[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590256":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":40,"responsibleParty":60,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":25,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":92,"whyStopped":25,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotics group","ACTIVE_COMPARATOR","Probiotics is a mix of probiotic strains.",[13],"Other: Probiotic",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","Capsule of sugar, same appearance than the probiotic.",[19],"Other: Placebo",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Probiotic","Participant will take 1 intravaginal capsule once a day at bedtime between inclusion in the study until delivery",[9],null,{"type":6,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"Placebo",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Jean-Charles Pasquier","CONTACT","819-679-2212","jean-charles.pasquier@umontreal.ca",{"name":36,"role":32,"phone":37,"phoneExt":38,"email":39},"Sarah Bilodeau","514-890-8000","30620","sarah.bilodeau.chum@ssss.gouv.qc.ca",[41],{"facility":42,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Centre de recherche du CHUM","Montreal","Quebec","H2X 0A9","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-73.58781,45.50884,{"lat":52,"lon":51},[55,56,58],{"name":36,"role":32,"phone":37,"phoneExt":38,"email":39},{"name":57,"role":32,"phone":25,"phoneExt":25,"email":25},"Bilodeau",{"name":31,"role":59,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":61,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[63],{"name":64,"class":65},"Lallemand Health Solutions, Canada","UNKNOWN","100590256","vaginal-probiotics-during-pregnancy-after-premature-24-32-weeks-of-gestation-preterm-rupture-of-membranes-100590256",false,"NCT06965049","Vaginal Probiotics During Pregnancy After Premature (24-32 Weeks of Gestation) Preterm Rupture of Membranes","Multicentric Clinical Pilot Trial Testing the Association Between Antibiotics and Vaginal Probiotics for Patients With Prematured Rupture of Membranes Between 24 and 32 Weeks of Amenorrhea ( PROB-PROM Study)","PROB-PROM","Inclusion Criteria:\n\n* women ≥ 18 years of age;\n* mono-fetal pregnancy;\n* treated for PPROM between 24 and 32 weeks of gestation with latency period between 12 hours and \\\u003C 7 days in one of the study centers with expectant management;\n* speaking and able to read French or English.\n\nExclusion Criteria:\n\n* Presence of active labor;\n* Situation contraindicating expectant management (e.g., infection);\n* Significant malformation, chromosomal anomaly, or fetal death;\n* Signs of fetal distress;\n* Allergy or intolerance to any of the following substances: vitamin C (ascorbic acid), magnesium stearate, maltodextrin, gelatin, yeast, sucrose, trehalose;\n* Allergy to soy or lactose;\n* Weakened immune system (e.g., AIDS, prolonged corticosteroid treatment, etc.);\n* Vaginal probiotics intake 15 days before study inclusion;\n* Oral probiotic intake 30 days before study inclusion.","FEMALE","18 Years",{"count":77,"type":78},80,"ESTIMATED","INTERVENTIONAL",[81],"NA","The goal of this clinical trial is to evaluate the feasibility of the randomized controlled trial (RCT).\n\nSecondary objectives include comparing the microbiota of preterm babies born after premature rupture of membranes across study groups.\n\nTo achieve this, participants will be asked to:\n\n* Use the vaginal study product from the time of membrane rupture until delivery\n* Keep a diary documenting their symptoms and treatment adherence\n* Provide vaginal secretion samples and stool samples from their baby",[84,85,86],"Pregnancy","Prematurity","PPROM",[88,89,86,90,91],"pregnancy","prematurity","vaginal probiotics","microbiota","NOT_YET_RECRUITING","2025-05-01",{"date":95,"type":96},"2025-05-11","ACTUAL",{"date":98,"type":78},"2025-09-01",{"date":100,"type":78},"2026-05",{"name":5,"class":6},1]