[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616431":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":49,"collaborators":11,"id":53,"slug":11,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":11,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":11,"enrollmentInfo":61,"targetDuration":11,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University of Roma La Sapienza","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment: Magnesium-PEA-HMW Hyaluronic Acid-Vitamin B6-Vitamin D + Vaginal Progesterone","EXPERIMENTAL",null,[13],"Drug: Magnesium-PEA-HMW Hyaluronic Acid-Vitamin B6-Vitamin D + Vaginal Progesterone",{"label":15,"type":16,"description":11,"interventionNames":17},"Control: Vaginal Progesterone Only","ACTIVE_COMPARATOR",[18],"Other: Standard Treatment (Guideline-Based)",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Magnesium-PEA-HMW Hyaluronic Acid-Vitamin B6-Vitamin D + Vaginal Progesterone","Participants randomized to the treatment arm will receive a combination oral supplement containing Magnesium (450 mg), Palmitoylethanolamide (200 mg), high-molecular-weight Hyaluronic Acid (200 mg), Vitamin B6 (2.6 mg), and Vitamin D (50 µg \u002F 2000 IU), administered as two tablets per day. The supplement will be given in addition to standard vaginal progesterone (200 mg once daily). Treatment begins at enrollment (20-34 weeks' gestation) and continues until 37 weeks of gestati",[9],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Standard Treatment (Guideline-Based)","Participants randomized to the control arm will receive standard therapy consisting of vaginal progesterone (200 mg once daily) from enrollment (20-34 weeks' gestation) until 37 weeks of gestation. No additional supplements or investigational products will be administered.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Giuseppe RIZZO, Professor","CONTACT","+393386973001","giuseppe.rizzo@uniroma1.it",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":11},"Policlinico Umberto I","RECRUITING","Rome","RM","00161","Italy",{"type":44,"coordinates":45},"Point",[46,47],12.51133,41.89193,{"lat":47,"lon":46},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Giuseppe Rizzo","Prof. Giuseppe Rizzo","100616431",false,"NCT07305519","The Combined Effect of Magnesium, Palmitoylethanolamide, High-Molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in Preventing Preterm Birth:","The Combined Effect of Magnesium, Palmitoylethanolamide, High-Molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in Preventing Preterm Birth: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Signed informed consent\n\nSingleton pregnancy\n\nMaternal age ≥ 18 years\n\nGestational age between 20+0 and 34+0 weeks at enrollment\n\nCervical length between 15 mm and 30 mm measured by transvaginal ultrasound\n\nExclusion Criteria:\n\n* Fetal structural anomalies\n\nMaternal chronic diseases or pregnancy-related conditions, including diabetes, hypertension, preeclampsia, cardiovascular disease, infections, or autoimmune disorders\n\nMultiple gestation\n\nFetal growth abnormalities (estimated fetal weight \\\u003C10th or \\>90th percentile)\n\nPrelabor rupture of membranes (PROM)","FEMALE","18 Years",{"count":62,"type":63},150,"ESTIMATED","INTERVENTIONAL",[66],"NA","The aim of the study is to assess the effect of a combination of Magnesium, Palmitoylethanolamide, high-molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in women at risk of preterm birth (PTB).",[69],"Preterm Labor",[71,72,73,74,75,76,77],"preterm labor","preterm birth","prematurity","magnesium","hyaluronic acid","vitamin B6","Vitamin D","2026-04-28",{"date":80,"type":81},"2026-04-29","ACTUAL",{"date":83,"type":81},"2026-04-01",{"date":85,"type":63},"2028-01-01",{"name":5,"class":6},1]