[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chorioamnionitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chorioamnionitis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,79,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100609203","il-6-and-lactates-in-cord-blood-and-neonatal-outcomes-100609203",false,"NCT07211503","IL-6 and Lactates in Cord Blood and Neonatal Outcomes","Evaluating Correlation Ccrd Blood IL 6 and Neonatal Outcome and CTG Inflammatory Pattern","ECCO-IL6","Inclusion Criteria:\n\nSOFI case group:\n\n* Women with gestational age \\>37 weeks who access the delivery room of the Obstetrics and Obstetric Pathology Unit for labor.\n* Single fetus in cephalic presentation\n* Age ≥18 years\n* Presence of CTG characteristics associated with fetal inflammation\u002Finfection (fetal heart rate (fetal heart rate (FHR) \\>150 bpm with gestational age \\>40 weeks or a 10% increase in FHR, absence of cycling, fetal tachycardia \\>=160 bpm, variability \\\u003C5 bpm)\n* Signed informed consent form by the patient.\n\nNEFI control group:\n\n* Women with gestation \\>37 weeks who access the delivery room of the Obstetrics and Obstetric Pathology Unit for labor.\n* Single fetus in cephalic presentation.\n* Age ≥18 years.\n* Patients with a CTG tracing that does not show features associated with fetal inflammation\u002Finfection (fetal heart rate (FHR) between 110-150 bpm, normal cycling, and normal variability between 5 and 25 bpm).\n* Patient signed informed consent form.\n\nExclusion Criteria:\n\n* Failure to sign informed consent\n* Intrauterine fetal death\n* Congenital fetal and\u002For chromosomal abnormalities\n* Maternal cardiac abnormalities and\u002For cardiac therapy and\u002For therapy with a direct effect on maternal heart rate (e.g., labetalol, digoxin)\n* Twin or multiple pregnancy",true,"FEMALE","18 Years",{"count":21,"type":22},160,"ESTIMATED","OBSERVATIONAL","The goal of this observational study or clinical trial is to evaluate interleukin-6 (IL-6) and lactate levels in maternal and cord blood to identify early signs of fetal inflammation or infection.\n\nTwo groups of women with full-term pregnancies will be compared: • Case group (SOFI): women with a cardiotocograph (CTG) pattern suspicious for fetal infection\u002Finflammation • Control group (NEFI): women with a normal cardiotocograph (CTG) pattern without signs of inflammation. The primary outcome is to evaluate whether IL-6 levels detected in the umbilical artery, alone or in combination with maternal IL-6 values, are associated with a cardiotocograph (CTG) pattern suggestive of fetal inflammation and\u002For a clinical picture suggestive of chorioamnionitis. Identifying a possible correlation between IL-6\u002Flactate levels and fetal inflammatory status could facilitate more timely treatment of at-risk infants in the future, contributing to the reduction of adverse outcomes both in the neonatal period and in the long-term.\n\nSecondary outcome are: -Comparison of fetal and maternal IL-6 levels between infants with a composite adverse outcome; - Comparison of fetal and maternal IL-6 levels in patients with and without signs of histological chorioamnionitis.",[26,27,28,29],"Fetal Infection","Fetal Inflammatory Response Syndrome","Chorioamnionitis","Chorioamnionitis Affecting Fetus or Newborn",[31,32,33,34,35],"il6","chorioamnionitis","FIRS","lactates","labour","NOT_YET_RECRUITING","2025-09-30",{"date":39,"type":40},"2025-10-08","ACTUAL",{"date":42,"type":22},"2025-10-01",{"date":44,"type":22},"2027-04-30",{"name":46,"class":47},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":17,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100604637","amniotic-fluid--the-preterm-gut-100604637","NCT07152106","Amniotic Fluid & the Preterm Gut","The Impact of Amniotic Fluid on the Development and Microbial Colonization of the Preterm Intestinal Tract: the AMFIBIE Study","AMFIBIE","Inclusion Criteria:\n\n* Maternal age ≥16 years\n* Written informed consent\n* Successful collection of amniotic fluid\n\nExclusion Criteria:\n\n* Pregnancies complicated by fetal congenital and\u002For chromosomal abnormalities.\n* Insufficient proficiency of Dutch or English language","16 Years",{"count":59,"type":22},275,"Background:\n\nNecrotizing enterocolitis (NEC) and sepsis in preterm infants have been linked to intestinal immaturity and preclinical gut microbiota alterations. An important yet understudied contributor in the development of the gastrointestinal tract (GIT) is amniotic fluid (AF). Knowledge is lacking on the critical shifts that may occur in AF in extremely preterm birth. The aim of the current study is to assess the composition of AF using advanced biomedical techniques. Secondary objectives are to assess AF profiles of infants with chorioamnionitis (CAM) and\u002For fetal growth restriction (FGR), assess key metabolites across gestation, correlate AF profiles with neonatal outcomes, and explore associations with early gut microbiota.\n\nMethods:\n\nln this multicenter, prospective, cohort study, AF (\\~5 mL) will be collected from obstetric patients delivering their infants extremely preterm (gestational age (GA) 24+0\u002F7-27+6\u002F7 weeks, n=125), either during vaginal delivery or cesarean section (CS). Additionally, AF samples will be collected from a reference group (n=150), including early midtrimester (GA \\\u003C23+\u002F7 weeks), very early and moderate to late preterm (GA 28+0\u002F6-36+6\u002F7 weeks), and full-term pregnancies (GA 37+0\u002F7-41+6\u002F7 weeks). Thorough characterization of AF will be conducted, including microbial profiling and metabolomics. Microbiota profiling of neonatal fecal samples will be conducted to assess the association between AF and early neonatal gut colonization patterns.