[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491081":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":53,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":24,"enrollmentInfo":69,"targetDuration":24,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University Hospital, Bordeaux","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Trans-cervical balloon","EXPERIMENTAL","Induction of labor by cervical ripening with trans-cervical balloon (Foley catheter).",[13],"Device: Trans-cervical balloon",{"label":15,"type":16,"description":17,"interventionNames":18},"Misoprostol","ACTIVE_COMPARATOR","Induction of labor by cervical ripening with Prostaglandins (Misoprostol per os)",[19],"Drug: Misoprostol",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DEVICE",[9],null,{"type":26,"name":15,"description":17,"armGroupLabels":27,"otherNames":24},"DRUG",[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Hanane Bouchghoul, MD","CONTACT","+335 57 82 16 12","hanane.bouchghoul@chu-bordeaux.fr",{"name":35,"role":31,"phone":24,"phoneExt":24,"email":36},"Loic Sentilhes, MD, PhD","loic.sentilhes@chu-bordeaux.fr",[38],{"facility":39,"status":40,"city":41,"state":24,"zip":24,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"CHU Bordeaux","RECRUITING","Bordeaux","France","FR",{"type":45,"coordinates":46},"Point",[47,48],-0.58046,44.84124,{"lat":48,"lon":47},[51],{"name":30,"role":31,"phone":52,"phoneExt":24,"email":33},"+335 56 79 55 79",{"type":54,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[56],{"name":57,"class":58},"French Ministry of Social Affairs and Health","UNKNOWN","100491081","prostaglandins-versus-trans-cervical-balloon-for-induction-of-labor-in-fetal-growth-restriction-probin-100491081",false,"NCT05674487","Prostaglandins Versus Trans-cervical Balloon for Induction of Labor in Fetal Growth Restriction (PROBIN)","Prostaglandins Versus Trans-Cervical Balloon for Induction of Labor in Fetal Growth Restriction: a Multicenter Open-label Randomized Trial","PROBIN","Inclusion Criteria:\n\n* Age over 18 years\n* Singleton gestation, with cephalic presentation\n* Gestational age at randomization between entre 34 weeks of gestation and 0 day and 41 weeks of gestation and 0 day\n* Fetal growth restriction (FGR). FGR is defined at the third trimester by an abdominal circumference below the 10th centile and\u002For an estimated fetal weight below the 10th centile (according to local curve), according to the trial DIGITAT. Fetus with normal and abnormal Doppler index can be included.\n* Plan for induction of labor whatever the indication (fetal growth restriction or other), the induction of labor is the induction of birth by vaginal delivery\n* Bishop Score below 6\n* Affiliated or beneficiary to a health security system\n* Signed informed consent\n\nExclusion Criteria:\n\n* Contraindication to an induction of labor\n* History of previous cesarean delivery, myomectomy by laparotomy or laparoscopy\n* Contraindication to misoprostol or trans-cervical balloon\n* Known HIV positivity (because of modified delivery plan)\n* Known major fetal anomaly or chromosomic anomaly\n* Fetal demise\n* Patient under legal protection\n* Poor understanding of the French language","FEMALE","18 Years",{"count":70,"type":71},774,"ESTIMATED","INTERVENTIONAL",[74],"NA","The goal of this randomized trial is to compare two methods of induction in a fetal growth restriction population. The main question it aims to answer is:\n\n• Is trans-cervical balloon superior to prostaglandins in reducing the cesarean section rate, without increasing neonatal morbidity? Participants will have an induction of labour by cervical ripening with trans-cervical balloon in the trans-cervical balloon catheter arm and with Prostaglandins in the Misoprostol arm.\n\nResearchers will compare two methods of induction: trans-cervical balloon and prostaglandins to see if trans-cervical balloon is associated with a lower risk of cesarean delivery.",[77],"Fetal Growth Restriction",[79,80,81,82,83],"Fetal growth restriction","Cesarean section","Induction of labor","Cervical ripening","Neonatal morbidity","2025-03-28",{"date":86,"type":87},"2025-04-02","ACTUAL",{"date":89,"type":87},"2024-04-09",{"date":91,"type":71},"2026-12-01",{"name":5,"class":6},1]