[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585775":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":35,"centralContacts":40,"locations":29,"responsibleParty":49,"collaborators":29,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":29,"maxAge":29,"enrollmentInfo":60,"targetDuration":29,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":73,"whyStopped":29,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":29},{"fullName":5,"class":6},"University of Melbourne","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Erythromycin 250mg + placebo","ACTIVE_COMPARATOR","Erythromycin 250mg, four times a day, for 7 days. Oral preparation only.\n\nPlacebo tablets instead of penicillin for blinding purposes.",[13],"Drug: Erythromycin 250mg + placebo",{"label":15,"type":10,"description":16,"interventionNames":17},"Azithromycin 500mg + placebo","Azithromycin 500mg daily for 7 days. Oral preparation only.\n\nPlacebo tablets instead of penicillin for blinding purposes.",[18],"Drug: Azithromycin 500mg + placebo",{"label":20,"type":10,"description":21,"interventionNames":22},"Erythromycin 250mg and Amoxicillin 500mg","Erythromycin 250mg, four times a day AND Amoxicillin 500mg three times a day, for 7 days. Oral preparations only.",[23],"Drug: Erythromycin 250mg and Amoxicillin 500mg",[25,30,32],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Antibiotic.",[9],null,{"type":26,"name":15,"description":27,"armGroupLabels":31,"otherNames":29},[15],{"type":26,"name":20,"description":33,"armGroupLabels":34,"otherNames":29},"Antibiotics.",[20],[36],{"name":37,"affiliation":38,"role":39},"Clare Whitehead, MBChB, PhD","University of Melbourne and Royal Women's Hospital (Melbourne)","PRINCIPAL_INVESTIGATOR",[41,45],{"name":37,"role":42,"phone":43,"phoneExt":29,"email":44},"CONTACT","00610383452000","clarew@unimelb.edu.au",{"name":46,"role":42,"phone":47,"phoneExt":29,"email":48},"Kelly Fredell","0061432975273","info@platipustrial.org",{"type":50,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100585775","preterm-rupture-of-membranes-optimising-antibiotics-trial-100585775",false,"NCT06906757","Preterm Rupture of Membranes Optimising Antibiotics Trial","Preterm Rupture of Membranes Optimising Antibiotics Trial (PROMOAT). A Pregnancy Domain Within PLATIPUS.","PROMOAT","PLATFORM ELIGIBILITY\n\nParticipants must meet all core PLATIPUS platform inclusion criteria:\n\n* Considered to be at risk of birth before 37 weeks gestation (spontaneous and provider-initiated)\n* Receiving pregnancy care at a participating site (hospital) at the time of eligibility assessment and\n* Meet eligibility criteria for one or more platform domains.\n\nParticipants will be excluded from participation if they meet any core PLATIPUS platform exclusion criteria:\n\n* Inability to consent for themselves\n* Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening).\n\nPregnant women and people who meet ALL of the core platform inclusion criteria and none of the exclusion criteria will be considered for PROMOAT-specific eligibility.\n\nPROMOAT-SPECIFIC ELIGIBILITY\n\nPlatform-eligible participants must meet all PROMOAT-specific inclusion criteria:\n\n1. Women with singleton or multiple pregnancies complicated by preterm prelabour rupture of membranes (PPROM) \\\u003C 37+0 weeks' gestation as determined by the treating clinician and standard criteria:\n\n   * Maternal history consistent with loss of fluid per vagina\n   * Evidence of a pool of fluid in the vagina on sterile speculum examination\n   * +\u002F- positive testing for IGFBP-1 (Actim PROM) or PAMG-1 (Amnisure) AND\n2. Are eligible for at least two treatment arms within the domain\n3. The fetus\u002Ffetuses are alive at randomisation\n4. The pregnancy is continuing and active neonatal management is planned.\n\nParticipants will be excluded from participation if they meet core PLATIPUS platform exclusion criteria:\n\n* Inability to consent for themselves OR\n* Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening).\n\nParticipants will be excluded from participation if they meet any PROMOAT-specific exclusion criteria:\n\n1. Antibiotic treatment for \\> 24 hours administered with the aim of preventing infection from PPROM\n2. Suspected maternal or fetal infection (chorioamnionitis)\n3. Maternal or fetal indication for immediate birth\n4. Established preterm labour (cervical dilatation ≥ 3cm AND regular contractions)\n5. No appropriate antibiotic available within domain intervention arms due to allergy, contraindications, drug interactions, drug availability, or previous history of antibiotic-resistant infection\u002Fs\n6. Women with a previous infant affected by GBS sepsis\n7. Major congenital fetal anomaly.\n\nPlatform-eligible participants who meet all PROMOAT-specific inclusion criteria and none of the PROMOAT-specific exclusion criteria will be eligible to participate in PROMOAT.","FEMALE",{"count":61,"type":62},3900,"ESTIMATED","INTERVENTIONAL",[65],"NA","The goal of this clinical trial is to learn which antibiotic regimen works best to prevent infection in pregnant women whose waters break early (preterm, pre-labour rupture of membranes, or PPROM) and assess the health outcomes of babies born to pregnant women who have received these antibiotics.\n\nPROMOAT aims to answer the question: Which antibiotic or combined antibiotic regimen most effectively prevents infection in pregnant women with PPROM \\\u003C 37+0 weeks' gestation.\n\nResearchers will compare three antibiotic regimens already used in clinical practice to prevent infection in pregnant women with PPROM.\n\nParticipants will be randomly allocated to the antibiotic regimen they will follow for seven days, or until birth (whichever is earlier). All antibiotics will be taken orally.\n\nNeonatal health outcomes will be collected at 42 weeks postmenstrual age and maternal birth and postpartum care outcomes assessed at 42 days postpartum.\n\nQuestionnaires will capture maternal mood at time of consent and at 42 days postpartum. Antibiotic tolerance will be assessed at the time antibiotic treatment is ceased.\n\nThis trial will be undertaken as part of the PLATIPUS trial (NCT06461429).",[68,69],"PPROM","Preterm",[71,72],"Pregnancy, Preterm, PPROM, Antibiotics","chorioamnionitis","NOT_YET_RECRUITING","2025-03-31",{"date":76,"type":77},"2025-04-02","ACTUAL",{"date":79,"type":62},"2025-09",{"date":81,"type":62},"2050-12",{"name":5,"class":6}]