[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100334645":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":31,"locations":31,"responsibleParty":32,"collaborators":31,"id":34,"slug":31,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":31,"eligibilityCriteria":39,"healthyVolunteers":40,"sex":41,"minAge":42,"maxAge":31,"enrollmentInfo":43,"targetDuration":31,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":31,"overallStatus":52,"whyStopped":31,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":31},{"fullName":5,"class":6},"QH Medical Technology Ltd.","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"pessary","EXPERIMENTAL","the test group is pessary.The pregnant woman is assigned to the pessary group and after having excluded a vaginal infection the pessary will be inserted directly.",[13],"Device: pessary",{"label":15,"type":16,"description":17,"interventionNames":18},"Progesterone","ACTIVE_COMPARATOR","the control group is progesterone. Pregnant women in the control group were treated by 200 mg QN, it is used for 34 gestational weeks.",[19],"Drug: Progesterone",[21,27],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","progeaterone:Utrogestan is one of the normal drugs in China to prevent spontaneous preterm birth, the Utrogestan used in this study is from Laboratories Besins International.",[15],[26],"Utrogestan",{"type":28,"name":9,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","pessary: The cervical pessary is a vaginal device (silicone ring) that is used to treat pregnant women for preventing spontaneous preterm birth.",[9],null,{"type":33,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100334645",false,"NCT03637062","Verify the Safety and Effectiveness of the Cerclage Pessary in Prevention and Treatment of High-risk Preterm Pregnancy","Verify the Safety and Effectiveness of the Cerclage Pessary in the Prevention and Treatment of High-risk Preterm Pregnancy","Inclusion Criteria:\n\n* Women with a pregnancy and a history of at least one spontaneous preterm birth before 34+0 weeks and\u002For a history of late abortion\n* 12+0 -18+0 weeks of gestation\n* Minimal age of 18 years\n* Informed consent signature\n\nExclusion Criteria:\n\n* The previous preterm delivery is iatrogenic proterm labor\n* Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)\n* The pregnant woman with severe cervical erosion, cervical polyp, hemorrhage and the doctors think she could not use cerclage pessary\n* The pregnant woman with uterine cervicitis\n* The pregnant woman that has been confirmed premature birth\n* Cerclage prior to randomisation\n* Cerclage prior to randomisation\n* Placenta previa totalis\n* Active vaginal bleeding at the moment of randomization\n* Spontaneous rupture of membranes at the time of randomization\n* Silicone allergy\n* Painful regular uterine contractions\n* The pregnant woman have the indication of operation cervical cerclage\n* Current participation in other RCT",true,"FEMALE","18 Years",{"count":44,"type":45},300,"ESTIMATED","INTERVENTIONAL",[48],"NA","Verify the safety and effectiveness of the cerclage pessary in the prevention and treatment of high-risk preterm pregnancy.",[51],"High Risk Pregnancy","NOT_YET_RECRUITING","2023-11-14",{"date":55,"type":56},"2023-11-18","ACTUAL",{"date":58,"type":45},"2024-12-01",{"date":60,"type":45},"2026-12-01",{"name":5,"class":6}]