[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551712":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":48,"responsibleParty":67,"collaborators":26,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":26,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":51,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Mỹ Đức Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Combined therapy group (cervical cerclage plus vaginal progesterone)","EXPERIMENTAL","Women will be receiving the cervical cerclage according to local protocol within a week after randomization, using the McDonald technique.\n\nWithin one day after the procedure, they will be receiving 200 mg vaginal progesterone, purchased from the manufacturer (Cyclogest® 200mg, Actavis, United Kingdom), once daily at bedtime. Participants will be asked to record their drug application in a patient diary sheet.",[13,14],"Procedure: Cervical cerclage","Drug: Vaginal progesterone",{"label":16,"type":17,"description":18,"interventionNames":19},"Progesterone only group","ACTIVE_COMPARATOR","Women allocated to the progesterone only group will be receiving 200 mg vaginal progesterone, purchased from the manufacturer (Cyclogest® 200mg, Actavis, United Kingdom), once daily at bedtime. Participants will be asked to record their drug application in a patient diary sheet.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Cervical cerclage","Cervical cerclage using the McDonald technique under anaesthesia.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Vaginal progesterone","Cyclogest® 200mg, Actavis, United Kingdom, applied once daily at bedtime.",[9,16],[33],"Cyclogest® 200 mg",[35],{"name":36,"affiliation":37,"role":38},"Lan N Vuong, MD, PhD","University of Medicine and Pharmacy at Ho Chi Minh City","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Thanh V Le, MD","CONTACT","+84934124733","bsthanh.lv@myduchospital.vn",{"name":36,"role":42,"phone":46,"phoneExt":26,"email":47},"+84903008889","drlan@yahoo.com.vn",[49],{"facility":50,"status":51,"city":52,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"My Duc Hospital","RECRUITING","Ho Chi Minh City","70000","Vietnam","VN",{"type":57,"coordinates":58},"Point",[59,60],106.62965,10.82302,{"lat":60,"lon":59},[63],{"name":64,"role":42,"phone":65,"phoneExt":26,"email":66},"Tuong M Ho, MD","+84 90 3633377","tuongho.ivfmd@gmail.com",{"type":68,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100551712","cerclage-with-progesterone-versus-progesterone-only-in-singleton-pregnancies-100551712",false,"NCT06463652","Cerclage With Progesterone Versus Progesterone Only in Singleton Pregnancies","Cervical Cerclage With Vaginal Progesterone Versus Vaginal Progesterone Only for Preterm Birth Prevention in Women With a Singleton Pregnancy and a Short Cervical Length: a Randomized Clinical Trial","RESILIENT","Inclusion Criteria:\n\n* Maternal age ≥18 years\n* Singleton pregnancy\n* Cervical length ≤ 25 mm, measured by TVS at the second-trimester ultrasonography (16 0\u002F7 - 24 0\u002F7 weeks of gestation)\n* Not participating in any other study which has intervention on maternity or fetus\n* Provision of written informed consent as shown by a signature on the participant consent form.\n\nExclusion Criteria:\n\n* Cervical dilation with visible amniotic membranes or amniotic membranes prolapsed into the vagina\n* Major congenital abnormalities of the fetus\n* Intrauterine fetal demise\n* Presence of severe vaginal discharge\\*\n* Presence of vaginitis or cervicitis\\*\n* Presence of vaginal bleeding\\*\n* Placenta previa or vasa previa\n* Preterm premature rupture of membranes\n* Preterm labor without ruptured membrane at the time of screening\n* Suspected chorioamnionitis\n* Unable to undergo cerclage\n* Cerclage in place\n* Allergy to progesterone\n\n(\\*Women with acute cervicitis, vaginitis or severe vaginal discharge are eligible once they have been treated and if they have a CL ≤25 mm between 16 0\u002F7 - 24 0\u002F7 weeks of gestation.)","FEMALE","18 Years",{"count":80,"type":81},328,"ESTIMATED","INTERVENTIONAL",[84],"NA","This study compares the effectiveness of cervical cerclage with vaginal progesterone to vaginal progesterone only for the prevention of preterm birth in women with a singleton pregnancy and a short cervical length. Participants will be randomly assigned in a 1:1 ratio to receive cerclage plus progesterone or progesterone only.",[87,88],"Preterm Birth","Short Cervix",[90,91,92,93],"Cerclage","Progesterone","Singleton","Preterm birth","2025-09-10",{"date":96,"type":97},"2025-09-16","ACTUAL",{"date":99,"type":97},"2024-06-26",{"date":101,"type":81},"2026-10",{"name":5,"class":6},1]