[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Central and Eastern European Gynecologic Oncology Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100601206","phase-3-tailored-therapeutic-regime-in-patients-with-preterm-premature-rupture-of-membranes-to-prolong-pregnancy-improve-maternal-and-neonatal-outcomes-and-reduce-antibiotic-burden-100601206",false,"NCT07107477","TAILORED Therapeutic Regime in Patients With Preterm Premature Rupture Of Membranes to Prolong Pregnancy, Improve Maternal and Neonatal Outcomes, and Reduce Antibiotic Burden","Prospective Randomized Controlled Trial to Evaluate if Tailored Antibiotic and Steroid Therapy Based on the Interleukin-6 (IL-6) Value in Amniotic Fluid Obtained by Amniocentesis in Patients With Premature Rupture of Membranes is Associated With Pregnancy Prolongation Compared to Standard Management.","TAILORED-PROM","Inclusion Criteria:\n\n* pPPROM Confirmed by Amnisure test1 and\u002For clinical signs of pPROM on examination (Clinical signs of pPROM: presence of visual pooling of amniotic fluid during sterile speculum examination)\n* Weeks of pregnancy 22+03 - 33+64\n* Singleton pregnancy\n* Signed informed consent form (ICF)\n* Completely uncomplicated pregnancy until the occurrence of pPROM\n\nExclusion Criteria:\n\n* active labour (uterine activity leading to cervical dilatation greater than 4 cm)\n* Obstetrical reason for immediate delivery such as heavy vaginal bleeding, prolapsed cord, or foetal distress\n* Multiple pregnancy\n* Pregnancy with chromosomal or severe morphological abnormality\n* Signs of chorioamnionitis at the admission (clinical and\u002For laboratory)\n* Patients with severe immunological compromise (immunodeficient)\n* Patients with an oncological disease\u002Fimmunosuppression\n* Patients with an active drug abuse\n* Non-compliant patients\n* Any contraindication according to the valid SmPC for the administered product","FEMALE","18 Years",{"count":20,"type":21},138,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this clinical trial is to learn whether tailoring antibiotic and steroid treatment based on a lab result (interleukin-6, or IL-6) from amniotic fluid can help safely prolong pregnancy in people with preterm premature rupture of membranes (pPROM). This condition means the water breaks too early, before 37 weeks of pregnancy, which increases the risk of infection and early birth.\n\nThe main questions the study aims to answer are:\n\n1. Can using IL-6 levels to guide treatment help the pregnancy last more than 7 days after pPROM?\n2. Can this approach improve health outcomes for both the parent and the baby?\n\nResearchers will compare two groups:\n\n1. A tailored treatment group, where IL-6 levels from amniotic fluid help decide when to give steroids and antibiotics.\n2. A standard care group, where everyone receives the same treatment right after diagnosis.\n\nParticipants will:\n\n* Be screened to confirm pPROM and eligibility.\n* Be randomly assigned to one of the two groups.\n* Receive regular check-ups and monitoring in the hospital until delivery.\n* In the tailored group, have weekly amniocentesis (a safe procedure to collect amniotic fluid) if needed.\n\nThe study includes follow-up for 6 months after birth to track both the baby's and parent's health.\n\nThis research may help doctors better time treatments, reduce unnecessary use of medications, and improve outcomes for families facing pPROM.",[27],"Preterm Premature Rupture of Membranes (PPROM)","RECRUITING","2026-06-16",{"date":31,"type":32},"2026-06-18","ACTUAL",{"date":34,"type":32},"2025-05-01",{"date":36,"type":21},"2028-05-01",{"name":38,"class":39},"The Central and Eastern European Gynecologic Oncology Group","OTHER",3,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100438466","phase-3-intermediate-risk-cervical-cancer-radical-surgery---adjuvant-radiotherapy-100438466","NCT04989647","Intermediate Risk Cervical Cancer: Radical Surgery +\u002F- Adjuvant Radiotherapy","An International Randomised Trial of Radical Surgery Followed by Adjuvant (Chemo)Radiation Versus no Further Treatment in Patients With Early-stage, Intermediate-risk Cervical Cancer Patients","CERVANTES","Inclusion Criteria:\n\n* Pathologically confirmed invasive cervical cancer\n* FIGO IB1-IIA\n* Squamous cell cancer or HPV-related adenocarcinoma\n* Presence of tumour-related risk factors as follows:\n\n  1. tumour ≥4 cm OR\n  2. tumour\\>2 cm \\\u003C4 cm AND lymphovascular space invasion OR\n  3. tumour \\>2 cm \\\u003C4 cm AND tumour free distance \\\u003C3 mm OR\n  4. tumour \\>2 cm \\\u003C4 cm AND deep stromal invasion (\\>2\u002F3)\n* No evidence of suspicious pelvic lymph nodes or distant metastases on imaging (by radiological subjective assessment before surgery and negative pelvic LN on final pathology)\n* ECOG performance status 0-1\n* Deemed suitable and fit for radical surgery followed by adjuvant radiotherapy\n* Negative pregnancy test (if applicable)\n* Negative HIV test (only performed in high-risk countries or patients who have moved from those countries within the past 10 years)\n\nExclusion Criteria:\n\n* Adenosquamous cancer or adenocarcinoma unusual type (non-HPV related - such as: mucinous, clear cell, mesonephric) or other rare tumour types (those not listed in the inclusion criteria)\n* Inconclusive primary site of disease\n* Unequivocally positive lymph node by imaging (by radiological subjective assessment)\n* FIGO \\\u003CIB1 \u002F \\>IIA\n* Previous pelvic malignancy\n* History of second primary cancer outside pelvis if ≤ 3 years complete clinical remission (CCR)\n* Previous pelvic radiotherapy\n* Neoadjuvant chemotherapy prior surgical treatment\n* Low likelihood of patient compliance to the follow-up","85 Years",{"count":51,"type":21},514,[24],"The objective of the trial is to evaluate if adjuvant (chemo)radiation is associated with a disease-free survival benefit after radical surgery in patients with intermediate risk cervical cancer. The primary endpoint of the study is the disease-free survival from the day of randomisation. A total of 514 patients are required to achieve 80% power on 5% significance level with non-inferiority margin of 5% to test the difference between the ARMs using Cox proportional hazards model. The maximal tolerated margin for non-inferiority in 2-year DFS is 5% (including expected drop-out rate of 10%).",[55],"Cervical Cancer",[57,58,59],"intermediate risk cervical cancer","adjuvant radiotherapy","disease free survival","2023-09-05",{"date":62,"type":32},"2023-09-07",{"date":64,"type":32},"2022-06-10",{"date":66,"type":21},"2032-12",{"name":38,"class":39},1,""]