\n\nDiscussion and expected results:\n\nAF profiles associated with CAM and\u002For FGR in extremely preterm infants are expected to be identified, as well as relevant associations with neonatal health outcomes (including NEC and sepsis) and early neonatal gut colonization patterns. The current study will not only increase the understanding of the GIT development and the pathogenesis of NEC and sepsis but may also aid in the identification of high-risk infants. In the future, these findings may facilitate early targeted microbiota-based interventions to prevent disease progression and ultimately improve clinical outcomes.",[28,29,62,63,64,65,66,67],"Necrotizing Enterocolitis of Newborn","Neonatal Sepsis, Early-Onset","Neonatal Sepsis, Late-Onset","Fetal Growth Restriction (FGR)","Preterm Birth Complication","Prematurity Complications","RECRUITING","2025-08-28",{"date":71,"type":40},"2025-09-03",{"date":73,"type":40},"2024-10-14",{"date":75,"type":22},"2027-10-14",{"name":77,"class":47},"Maxima Medical Center",2,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":48},"100581340","comparing-infectious-morbidity-among-women-with-meconium-stained-amniotic-fluid-at-term-between-those-treated-with-prophylactic-antibiotics-zinacef-vs-placebo-100581340","NCT06849037","Comparing Infectious Morbidity Among Women With Meconium-stained Amniotic Fluid at Term, Between Those Treated With Prophylactic Antibiotics Zinacef vs. Placebo","and Infectious Morbidity Among Women With Meconium-stained Amniotic Fluid at Term, Between Those Who Will be Treated With Prophylactic Antibiotics Zinacef vs. Placebo","Inclusion Criteria:\n\n* singleton pregnancy at term\n* meconium-stained amniotic fluid\n\nExclusion Criteria:\n\n* Intrauterine fetal death\n* GBS carriers\n* zinacef allergy\n* antibiotic treatment for other indication",{"count":87,"type":22},182,"INTERVENTIONAL",[90],"NA","Our randomized controlled double blind clinical trail aims to compare maternal and neonatal infectious morbidity between women with meconium-stained amniotic fluid treated with zinacef vs. placebo.",[93,28],"Meconium-stained Amniotic Fluid",[95,96,97,32,98],"meconium-stained amniotic fluid","antibiotic treatment","infectious morbidity","zinacef","2025-07-16",{"date":101,"type":40},"2025-07-20",{"date":103,"type":40},"2025-02-18",{"date":105,"type":22},"2029-02-13",{"name":107,"class":108},"Western Galilee Hospital-Nahariya","OTHER_GOV",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":88,"phases":119,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":48},"100589163","phase-4-antipyretic-treatment-for-intrapartum-fever-dipyrone-vs-acetaminophen-rct-100589163","NCT06950840","Antipyretic Treatment for Intrapartum Fever: Dipyrone vs Acetaminophen (RCT)","Intravenous Dipyrone Compared With Intravenous Acetaminophen for Maternal Fever During Labor: A Randomised Controlled Trial","PARADIP","Inclusion Criteria:\n\n* Women undergoing a trial of vaginal delivery, with suspected intra-amniotic infection defined as isolated maternal fever of 39°C or greater, or an sustained oral temperature of 38-38.9°C for at least 30 minutes or with one or more of the following: maternal leukocytosis, purulent cervical drainage, or fetal tachycardia.\n\nExclusion Criteria:\n\n* Known history of adverse events for dipyrone or acetaminophen\n* Age \\\u003C18 years\n* Gestational age \\\u003C24 weeks\n* Intrauterine fetal death\n* Fever onset prior to delivery\n* Known liver disease\n* Known leukopenia\n* In addition, those who will develop allergic event or any adverse event possible related to any of the antipyretics used will be excluded from the",{"count":118,"type":22},140,[120],"PHASE4","Chorioamnionitis, or intraamniotic infection, is a common condition affecting 2-5% of all term births. This condition poses well-recognized maternal and neonatal risks, and entails a series of clinical management decisions concerning both the mother and neonate. Therefore, timely detection and treatment of chorioamnionitis is of paramount importance. The occurrence of chorioamnionitis is associated with a higher risk of labor abnormalities, which increase the risk of cesarean delivery (CD) 3 to 4 fold.\n\nAs recommended by current guidelines, treatment of suspected intraamniotic infection should include broad-spectrum antibiotics. In addition, the use of antipyretics is advocated. This is particularly important during the intrapartum period since fetal acidosis in the setting of fever has been associated with a marked increase in the incidence of neonatal encephalopathy. Maternal fever even in the absence of documented fetal acidosis is associated with adverse neonatal outcomes, particularly neonatal encephalopathy, though it is unclear to what extent the etiology of the fever rather than the fever itself is causative . Furthermore, treating intrapartum fever with antipyretics may also be helpful in reducing fetal tachycardia thereby avoiding the tendency to perform cesarean for a non-reassuring fetal status. Nevertheless, it remains understudied which is the most appropriate antipyretic agent in this regard, where both dipyrone and acetaminophen are safe alternatives . Antipyretic agent with a faster onset of action may be preferable in this setting.",[123,28],"Intrapartum Fever",[125,35,126,127,128],"maternal fever","acetaminophen","dipyrone","metamizole","2025-06-30",{"date":131,"type":40},"2025-07-03",{"date":133,"type":22},"2025-08-01",{"date":135,"type":22},"2027-05",{"name":137,"class":108},"Wolfson Medical Center"]