[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619395":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":19,"studyPopulation":11,"armGroups":20,"interventions":29,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":35,"collaborators":11,"id":37,"slug":11,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":40,"acronym":11,"eligibilityCriteria":41,"healthyVolunteers":42,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":11,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":62,"whyStopped":11,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":11},{"fullName":5,"class":6},"Queen Savang Vadhana Memorial Hospital, Thailand","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"proportion of women remaining pregnant more than 7 days after initiation of tocolytic",null,"within 7 days from the start of tocolytic",{"allocation":14,"interventionModel":15,"interventionModelDescription":11,"primaryPurpose":16,"observationalModel":11,"timePerspective":11,"maskingInfo":17},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":18,"maskingDescription":11,"whoMasked":11},"NONE","Participants in the intervention group are pregnant women diagnosed with preterm labor between 24 and 33 weeks of gestation. They receive:\n\n* Gynoflor® vaginal tablets (containing Lactobacillus acidophilus KS400 and 0.03 mg estriol)\n* Dosage: 1 tablet inserted vaginally at bedtime for 6 consecutive days\n* Start time: On the same day as starting standard tocolytic therapy (such as nifedipine, terbutaline, or magnesium sulfate)\n* Purpose: To restore healthy vaginal flora, reduce risk of ascending infection, and potentially prolong pregnancy duration\n\nThe control group receives only standard tocolytic therapy, without Gynoflor®.\n\nOutcomes (Detailed Description):\n\nPrimary Outcome:\n\n* Rate of pregnancy prolongation beyond 7 days from the initiation of tocolytic therapy\n\nSecondary Outcomes:\n\n1. Gestational age at delivery ≥34 weeks\n2. Length of hospital stay (in days)\n3. Use of second-line tocolytic agents (e.g., switching due to inefficacy or side effects)\n4. Readmission within 14 days after discharge\n5. Incidence of side effects from Gynoflor® (especially local symptoms like vaginal burning or irritation)",[21,26],{"label":22,"type":23,"description":11,"interventionNames":24},"gynoflor group","EXPERIMENTAL",[25],"Drug: Gynoflor",{"label":27,"type":28,"description":11,"interventionNames":11},"control group","NO_INTERVENTION",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"DRUG","Gynoflor","Participants in this group will receive Gynoflor vaginal tablets (containing Lactobacillus acidophilus and estriol) administered once daily for 7 consecutive days. This intervention aims to evaluate whether restoring vaginal flora with Gynoflor can prolong pregnancy time compared to no intervention.",[22],{"type":36,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100619395",false,"NCT07344064","The Effects of Adjunctive Therapy With Vaginal Tablets Lactobacillus Acidophilus and a Low Dose Estriol (Gynoflor®) to Prolong Pregnancy Time in Preterm Labor, A Randomized Controlled Trial","Inclusion Criteria\n\n\\- Pregnant women diagnosed with preterm labor or threatened preterm labor, with a gestational age between 24 and 33 weeks, who are receiving tocolytic therapy.\n\nExclusion Criteria\n\n* Age under 18 years or 35 years and older\n* Incomplete course of Gynoflor® (less than 6 days of use)\n* Presence of contraindications to tocolysis\n* Preterm premature rupture of membranes (PPROM)\n* Unable to be contacted for follow-up\n* History of allergy to probiotics or Gynoflor®\n* Multiple gestation\n* History of short cervix diagnosed between 16-24 weeks of gestation\n* History of previous preterm labor (PTL)\n* Pregnancy achieved via assisted reproductive technology (ART)\n* Presence of fetal anomaly\n* History of antepartum hemorrhage\n* Substance abuse, including cigarette smoking, alcohol, cocaine, or heroin use\n* Other causes of preterm labor such as uterine overdistension (e.g., polyhydramnios, multifetal gestation), uterine abnormalities (e.g., myoma uteri), or systemic infections, except vaginitis",true,"FEMALE","18 Years","35 Years",{"count":47,"type":48},80,"ESTIMATED","INTERVENTIONAL",[51],"NA","The study aim to study The Adjunctive therapy with vaginal tablets containing Lactobacillus acidophilus KS400 and low-dose Estriol (Gynoflor®) in addition to standard tocolytic treatment administered once daily for 6 days starting the same day as tocolytic therapy, in pregnant women diagnosed with preterm labor at gestational age 24-33 weeks .Primary Outcome is the rate of pregnancy prolongation beyond 7 days after initiation of tocolytic therapy.",[54,55,56],"Threaten Preterm","Prethrem Labour","Bacterial Vaginitis",[58,32,59,60,61],"Lactobacillus","Threaten preterm","Bacterial vaginitis","Probiotic","NOT_YET_RECRUITING","2026-01-07",{"date":65,"type":66},"2026-01-15","ACTUAL",{"date":68,"type":48},"2026-02",{"date":70,"type":48},"2026-10",{"name":5,"class":6}]