[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514140":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":10,"centralContacts":28,"locations":37,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":70,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":78,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"First arm (primary objective):",null,"First arm (primary objective): Adnexal mass scanned at 11-14 weeks. If the decision is to manage the adnexal mass conservatively, the patient is to be re-scanned once more: 0 - 90 days postpartum. In addition, the patient will be asked to enter into the third arm of the study (see below) knowing that she can opt out from that arm at any point. If she consents to participate in the third arm, she will participate in a series of longitudinal examinations as described for the third arm.\n\nAll patients with a mass detected before 11 weeks will also be scanned at 11-14 weeks and can enter all three arms of the study. In this scenario, if more than one scan is performed during pregnancy before 11 weeks, only the first of several scans before 11 weeks will be included for the second and third arms of the study.",[13],"Diagnostic Test: Ultrasound",{"label":15,"type":10,"description":16,"interventionNames":17},"Second arm (secondary objective):","Second arm (secondary objective): Adnexal mass is seen for the first time during that pregnancy at any gestation. If the decision is to manage the adnexal mass conservatively, the patient is to be re-scanned once more: 0 - 90 days postpartum. For patients with a mass detected before 11 weeks, see also above (they will be re-scanned at both 11-14 weeks and at 0-90 days postpartum).\n\nIn addition, the patient will be asked to enter into the third arm of the study knowing that she can opt out from that arm at any point. If she consents to this, she will participate in a series of longitudinal examinations as described for the third arm.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Third arm (secondary objective):","Third arm (secondary objective): Patients from the first and second arms who agree to enrol into the third arm i.e. longitudinal examination of an adnexal mass during pregnancy. For the purposes of the longitudinal evaluation, the time points for the ultrasound examination are:\n\n* initial presenting scan if \\\u003C11 weeks;\n* 11-14 weeks;\n* 16 week scan - endometriomas ONLY;\n* second trimester routine scan (18-22 weeks);\n* 30-34 weeks;\n* any additional scans during pregnancy which resulted in either conservative management with extra scans or surgical intervention (with reason for the extra scan or for surgery documented);\n* 0-90 days postpartum.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DIAGNOSTIC_TEST","Ultrasound","A standardised transvaginal (supplemented with transabdominal if transvaginal is not sufficient) examination is performed. When a colour Doppler ultrasound examination is performed, the pulse repetition frequency should be 0.3-0.6 KHz. The colour Doppler gain should be increased until colour Doppler artefacts appear and then lowered until just below the reappearance of colour Doppler artefacts. Ultrasound frequency and \"priority\" (grey scale or colour\u002FPower Doppler) must also be optimised when using colour\u002Fpower Doppler. Doppler ultrasound should be used with all masses included, irrespective of gestational age.",[9,15,19],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Dirk Timmerman, Professor","CONTACT","+3216344201","dirk.timmerman@uzleuven.be",{"name":35,"role":31,"phone":32,"phoneExt":10,"email":36},"Wouter Froyman, Professor","wouter.froyman@uzleuven.be",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"UZ Leuven","RECRUITING","Leuven","Vlaams-Brabant","3000","Belgium","BE",{"type":47,"coordinates":48},"Point",[49,50],4.70093,50.87959,{"lat":50,"lon":49},[53],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100514140","prospective-validation-of-the-adnex-model-for-discrimination-between-benign-and-malignant-adnexal-masses-in-pregnancy-international-ovarian-tumour-analysis-in-pregnancy-study-p-iota-100514140",false,"NCT05974618","Prospective Validation of the ADNEX Model for Discrimination Between Benign and Malignant Adnexal Masses in Pregnancy: International Ovarian Tumour Analysis in Pregnancy Study (p-IOTA)","Prospective Validation of the ADNEX Model for Discrimination Between Benign and Malignant Adnexal Masses in Pregnancy: the International Ovarian Tumour Analysis in Pregnancy Study (p-IOTA).","pIOTA","Inclusion Criteria:\n\n* • Consecutive patients with non-physiological adnexal masses or physiological cysts measuring 5cm or more in largest dimension;\n\n  * In case of more than one mass seen, only most suspicious mass to be included OR in case of two similar masses, the one with the largest dimension or most easily accessible with ultrasound;\n  * Previously recruited patient presenting with a different mass in subsequent pregnancy;\n  * Age 18 years and above.\n\nExclusion Criteria:\n\n* • Cysts deemed to be clearly physiological WHEN smaller than 5 cm (largest diameter);\n\n  * Non-adnexal masses, e.g. peritoneal inclusion cysts (when diagnosis is certain) and peritoneal carcinomatosis with no adnexal mass;\n  * The denial or withdrawal of written informed consent;\n  * Same cyst already recruited for p-IOTA in a previous pregnancy.\n  * Age \\\u003C 18 years","FEMALE","18 Years","50 Years",{"count":68,"type":69},1000,"ESTIMATED","1 Year","OBSERVATIONAL","Prospective Validation of the ADNEX Model for discrimination between benign and malignant adnexal masses in pregnancy:\n\nInternational Ovarian Tumour Analysis in pregnancy study (p-IOTA)",[74,75,76,77],"Adnexal Mass","Adnexal Tumor","Adnexal Cyst","Pregnancy Related",[79,80,81,82,83,84,85],"IOTA","ovarian mass","pregnancy","ultrasound","post-partum","benign","malignant","2023-07-25",{"date":88,"type":89},"2023-08-03","ACTUAL",{"date":91,"type":89},"2023-06-05",{"date":93,"type":69},"2026-07",{"name":5,"class":6},1]