[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499952":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":105,"collaborators":25,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":25,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"University Hospital, Montpellier","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: Hysteroscopy","EXPERIMENTAL","Patients randomized to the hysteroscopy arm will receive misoprostol antibiotic prophylaxis to dilate the cervix before surgery, and anti-adhesion barrier gels will be used, according to routine procedures at each center. In case of intrauterine retention complicated by endometritis, antibiotic treatment for 48 hours (penicillin, metronidazole, fluoroquinolones or a combination of these antibiotics) will be administered according to the standard practice of each center. Evacuated retention product will be sent for pathological examination. Rh-negative women will receive prophylaxis to prevent Rh alloimmunization.",[13],"Procedure: hysteroscopy",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B: Aspiration","Patients randomized to the aspiration arm will receive misoprostol antibiotic prophylaxis to dilate the cervix before surgery and anti-adhesion barrier gels will be used, according to routine procedures at each center. In case of intrauterine retention complicated by endometritis, antibiotic treatment for 48 hours (penicillin, metronidazole, fluoroquinolones or a combination of these antibiotics) will be administered according to the standard practice of each center. Evacuated retention product will be sent for pathological examination. Rh-negative women will receive prophylaxis to prevent Rh alloimmunization.",[18],"Procedure: Aspiration",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","hysteroscopy","The procedure is performed by a gynecologic surgeon under general or spinal anesthesia, depending on the standard practice of the center involved, with the patient in the gynecologic position. Antibiotic prophylaxis may be administered according to the standard practice of the center. The equipment available at each center will be used for operative hysteroscopy. The use of energy is usually unnecessary and saline will be preferred. Before the operation, the appearance of the uterine cavity will be described. The selected design product will be resected from top to bottom using the surgical resector, without electrical energy, as this method is known to be the most protective of the endometrium in previous studies. Electric current should be used only as a last resort, in cases where the selected design cannot be removed without it. If there is active bleeding after the procedure, elective coagulation via the hysteroscope may be performed to stop intrauterine bleeding.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Aspiration","The aspiration will be performed by a gynecological surgeon, according to the center's standard protocol. A flexible or rigid cannula can be used. Antibiotic prophylaxis, the diameter of the cannula used, the cervical preparation required, and the use of intraoperative ultrasound guidance will be left to the discretion of the operator and the standard practice of the center. In most centers, the cervix is dilated with a Hegar dilator of up to 9 mm in size.",[15],[31],{"name":32,"affiliation":33,"role":34},"Martha DURAES, MD","CHU de Montpellier","STUDY_DIRECTOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+334 67 33 65 32","m-duraes@chu-montpellier.fr",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"Elodie GUIBERT, CRA","+334 67 33 53 17","elodie.guibert@chu-montpellier.fr",[45,64,77,91],{"facility":46,"status":47,"city":48,"state":25,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"CHU de Bordeaux - Hôpital Pellegrin","RECRUITING","Bordeaux","33000","France","FR",{"type":53,"coordinates":54},"Point",[55,56],-0.58046,44.84124,{"lat":56,"lon":55},[59,62],{"name":60,"role":37,"phone":25,"phoneExt":25,"email":61},"Loïc SENTILHES, MD PhD","loic.sentilhes@chu-bordeaux.fr",{"name":60,"role":63,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":65,"status":47,"city":66,"state":25,"zip":67,"country":50,"countryCode":51,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"CHU de Montpellier - Hôpital Arnaud de