[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"labor-and-delivery-complication\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:labor-and-delivery-complication":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100562588","phase-3-azithromycin-prophylaxis-for-prelabor-cesarean-delivery-trial-100562588",false,"NCT06605118","Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial","Azithromycin Prophylaxis for Prelabor Cesarean Delivery Trial","PRECEDE","Inclusion Criteria:\n\n* ≥ 23 weeks' gestation (ACOG dating criteria)\n* Scheduled or prelabor cesarean delivery\n* Singleton or twin gestation\n\nExclusion Criteria:\n\n* Allergy or contraindication to azithromycin or macrolide antibiotics, including those with a history of cholestatic jaundice\u002Fhepatic dysfunction associated with prior use of azithromycin\n* Chorioamnionitis\n* Bacterial infection (e.g., pyelonephritis) requiring ongoing antibiotic treatment after delivery\n* Premature rupture of membranes (PROM) or labor (i.e., contractions with ongoing cervical change)\n* Fetal demise or known major congenital anomaly\n* Azithromycin treatment within 7 days\n* Planned use of antimicrobial prophylaxis after delivery for any reason\n* Known structural heart disease or active cardiomyopathy (current ejection fraction\\\u003C40%)\n* Known arrhythmia with QT prolongation or taking scheduled medications known to prolong the QT interval such that it would preclude the use of azithromycin\n* Refusal or unable to obtain consent (e.g., language barrier)\n* Participating in another intervention study that influences the primary outcome in this study\n* Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded.",true,"FEMALE",{"count":20,"type":21},8000,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive standard of care preoperative antibiotics (excluding azithromycin). The primary endpoint is a maternal infection composite defined as any one of the following up to 6 weeks postpartum: endometritis, wound infection, abscess, septic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection.",[27,28,29],"Obstetrical Complications","Labor and Delivery Complication","Cesarean Delivery",[31,32,33,34,35],"cesarean delivery","infection","maternal morbidity","antibiotics","prevention","RECRUITING","2026-04-03",{"date":39,"type":40},"2026-04-09","ACTUAL",{"date":42,"type":40},"2024-11-06",{"date":44,"type":21},"2027-11-30",{"name":46,"class":47},"The George Washington University Biostatistics Center","OTHER",14,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100491630","maternal-oxygen-supplementation-for-intrauterine-resuscitation-100491630","NCT05681624","Maternal Oxygen Supplementation for Intrauterine Resuscitation","Maternal Oxygen Supplementation for Intrauterine Resuscitation: a Multicenter Randomized Trial","MOXY","Inclusion Criteria:\n\n* Singleton gestation\n* Gestational age\\>=37 weeks\n* Spontaneous labor or induction of labor\n* English or spanish speaking\n* Planned continuous fetal monitoring\n\nExclusion Criteria:\n\n* Preterm gestation\n* Major fetal anomaly\n* Multiple gestation\n* Category III fetal monitoring at time of admission\n* Maternal hypoxia \\\u003C95%\n* Planned or scheduled cesarean delivery Excluded from randomization if receiving nitrous oxide for analgesia at time of randomization.",{"count":58,"type":21},2124,[60],"NA","More than 80% of the 3 million women who labor and deliver each year in the United States undergo continuous electronic fetal monitoring (EFM) during labor in order to fetal hypoxia and prevent the transition to acidemia, expedited operative delivery, and\u002For neonatal morbidity. Category II EFM is the most commonly observed group of fetal heart rate features in labor. One common response to Category II EFM is maternal oxygen (O2) supplementation. The theoretic rationale for O2 administration is that it increases O2 transfer to a hypoxic fetus. There are conflicting national guidelines regarding O2 administration - the American College of Obstetricians and Gynecologists suggest O2 is ineffective, whereas the Association of Women's Health, Obstetric, and Neonatal Nurses recommend continued use given lack of definitive data on safety and efficacy. A recent national survey of nearly 600 Labor \\& Delivery providers in February 2022 revealed that 49% still use O2 . Thus, there remains equipoise on the topic and high-quality data on the safety of intrapartum O2 is needed. None of the trials to date have studied the effect of intrapartum O2 on important clinical measures of neonatal or maternal morbidity. This safety data is imperative because the field of obstetrics must hold supplemental O2 to the same rigorous standards applied to any drug used in pregnancy. Without data on these definitive outcomes, it will be challenging to implement evidence-based recommendations for supplemental O2 use on Labor \\& Delivery. The investigators will conduct a large, multicenter, randomized noninferiority trial of O2 supplementation versus room air in patients with Category II EFM in labor.",[63,64,28],"Fetal Distress","Fetal Hypoxia","2026-02-25",{"date":67,"type":40},"2026-02-27",{"date":69,"type":40},"2023-05-22",{"date":71,"type":21},"2028-12-31",{"name":73,"class":47},"Washington University School of Medicine",1]