[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616431":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":50,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":11,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"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,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":11},"Policlinico Umberto I","RECRUITING","Rome","RM","00161","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],12.51133,41.89193,{"lat":48,"lon":47},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Giuseppe Rizzo","Prof. Giuseppe Rizzo","100616431","the-combined-effect-of-magnesium-palmitoylethanolamide-high-molecular-weight-hyaluronic-acid-vitamin-b6-and-vitamin-d-in-preventing-preterm-birth-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":64,"type":65},150,"ESTIMATED","INTERVENTIONAL",[68],"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).",[71],"Preterm Labor",[73,74,75,76,77,78,79],"preterm labor","preterm birth","prematurity","magnesium","hyaluronic acid","vitamin B6","Vitamin D","2026-04-28",{"date":82,"type":83},"2026-04-29","ACTUAL",{"date":85,"type":83},"2026-04-01",{"date":87,"type":65},"2028-01-01",{"name":5,"class":6},1]