Villeneuve","Montpellier","34295",{"type":53,"coordinates":69},[70,71],3.87635,43.61093,{"lat":71,"lon":70},[74,75,76],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},{"name":32,"role":63,"phone":25,"phoneExt":25,"email":25},{"facility":78,"status":47,"city":79,"state":25,"zip":80,"country":50,"countryCode":51,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"CHU de Nice - Hôpital Archet II","Nice","06202",{"type":53,"coordinates":82},[83,84],7.26608,43.70313,{"lat":84,"lon":83},[87,90],{"name":88,"role":37,"phone":25,"phoneExt":25,"email":89},"Jérôme DELOTTE, MD PhD","delotte.j@chu-nice.fr",{"name":88,"role":63,"phone":25,"phoneExt":25,"email":25},{"facility":92,"status":47,"city":93,"state":25,"zip":94,"country":50,"countryCode":51,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"CHU de Nîmes - Hôpital Carémeau","Nîmes","30029",{"type":53,"coordinates":96},[97,98],4.35788,43.83665,{"lat":98,"lon":97},[101,104],{"name":102,"role":37,"phone":25,"phoneExt":25,"email":103},"Renaud DE TAYRAC, MD PhD","renaud.detayrac@chu-nimes.fr",{"name":102,"role":63,"phone":25,"phoneExt":25,"email":25},{"type":106,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100499952","hysteroscopy-vs-endouterine-aspiration-in-the-management-of-trophoblastic-retention-100499952",false,"NCT05789940","Hysteroscopy vs. Endouterine Aspiration in the Management of Trophoblastic Retention","Hysteroscopy Versus Endouterine Aspiration in the Management of Trophoblastic Retention: A Prospective Randomized Multicenter Study","HARET","Inclusion Criteria:\n\n* Management for trophoblastic retention after early spontaneous miscarriage (\\\u003C14 weeks of amenorrhea)\n* Diagnosis of intrauterine trophoblastic retention by endovaginal pelvic ultrasound\n* Shared decision for surgical management\n\nExclusion Criteria:\n\n* Known uterine malformation\n* Patient who has received surgical treatment for current intrauterine retention\n* Patient with an intrauterine device (IUD)\n* Pregnancy obtained by medically assisted procreation\n* Indication for emergency surgical management for haemostatic purposes\n* Failure to obtain free, informed and written consent after a period of reflection\n* Person not affiliated or beneficiary of a national health insurance system\n* Person protected by law, under guardianship or curatorship\n* Person participating in other interventional research involving the human person","FEMALE","18 Years","42 Years",{"count":119,"type":120},220,"ESTIMATED","INTERVENTIONAL",[123],"NA","Introduction: Incomplete early miscarriage is defined as early miscarriage with persistent intrauterine material on ultrasound. Intrauterine retention of trophoblastic debris is not an uncommon phenomenon. These retentions may initially be asymptomatic but are often responsible for persistent metrorrhagia and endometritis. This symptomatology often accentuates the psychological distress of patients mourning the pregnancy. Incomplete miscarriages are mainly managed by the gynecological emergency department. The recommendations of the Collège National des Gynécologues et Obstétriciens Français (CNGOF) suggest as a first line of treatment: either surgical management or expectant care. The choice between the two is left to the discretion of the doctor and the patient. there are no clear recommendations as to the choice between hysteroscopy and aspiration. Within the teams, the choice is often made according to the habits and protocols of the service, according to the equipment available and the skills of the gynaecologists.\n\nAim: The main objective is to compare the efficacy of management by endo-uterine aspiration vs. management by hysteroscopy of trophoblastic retention after early miscarriage, at 6 weeks after surgery, by endovaginal ultrasound.\n\nMethods: This is a prospective, multicenter, randomized, open-label, two-arms, parallel therapeutic clinical trial comparing hysteroscopy versus endouterine aspiration for the management of trophoblastic retention after spontaneous miscarriage.\n\nPatients will be randomized (110 per arm) after verification of eligibility criteria and signature of consent, on the day of the operation:\n\n* Arm A: 110 patients treated by operative hysteroscopy\n* Arm B: 110 patients treated by endo-uterine aspiration",[126],"Miscarriage",[126,128,27,129,130],"Hysteroscopy","Fertility","Synechiae","2026-06-17",{"date":133,"type":134},"2026-06-22","ACTUAL",{"date":136,"type":134},"2023-09-18",{"date":138,"type":120},"2029-09-18",{"name":5,"class":6},4]