[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601206":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":36,"centralContacts":49,"locations":59,"responsibleParty":99,"collaborators":104,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":110,"sex":116,"minAge":117,"maxAge":36,"enrollmentInfo":118,"targetDuration":36,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":36,"overallStatus":62,"whyStopped":36,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"The Central and Eastern European Gynecologic Oncology Group","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"ARM A: TAilored management","EXPERIMENTAL","No steroids at admission Antibiotics - GBS prophylaxis + macrolides always at admission till results of amniotic fluid IL-6 Amniocentesis (Within 24 hours of admission to the hospital)\n\n* Based on the amniotic fluid IL-6 results:\n* IL-6 ˂ 2600 - discontinuing GBS prophylaxis + macrolides, no steroids.\n* IL-6 ≥ 2600 - Steroids and initial broad spectrum ABX, adjustment according to cultures and PCR",[13,14,15,16],"Procedure: Tailored antibiotic and steroid therapy based on the IL-6 value in amniotic fluid obtained by amniocentesis in patients with premature rupture of membranes","Drug: Antenatal steroids administration","Drug: Neuroprotection","Drug: antibiotic prophylaxis",{"label":18,"type":19,"description":20,"interventionNames":21},"ARM B: standard care","ACTIVE_COMPARATOR","Antenatal steroids - always at admission Antibiotics - GBS prophylaxis + macrolides, lasting for 7-10days, then discontinued.",[14,15,16,22],"Drug: Antibiotics administration",[24,31,37,41,45],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"PROCEDURE","Tailored antibiotic and steroid therapy based on the IL-6 value in amniotic fluid obtained by amniocentesis in patients with premature rupture of membranes","In Arm A, Amniocentesis will be performed once a week until delivery, with a maximum of seven procedures per patient. If the pregnancy continues beyond this period, follow-up will proceed without further amniocentesis.\n\n* If IL-6 ≥ 2600:\n* steroids and initial broad spectrum ABX will be administered,\n* rotation of ABX according to cultures and PCR.\n* If steroids already administered, a second course can be administered prior to 34+0 if at least 7 days have passed after the previous course.",[9],[30],"amniocentesis",{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Antenatal steroids administration","1. Clinical and\u002For laboratory signs of chorioamnionitis will result in an intervention consisting of the course of antenatal steroids (if not already administered, or as a single course prior 34+0 if at least 7 days have passed after the previous course), initial broad spectrum antibiotics, or delivery, depending on the week of pregnancy and clinical status.\n2. Uterine activity with progression of vaginal finding will result in course of antenatal steroids (if not already administered, or as a single course prior 34+0 if at least 7 days have passed after the previous course) and tocolysis",[9,18],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Neuroprotection","In patients with imminent preterm birth prior 32+0 week of pregnancy, foetal neuroprotection will be administered consisting of MgSO4 in an intravenous loading dose of 4 g (administered slowly over 20-30 min), followed by a 1 g per hour maintenance dose. This regimen should continue until birth but should be stopped after 24 h if undelivered.",[9,18],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"antibiotic prophylaxis","Antibiotics - Group B Streptococcus (GBS) prophylaxis + macrolides, always at admission.",[9,18],{"type":32,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"Antibiotics administration","1. GBS prophylaxis + macrolides: Penicillin G (benzylpenicillin) 5mil IU IV initially and then 2-3 IU (dose adjusted to body weight) IV every 4h twice, then every 6h + Clarithromycin 500mg po every 12h for 7-10 days or till delivery.\n2. Initial broad spectrum ABX: Ampicillin\u002Fsulbactam 3g IV every 6 hours + Gentamicin 5 mg\u002Fkg IV (\\\u003C60 kg 240 mg, 61-80 kg 320 mg, \\>80 kg 400 mg) every 24h for 5-7 days according to the clinical state.\n\nComments:\n\nAlternative ABX in patients with allergy to PCN\u002FAMP: Vancomycin 1g IV every 12 h or Clindamycin 600-900g IV every 8h taking antibiotic sensitivity into account.\n\nBefore administering the third dose of gentamicin, its serum level should be determined (at a level \\>4 umol\u002Fl, the dose must be reduced).",[18],[50,55],{"name":51,"role":52,"phone":53,"phoneExt":36,"email":54},"Katerina Mackova, MD, PhD, PhD","CONTACT","+420733253563","katerina.mackova@vfn.cz",{"name":56,"role":52,"phone":57,"phoneExt":36,"email":58},"Martina Boricnova, PhD","+420736122654","martina.borcinova@vfn.cz",[60,76,89],{"facility":61,"status":62,"city":63,"state":36,"zip":36,"country":64,"countryCode":36,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"University Hospital Brno","RECRUITING","Brno","Czechia",{"type":66,"coordinates":67},"Point",[68,69],16.60796,49.19522,{"lat":69,"lon":68},[72],{"name":73,"role":52,"phone":74,"phoneExt":36,"email":75},"Lukas Hruban, Ass. Prof.","+420532233961","Hruban.Lukas@fnbrno.cz",{"facility":77,"status":62,"city":78,"state":36,"zip":79,"country":64,"countryCode":36,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"General University Hospital in Prague","Prague","128 08",{"type":66,"coordinates":81},[82,83],14.42076,50.08804,{"lat":83,"lon":82},[86],{"name":87,"role":52,"phone":88,"phoneExt":36,"email":58},"Martina Borčinová","736122654",{"facility":90,"status":62,"city":78,"state":36,"zip":36,"country":64,"countryCode":36,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"Institute for Mother and Child Care in Prague - Podolí",{"type":66,"coordinates":92},[82,83],{"lat":83,"lon":82},[95],{"name":96,"role":52,"phone":97,"phoneExt":36,"email":98},"Hynek Heřman, MD, Ph.D., LL.M., MHA","+420296511111","info@upmd.eu",{"type":100,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":103,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","David Cibula","Prof. Dr.","General University Hospital, Prague",[105,107],{"name":106,"class":6},"Brno University Hospital",{"name":103,"class":6},"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":119,"type":120},138,"ESTIMATED","INTERVENTIONAL",[123],"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.",[126],"Preterm Premature Rupture of Membranes (PPROM)","2026-06-16",{"date":129,"type":130},"2026-06-18","ACTUAL",{"date":132,"type":130},"2025-05-01",{"date":134,"type":120},"2028-05-01",{"name":5,"class":6},3]