomes include need for additional induction methods, mode of delivery, maternal and neonatal outcomes, pain, patient satisfaction, and breastfeeding rates. The study aims to evaluate the efficacy and safety of incorporating a physiologic intervention into standard mechanical cervical ripening.",[64,65],"Induction of Labor","Cervical Ripening","NOT_YET_RECRUITING","2025-12-19",{"date":69,"type":70},"2026-01-05","ACTUAL",{"date":72,"type":58},"2026-01-01",{"date":74,"type":58},"2028-01-01",{"name":5,"class":6}]