[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484307":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":19,"centralContacts":27,"locations":36,"responsibleParty":52,"collaborators":54,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":7,"enrollmentInfo":67,"targetDuration":7,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":39,"whyStopped":7,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",null,[9,13,16],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"BIOLOGICAL","Collection of vaginal secretions","In all women included: Vaginal secretion sampling at the time of the obstetrical emergency consultation.",{"type":10,"name":14,"description":15,"armGroupLabels":7,"otherNames":7},"Collection of the placenta and the membranes","In cohort 1, for 30 patients at the Port Royal Maternity Hospital, the placenta and membranes will be collected after delivery",{"type":6,"name":17,"description":18,"armGroupLabels":7,"otherNames":7},"Administration of EPDS questionnaire","In cohort 3, the EPDS questionnaire will be administered to all participants after the consultation in the emergency department.",[20,24],{"name":21,"affiliation":22,"role":23},"Jeanne SIBIUDE, MD, PhD","APHP","PRINCIPAL_INVESTIGATOR",{"name":25,"affiliation":22,"role":26},"François GOFFINET, Pr","STUDY_CHAIR",[28,32],{"name":21,"role":29,"phone":30,"phoneExt":7,"email":31},"CONTACT","+33 1 47 60 66 11","jeanne.sibiude@aphp.fr",{"name":33,"role":29,"phone":34,"phoneExt":7,"email":35},"Karima MESBAHI IHADJADENE, Project Manager","33 1 58 41 12 11","karima.mesbahi@aphp.fr",[37],{"facility":38,"status":39,"city":40,"state":7,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Louis Mourier Hospital","RECRUITING","Colombes","92700","France","FR",{"type":45,"coordinates":46},"Point",[47,48],2.25404,48.91882,{"lat":48,"lon":47},[51],{"name":21,"role":29,"phone":30,"phoneExt":7,"email":31},{"type":53,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[55],{"name":56,"class":6},"URC-CIC Paris Descartes Necker Cochin","100484307","development-and-clinical-evaluation-of-an-innovative-medical-device-to-predict-preterm-birth-predimap-100484307",false,"NCT05586334","Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth (PrediMAP)","Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth: From Basic Research to Obstetric Emergencies","PrediMAP","Inclusion Criteria:\n\n* Pregnant with live fetus(es)\n* Emergency room visit between 22 and 34 days of pregnancy + 6 days\n* For a suspicion of PTL defined by :\n\n  * Uterine contractions (UC) objectified during the consultation (questioning, clinical examination, external tocography),\n  * And\u002For clinical or ultrasound changes of the uterine cervix;\n* OR for any other reason but with EC and\u002For clinical or ultrasound changes of the cervix on clinical examination\n* Social security coverage or AME: patients receiving AME are at higher risk of PAD and preterm delivery.\n* Signature of consent\n\nExclusion Criteria\n\n* Age \\\u003C 18 years;\n* Premature rupture of membranes\n* Patient in labor with imminent delivery.\n* Total absence of social care\n* Minor or protected adult (guardianship or curatorship)\n* Persons who do not speak French and not accompanied by a French-speaking third party\n* Multiple pregnancy \\>= 3","FEMALE","18 Years",{"count":68,"type":69},3600,"ESTIMATED","INTERVENTIONAL",[72],"NA","The purpose of this study is to clinically validate the predictive performance (sensitivity and specificity) of the PrediMAP in-vitro diagnostic medical device to predict delivery within 7 days in the target population of women consulting obstetric emergencies for preterm labor (PTL).",[75],"Preterm Labor",[77,78,79,80,81],"obstetrics","medical device","preterm labor","preterm birth","prediction","2025-11-17",{"date":84,"type":85},"2025-11-20","ACTUAL",{"date":87,"type":85},"2023-06-08",{"date":89,"type":69},"2027-12",{"name":5,"class":6},1]